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EUROPEAN PHARMACOPOEIA 6.0 INDEX Monographs deleted from the 5 th Edition are not included in the index; a list of deleted texts is found in the Contents of Volume 1, page xxix. English index ........................................................................ 3263 Latin index ................................................................................. 3293 General Notices (1) apply to all monographs and other texts 3261

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EUROPEAN PHARMACOPOEIA 6.0

INDEXMonographs deleted from the 5th Edition are not included in the index; a list of deleted texts is found in the Contents ofVolume 1, page xxix.

English index ........................................................................ 3263 Latin index ................................................................................. 3293

General Notices (1) apply to all monographs and other texts 3261

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EUROPEAN PHARMACOPOEIA 6.0

3262 See the information section on general monographs (cover pages)

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EUROPEAN PHARMACOPOEIA 6.0 Index

Numerics1. General notices .......................................................................... 32.1.1. Droppers ..............................................................................152.1.2. Comparative table of porosity of sintered-glassfilters..............................................................................................15

2.1.3. Ultraviolet ray lamps for analytical purposes..............152.1.4. Sieves ...................................................................................162.1.5. Tubes for comparative tests ............................................172.1.6. Gas detector tubes.............................................................172.1. Apparatus ...............................................................................152.2.10. Viscosity - Rotating viscometer method .................... 282.2.11. Distillation range ............................................................ 302.2.12. Boiling point ....................................................................312.2.13. Determination of water by distillation........................312.2.14. Melting point - capillary method................................. 322.2.15. Melting point - open capillary method ...................... 322.2.16. Melting point - instantaneous method ...................... 332.2.17. Drop point ........................................................................ 332.2.18. Freezing point................................................................. 352.2.19. Amperometric titration ................................................. 352.2.1. Clarity and degree of opalescence of liquids...............212.2.20. Potentiometric titration ................................................ 352.2.21. Fluorimetry...................................................................... 362.2.22. Atomic emission spectrometry .................................... 362.2.23. Atomic absorption spectrometry ................................ 372.2.24. Absorption spectrophotometry, infrared .................. 392.2.25. Absorption spectrophotometry, ultraviolet andvisible.............................................................................................41

2.2.26. Paper chromatography ................................................. 432.2.27. Thin-layer chromatography .......................................... 432.2.28. Gas chromatography ..................................................... 452.2.29. Liquid chromatography ................................................ 462.2.2. Degree of coloration of liquids...................................... 222.2.30. Size-exclusion chromatography .................................. 472.2.31. Electrophoresis ............................................................... 482.2.32. Loss on drying ................................................................ 532.2.33. Nuclear magnetic resonance spectrometry .............. 542.2.34. Thermal analysis............................................................. 552.2.35. Osmolality ........................................................................ 572.2.36. Potentiometric determination of ionicconcentration using ion-selective electrodes....................... 58

2.2.37. X-ray fluorescence spectrometry................................. 592.2.38. Conductivity .................................................................... 592.2.39. Molecular mass distribution in dextrans .................. 602.2.3. Potentiometric determination of pH............................ 242.2.40. Near-infrared spectrophotometry ............................... 622.2.41. Circular dichroism.......................................................... 662.2.42. Density of solids ............................................................. 672.2.43. Mass spectrometry ......................................................... 682.2.44. Total organic carbon in water for pharmaceuticaluse..................................................................................................71

2.2.45. Supercritical fluid chromatography............................712.2.46. Chromatographic separation techniques.................. 722.2.47. Capillary electrophoresis .............................................. 772.2.48. Raman spectrometry ..................................................... 822.2.49. Falling ball viscometer method................................... 842.2.4. Relationship between reaction of solution,approximate pH and colour of certain indicators .............. 25

2.2.54. Isoelectric focusing........................................................ 842.2.55. Peptide mapping............................................................. 862.2.56. Amino acid analysis ....................................................... 892.2.57. Inductively coupled plasma-atomic emissionspectrometry ............................................................................... 96

2.2.58. Inductively coupled plasma-mass spectrometry ...... 982.2.5. Relative density................................................................. 252.2.6. Refractive index ................................................................ 262.2.7. Optical rotation ................................................................. 262.2.8. Viscosity.............................................................................. 272.2.9. Capillary viscometer method ......................................... 27

2.2. Physical and physicochemical methods...........................212.3.1. Identification reactions of ions and functionalgroups ........................................................................................ 103

2.3.2. Identification of fatty oils by thin-layerchromatography....................................................................... 106

2.3.3. Identification of phenothiazines by thin-layerchromatography....................................................................... 107

2.3.4. Odour ................................................................................ 1072.3. Identification....................................................................... 1032.4.10. Lead in sugars............................................................... 1152.4.11. Phosphates......................................................................1162.4.12. Potassium........................................................................1162.4.13. Sulphates ........................................................................1162.4.14. Sulphated ash ................................................................1162.4.15. Nickel in polyols ............................................................1162.4.16. Total ash..........................................................................1162.4.17. Aluminium.......................................................................1172.4.18. Free formaldehyde ........................................................1172.4.19. Alkaline impurities in fatty oils ..................................1172.4.1. Ammonium........................................................................1112.4.21. Foreign oils in fatty oils by thin-layerchromatography........................................................................117

2.4.22. Composition of fatty acids by gas chromato-graphy .........................................................................................118

2.4.23. Sterols in fatty oils ....................................................... 1202.4.24. Identification and control of residual solvents...... 1212.4.25. Ethylene oxide and dioxan......................................... 1262.4.26. N,N-Dimethylaniline .................................................... 1272.4.27. Heavy metals in herbal drugs and fatty oils ........... 1282.4.28. 2-Ethylhexanoic acid ................................................... 1292.4.29. Composition of fatty acids in oils rich in omega-3acids............................................................................................ 130

2.4.2. Arsenic ...............................................................................1112.4.30. Ethylene glycol and diethylene glycol in ethoxylatedsubstances ..................................................................................131

2.4.31. Nickel in hydrogenated vegetable oils ......................1312.4.32. Total cholesterol in oils rich in omega-3 acids ...... 1322.4.3. Calcium..............................................................................1112.4.4. Chlorides .......................................................................... 1122.4.5. Fluorides .......................................................................... 1122.4.6. Magnesium....................................................................... 1122.4.7. Magnesium and alkaline-earth metals ....................... 1122.4.8. Heavy metals ................................................................... 1122.4.9. Iron .................................................................................... 1152.4. Limit tests .............................................................................1112.5.10. Oxygen-flask method................................................... 1402.5.11. Complexometric titrations.......................................... 1402.5.12. Water : semi-micro determination..............................1412.5.13. Aluminium in adsorbed vaccines...............................1412.5.14. Calcium in adsorbed vaccines ................................... 1422.5.15. Phenol in immunosera and vaccines ....................... 1422.5.16. Protein in polysaccharide vaccines .......................... 1422.5.17. Nucleic acids in polysaccharide vaccines ................ 1422.5.18. Phosphorus in polysaccharide vaccines.................. 1422.5.19. O-Acetyl in polysaccharide vaccines......................... 1432.5.1. Acid value......................................................................... 1372.5.20. Hexosamines in polysaccharide vaccines................ 1432.5.21. Methylpentoses in polysaccharide vaccines ........... 1432.5.22. Uronic acids in polysaccharide vaccines ................. 1442.5.23. Sialic acid in polysaccharide vaccines ..................... 1442.5.24. Carbon dioxide in gases.............................................. 1442.5.25. Carbon monoxide in gases ......................................... 1452.5.26. Nitrogen monoxide and nitrogen dioxide ingases ........................................................................................... 146

2.5.27. Oxygen in gases ............................................................ 1462.5.28. Water in gases............................................................... 1462.5.29. Sulphur dioxide ............................................................ 1462.5.2. Ester value ....................................................................... 1372.5.30. Oxidising substances................................................... 147

General Notices (1) apply to all monographs and other texts 3263

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Index EUROPEAN PHARMACOPOEIA 6.0

2.5.31. Ribose in polysaccharide vaccines............................ 1472.5.32. Water : micro determination ...................................... 1472.5.33. Total protein.................................................................. 1482.5.34. Acetic acid in synthetic peptides .............................. 1512.5.35. Nitrous oxide in gases ................................................. 1522.5.36. Anisidine value ............................................................. 1522.5.3. Hydroxyl value ................................................................ 1372.5.4. Iodine value ..................................................................... 1372.5.5. Peroxide value................................................................. 1382.5.6. Saponification value ...................................................... 1392.5.7. Unsaponifiable matter ................................................... 1392.5.8. Determination of primary aromaticamino-nitrogen ......................................................................... 139

2.5.9. Determination of nitrogen by sulphuric aciddigestion .................................................................................... 139

2.5. Assays ................................................................................... 1372.6.10. Histamine ....................................................................... 1652.6.11. Depressor substances.................................................. 1662.6.12. Microbiological examination of non-sterile products :total viable aerobic count ...................................................... 166

2.6.13. Microbiological examination of non-sterile products :test for specified micro-organisms ....................................... 173

2.6.14. Bacterial endotoxins .................................................... 1822.6.15. Prekallikrein activator................................................. 1892.6.16. Tests for extraneous agents in viral vaccines forhuman use................................................................................. 190

2.6.17. Test for anticomplementary activity ofimmunoglobulin........................................................................191

2.6.18. Test for neurovirulence of live virus vaccines........ 1932.6.19. Test for neurovirulence of poliomyelitis vaccine(oral) ........................................................................................... 193

2.6.1. Sterility ............................................................................. 1552.6.20. Anti-A and anti-B haemagglutinins(indirect method) ..................................................................... 195

2.6.21. Nucleic acid amplification techniques ..................... 1952.6.22. Activated coagulation factors .................................... 1982.6.24. Avian viral vaccines : tests for extraneous agents inseed lots ..................................................................................... 198

2.6.25. Avian live virus vaccines : tests for extraneous agentsin batches of finished product .............................................. 202

2.6.26. Test for anti-D antibodies in human immunoglobulinfor intravenous administration ............................................. 205

2.6.27. Microbiological control of cellular products .......... 2052.6.2. Mycobacteria ................................................................... 1592.6.7. Mycoplasmas.................................................................... 1592.6.8. Pyrogens........................................................................... 1642.6.9. Abnormal toxicity ........................................................... 1652.6. Biological tests ................................................................... 1552.7.10. Assay of human coagulation factor VII ................... 2282.7.11. Assay of human coagulation factor IX ..................... 2292.7.12. Assay of heparin in coagulation factors .................. 2302.7.13. Assay of human anti-D immunoglobulin................. 2302.7.14. Assay of hepatitis A vaccine ....................................... 2322.7.15. Assay of hepatitis B vaccine (rDNA)......................... 2332.7.16. Assay of pertussis vaccine (acellular)....................... 2332.7.17. Assay of human antithrombin III .............................. 2342.7.18. Assay of human coagulation factor II ...................... 2342.7.19. Assay of human coagulation factor X ...................... 2352.7.19. Assay of human coagulation factor X (2.7.19.)....... 2352.7.1. Immunochemical methods ........................................... 2092.7.20. In vivo assay of poliomyelitis vaccine(inactivated) .............................................................................. 235

2.7.21. Assay of human von Willebrand factor.................... 2372.7.22. Assay of human coagulation factor XI..................... 2382.7.23. Numeration of CD34/CD45+ cells inhaematopoietic products........................................................ 238

2.7.24. Flow cytometry ............................................................. 2402.7.27. Flocculation value (Lf) of diphtheria and tetanustoxins and toxoids (Ramon assay)........................................ 241

2.7.28. Colony-forming cell assay for humanhaematopoietic progenitor cells ........................................... 242

2.7.29. Nucleated cell count and viability............................. 2432.7.2. Microbiological assay of antibiotics .............................2102.7.4. Assay of human coagulation factor VIII .....................2162.7.5. Assay of heparin...............................................................2172.7.6. Assay of diphtheria vaccine (adsorbed) ......................2172.7.7. Assay of pertussis vaccine............................................. 2222.7.8. Assay of tetanus vaccine (adsorbed)........................... 2232.7.9. Test for Fc function of immunoglobulin ................... 2272.7. Biological assays ................................................................ 2092.8.10. Solubility in alcohol of essential oils ....................... 2502.8.11. Assay of 1,8-cineole in essential oils ........................ 2502.8.12. Determination of essential oils in herbal drugs .... 2512.8.13. Pesticide residues......................................................... 2522.8.14. Determination of tannins in herbal drugs .............. 2552.8.15. Bitterness value ............................................................ 2552.8.16. Dry residue of extracts................................................ 2562.8.17. Loss on drying of extracts .......................................... 2562.8.18. Determination of aflatoxin B1 in herbal drugs ...... 2562.8.1. Ash insoluble in hydrochloric acid ............................. 2492.8.20. Herbal drugs : sampling and sample preparation.. 2582.8.2. Foreign matter ................................................................ 2492.8.3. Stomata and stomatal index ........................................ 2492.8.4. Swelling index ................................................................. 2492.8.5. Water in essential oils.................................................... 2492.8.6. Foreign esters in essential oils .................................... 2502.8.7. Fatty oils and resinified essential oils in essentialoils............................................................................................... 250

2.8.8. Odour and taste of essential oils................................. 2502.8.9. Residue on evaporation of essential oils ................... 2502.8. Methods in pharmacognosy ............................................ 2492.9.10. Ethanol content and alcoholimetric tables ............ 2812.9.11. Test for methanol and 2-propanol ............................ 2822.9.12. Sieve test ........................................................................ 2832.9.14. Specific surface area by air permeability ................ 2832.9.15. Apparent volume .......................................................... 2852.9.16. Flowability...................................................................... 2862.9.17. Test for extractable volume of parenteralpreparations .............................................................................. 287

2.9.18. Preparations for inhalation : aerodynamic assessmentof fine particles ........................................................................ 287

2.9.19. Particulate contamination : sub-visible particles... 3002.9.1. Disintegration of tablets and capsules....................... 2632.9.20. Particulate contamination : visible particles .......... 3022.9.22. Softening time determination of lipophilicsuppositories............................................................................. 302

2.9.23. Pycnometric density of solids.................................... 3042.9.25. Dissolution test for medicated chewing gums....... 3042.9.26. Specific surface area by gas adsorption.................. 3062.9.27. Uniformity of mass of delivered doses from multidosecontainers.................................................................................. 309

2.9.29. Intrinsic dissolution..................................................... 3092.9.2. Disintegration of suppositories and pessaries ......... 2652.9.31. Particle size analysis by laser light diffraction .......3112.9.33. Characterisation of crystalline and partiallycrystalline solids by X-ray powder diffraction (XRPD) .....314

2.9.36. Powder flow................................................................... 3202.9.37. Optical microscopy....................................................... 3232.9.38. Particle-size distribution estimation by analyticalsieving ........................................................................................ 325

2.9.3. Dissolution test for solid dosage forms ..................... 2662.9.40. Uniformity of dosage units......................................... 3272.9.41. Friability of granules and spheroids ........................ 3302.9.42. Dissolution test for lipophilic solid dosage forms.. 3322.9.43. Apparent dissolution ................................................... 3322.9.4. Dissolution test for transdermal patches .................. 2752.9.5. Uniformity of mass of single-dose preparations....... 2782.9.6. Uniformity of content of single-dose preparations.. 278

3264 See the information section on general monographs (cover pages)

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2.9.7. Friability of uncoated tablets ....................................... 2782.9.8. Resistance to crushing of tablets................................ 2792.9.9. Measurement of consistency by penetrometry ........ 2792.9. Pharmaceutical technical procedures ........................... 2633.1.10. Materials based on non-plasticised poly(vinyl chloride)for containers for non-injectable, aqueous solutions ...... 360

3.1.11. Materials based on non-plasticised poly(vinylchloride) for containers for dry dosage forms for oraladministration .......................................................................... 362

3.1.1.1. Materials based on plasticised poly(vinyl chloride) forcontainers for human blood and blood components....... 339

3.1.1.2. Materials based on plasticised poly(vinyl chloride)for tubing used in sets for the transfusion of blood andblood components ................................................................... 342

3.1.13. Plastic additives ............................................................ 3643.1.14. Materials based on plasticised poly(vinyl chloride)for containers for aqueous solutions for intravenousinfusion ...................................................................................... 366

3.1.15. Polyethylene terephthalate for containers forpreparations not for parenteral use..................................... 369

3.1.1. Materials for containers for human blood and bloodcomponents............................................................................... 339

3.1.3. Polyolefines...................................................................... 3443.1.4. Polyethylene without additives for containersfor parenteral preparations and for ophthalmicpreparations .............................................................................. 348

3.1.5. Polyethylene with additives for containersfor parenteral preparations and for ophthalmicpreparations .............................................................................. 349

3.1.6. Polypropylene for containers and closures forparenteral preparations and ophthalmic preparations ... 352

3.1.7. Poly(ethylene - vinyl acetate) for containers and tubingfor total parenteral nutrition preparations ........................ 356

3.1.8. Silicone oil used as a lubricant ................................... 3583.1.9. Silicone elastomer for closures and tubing .............. 3583.1. Materials used for the manufacture of containers ..... 3393.2.1. Glass containers for pharmaceutical use .................. 3733.2.2.1. Plastic containers for aqueous solutions forinfusion ...................................................................................... 379

3.2.2. Plastic containers and closures for pharmaceuticaluse............................................................................................... 378

3.2.3. Sterile plastic containers for human blood andblood components ................................................................... 379

3.2.4. Empty sterile containers of plasticised poly(vinylchloride) for human blood and blood components.......... 381

3.2.5. Sterile containers of plasticised poly(vinyl chloride) forhuman blood containing anticoagulant solution ............. 382

3.2.6. Sets for the transfusion of blood and bloodcomponents............................................................................... 383

3.2.8. Sterile single-use plastic syringes ............................... 3843.2.9. Rubber closures for containers for aqueousparenteral preparations, for powders and forfreeze-dried powders ............................................................... 386

3.2. Containers ........................................................................... 3734.1.1. Reagents ........................................................................... 3914.1.2. Standard solutions for limit tests................................ 5044.1.3. Buffer solutions .............................................................. 5084.1. Reagents, standard solutions, buffer solutions ........... 3914.2.1. Primary standards for volumetric solutions..............5144.2.2. Volumetric solutions.......................................................5144.2. Volumetric analysis.............................................................5144-Aminobenzoic acid ............................................................... 11644. Reagents.................................................................................. 3915.10. Control of impurities in substances for pharmaceuticaluse............................................................................................... 653

5.11. Characters section in monographs .............................. 6595.1.1. Methods of preparation of sterile products .............. 5255.1.2. Biological indicators of sterilisation........................... 5275.12. Reference standards........................................................ 663

5.1.3. Efficacy of antimicrobial preservation ....................... 5285.14. Gene transfer medicinal products for human use .... 6695.1.4. Microbiological quality of pharmaceuticalpreparations .............................................................................. 529

5.1.5. Application of the F0 concept to steam sterilisation ofaqueous preparations ............................................................. 531

5.1.6. Alternative methods for control of microbiologicalquality......................................................................................... 532

5.1.7. Viral safety........................................................................ 5435.1. General texts on microbiology ........................................ 5255.2.1. Terminology used in monographs on biologicalproducts ..................................................................................... 547

5.2.2. Chicken flocks free from specified pathogens for theproduction and quality control of vaccines........................ 547

5.2.3. Cell substrates for the production of vaccines forhuman use................................................................................. 550

5.2.4. Cell cultures for the production of veterinaryvaccines...................................................................................... 553

5.2.5. Substances of animal origin for the production ofveterinary vaccines.................................................................. 555

5.2.6. Evaluation of safety of veterinary vaccines andimmunosera ............................................................................. 556

5.2.7. Evaluation of efficacy of veterinary vaccines andimmunosera .............................................................................. 557

5.2.8. Minimising the risk of transmitting animal spongiformencephalopathy agents via human and veterinary medicinalproducts ..................................................................................... 558

5.2.9. Evaluation of safety of each batch of veterinaryvaccines and immunosera...................................................... 567

5.2. General texts on biological products............................. 5475.3. Statistical analysis of results of biological assays andtests............................................................................................. 571

5.4. Residual solvents ............................................................... 6035.5. Alcoholimetric tables ........................................................ 6135.6. Assay of interferons........................................................... 6275.7. Table of physical characteristics of radionuclidesmentioned in the European Pharmacopoeia..................... 633

5.8. Pharmacopoeial harmonisation ..................................... 6455.9. Polymorphism..................................................................... 649

AAbbreviations and symbols (1.) ................................................... 3Abnormal toxicity (2.6.9.)......................................................... 165Absorption spectrophotometry, infrared (2.2.24.) ................ 39Absorption spectrophotometry, ultraviolet and visible(2.2.25.) .........................................................................................41

Acacia.......................................................................................... 1087Acacia, spray-dried ................................................................... 1087Acamprosate calcium .............................................................. 1088Acarbose..................................................................................... 1089Acebutolol hydrochloride....................................................... 1091Aceclofenac................................................................................ 1093Acesulfame potassium ............................................................1095Acetazolamide...........................................................................1096Acetic acid, glacial ................................................................... 1097Acetic acid in synthetic peptides (2.5.34.) ............................ 151Acetone....................................................................................... 1098Acetylcholine chloride ............................................................ 1099Acetylcysteine ........................................................................... 1100β-Acetyldigoxin ..........................................................................1101Acetylsalicylic acid ................................................................... 1103Acetyltryptophan, N- ............................................................... 1104Acetyltyrosine, N- ..................................................................... 1106Aciclovir ..................................................................................... 1107Acid value (2.5.1.)....................................................................... 137Acitretin...................................................................................... 1109Actinobacillosis vaccine (inactivated), porcine .................... 943Activated charcoal.................................................................... 1488Activated coagulation factors (2.6.22.).................................. 198

General Notices (1) apply to all monographs and other texts 3265

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Additives, plastic (3.1.13.)......................................................... 364Adenine ...................................................................................... 1110Adenosine ...................................................................................1111Adenovirus vectors for human use ........................................ 670Adipic acid ................................................................................. 1113Adrenaline tartrate ...................................................................1114Aerodynamic assessment of fine particles in preparations forinhalation (2.9.18.) .................................................................. 287

Aflatoxin B1 in herbal drugs, determination of (2.8.18.) ... 256Agar............................................................................................. 1115Agnus castus fruit.................................................................... 1116Agrimony ....................................................................................1117Air, medicinal ............................................................................ 1118Air, synthetic medicinal .......................................................... 1121Alanine ....................................................................................... 1121Albendazole............................................................................... 1122Albumin solution, human.......................................................2057Alchemilla .................................................................................. 1123Alcoholimetric tables (2.9.10.) ................................................ 281Alcoholimetric tables (5.5.) ...................................................... 613Alcuronium chloride................................................................ 1124Alexandrian senna pods .........................................................2870Alfacalcidol ................................................................................ 1126Alfadex........................................................................................ 1127Alfentanil hydrochloride......................................................... 1128Alfuzosin hydrochloride ......................................................... 1130Alginic acid ................................................................................ 1131Alkaline-earth metals and magnesium (2.4.7.) .................... 112Alkaline impurities in fatty oils (2.4.19.) ................................117Allantoin..................................................................................... 1131Allergen products....................................................................... 679Allopurinol................................................................................. 1132all-rac-α-Tocopherol.................................................................3086all-rac-α-Tocopheryl acetate ..................................................3089Almagate .................................................................................... 1134Almond oil, refined .................................................................. 1136Almond oil, virgin .................................................................... 1136Aloes, Barbados........................................................................ 1137Aloes, Cape ................................................................................ 1138Aloes dry extract, standardised............................................. 1139Alphacyclodextrin .................................................................... 1127Alprazolam ................................................................................ 1139Alprenolol hydrochloride ........................................................1141Alprostadil ................................................................................. 1143Alteplase for injection ............................................................. 1145Alternative methods for control of microbiological quality(5.1.6.)......................................................................................... 532

Alum............................................................................................ 1149Aluminium (2.4.17.) ....................................................................117Aluminium chloride hexahydrate ......................................... 1149Aluminium hydroxide, hydrated, for adsorption............... 1150Aluminium in adsorbed vaccines (2.5.13.).............................141Aluminium magnesium silicate............................................. 1151Aluminium oxide, hydrated.................................................... 1152Aluminium phosphate gel ...................................................... 1152Aluminium phosphate, hydrated .......................................... 1153Aluminium sulphate ................................................................ 1154Alverine citrate ......................................................................... 1154Amantadine hydrochloride .................................................... 1156Ambroxol hydrochloride......................................................... 1156Amfetamine sulphate .............................................................. 1158Amidotrizoic acid dihydrate................................................... 1158Amikacin .................................................................................... 1159Amikacin sulphate ................................................................... 1161Amiloride hydrochloride......................................................... 1163Amino acid analysis (2.2.56.) ..................................................... 89Aminobenzoic acid, 4- ............................................................. 1164Aminocaproic acid ................................................................... 1166Aminoglutethimide.................................................................. 1167

Amiodarone hydrochloride .................................................... 1168Amisulpride ............................................................................... 1170Amitriptyline hydrochloride .................................................. 1172Amlodipine besilate ................................................................. 1173Ammonia (13N) injection ........................................................... 981Ammonia solution, concentrated ......................................... 1175Ammonio methacrylate copolymer (type A) ...................... 1175Ammonio methacrylate copolymer (type B) .......................1176Ammonium (2.4.1.) .....................................................................111Ammonium bromide................................................................ 1177Ammonium chloride................................................................ 1178Ammonium glycyrrhizate....................................................... 1179Ammonium hydrogen carbonate .......................................... 1180Amobarbital............................................................................... 1180Amobarbital sodium ................................................................ 1181Amoxicillin sodium .................................................................. 1182Amoxicillin trihydrate ............................................................. 1184Amperometric titration (2.2.19.) ............................................... 35Amphotericin B ........................................................................ 1187Ampicillin, anhydrous ............................................................ 1188Ampicillin sodium .................................................................... 1190Ampicillin trihydrate ............................................................... 1193Anaesthetic ether ..................................................................... 1834Analysis, thermal (2.2.34.).......................................................... 55Analytical sieving, particle-size distribution estimation by(2.9.38.) ...................................................................................... 325

Angelica root ............................................................................. 1196Animal anti-T lymphocyte immunoglobulin for humanuse.............................................................................................1203

Animal immunosera for human use....................................... 685Animal spongiform encephalopathies, products with risk oftransmitting agents of............................................................. 694

Animal spongiform encephalopathy agents, minimising therisk of transmitting via human and veterinary medicinalproducts (5.2.8.) ....................................................................... 558

Aniseed ....................................................................................... 1199Anise oil...................................................................................... 1197Anisidine value (2.5.36.) ........................................................... 152Antazoline hydrochloride....................................................... 1199Anthrax spore vaccine (live) for veterinary use................... 859Anthrax vaccine for human use (adsorbed, prepared fromculture filtrates) ....................................................................... 757

Anti-A and anti-B haemagglutinins (indirect method)(2.6.20.) ...................................................................................... 195

Antibiotics, microbiological assay of (2.7.2.) .........................210Antibodies for human use, monoclonal ................................ 690Anticoagulant and preservative solutions for human blood...................................................................................................1200

Anticomplementary activity of immunoglobulin (2.6.17.) ..191Anti-D antibodies in human immunoglobulins for intravenousadministration, test for (2.6.26.) ........................................... 205

Anti-D immunoglobulin for intravenous administration,human ......................................................................................2059

Anti-D immunoglobulin, human ...........................................2058Anti-D immunoglobulin, human, assay of (2.7.13.)............. 230Antimicrobial preservation, efficacy of (5.1.3.) .................... 528Antiserum, European viper venom ........................................ 970Antithrombin III concentrate, human .................................2060Antithrombin III, human, assay of (2.7.17.) .......................... 234Anti-T lymphocyte immunoglobulin for human use,animal.......................................................................................1203

Apomorphine hydrochloride .................................................1207Apparatus (2.1.) .............................................................................15Apparent dissolution (2.9.43.) ................................................. 332Apparent volume (2.9.15.)........................................................ 285Application of the F0 concept to steam sterilisation ofaqueous preparations (5.1.5.)................................................ 531

Aprotinin ....................................................................................1208Aprotinin concentrated solution...........................................1209

3266 See the information section on general monographs (cover pages)

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Arachis oil, hydrogenated ...................................................... 1211Arachis oil, refined................................................................... 1211Arginine...................................................................................... 1212Arginine aspartate ................................................................... 1213Arginine hydrochloride........................................................... 1214Arnica flower............................................................................. 1215Arnica tincture.......................................................................... 1216Arsenic (2.4.2.) .............................................................................111Arsenious trioxide for homoeopathic preparations.......... 1073Articaine hydrochloride.......................................................... 1217Artichoke leaf............................................................................ 1219Ascorbic acid ............................................................................. 1221Ascorbyl palmitate ...................................................................1222Ash insoluble in hydrochloric acid (2.8.1.) ........................... 249Ash leaf.......................................................................................1222Asparagine monohydrate .......................................................1223Aspartame..................................................................................1224Aspartic acid..............................................................................1225Assay of 1,8-cineole in essential oils (2.8.11.) ...................... 250Assay of diphtheria vaccine (adsorbed) (2.7.6.) ....................217Assay of heparin (2.7.5.) ............................................................217Assay of heparin in coagulation factors (2.7.12.) ................ 230Assay of hepatitis A vaccine (2.7.14.) ..................................... 232Assay of hepatitis B vaccine (rDNA) (2.7.15.) ...................... 233Assay of human anti-D immunoglobulin (2.7.13.)............... 230Assay of human antithrombin III (2.7.17.) ............................ 234Assay of human coagulation factor II (2.7.18.).................... 234Assay of human coagulation factor IX (2.7.11.)................... 229Assay of human coagulation factor VII (2.7.10.) ................. 228Assay of human coagulation factor VIII (2.7.4.)...................216Assay of human coagulation factor X (2.7.19.) .................... 235Assay of human coagulation factor XI (2.7.22.) .................. 238Assay of human von Willebrand factor (2.7.21.) ................. 237Assay of interferons (5.6.)......................................................... 627Assay of pertussis vaccine (2.7.7.)........................................... 222Assay of pertussis vaccine (acellular) (2.7.16.) .................... 233Assay of poliomyelitis vaccine (inactivated), in vivo(2.7.20.) ...................................................................................... 235

Assay of tetanus vaccine (adsorbed) (2.7.8.) ........................ 223Assays (2.5.) ................................................................................. 137Astemizole .................................................................................1226Atenolol ......................................................................................1228Atomic absorption spectrometry (2.2.23.) .............................. 37Atomic emission spectrometry (2.2.22.).................................. 36Atomic emission spectrometry, inductively coupled plasma-(2.2.57.) ........................................................................................ 96

Atracurium besilate .................................................................1230Atropine .....................................................................................1232Atropine sulphate.....................................................................1234Aujeszky’s disease vaccine (inactivated) for pigs................ 859Aujeszky’s disease vaccine (live) for pigs for parenteraladministration .......................................................................... 861

Avian infectious bronchitis vaccine (inactivated)................ 864Avian infectious bronchitis vaccine (live) ............................. 865Avian infectious bursal disease vaccine (inactivated) ........ 867Avian infectious bursal disease vaccine (live) ...................... 869Avian infectious encephalomyelitis vaccine (live) ............... 871Avian infectious laryngotracheitis vaccine (live)................. 872Avian live virus vaccines : tests for extraneous agents inbatches of finished product (2.6.25.)................................... 202

Avian paramyxovirus 1 (Newcastle disease) vaccine(inactivated) .............................................................................. 937

Avian paramyxovirus 3 vaccine (inactivated)....................... 874Avian tuberculin purified protein derivative...................... 3146Avian viral tenosynovitis vaccine (live).................................. 875Avian viral vaccines : tests for extraneous agents in seed lots(2.6.24.) ...................................................................................... 198

Azaperone for veterinary use ................................................1234Azathioprine..............................................................................1236

Azelastine hydrochloride........................................................1236Azithromycin.............................................................................1238

BBacampicillin hydrochloride..................................................1243Bacitracin...................................................................................1245Bacitracin zinc ..........................................................................1247Baclofen .....................................................................................1250Bacterial cells used for the manufacture of plasmid vectorsfor human use .......................................................................... 676

Bacterial endotoxins (2.6.14.).................................................. 182Bambuterol hydrochloride..................................................... 1251Barbados aloes ......................................................................... 1137Barbital.......................................................................................1252Barium chloride dihydrate for homoeopathicpreparations ............................................................................ 1073

Barium sulphate.......................................................................1253Basic butylated methacrylate copolymer............................1254BCG for immunotherapy .......................................................... 758BCG vaccine, freeze-dried ........................................................ 759Bearberry leaf ...........................................................................1255Beclometasone dipropionate, anhydrous ...........................1256Beclometasone dipropionate monohydrate .......................1258Bee for homoeopathic preparations, honey....................... 1079Beeswax, white .........................................................................1260Beeswax, yellow........................................................................ 1261Belladonna leaf......................................................................... 1261Belladonna leaf dry extract, standardised ..........................1263Belladonna leaf tincture, standardised................................1264Belladonna, prepared ..............................................................1265Bendroflumethiazide ..............................................................1266Benfluorex hydrochloride ......................................................1267Benperidol .................................................................................1269Benserazide hydrochloride ....................................................1270Bentonite ................................................................................... 1271Benzalkonium chloride...........................................................1272Benzalkonium chloride solution ..........................................1273Benzathine benzylpenicillin ..................................................1283Benzbromarone........................................................................1273Benzethonium chloride ..........................................................1275Benzocaine ................................................................................ 1276Benzoic acid .............................................................................. 1276Benzoin, Siam...........................................................................1277Benzoin, Sumatra ....................................................................1278Benzoin tincture, Siam ...........................................................1278Benzoin tincture, Sumatra.....................................................1279Benzoyl peroxide, hydrous ....................................................1280Benzyl alcohol .......................................................................... 1281Benzyl benzoate .......................................................................1283Benzylpenicillin, benzathine .................................................1283Benzylpenicillin potassium....................................................1285Benzylpenicillin, procaine......................................................1287Benzylpenicillin sodium .........................................................1288Betacarotene .............................................................................1290Betacyclodextrin ...................................................................... 1291Betadex ...................................................................................... 1291Betahistine dihydrochloride ..................................................1292Betahistine mesilate ................................................................1293Betamethasone.........................................................................1295Betamethasone acetate ..........................................................1297Betamethasone dipropionate ................................................1298Betamethasone sodium phosphate......................................1300Betamethasone valerate ......................................................... 1301Betaxolol hydrochloride .........................................................1303Bezafibrate ................................................................................1304Bifonazole..................................................................................1306Bilberry fruit, dried .................................................................1307Bilberry fruit, fresh..................................................................1307Biological assays (2.7.) .............................................................. 209

General Notices (1) apply to all monographs and other texts 3267

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Biological assays and tests, statistical analysis of results of(5.3.)............................................................................................ 571

Biological indicators of sterilisation (5.1.2.) ........................ 527Biological products, general texts on (5.2.).......................... 547Biological products, terminology used in monographs on(5.2.1.)......................................................................................... 547

Biological tests (2.6.) ................................................................. 155Biotin ..........................................................................................1308Biperiden hydrochloride.........................................................1309Biphasic insulin injection....................................................... 2140Biphasic isophane insulin injection ..................................... 2140Birch leaf.................................................................................... 1311Bisacodyl.................................................................................... 1312Bismuth subcarbonate............................................................ 1313Bismuth subgallate.................................................................. 1314Bismuth subnitrate, heavy ..................................................... 1315Bismuth subsalicylate ............................................................. 1316Bistort rhizome ........................................................................ 1317Bitter fennel ..............................................................................1873Bitter-fennel fruit oil................................................................ 1318Bitterness value (2.8.15.).......................................................... 255Bitter-orange epicarp and mesocarp.................................... 1319Bitter-orange-epicarp and mesocarp tincture ....................1320Bitter-orange flower ................................................................1320Bitter-orange-flower oil ...........................................................2490Black horehound ..................................................................... 1321Bleomycin sulphate .................................................................1322Blood and blood components, empty sterile containers ofplasticised poly(vinyl chloride) for (3.2.4.) ......................... 381

Blood and blood components, materials for containers for(3.1.1.)......................................................................................... 339

Blood and blood components, sets for the transfusion of(3.2.6.) ........................................................................................ 383

Blood and blood components, sterile plastic containers for(3.2.3.) ........................................................................................ 379

Blood, anticoagulant and preservative solutions for .......1200Blood, sterile containers of plasticised poly(vinyl chloride)containing anticoagulant solution (3.2.5.) ......................... 382

Bogbean leaf .............................................................................1323Boiling point (2.2.12.) ..................................................................31Boldo leaf...................................................................................1324Borage (starflower) oil, refined.............................................1326Borax ..........................................................................................1326Boric acid...................................................................................1327Botulinum antitoxin .................................................................. 965Botulinum toxin type A for injection...................................1327Bovine infectious rhinotracheitis vaccine (live) .................. 924Bovine insulin ........................................................................... 2135Bovine leptospirosis vaccine (inactivated)............................ 876Bovine parainfluenza virus vaccine (live)............................. 878Bovine respiratory syncytial virus vaccine (live)................. 879Bovine serum............................................................................1329Bovine tuberculin purified protein derivative ................... 3147Bovine viral diarrhoea vaccine (inactivated)........................ 880Bromazepam ............................................................................. 1331Bromhexine hydrochloride ....................................................1332Bromocriptine mesilate ..........................................................1333Bromperidol ..............................................................................1335Bromperidol decanoate ..........................................................1337Brompheniramine maleate.....................................................1339Brotizolam .................................................................................1340Brucellosis vaccine (live) (Brucella melitensis Rev. 1 strain)for veterinary use..................................................................... 881

Buccal tablets and sublingual tablets.................................... 734Buckwheat herb ....................................................................... 1341Budesonide................................................................................1342Bufexamac .................................................................................1344Buffer solutions (4.1.3.) ............................................................ 508Buflomedil hydrochloride ......................................................1345

Bumetanide ...............................................................................1346Bupivacaine hydrochloride ....................................................1347Buprenorphine .........................................................................1349Buprenorphine hydrochloride ..............................................1350Buserelin.................................................................................... 1351Buspirone hydrochloride........................................................1353Busulfan.....................................................................................1355Butcher’s broom.......................................................................1355Butylated methacrylate copolymer, basic...........................1254Butylhydroxyanisole................................................................1357Butylhydroxytoluene...............................................................1357Butyl parahydroxybenzoate...................................................1358

CCabergoline ...............................................................................1363Cachets ......................................................................................... 719Cadmium sulphate hydrate for homoeopathicpreparations ............................................................................ 1074

Caffeine ......................................................................................1364Caffeine monohydrate.............................................................1365Calcifediol ..................................................................................1366Calcipotriol, anhydrous ..........................................................1367Calcipotriol monohydrate ......................................................1370Calcitonin (salmon)..................................................................1372Calcitriol.....................................................................................1375Calcium (2.4.3.)............................................................................111Calcium acetate ........................................................................ 1376Calcium ascorbate....................................................................1377Calcium carbonate ...................................................................1378Calcium carboxymethylcellulose .......................................... 1422Calcium chloride dihydrate....................................................1378Calcium chloride hexahydrate ..............................................1379Calcium dobesilate monohydrate .........................................1380Calcium folinate .......................................................................1380Calcium glucoheptonate.........................................................1383Calcium gluconate ...................................................................1384Calcium gluconate for injection............................................1385Calcium glycerophosphate.....................................................1386Calcium hydrogen phosphate, anhydrous ..........................1387Calcium hydrogen phosphate dihydrate .............................1388Calcium hydroxide ...................................................................1389Calcium in adsorbed vaccines (2.5.14.) ................................. 142Calcium iodide tetrahydrate for homoeopathic prepara-tions .......................................................................................... 1074

Calcium lactate, anhydrous ...................................................1389Calcium lactate monohydrate ...............................................1390Calcium lactate pentahydrate ...............................................1390Calcium lactate trihydrate...................................................... 1391Calcium levofolinate pentahydrate ......................................1392Calcium levulinate dihydrate.................................................1394Calcium pantothenate.............................................................1395Calcium phosphate ..................................................................1396Calcium stearate.......................................................................1397Calcium sulphate dihydrate ...................................................1398Calendula flower ......................................................................1398Calf coronavirus diarrhoea vaccine (inactivated)................ 882Calf rotavirus diarrhoea vaccine (inactivated)..................... 884Calicivirosis vaccine (inactivated), feline............................... 909Calicivirosis vaccine (live), feline .............................................910Camphor, D- ............................................................................... 1400Camphor, racemic .................................................................... 1401Canine adenovirus vaccine (inactivated) .............................. 885Canine adenovirus vaccine (live) ............................................ 886Canine distemper vaccine (live) .............................................. 887Canine leptospirosis vaccine (inactivated)............................ 888Canine parainfluenza virus vaccine (live)............................. 890Canine parvovirosis vaccine (inactivated)............................. 891Canine parvovirosis vaccine (live) .......................................... 892Cape aloes.................................................................................. 1138

3268 See the information section on general monographs (cover pages)

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Capillary electrophoresis (2.2.47.)............................................ 77Capillary viscometer method (2.2.9.)....................................... 27Caprylic acid.............................................................................. 1402Caprylocaproyl macrogolglycerides..................................... 1403Capsicum.................................................................................... 1404Capsicum oleoresin, refined and quantified ...................... 1405Capsicum tincture, standardised .......................................... 1406Capsules ........................................................................................717Capsules and tablets, disintegration of (2.9.1.) ................... 263Capsules, gastro-resistant......................................................... 718Capsules, hard ............................................................................ 718Capsules, intrauterine............................................................... 726Capsules, modified-release ....................................................... 718Capsules, oromucosal ............................................................... 734Capsules, rectal........................................................................... 745Capsules, soft .............................................................................. 718Capsules, vaginal........................................................................ 752Captopril .................................................................................... 1407Caraway fruit............................................................................. 1408Caraway oil ................................................................................ 1408Carbachol................................................................................... 1410Carbamazepine ..........................................................................1411Carbasalate calcium................................................................. 1412Carbidopa .................................................................................. 1413Carbimazole ...............................................................................1414Carbocisteine ............................................................................ 1415Carbomers ................................................................................. 1416Carbon dioxide ..........................................................................1417Carbon dioxide in gases (2.5.24.) ........................................... 144Carbon monoxide (15O) ............................................................. 982Carbon monoxide in gases (2.5.25.)....................................... 145Carboplatin................................................................................ 1419Carboprost trometamol .......................................................... 1420Carboxymethylcellulose calcium .......................................... 1422Carboxymethylcellulose sodium........................................... 1423Carboxymethylcellulose sodium, cross-linked ................... 1626Carboxymethylcellulose sodium, low-substituted............. 1424Carisoprodol.............................................................................. 1421Carmellose calcium.................................................................. 1422Carmellose sodium .................................................................. 1423Carmellose sodium and microcrystalline cellulose ..........2422Carmellose sodium, low-substituted .................................... 1424Carmustine ................................................................................ 1425Carnauba wax ........................................................................... 1425Carteolol hydrochloride.......................................................... 1426Carvedilol................................................................................... 1427Cascara ....................................................................................... 1429Cascara dry extract, standardised ........................................ 1430Cassia oil .................................................................................... 1431Castor oil, hydrogenated ........................................................ 1432Castor oil, polyoxyl ..................................................................2304Castor oil, polyoxyl hydrogenated........................................2303Castor oil, refined .................................................................... 1433Castor oil, virgin....................................................................... 1434Catgut, sterile............................................................................ 1045Catgut, sterile, in distributor for veterinary use ............... 1057CD34/CD45+ cells in haematopoietic products, numerationof (2.7.23.).................................................................................. 238

Cefaclor ...................................................................................... 1435Cefadroxil monohydrate ......................................................... 1436Cefalexin monohydrate........................................................... 1438Cefalotin sodium ...................................................................... 1440Cefamandole nafate ................................................................. 1441Cefapirin sodium...................................................................... 1443Cefatrizine propylene glycol.................................................. 1444Cefazolin sodium...................................................................... 1445Cefepime dihydrochloride monohydrate ............................ 1448Cefixime ..................................................................................... 1450Cefoperazone sodium ............................................................. 1451

Cefotaxime sodium .................................................................. 1453Cefoxitin sodium ...................................................................... 1455Cefradine.................................................................................... 1457Ceftazidime................................................................................ 1459Ceftriaxone sodium.................................................................. 1461Cefuroxime axetil ..................................................................... 1462Cefuroxime sodium.................................................................. 1464Celiprolol hydrochloride......................................................... 1465Cell count and viability, nucleated (2.7.29.) ......................... 243Cell cultures for the production of veterinary vaccines(5.2.4.) ........................................................................................ 553

Cell substrates for the production of vaccines for human use(5.2.3.) ........................................................................................ 550

Cellular products, microbiological control of (2.6.27.) ...... 205Cellulose acetate ...................................................................... 1467Cellulose acetate butyrate...................................................... 1468Cellulose acetate phthalate.................................................... 1468Cellulose, microcrystalline..................................................... 1469Cellulose (microcrystalline) and carmellose sodium........2422Cellulose, powdered ................................................................ 1473Centaury .................................................................................... 1477Centella ...................................................................................... 1477Cetirizine dihydrochloride ..................................................... 1479Cetostearyl alcohol .................................................................. 1480Cetostearyl alcohol (type A), emulsifying ........................... 1481Cetostearyl alcohol (type B), emulsifying........................... 1482Cetostearyl isononanoate....................................................... 1484Cetrimide ................................................................................... 1484Cetyl alcohol ............................................................................. 1485Cetyl palmitate.......................................................................... 1486Cetylpyridinium chloride........................................................ 1486Ceylon cinnamon bark oil ......................................................1543Ceylon cinnamon leaf oil........................................................1544CFC assay for human haematopoietic progenitor cells(2.7.28.) ...................................................................................... 242

Chamomile flower, Roman..................................................... 1487Characterisation of crystalline and partially crystalline solidsby X-ray powder diffraction (XRPD) (2.9.33.) .....................314

Characters section in monographs (5.11.)............................ 659Charcoal, activated .................................................................. 1488Chenodeoxycholic acid .......................................................... 1489Chewing gum, medicated (2.9.25.) ......................................... 304Chewing gums, medicated ....................................................... 719Chicken flocks free from specified pathogens for theproduction and quality control of vaccines (5.2.2.).......... 547

Chicken infectious anaemia vaccine (live) ............................ 925Chitosan hydrochloride .......................................................... 1490Chlamydiosis vaccine (inactivated), feline ............................911Chloral hydrate......................................................................... 1491Chlorambucil............................................................................. 1492Chloramine ................................................................................ 3103Chloramphenicol...................................................................... 1492Chloramphenicol palmitate ................................................... 1493Chloramphenicol sodium succinate..................................... 1495Chlorcyclizine hydrochloride ................................................ 1496Chlordiazepoxide ..................................................................... 1497Chlordiazepoxide hydrochloride .......................................... 1498Chlorhexidine diacetate.......................................................... 1499Chlorhexidine digluconate solution ....................................1500Chlorhexidine dihydrochloride .............................................1502Chlorides (2.4.4.) ........................................................................ 112Chlorobutanol, anhydrous .....................................................1503Chlorobutanol hemihydrate ..................................................1504Chlorocresol ..............................................................................1504Chloroquine phosphate ..........................................................1505Chloroquine sulphate..............................................................1506Chlorothiazide ..........................................................................1507Chlorphenamine maleate .......................................................1508Chlorpromazine hydrochloride.............................................1509

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Chlorpropamide........................................................................ 1510Chlorprothixene hydrochloride ............................................ 1511Chlortalidone ............................................................................ 1513Chlortetracycline hydrochloride........................................... 1514Cholecalciferol .......................................................................... 1516Cholecalciferol concentrate (oily form)............................... 1517Cholecalciferol concentrate (powder form)........................ 1519Cholecalciferol concentrate (water-dispersible form)....... 1521Cholera vaccine ...........................................................................761Cholera vaccine, freeze-dried ...................................................761Cholera vaccine (inactivated, oral) ......................................... 762Cholesterol ................................................................................1524Cholesterol in oils rich in omega-3 acids, total (2.4.32.) ... 132Chondroitin sulphate sodium................................................1525Chromatographic separation techniques (2.2.46.) ............... 72Chromatography, gas (2.2.28.).................................................. 45Chromatography, liquid (2.2.29.) ............................................. 46Chromatography, paper (2.2.26.).............................................. 43Chromatography, size-exclusion (2.2.30.)............................... 47Chromatography, supercritical fluid (2.2.45.) ........................71Chromatography, thin-layer (2.2.27.) ....................................... 43Chromium (51Cr) edetate injection ......................................... 983Chymotrypsin............................................................................1527Ciclopirox...................................................................................1528Ciclopirox olamine ...................................................................1530Ciclosporin ................................................................................ 1531Cilastatin sodium .....................................................................1533Cilazapril ....................................................................................1534Cimetidine..................................................................................1536Cimetidine hydrochloride.......................................................1537Cinchocaine hydrochloride....................................................1538Cinchona bark ..........................................................................1539Cinchona liquid extract, standardised.................................1540Cineole........................................................................................ 1541Cineole in essential oils, 1,8-, assay of (2.8.11.) ................... 250Cinnamon ..................................................................................1542Cinnamon bark oil, Ceylon ....................................................1543Cinnamon leaf oil, Ceylon ......................................................1544Cinnamon tincture...................................................................1545Cinnarizine ................................................................................1545Ciprofibrate ...............................................................................1547Ciprofloxacin.............................................................................1548Ciprofloxacin hydrochloride..................................................1550Circular dichroism (2.2.41.) ....................................................... 66Cisapride monohydrate........................................................... 1551Cisapride tartrate .....................................................................1552Cisplatin .....................................................................................1554Citric acid, anhydrous .............................................................1554Citric acid monohydrate .........................................................1555Citronella oil..............................................................................1556Cladribine ..................................................................................1557Clarithromycin..........................................................................1559Clarity and degree of opalescence of liquids (2.2.1.).............21Clary sage oil............................................................................. 1561Clazuril for veterinary use .....................................................1562Clebopride malate ....................................................................1564Clemastine fumarate ...............................................................1566Clenbuterol hydrochloride.....................................................1567Clindamycin hydrochloride....................................................1568Clindamycin phosphate ..........................................................1570Clioquinol .................................................................................. 1571Clobazam ...................................................................................1572Clobetasol propionate.............................................................1573Clobetasone butyrate ..............................................................1575Clofazimine................................................................................1577Clofibrate ...................................................................................1578Clomifene citrate ......................................................................1579Clomipramine hydrochloride.................................................1580Clonazepam...............................................................................1582

Clonidine hydrochloride.........................................................1583Closantel sodium dihydrate for veterinary use .................1584Clostridium botulinum vaccine for veterinary use ............. 894Clostridium chauvoei vaccine for veterinary use................ 894Clostridium novyi alpha antitoxin for veterinary use ........ 973Clostridium n ovyi (t yp e B) vaccine for veterinar y u se ...... 895Clostridium perfringens beta antitoxin for veterinary use..................................................................................................... 974

Clostridium perfringens epsilon antitoxin for veterinary use..................................................................................................... 975

Clostridium perfringens vaccine for veterinary use ........... 897Clostridium septicum vaccine for veterinary use................ 899Closures and containers for parenteral preparations andophthalmic preparations, polypropylene for (3.1.6.)........ 352

Closures and containers for pharmaceutical use, plastic(3.2.2.) ........................................................................................ 378

Closures and tubing, silicone elastomer for (3.1.9.) ........... 358Closures for containers for aqueous parenteral preparations,for powders and for freeze-dried powders, rubber(3.2.9.) ........................................................................................ 386

Clotrimazole..............................................................................1586Clove ...........................................................................................1587Clove oil .....................................................................................1588Cloxacillin sodium....................................................................1589Clozapine ...................................................................................1590Coagulation factor II, assay of (2.7.18.)................................. 234Coagulation factor IX, human...............................................2064Coagulation factor IX, human, assay of (2.7.11.)................. 229Coagulation factors, activated (2.6.22.)................................. 198Coagulation factors, assay of heparin (2.7.12.) ................... 230Coagulation factor VII, human ............................................. 2061Coagulation factor VII, human, assay of (2.7.10.) ............... 228Coagulation factor VIII, human............................................2062Coagulation factor VIII, human, assay of (2.7.4.).................216Coagulation factor VIII (rDNA), human .............................2063Coagulation factor X, assay of (2.7.19.) ................................. 235Coagulation factor XI, human...............................................2065Coagulation factor XI, human, assay of (2.7.22.) ................ 238Coated granules ......................................................................... 724Coated tablets ............................................................................. 749Cocaine hydrochloride............................................................1592Coconut oil, refined.................................................................1593Cocoyl caprylocaprate.............................................................1594Codeine ......................................................................................1594Codeine hydrochloride dihydrate.........................................1596Codeine phosphate hemihydrate..........................................1598Codeine phosphate sesquihydrate .......................................1599Codergocrine mesilate ............................................................ 1601Cod-liver oil (type A)................................................................ 1603Cod-liver oil (type B)................................................................ 1607Cola ............................................................................................. 1611Colchicine .................................................................................. 1612Colestyramine ........................................................................... 1613Colibacillosis vaccine (inactivated), neonatal piglet........... 934Colibacillosis vaccine (inactivated), neonatal ruminant .... 936Colistimethate sodium ............................................................ 1614Colistin sulphate ...................................................................... 1615Colloidal anhydrous silica ......................................................2877Colloidal hydrated silica .........................................................2877Colloidal silica, hydrophobic .................................................2878Colloidal silver, for external use ...........................................2879Colony-forming cell assay for human haematopoieticprogenitor cells (2.7.28.) ........................................................ 242

Colophony ..................................................................................1617Coloration of liquids (2.2.2.)...................................................... 22Common stinging nettle for homoeopathicpreparations ............................................................................ 1075

Comparative table of porosity of sintered-glass filters(2.1.2.)............................................................................................15

3270 See the information section on general monographs (cover pages)

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Complexometric titrations (2.5.11.)........................................ 140Composition of fatty acids by gas chromatography(2.4.22.) .......................................................................................118

Composition of fatty acids in oils rich in omega-3 acids(2.4.29.) ...................................................................................... 130

Compressed lozenges................................................................ 734Concentrated solutions for haemodialysis .........................2022Concentrates for injections or infusions............................... 736Concentrates for intrauterine solutions................................ 726Conductivity (2.2.38.) .................................................................. 59Coneflower herb, purple ........................................................2785Coneflower root, narrow-leaved............................................2483Coneflower root, pale..............................................................2602Coneflower root, purple .........................................................2787Conjugated estrogens .............................................................1824Containers (3.2.)......................................................................... 373Containers and closures for parenteral preparations andophthalmic preparations, polypropylene for (3.1.6.)........ 352

Containers and closures for pharmaceutical use, plastic(3.2.2.) ........................................................................................ 378

Containers and tubing for total parenteral nutritionpreparations, poly(ethylene - vinyl acetate) for (3.1.7.) ... 356

Containers for aqueous solutions for infusion, plastic(3.2.2.1.) ..................................................................................... 379

Containers for aqueous solutions for intravenous infusion,materials based on plasticised poly(vinyl chloride) for(3.1.14.) ...................................................................................... 366

Containers for dry dosage forms for oral administration,materials based on non-plasticised poly(vinyl chloride) for(3.1.11.)....................................................................................... 362

Containers for human blood and blood components,materials based on plasticised poly(vinyl chloride) for(3.1.1.1.) ..................................................................................... 339

Containers for human blood and blood components,materials for (3.1.1.) ................................................................ 339

Containers for human blood and blood components, plastic,sterile (3.2.3.) ............................................................................ 379

Containers for non-injectable aqueous solutions, materialsbased on non-plasticised poly(vinyl chloride) for(3.1.10.) ...................................................................................... 360

Containers for parenteral preparations and for ophthalmicpreparations, polyethylene with additives for (3.1.5.) ..... 349

Containers for parenteral preparations and for ophthalmicpreparations, polyethylene without additives for(3.1.4.)......................................................................................... 348

Containers for pharmaceutical use, glass (3.2.1.)............... 373Containers for preparations not for parenteral use,polyethylene terephthalate for (3.1.15) .............................. 369

Containers of plasticised poly(vinyl chloride) for humanblood and blood components, empty sterile (3.2.4.) ........ 381

Containers of plasticised poly(vinyl chloride) for human bloodcontaining anticoagulant solution, sterile (3.2.5.)............ 382

Contamination, microbial : test for specified micro-organisms(2.6.13.) ...................................................................................... 173

Contamination, microbial : total viable aerobic count(2.6.12.) ...................................................................................... 166

Content uniformity of single-dose preparations (2.9.6.).... 278Control of impurities in substances for pharmaceutical use(5.10.).......................................................................................... 653

Control of microbiological quality, alternative methods for(5.1.6.)......................................................................................... 532

Copolymer, basic butylated methacrylate ..........................1254Copolymer, methacrylic acid - ethyl acrylate (1:1) ...........2371Copolymer (type A), ammonio methacrylate ..................... 1175Copolymer (type B), ammonio methacrylate ......................1176Copovidone.................................................................................1617Copper acetate monohydrate for homoeopathic prepara-tions .......................................................................................... 1075

Copper for homoeopathic preparations.............................. 1076

Copper sulphate, anhydrous.................................................. 1619Copper sulphate pentahydrate.............................................. 1620Coriander ................................................................................... 1620Coriander oil ............................................................................. 1621Cortisone acetate ..................................................................... 1622Cotton, absorbent .................................................................... 1624Cottonseed oil, hydrogenated .............................................. 1625Couch grass rhizome .............................................................. 1625Creams.......................................................................................... 747Cresol, crude ............................................................................. 1626Croscarmellose sodium........................................................... 1626Crospovidone ............................................................................ 1628Crotamiton ................................................................................ 1629Crystalline and partially crystalline solids, characterisationby X-ray powder diffraction (XRPD) of (2.9.33.) ................314

Cutaneous application, liquid preparations for................... 728Cutaneous application, powders for ...................................... 738Cutaneous application, semi-solid preparations for ........... 746Cutaneous application, veterinary liquid preparationsfor ................................................................................................ 752

Cutaneous foams........................................................................ 728Cyanocobalamin ....................................................................... 1630Cyanocobalamin (57Co) capsules ............................................ 983Cyanocobalamin (57Co) solution ............................................. 984Cyanocobalamin (58Co) capsules ............................................ 985Cyanocobalamin (58Co) solution ............................................. 986Cyclizine hydrochloride .......................................................... 1631Cyclopentolate hydrochloride ............................................... 1632Cyclophosphamide................................................................... 1633Cyproheptadine hydrochloride ............................................. 1634Cyproterone acetate ................................................................ 1635Cysteine hydrochloride monohydrate ................................. 1636Cystine........................................................................................ 1637Cytarabine ................................................................................. 1638

DDacarbazine............................................................................... 1641Dalteparin sodium ................................................................... 1642Danaparoid sodium ................................................................. 1644Dapsone ..................................................................................... 1646Daunorubicin hydrochloride ................................................. 1647D-Camphor ................................................................................. 1400Decyl oleate ............................................................................... 1648Deferoxamine mesilate............................................................ 1649Degree of coloration of liquids (2.2.2.).................................... 22Dembrexine hydrochloride monohydrate for veteri-nary use ................................................................................... 1650

Demeclocycline hydrochloride.............................................. 1651Density of solids (2.2.42.) ........................................................... 67Density, relative (2.2.5.) .............................................................. 25Dental type silica......................................................................2878Depressor substances (2.6.11.)................................................ 166Deptropine citrate.................................................................... 1653Dequalinium chloride.............................................................. 1654Desipramine hydrochloride ...................................................1655Deslanoside ............................................................................... 1656Desmopressin............................................................................1657Desogestrel ................................................................................ 1658Desoxycortone acetate............................................................ 1659Detector tubes, gas (2.1.6.) .........................................................17Determination of aflatoxin B1 in herbal drugs (2.8.18.).... 256Determination of essential oils in herbal drugs (2.8.12.).. 251Determination of nitrogen by sulphuric acid digestion(2.5.9.) ........................................................................................ 139

Determination of primary aromatic amino-nitrogen(2.5.8.) ........................................................................................ 139

Determination of tannins in herbal drugs (2.8.14.)............ 255Determination of water by distillation (2.2.13.) .....................31Detomidine hydrochloride for veterinary use ...................1660

General Notices (1) apply to all monographs and other texts 3271

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Devil’s claw dry extract........................................................... 1662Devil’s claw root ....................................................................... 1662Dexamethasone ........................................................................1663Dexamethasone acetate.......................................................... 1665Dexamethasone isonicotinate ............................................... 1666Dexamethasone sodium phosphate ..................................... 1667Dexchlorpheniramine maleate .............................................. 1669Dexpanthenol............................................................................ 1670Dextran 1 for injection............................................................ 1671Dextran 40 for injection ......................................................... 1672Dextran 60 for injection ......................................................... 1673Dextran 70 for injection ......................................................... 1674Dextranomer ............................................................................. 1675Dextrans, molecular mass distribution in (2.2.39.) .............. 60Dextrin........................................................................................ 1675Dextromethorphan hydrobromide ....................................... 1676Dextromoramide tartrate .......................................................1677Dextropropoxyphene hydrochloride....................................1678Diazepam ...................................................................................1679Diazoxide ................................................................................... 1680Dibrompropamidine diisetionate .......................................... 1681Dibutyl phthalate ..................................................................... 1682Dichloromethane......................................................................2387Diclazuril for veterinary use.................................................. 1683Diclofenac potassium .............................................................. 1685Diclofenac sodium ................................................................... 1686Dicloxacillin sodium ................................................................ 1687Dicycloverine hydrochloride.................................................. 1689Didanosine.................................................................................1689Dienestrol .................................................................................. 1691Diethylcarbamazine citrate .................................................... 1693Diethylene glycol and ethylene glycol in ethoxylatedsubstances (2.4.30.)..................................................................131

Diethylene glycol monoethyl ether...................................... 1694Diethylene glycol palmitostearate ........................................ 1695Diethyl phthalate ..................................................................... 1692Diethylstilbestrol ...................................................................... 1696Diffraction, laser light, particle size analysis by (2.9.31.) ..311Diflunisal.................................................................................... 1697Digitalis leaf .............................................................................. 1698Digitoxin..................................................................................... 1700Digoxin ....................................................................................... 1701Dihydralazine sulphate, hydrated ........................................ 1703Dihydrocodeine hydrogen tartrate....................................... 1704Dihydroergocristine mesilate ................................................ 1705Dihydroergotamine mesilate ................................................. 1708Dihydroergotamine tartrate .................................................. 1709Dihydrostreptomycin sulphate for veterinary use ............ 1710Dihydrotachysterol .................................................................. 1712Diltiazem hydrochloride ......................................................... 1714Dimenhydrinate........................................................................ 1715Dimercaprol............................................................................... 1716Dimethylacetamide ...................................................................1717Dimethylaniline, N,N- (2.4.26.) ................................................ 127Dimethyl sulfoxide ................................................................... 1716Dimeticone ................................................................................ 1718Dimetindene maleate .............................................................. 1719Dinoprostone ............................................................................ 1722Dinoprost trometamol............................................................. 1720Diosmin ...................................................................................... 1723Dioxan and ethylene oxide (2.4.25.) ...................................... 126Dip concentrates ........................................................................ 753Diphenhydramine hydrochloride.......................................... 1725Diphenoxylate hydrochloride ................................................ 1726Diphtheria and tetanus toxins and toxoids, flocculation value(Lf) of, (Ramon assay) (2.7.27.) ............................................. 241

Diphtheria and tetanus vaccine (adsorbed) ......................... 763Diphtheria and tetanus vaccine (adsorbed, reduced antigen(s)content)...................................................................................... 764

Diphtheria antitoxin .................................................................. 965Diphtheria, tetanus and hepatitis B (rDNA) vaccine(adsorbed).................................................................................. 765

Diphtheria, tetanus and pertussis (acellular, component)vaccine (adsorbed)................................................................... 767

Diphtheria, tetanus and pertussis vaccine (adsorbed) ..... 768Diphtheria, tetanus and poliomyelitis (inactivated) vaccine(adsorbed, reduced antigen(s) content) .............................. 770

Diphtheria, tetanus, pertussis (acellular, component) andhaemophilus type b conjugate vaccine (adsorbed) .......... 771

Diphtheria, tetanus, pertussis (acellular, component) andhepatitis B (rDNA) vaccine (adsorbed) ............................... 774

Diphtheria, tetanus, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed) .................. 775

Diphtheria, tetanus, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed, reducedantigen(s) content) .................................................................. 778

Diphtheria, tetanus, pertussis (acellular, component),hepatitis B (rDNA), poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) .......... 780

Diphtheria, tetanus, pertussis (acellular, component),poliomyelitis (inactivated) and haemophilus type bconjugate vaccine (adsorbed)................................................ 783

Diphtheria, tetanus, pertussis and poliomyelitis (inactivated)vaccine (adsorbed)................................................................... 785

Diphtheria, tetanus, pertussis, poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) .......... 787

Diphtheria vaccine (adsorbed) ................................................ 789Diphtheria vaccine (adsorbed), assay of (2.7.6.) ...................217Diphtheria vaccine (adsorbed, reduced antigen content).. 791Dipivefrine hydrochloride ...................................................... 1727Dipotassium clorazepate ........................................................ 1728Dipotassium phosphate .......................................................... 1729Diprophylline ............................................................................ 1730Dipyridamole............................................................................. 1731Dirithromycin............................................................................ 1732Disintegration of suppositories and pessaries (2.9.2.) ....... 265Disintegration of tablets and capsules (2.9.1.) .................... 263Disodium edetate ..................................................................... 1734Disodium phosphate, anhydrous.......................................... 1735Disodium phosphate dihydrate............................................. 1735Disodium phosphate dodecahydrate ................................... 1736Disopyramide ............................................................................ 1737Disopyramide phosphate........................................................ 1738Dispersible tablets ..................................................................... 750Dissolution, apparent (2.9.43.)................................................ 332Dissolution, intrinsic (2.9.29.) ................................................. 309Dissolution test for lipophilic solid dosage forms(2.9.42.) ...................................................................................... 332

Dissolution test for solid dosage forms (2.9.3.) ................... 266Dissolution test for transdermal patches (2.9.4.)................ 275Distemper vaccine (live), canine ............................................. 887Distemper vaccine (live) for mustelids .................................. 900Distillation range (2.2.11.).......................................................... 30Distribution estimation by analytical sieving, particle-size(2.9.38.) ...................................................................................... 325

Disulfiram .................................................................................. 1739Dithranol.................................................................................... 1740DL-Methionine ...........................................................................2380DL-α-Tocopheryl hydrogen succinate...................................3093Dobutamine hydrochloride.....................................................1741Docusate sodium...................................................................... 1743Dodecyl gallate ......................................................................... 1744Dog rose ..................................................................................... 1744Domperidone ............................................................................ 1745Domperidone maleate ............................................................. 1747Dopamine hydrochloride........................................................ 1749Dopexamine dihydrochloride ................................................ 1750Dorzolamide hydrochloride ................................................... 1752

3272 See the information section on general monographs (cover pages)

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Dosage units, uniformity of (2.9.40.) ..................................... 327Dosulepin hydrochloride........................................................ 1753Doxapram hydrochloride........................................................ 1754Doxazosin mesilate .................................................................. 1756Doxepin hydrochloride ........................................................... 1757Doxorubicin hydrochloride.................................................... 1759Doxycycline hyclate ................................................................. 1760Doxycycline monohydrate...................................................... 1762Doxylamine hydrogen succinate........................................... 1763Droperidol.................................................................................. 1765Droppers (2.1.1.)............................................................................15Drop point (2.2.17.)...................................................................... 33Drops (nasal) and sprays (liquid nasal) ................................. 731Drops, oral ................................................................................... 730Dry extracts ................................................................................. 684Dry residue of extracts (2.8.16.).............................................. 256Duck plague vaccine (live) ....................................................... 901Duck viral hepatitis type I vaccine (live)............................... 902Dwarf pine oil ........................................................................... 1766

EEar drops and ear sprays.......................................................... 720Ear powders ................................................................................ 720Ear preparations......................................................................... 719Ear preparations, semi-solid .................................................... 720Ear sprays and ear drops.......................................................... 720Ear tampons................................................................................ 720Ear washes................................................................................... 720Ebastine ..................................................................................... 1771Econazole .................................................................................. 1772Econazole nitrate ..................................................................... 1773Edetic acid ................................................................................. 1774Edrophonium chloride............................................................ 1775Effervescent granules................................................................ 724Effervescent powders ................................................................ 739Effervescent tablets ................................................................... 749Efficacy of antimicrobial preservation (5.1.3.) ..................... 528Egg drop syndrome ′76 vaccine (inactivated)...................... 904Elder flower............................................................................... 1776Electrophoresis (2.2.31.) ............................................................. 48Electrophoresis, capillary (2.2.47.) ........................................... 77Eleutherococcus....................................................................... 1777Emedastine difumarate........................................................... 1779Emetine hydrochloride heptahydrate.................................. 1780Emetine hydrochloride pentahydrate.................................. 1781Empty sterile containers of plasticised poly(vinyl chloride)for human blood and blood components (3.2.4.) ............. 381

Emulsifying cetostearyl alcohol (type A) ............................ 1481Emulsifying cetostearyl alcohol (type B)............................ 1482Emulsions, solutions and suspensions, oral ........................ 729Enalaprilat dihydrate .............................................................. 1784Enalapril maleate ..................................................................... 1782Encephalitis vaccine (inactivated), tick-borne ..................... 845Endotoxins, bacterial (2.6.14.)................................................. 182Enilconazole for veterinary use............................................ 1785Enoxaparin sodium.................................................................. 1787Enoxolone.................................................................................. 1788Ephedrine, anhydrous............................................................. 1789Ephedrine hemihydrate .......................................................... 1790Ephedrine hydrochloride ....................................................... 1791Ephedrine hydrochloride, racemic....................................... 1792Epinephrine tartrate ................................................................1114Epirubicin hydrochloride ....................................................... 1793Equine herpesvirus vaccine (inactivated) ............................. 905Equine influenza vaccine (inactivated) ................................. 907Equisetum stem........................................................................ 1794Ergocalciferol............................................................................ 1795Ergometrine maleate............................................................... 1797Ergotamine tartrate................................................................. 1798

Erysipelas vaccine (inactivated), swine ................................. 955Erythritol ................................................................................... 1800Erythromycin ............................................................................ 1801Erythromycin estolate............................................................. 1803Erythromycin ethylsuccinate................................................. 1806Erythromycin lactobionate .................................................... 1808Erythromycin stearate ............................................................ 1810Erythropoietin concentrated solution................................. 1813Eserine salicylate .....................................................................2677Eserine sulphate.......................................................................2678Esketamine hydrochloride ......................................................1817Essential oils ............................................................................... 680Essential oils, assay of 1,8-cineole in (2.8.11.) ..................... 250Essential oils, fatty oils and resinified essential oils in(2.8.7.)......................................................................................... 250

Essential oils, foreign esters in (2.8.6.) ................................. 250Essential oils in herbal drugs, determination of (2.8.12.).. 251Essential oils, odour and taste (2.8.8.) .................................. 250Essential oils, residue on evaporation (2.8.9.) ..................... 250Essential oils, solubility in alcohol (2.8.10.)......................... 250Essential oils, water in (2.8.5.) ................................................ 249Ester value (2.5.2.) ..................................................................... 137Estradiol benzoate................................................................... 1818Estradiol hemihydrate............................................................. 1819Estradiol valerate ..................................................................... 1821Estriol ......................................................................................... 1822Estrogens, conjugated ............................................................ 1824Etacrynic acid ........................................................................... 1826Etamsylate .................................................................................1827Ethacridine lactate monohydrate......................................... 1828Ethambutol hydrochloride..................................................... 1829Ethanol (96 per cent) .............................................................. 1829Ethanol, anhydrous ................................................................. 1831Ethanol content and alcoholimetric tables (2.9.10.) .......... 281Ether ........................................................................................... 1833Ether, anaesthetic ....................................................................1834Ethinylestradiol ........................................................................ 1834Ethionamide.............................................................................. 1835Ethosuximide ............................................................................1836Ethoxylated substances, ethylene glycol and diethyleneglycol in (2.4.30.) ......................................................................131

Ethyl acetate ............................................................................. 1838Ethyl acrylate - methacrylic acid copolymer (1:1) ............2371Ethylcellulose ........................................................................... 1841Ethylenediamine ...................................................................... 1843Ethylene glycol and diethylene glycol in ethoxylatedsubstances (2.4.30.)..................................................................131

Ethylene glycol monopalmitostearate................................. 1842Ethylene glycol monostearate............................................... 1842Ethylene oxide and dioxan (2.4.25.) ...................................... 126Ethylhexanoic acid, 2- (2.4.28.) ............................................... 129Ethylmorphine hydrochloride...............................................1843Ethyl oleate ............................................................................... 1838Ethyl parahydroxybenzoate...................................................1839Ethyl parahydroxybenzoate sodium ....................................1840Etidronate disodium................................................................ 1844Etilefrine hydrochloride ......................................................... 1845Etodolac ..................................................................................... 1847Etofenamate ..............................................................................1849Etofylline.................................................................................... 1850Etomidate .................................................................................. 1851Etoposide ................................................................................... 1852Eucalyptus leaf ......................................................................... 1857Eucalyptus oil ........................................................................... 1858Eugenol ...................................................................................... 1859European goldenrod ...............................................................2000European viper venom antiserum.......................................... 970Evaluation of efficacy of veterinary vaccines and immunosera(5.2.7.)......................................................................................... 557

General Notices (1) apply to all monographs and other texts 3273

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Evaluation of safety of each batch of veterinary vaccines andimmunosera (5.2.9.) ................................................................ 567

Evaluation of safety of veterinary vaccines and immunosera(5.2.6.) ........................................................................................ 556

Evening primrose oil, refined................................................1860Extractable volume of parenteral preparations, test for(2.9.17.)....................................................................................... 287

Extracts ........................................................................................ 682Extracts, dry ................................................................................ 684Extracts, dry residue of (2.8.16.)............................................. 256Extracts, liquid............................................................................ 683Extracts, loss on drying of (2.8.17.)........................................ 256Extracts, soft ............................................................................... 684Extraneous agents in viral vaccines for human use, tests for(2.6.16.) ...................................................................................... 190

Extraneous agents : tests in batches of finished product ofavian live virus vaccines (2.6.25.)......................................... 202

Extraneous agents : tests in seed lots of avian viral vaccines(2.6.24.) ...................................................................................... 198

Eye drops ..................................................................................... 721Eye lotions ................................................................................... 721Eye preparations ........................................................................ 721Eye preparations, semi-solid .................................................... 722

FF0 concept to steam sterilisation of aqueous preparations,application of (5.1.5.) .............................................................. 531

Factor II, human coagulation, assay of (2.7.18.) ................. 234Factor IX, human coagulation ..............................................2064Factor IX, human coagulation, assay of (2.7.11.) ................ 229Factor VII, human coagulation............................................. 2061Factor VII, human coagulation, assay of (2.7.10.) .............. 228Factor VIII, human coagulation ...........................................2062Factor VIII, human coagulation, assay of (2.7.4.) ................216Factor VIII (rDNA), human coagulation .............................2063Factor X, human coagulation, assay of (2.7.19.) ................. 235Factor XI, human coagulation ..............................................2065Factor XI, human coagulation, assay of (2.7.22.)................ 238Falling ball viscometer method (2.2.49.) ................................ 84Famotidine.................................................................................1865Fatty acids, composition by gas chromatography(2.4.22.) .......................................................................................118

Fatty oils, alkaline impurities in (2.4.19.) ..............................117Fatty oils and herbal drugs, heavy metals in (2.4.27.) ....... 128Fatty oils and resinified essential oils in essential oils(2.8.7.)......................................................................................... 250

Fatty oils, foreign oils in, by thin-layer chromatography(2.4.21.) .......................................................................................117

Fatty oils, identification by thin-layer chromatography(2.3.2.) ........................................................................................ 106

Fatty oils, sterols in (2.4.23.) ................................................... 120Fatty oils, vegetable................................................................... 712Fc function of immunoglobulin, test for (2.7.9.) ................. 227Febantel for veterinary use....................................................1870Felbinac ......................................................................................1866Feline calicivirosis vaccine (inactivated) ............................... 909Feline calicivirosis vaccine (live)..............................................910Feline chlamydiosis vaccine (inactivated)..............................911Feline infectious enteritis (feline panleucopenia) vaccine(inactivated) .............................................................................. 912

Feline infectious enteritis (feline panleucopenia) vaccine(live) .............................................................................................913

Feline leukaemia vaccine (inactivated)...................................914Feline panleucopenia vaccine (inactivated).......................... 912Feline panleucopenia vaccine (live) ........................................913Feline viral rhinotracheitis vaccine (inactivated) .................916Feline viral rhinotracheitis vaccine (live)...............................917Felodipine ..................................................................................1867Felypressin.................................................................................1869

Fenbendazole for veterinary use .......................................... 1871Fenbufen .................................................................................... 1872Fennel, bitter............................................................................. 1873Fennel, sweet............................................................................. 1874Fenofibrate ................................................................................ 1875Fenoterol hydrobromide......................................................... 1876Fentanyl .....................................................................................1878Fentanyl citrate.........................................................................1879Fenticonazole nitrate .............................................................. 1880Fenugreek.................................................................................. 1882Fermentation, products of ....................................................... 693Ferric chloride hexahydrate .................................................. 1882Ferrous fumarate ..................................................................... 1883Ferrous gluconate.................................................................... 1884Ferrous sulphate, dried........................................................... 1885Ferrous sulphate heptahydrate.............................................1886Feverfew ..................................................................................... 1887Fexofenadine hydrochloride .................................................. 1888Fibrinogen, human ..................................................................2066Fibrin sealant kit ......................................................................1890Finasteride................................................................................. 1891Fish oil, rich in omega-3 acids...............................................1893Flavoxate hydrochloride ......................................................... 1895Flecainide acetate .................................................................... 1896Flocculation value (Lf) of diphtheria and tetanus toxins andtoxoids (Ramon assay) (2.7.27.) ............................................ 241

Flowability (2.9.16.) ................................................................... 286Flow cytometry (2.7.24.) ........................................................... 240Flubendazole ............................................................................ 1898Flucloxacillin sodium .............................................................. 1899Fluconazole ...............................................................................1900Flucytosine ................................................................................1902Fludarabine phosphate...........................................................1903Fludeoxyglucose (18F) injection .............................................. 986Fludrocortisone acetate..........................................................1906Flumazenil .................................................................................1908Flumazenil (N-[11C]methyl) injection ..................................... 989Flumequine ...............................................................................1909Flumetasone pivalate .............................................................. 1910Flunarizine dihydrochloride.................................................. 1911Flunitrazepam........................................................................... 1913Flunixin meglumine for veterinary use............................... 1914Fluocinolone acetonide .......................................................... 1915Fluocortolone pivalate............................................................ 1916Fluorescein ................................................................................ 1918Fluorescein sodium ................................................................. 1919Fluorides (2.4.5.) ........................................................................ 112Fluorimetry (2.2.21.) ................................................................... 36Fluorodopa (18F) (prepared by electrophilic substitution)injection ..................................................................................... 990

Fluorouracil...............................................................................1920Fluoxetine hydrochloride .......................................................1922Flupentixol dihydrochloride ..................................................1924Fluphenazine decanoate ........................................................1926Fluphenazine dihydrochloride..............................................1928Fluphenazine enantate ...........................................................1927Flurazepam monohydrochloride ..........................................1930Flurbiprofen .............................................................................. 1931Fluspirilene ...............................................................................1932Flutamide...................................................................................1933Fluticasone propionate ...........................................................1934Flutrimazole ..............................................................................1936Foams, cutaneous ...................................................................... 728Foams, intrauterine ................................................................... 726Foams, medicated ...................................................................... 723Foams, rectal ............................................................................... 746Foams, vaginal ............................................................................ 752Folic acid....................................................................................1938

3274 See the information section on general monographs (cover pages)

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Foot-and-mouth disease (ruminants) vaccine(inactivated) ...............................................................................918

Foreign esters in essential oils (2.8.6.) .................................. 250Foreign matter (2.8.2.) .............................................................. 249Foreign oils in fatty oils by thin-layer chromatography(2.4.21.) .......................................................................................117

Formaldehyde, free (2.4.18.) .....................................................117Formaldehyde solution (35 per cent) ..................................1939Formoterol fumarate dihydrate ............................................1940Foscarnet sodium hexahydrate.............................................1942Fosfomycin calcium .................................................................1943Fosfomycin sodium..................................................................1945Fosfomycin trometamol ..........................................................1946Fowl cholera vaccine (inactivated) ......................................... 920Fowl-pox vaccine (live) .............................................................. 921Framycetin sulphate................................................................1947Frangula bark ...........................................................................1949Frangula bark dry extract, standardised ............................1950Frankincense, Indian .............................................................. 2128Free formaldehyde (2.4.18.) ......................................................117Freezing point (2.2.18.)............................................................... 35Friability of granules and spheroids (2.9.41.) ...................... 330Friability of uncoated tablets (2.9.7.)..................................... 278Fructose ..................................................................................... 1951Fucus .......................................................................................... 2213Fumitory ....................................................................................1952Functional groups and ions, identification reactions of(2.3.1.)......................................................................................... 103

Furosemide................................................................................1953Furunculosis vaccine (inactivated, oil-adjuvanted, injectable)for salmonids ............................................................................ 922

Fusidic acid ...............................................................................1954

GGalactose....................................................................................1959Gallamine triethiodide ............................................................1959Gallium (67Ga) citrate injection ............................................... 992Gargles.......................................................................................... 733Garlic for homoeopathic preparations ................................ 1077Garlic powder............................................................................ 1961Gas chromatography (2.2.28.) ................................................... 45Gas detector tubes (2.1.6.) ..........................................................17Gases, carbon dioxide in (2.5.24.)........................................... 144Gases, carbon monoxide in (2.5.25.) ...................................... 145Gases, nitrogen monoxide and nitrogen dioxide in(2.5.26.) ...................................................................................... 146

Gases, nitrous oxide in (2.5.35.).............................................. 152Gases, oxygen in (2.5.27.) ......................................................... 146Gases, water in (2.5.28.)............................................................ 146Gas-gangrene antitoxin, mixed ................................................ 966Gas-gangrene antitoxin (novyi) ............................................... 966Gas-gangrene antitoxin (perfringens) .................................... 967Gas-gangrene antitoxin (septicum)......................................... 968Gastro-resistant capsules .......................................................... 718Gastro-resistant granules.......................................................... 724Gastro-resistant tablets ............................................................. 750Gelatin ........................................................................................ 1961Gels................................................................................................ 747Gels for injections ...................................................................... 737Gemcitabine hydrochloride....................................................1963Gemfibrozil ................................................................................1964General notices (1.)........................................................................ 3General texts on biological products (5.2.) .......................... 547General texts on microbiology (5.1.)...................................... 525Gene transfer medicinal products for human use (5.14.) .. 669Gentamicin sulphate................................................................1965Gentian root ..............................................................................1967Gentian tincture .......................................................................1968Ginger .........................................................................................1969

Gingival solutions ...................................................................... 733Ginkgo leaf ................................................................................1969Ginseng....................................................................................... 1971Glass containers for pharmaceutical use (3.2.1.) ................ 373Glibenclamide ...........................................................................1972Gliclazide.................................................................................... 1974Glimepiride ................................................................................1975Glipizide .....................................................................................1977Glossary.........................................................................................717Glossary (dosage forms) ............................................................717Glucagon, human.....................................................................1979Glucose, anhydrous ................................................................. 1981Glucose, liquid ..........................................................................1982Glucose, liquid, spray-dried....................................................1982Glucose monohydrate .............................................................1983Glutamic acid ............................................................................1984Glutathione................................................................................1985Glycerol ......................................................................................1987Glycerol (85 per cent)..............................................................1988Glycerol dibehenate .................................................................1990Glycerol distearate ................................................................... 1991Glycerol monocaprylate..........................................................1992Glycerol monocaprylocaprate................................................1993Glycerol monolinoleate ...........................................................1994Glycerol mono-oleate...............................................................1995Glycerol monostearate 40-55.................................................1996Glycerol triacetate.................................................................... 3112Glyceryl trinitrate solution.....................................................1997Glycine ........................................................................................1998Glycyrrhizate ammonium....................................................... 1179Goldenrod ..................................................................................1999Goldenrod, European..............................................................2000Goldenseal rhizome................................................................. 2001Gonadorelin acetate ................................................................2003Gonadotrophin, chorionic ......................................................2004Gonadotrophin, equine serum, for veterinary use............2005Goserelin ....................................................................................2005Gramicidin .................................................................................2007Granisetron hydrochloride.....................................................2009Granules ....................................................................................... 723Granules and powders for oral solutions andsuspensions............................................................................... 729

Granules and powders for syrups........................................... 730Granules and spheroids, friability of (2.9.41.)...................... 330Granules, coated......................................................................... 724Granules, effervescent............................................................... 724Granules, gastro-resistant......................................................... 724Granules, modified-release....................................................... 724Greater celandine ..................................................................... 2010Griseofulvin ............................................................................... 2011Guaiacol ..................................................................................... 2012Guaifenesin................................................................................ 2014Guanethidine monosulphate ................................................. 2015Guar ............................................................................................ 2016Guar galactomannan ............................................................... 2016

HHaematopoietic products, numeration of CD34/CD45+ cellsin (2.7.23.).................................................................................. 238

Haematopoietic progenitor cells, human, colony-forming cellassay for (2.7.28.) ..................................................................... 242

Haematopoietic stem cells, human ......................................2067Haemodiafiltration and for haemofiltration, solutionsfor ..............................................................................................2025

Haemodialysis, concentrated solutions for ........................2022Haemodialysis solutions, concentrated, water fordiluting..................................................................................... 2021

Haemodialysis, solutions for..................................................2022

General Notices (1) apply to all monographs and other texts 3275

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Haemofiltration and for haemodiafiltration,solutions for ............................................................................2025

Haemophilus type b (conjugate), diphtheria, tetanus andpertussis (acellular, component) vaccine (adsorbed)....... 771

Haemophilus type b (conjugate), diphtheria, tetanus,pertussis (acellular, component) and poliomyelitis(inactivated) vaccine (adsorbed) ........................................... 783

Haemophilus type b (conjugate), diphtheria, tetanus,pertussis (acellular, component), hepatitis B (rDNA) andpoliomyelitis (inactivated) vaccine (adsorbed) .................. 780

Haemophilus type b (conjugate), diphtheria, tetanus,pertussis and poliomyelitis (inactivated) vaccine(adsorbed).................................................................................. 787

Haemophilus type b conjugate vaccine................................. 792Haemorrhagic disease vaccine (inactivated), rabbit ........... 949Halofantrine hydrochloride ...................................................2027Haloperidol................................................................................2028Haloperidol decanoate............................................................2030Halothane .................................................................................. 2031Hamamelis leaf .........................................................................2033Hard capsules.............................................................................. 718Hard fat ......................................................................................2034Hard paraffin............................................................................. 2612Hawthorn berries .....................................................................2034Hawthorn leaf and flower ......................................................2035Hawthorn leaf and flower dry extract .................................2036Hawthorn leaf and flower liquid extract, quantified ........2037Heavy bismuth subnitrate ...................................................... 1315Heavy kaolin.............................................................................. 2213Heavy magnesium carbonate ................................................ 2315Heavy magnesium oxide.........................................................2320Heavy metals (2.4.8.) ................................................................. 112Heavy metals in herbal drugs and fatty oils (2.4.27.)......... 128Hedera helix for homoeopathic preparations.................... 1078Helium ........................................................................................2038Heparin, assay of (2.7.5.) ...........................................................217Heparin calcium .......................................................................2039Heparin in coagulation factors, assay of (2.7.12.) ............... 230Heparins, low-molecular-mass ............................................... 2041Heparin sodium........................................................................2040Hepatitis A immunoglobulin, human ..................................2068Hepatitis A (inactivated) and hepatitis B (rDNA) vaccine(adsorbed).................................................................................. 794

Hepatitis A vaccine, assay of (2.7.14.) .................................... 232Hepatitis A vaccine (inactivated, adsorbed) ......................... 795Hepatitis A vaccine (inactivated, virosome) ......................... 797Hepatitis B immunoglobulin for intravenous administration,human ......................................................................................2069

Hepatitis B immunoglobulin, human ..................................2069Hepatitis B (rDNA), diphtheria and tetanus vaccine(adsorbed).................................................................................. 765

Hepatitis B (rDNA), diphtheria, tetanus and pertussis(acellular, component) vaccine (adsorbed) ........................ 774

Hepatitis B (rDNA), diphtheria, tetanus, pertussis (acellular,component), poliomyelitis (inactivated) and haemophilustype b conjugate vaccine (adsorbed) ................................... 780

Hepatitis B vaccine (rDNA)...................................................... 800Hepatitis B vaccine (rDNA), assay of (2.7.15.) ..................... 233Hepatitis C virus (HCV), validation of nucleic acidamplification techniques for the detection of HCV RNA inplasma pools : Guidelines....................................................... 195

Heptaminol hydrochloride .....................................................2043Herbal drug preparations......................................................... 684Herbal drugs ............................................................................... 684Herbal drugs and fatty oils, heavy metals in (2.4.27.)........ 128Herbal drugs, determination of aflatoxin B1 in (2.8.18.)... 256Herbal drugs, determination of essential oils in herbal drugs(2.8.12.) ...................................................................................... 251

Herbal drugs, determination of tannins (2.8.14.) ............... 255

Herbal drugs for homoeopathic preparations ................... 1065Herbal teas................................................................................... 685Hexamidine diisetionate .........................................................2044Hexetidine..................................................................................2045Hexobarbital..............................................................................2047Hexosamines in polysaccharide vaccines (2.5.20.) ............. 143Hexylresorcinol.........................................................................2047Highly purified water .............................................................. 3212Histamine (2.6.10.)..................................................................... 165Histamine dihydrochloride ....................................................2049Histamine phosphate ..............................................................2049Histidine.....................................................................................2050Histidine hydrochloride monohydrate ................................ 2051Homatropine hydrobromide ..................................................2052Homatropine methylbromide ................................................2053Homoeopathic preparations .................................................. 1065Homoeopathic preparations, arsenious trioxide for ........1073Homoeopathic preparations, calcium iodide tetrahydratefor .............................................................................................. 1074

Homoeopathic preparations, common stinging nettlefor .............................................................................................. 1075

Homoeopathic preparations, copper acetate monohydratefor .............................................................................................. 1075

Homoeopathic preparations, copper for............................. 1076Homoeopathic preparations, garlic for ...............................1077Homoeopathic preparations, hedera helix for...................1078Homoeopathic preparations, herbal drugs for ..................1065Homoeopathic preparations, honey bee for....................... 1079Homoeopathic preparations, hyoscyamus for ................... 1079Homoeopathic preparations, hypericum for ...................... 1080Homoeopathic preparations, iron for .................................. 1081Homoeopathic preparations, mother tinctures for........... 1072Homoeopathic preparations, oriental cashew for............. 1082Homoeopathic preparations, saffron for............................. 1084Homoeopathic stocks (methods of preparation of) andpotentisation........................................................................... 1066

Honey .........................................................................................2055Honey bee for homoeopathic preparations........................ 1079Hop strobile...............................................................................2056Human albumin injection, iodinated (125I)............................ 993Human albumin solution .......................................................2057Human anti-D immunoglobulin ............................................2058Human anti-D immunoglobulin, assay of (2.7.13.).............. 230Human anti-D immunoglobulin for intravenousadministration ........................................................................2059

Human antithrombin III, assay of (2.7.17.) ........................... 234Human antithrombin III concentrate ..................................2060Human coagulation factor II, assay of (2.7.18.)................... 234Human coagulation factor IX................................................2064Human coagulation factor IX, assay of (2.7.11.).................. 229Human coagulation factor VII .............................................. 2061Human coagulation factor VII, assay of (2.7.10.) ................ 228Human coagulation factor VIII .............................................2062Human coagulation factor VIII, assay of (2.7.4.)..................216Human coagulation factor VIII (rDNA)...............................2063Human coagulation factor X, assay of (2.7.19.) ................... 235Human coagulation factor XI ................................................2065Human coagulation factor XI, assay of (2.7.22.) ................. 238Human fibrinogen....................................................................2066Human haematopoietic progenitor cells, colony-forming cellassay for (2.7.28.) ..................................................................... 242

Human haematopoietic stem cells .......................................2067Human hepatitis A immunoglobulin ...................................2068Human hepatitis B immunoglobulin ...................................2069Human hepatitis B immunoglobulin for intravenousadministration ........................................................................2069

Human insulin .......................................................................... 2137Human measles immunoglobulin.........................................2069Human normal immunoglobulin..........................................2070

3276 See the information section on general monographs (cover pages)

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Human normal immunoglobulin for intravenousadministration ........................................................................2072

Human plasma for fractionation...........................................2073Human plasma (pooled and treated for virusinactivation) ............................................................................2075

Human prothrombin complex...............................................2076Human rabies immunoglobulin............................................2078Human rubella immunoglobulin ..........................................2079Human tetanus immunoglobulin .........................................2079Human varicella immunoglobulin........................................2080Human varicella immunoglobulin for intravenousadministration ........................................................................ 2081

Human von Willebrand factor............................................... 2081Human von Willebrand factor, assay of (2.7.21.) ................ 237Hyaluronidase ..........................................................................2082Hydralazine hydrochloride ....................................................2083Hydrochloric acid, concentrated...........................................2085Hydrochloric acid, dilute ........................................................2085Hydrochlorothiazide................................................................2086Hydrocodone hydrogen tartrate 2.5-hydrate .....................2087Hydrocortisone.........................................................................2089Hydrocortisone acetate........................................................... 2091Hydrocortisone hydrogen succinate ....................................2092Hydrogenated arachis oil ....................................................... 1211Hydrogenated castor oil ......................................................... 1432Hydrogenated cottonseed oil ................................................1625Hydrogenated soya-bean oil...................................................2946Hydrogenated vegetable oils, nickel in (2.4.31.)...................131Hydrogenated wool fat............................................................3226Hydrogen peroxide solution (30 per cent) .........................2094Hydrogen peroxide solution (3 per cent)............................2094Hydromorphone hydrochloride ............................................2095Hydrophobic colloidal silica ..................................................2878Hydrous wool fat ......................................................................3227Hydroxocobalamin acetate.....................................................2096Hydroxocobalamin chloride...................................................2098Hydroxocobalamin sulphate ..................................................2099Hydroxycarbamide ................................................................... 2100Hydroxyethylcellulose............................................................. 2102Hydroxyethylmethylcellulose ................................................2390Hydroxyethyl salicylate........................................................... 2101Hydroxyl value (2.5.3.) .............................................................. 137Hydroxypropylbetadex............................................................ 2103Hydroxypropylcellulose .......................................................... 2105Hydroxypropylmethylcellulose.............................................. 2113Hydroxypropylmethylcellulose phthalate........................... 2115Hydroxyzine hydrochloride ................................................... 2106Hymecromone........................................................................... 2107Hyoscine..................................................................................... 2108Hyoscine butylbromide ........................................................... 2109Hyoscine hydrobromide.......................................................... 2110Hyoscyamine sulphate ............................................................ 2112Hyoscyamus for homoeopathic preparations .................... 1079Hypericum .................................................................................2958Hypericum for homoeopathic preparations ....................... 1080Hypromellose ............................................................................ 2113Hypromellose phthalate ......................................................... 2115

IIbuprofen ................................................................................... 2119Iceland moss.............................................................................. 2121ICH (5.8.)...................................................................................... 645Ichthammol ............................................................................... 2122Identification (2.3.) .................................................................... 103Identification and control of residual solvents (2.4.24.).... 121Identification of fatty oils by thin-layer chromatography(2.3.2.) ........................................................................................ 106

Identification of phenothiazines by thin-layerchromatography (2.3.3.) ......................................................... 107

Identification reactions of ions and functional groups(2.3.1.)......................................................................................... 103

Idoxuridine ................................................................................ 2122Ifosfamide .................................................................................. 2123Imipenem ................................................................................... 2125Imipramine hydrochloride ..................................................... 2126Immunochemical methods (2.7.1.) ......................................... 209Immunoglobulin for human use, anti-T lymphocyte,animal.......................................................................................1203

Immunoglobulin for intravenous administration, humananti-D ........................................................................................2059

Immunoglobulin for intravenous administration, humanhepatitis B ...............................................................................2069

Immunoglobulin for intravenous administration, humannormal ......................................................................................2072

Immunoglobulin for intravenous administration, humanvaricella.................................................................................... 2081

Immunoglobulin, human anti-D ...........................................2058Immunoglobulin, human anti-D, assay of (2.7.13.) ............. 230Immunoglobulin, human hepatitis A...................................2068Immunoglobulin, human hepatitis B ..................................2069Immunoglobulin, human measles ........................................2069Immunoglobulin, human normal .........................................2070Immunoglobulin, human rabies ...........................................2078Immunoglobulin, human rubella .........................................2079Immunoglobulin, human tetanus.........................................2079Immunoglobulin, human varicella .......................................2080Immunoglobulin, test for anticomplementary activity of(2.6.17.)........................................................................................191

Immunoglobulin, test for Fc function of (2.7.9.)................. 227Immunosera and vaccines, phenol in (2.5.15.) .................... 142Immunosera and vaccines, veterinary, evaluation of safety(5.2.6.) ........................................................................................ 556

Immunosera and vaccines, veterinary, evaluation of theefficacy (5.2.7) .......................................................................... 557

Immunosera and vaccines, veterinary, evaluation of thesafety of each batch (5.2.9.) ................................................... 567

Immunosera for human use, animal...................................... 685Immunosera for veterinary use............................................... 687Implants ....................................................................................... 737Impurities in substances for pharmaceutical use, control of(5.10.).......................................................................................... 653

Indapamide................................................................................ 2127Indian frankincense................................................................. 2128Indicators, relationship between approximate pH and colour(2.2.4.) .......................................................................................... 25

Indinavir sulphate.................................................................... 2130Indium (111In) chloride solution .............................................. 994Indium (111In) oxine solution ................................................... 995Indium (111In) pentetate injection........................................... 996Indometacin .............................................................................. 2132Inductively coupled plasma-atomic emission spectrometry(2.2.57.) ........................................................................................ 96

Inductively coupled plasma-mass spectrometry (2.2.58.).... 98Infectious bovine rhinotracheitis vaccine (live)................... 924Infectious bronchitis vaccine (inactivated), avian ............... 864Infectious bronchitis vaccine (live), avian............................. 865Infectious bursal disease vaccine (inactivated), avian........ 867Infectious bursal disease vaccine (live), avian ..................... 869Infectious chicken anaemia vaccine (live) ............................ 925Infectious encephalomyelitis vaccine (live), avian .............. 871Infectious laryngotracheitis vaccine (live), avian ................ 872Influenza vaccine (split virion, inactivated) ......................... 801Influenza vaccine (surface antigen, inactivated)................. 803Influenza vaccine (surface antigen, inactivated, prepared incell cultures) ............................................................................. 804

Influenza vaccine (surface antigen, inactivated,virosome) ................................................................................... 806

Influenza vaccine (whole virion, inactivated) ...................... 808

General Notices (1) apply to all monographs and other texts 3277

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Influenza vaccine (whole virion, inactivated, prepared in cellcultures) ......................................................................................810

Infrared absorption spectrophotometry (2.2.24.) ................. 39Infusions ...................................................................................... 736Inhalation gas, krypton (81MKr) ............................................. 1000Inhalation, preparations for..................................................... 739Inhalation, preparations for : aerodynamic assessment of fineparticles (2.9.18.) ..................................................................... 287

Injectable insulin preparations ............................................. 2146Injections ..................................................................................... 736Injections, gels for...................................................................... 737Injections or infusions, concentrates for .............................. 736Injections or infusions, powders for ...................................... 736Inositol, myo- ............................................................................2460Inserts, ophthalmic.................................................................... 722Insulin aspart ............................................................................ 2133Insulin, bovine .......................................................................... 2135Insulin, human.......................................................................... 2137Insulin injection, biphasic ...................................................... 2140Insulin injection, biphasic isophane .................................... 2140Insulin injection, isophane......................................................2141Insulin injection, soluble .........................................................2141Insulin lispro ..............................................................................2141Insulin, porcine......................................................................... 2144Insulin preparations, injectable ............................................ 2146Insulin zinc injectable suspension ....................................... 2148Insulin zinc injectable suspension (amorphous) .............. 2149Insulin zinc injectable suspension (crystalline) ................ 2149Interferon alfa-2 concentrated solution .............................. 2150Interferon gamma-1b concentrated solution ..................... 2153Interferons, assay of (5.6.)........................................................ 627International System (SI) units (1.) ........................................... 3Intramammary preparations for veterinary use .................. 725Intraruminal devices ................................................................. 725Intrauterine capsules ................................................................ 726Intrauterine foams ..................................................................... 726Intrauterine preparations for veterinary use ....................... 726Intrauterine solutions, suspensions....................................... 726Intrauterine sticks...................................................................... 726Intrauterine tablets.................................................................... 726Intrinsic dissolution (2.9.29.) .................................................. 309In vivo assay of poliomyelitis vaccine (inactivated)(2.7.20.) ...................................................................................... 235

Iobenguane (123I) injection....................................................... 997Iobenguane (131I) injection for diagnostic use ..................... 998Iobenguane (131I) injection for therapeutic use ................... 999Iobenguane sulphate for radiopharmaceuticalpreparations ............................................................................ 1000

Iodinated (125I) human albumin injection ............................. 993Iodinated povidone..................................................................2734Iodine.......................................................................................... 2156Iodine value (2.5.4.) ................................................................... 137Iohexol........................................................................................ 2157Ionic concentration, potentiometric determination of usingion-selective electrodes (2.2.36.)............................................. 58

Ions and functional groups, identification reactions of(2.3.1.)......................................................................................... 103

Ion-selective electrodes, potentiometric determination ofionic concentration (2.2.36.) ................................................... 58

Iopamidol ................................................................................... 2160Iopanoic acid............................................................................. 2162Iotalamic acid............................................................................ 2163Iotrolan....................................................................................... 2164Ioxaglic acid .............................................................................. 2167Ipecacuanha liquid extract, standardised ........................... 2168Ipecacuanha, prepared............................................................ 2169Ipecacuanha root ..................................................................... 2170Ipecacuanha tincture, standardised..................................... 2171Ipratropium bromide............................................................... 2172

Iron (2.4.9.) .................................................................................. 115Iron for homoeopathic preparations ................................... 1081Irrigation, preparations for ...................................................... 743Isoconazole................................................................................ 2173Isoconazole nitrate .................................................................. 2175Isoelectric focusing (2.2.54.)...................................................... 84Isoflurane....................................................................................2176Isoleucine................................................................................... 2177Isomalt........................................................................................ 2178Isoniazid..................................................................................... 2180Isophane insulin injection.......................................................2141Isoprenaline hydrochloride.................................................... 2181Isoprenaline sulphate.............................................................. 2182Isopropyl alcohol...................................................................... 2182Isopropyl myristate .................................................................. 2183Isopropyl palmitate.................................................................. 2184Isosorbide dinitrate, diluted ................................................. 2185Isosorbide mononitrate, diluted .......................................... 2186Isotretinoin ................................................................................ 2188Isoxsuprine hydrochloride ..................................................... 2189Ispaghula husk ......................................................................... 2191Ispaghula seed .......................................................................... 2192Isradipine ................................................................................... 2192Itraconazole .............................................................................. 2194Ivermectin.................................................................................. 2196Ivy leaf ........................................................................................ 2198

JJavanese turmeric .................................................................... 3150Java tea .......................................................................................2203Josamycin...................................................................................2204Josamycin propionate..............................................................2205Juniper........................................................................................2206Juniper oil ..................................................................................2207

KKanamycin acid sulphate ....................................................... 2211Kanamycin monosulphate...................................................... 2212Kaolin, heavy............................................................................. 2213Kelp ............................................................................................. 2213Ketamine hydrochloride ......................................................... 2214Ketobemidone hydrochloride................................................ 2215Ketoconazole ............................................................................ 2216Ketoprofen................................................................................. 2218Ketorolac trometamol .............................................................2220Ketotifen hydrogen fumarate ................................................ 2221Knotgrass...................................................................................2223Krypton (81mKr) inhalation gas.............................................. 1000

LLabetalol hydrochloride .........................................................2227Lactic acid..................................................................................2228Lactic acid, (S)- .........................................................................2229Lactitol monohydrate..............................................................2229Lactobionic acid ....................................................................... 2231Lactose, anhydrous..................................................................2232Lactose monohydrate..............................................................2233Lactulose....................................................................................2234Lactulose, liquid .......................................................................2236Lamivudine................................................................................2238Lansoprazole.............................................................................2240Laser light diffraction, particle size analysis by (2.9.31.) ..311Lauroyl macrogolglycerides ..................................................2242Lavender flower........................................................................2243Lavender oil...............................................................................2244Lead in sugars (2.4.10.) ............................................................ 115Leflunomide ..............................................................................2245Lemon oil ...................................................................................2246

3278 See the information section on general monographs (cover pages)

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Lemon verbena leaf .................................................................2248Leptospirosis vaccine (inactivated), bovine.......................... 876Leptospirosis vaccine (inactivated), canine .......................... 888Letrozole ....................................................................................2249Leucine.......................................................................................2250Leuprorelin................................................................................ 2251Levamisole for veterinary use ...............................................2253Levamisole hydrochloride ......................................................2254Levocabastine hydrochloride ................................................2255Levocarnitine ............................................................................2257Levodopa....................................................................................2258Levodropropizine .....................................................................2260Levomenthol ............................................................................. 2261Levomepromazine hydrochloride.........................................2262Levomepromazine maleate ....................................................2263Levomethadone hydrochloride .............................................2264Levonorgestrel ..........................................................................2266Levothyroxine sodium ............................................................2267Lidocaine ...................................................................................2268Lidocaine hydrochloride.........................................................2269Light liquid paraffin ................................................................ 2612Light magnesium carbonate.................................................. 2316Light magnesium oxide .......................................................... 2321Lime flower ...............................................................................2270Limit tests (2.4.)...........................................................................111Limit tests, standard solutions for (4.1.2.)............................ 504Lincomycin hydrochloride .....................................................2271Lindane ......................................................................................2272Linen thread, sterile, in distributor for veterinary use ...1058Linoleoyl macrogolglycerides................................................2273Linseed .......................................................................................2273Linseed oil, virgin .................................................................... 2274Liothyronine sodium............................................................... 2274Lipophilic solid dosage forms, dissolution test for(2.9.42.) ...................................................................................... 332

Liquid chromatography (2.2.29.) .............................................. 46Liquid extracts ............................................................................ 683Liquid glucose ..........................................................................1982Liquid glucose, spray-dried....................................................1982Liquid lactulose ........................................................................2236Liquid maltitol ..........................................................................2332Liquid paraffin .......................................................................... 2613Liquid preparations for cutaneous application ................... 728Liquid preparations for cutaneous application,veterinary .................................................................................. 752

Liquid preparations for inhalation ......................................... 740Liquid preparations for oral use............................................. 728Liquids, clarity and degree of opalescence of (2.2.1.) ...........21Liquid sorbitol (crystallising) ................................................2942Liquid sorbitol (non-crystallising) ........................................2943Liquid sorbitol, partially dehydrated ...................................2944Liquorice ethanolic liquid extract, standardised ..............2275Liquorice root ........................................................................... 2276Lisinopril dihydrate .................................................................2277Lithium carbonate ...................................................................2279Lithium citrate..........................................................................2279L-Methionine ([11C]methyl) injection.................................... 1001Lobeline hydrochloride...........................................................2280Lomustine.................................................................................. 2281Loosestrife .................................................................................2283Loperamide hydrochloride.....................................................2283Loperamide oxide monohydrate...........................................2285Loratadine .................................................................................2286Lorazepam.................................................................................2288Loss on drying (2.2.32.).............................................................. 53Loss on drying of extracts (2.8.17.) ........................................ 256Lovage root................................................................................2290Lovastatin .................................................................................. 2291Low-molecular-mass heparins ............................................... 2041

Lozenges and pastilles .............................................................. 734Lozenges, compressed .............................................................. 734Lubricant, silicone oil (3.1.8.).................................................. 358Lymecycline...............................................................................2292Lynestrenol................................................................................2294Lyophilisates, oral ...................................................................... 748Lysine acetate ...........................................................................2295Lysine hydrochloride...............................................................2296

MMacrogol 15 hydroxystearate ................................................2305Macrogol 20 glycerol monostearate ....................................2304Macrogol 40 sorbitol heptaoleate ........................................ 2310Macrogol 6 glycerol caprylocaprate.....................................2302Macrogol cetostearyl ether .................................................... 2301Macrogolglycerol cocoates.....................................................2302Macrogolglycerol hydroxystearate .......................................2303Macrogolglycerol ricinoleate .................................................2304Macrogol lauryl ether .............................................................2306Macrogol oleate ........................................................................2307Macrogol oleyl ether ...............................................................2308Macrogols...................................................................................2308Macrogol stearate..................................................................... 2311Macrogol stearyl ether............................................................ 2312Magaldrate................................................................................. 2312Magnesium (2.4.6.) .................................................................... 112Magnesium acetate tetrahydrate .......................................... 2313Magnesium and alkaline-earth metals (2.4.7.) ..................... 112Magnesium aspartate dihydrate ........................................... 2314Magnesium carbonate, heavy ................................................ 2315Magnesium carbonate, light .................................................. 2316Magnesium chloride 4.5-hydrate .......................................... 2317Magnesium chloride hexahydrate ........................................ 2316Magnesium citrate, anhydrous.............................................. 2318Magnesium glycerophosphate............................................... 2318Magnesium hydroxide ............................................................. 2319Magnesium lactate dihydrate ................................................2320Magnesium oxide, heavy.........................................................2320Magnesium oxide, light........................................................... 2321Magnesium peroxide ............................................................... 2321Magnesium pidolate ................................................................2322Magnesium stearate.................................................................2323Magnesium sulphate heptahydrate......................................2325Magnesium trisilicate ..............................................................2325Maize oil, refined......................................................................2326Maize starch ..............................................................................2326Malathion...................................................................................2327Maleic acid .................................................................................2328Malic acid ...................................................................................2329Mallow flower............................................................................2330Maltitol .......................................................................................2330Maltitol, liquid...........................................................................2332Maltodextrin ..............................................................................2333Mandarin oil ..............................................................................2333Manganese glycerophosphate, hydrated.............................2334Manganese sulphate monohydrate ......................................2335Mannheimia vaccine (inactivated) for cattle ........................ 927Mannheimia vaccine (inactivated) for sheep........................ 928Mannitol .....................................................................................2336Maprotiline hydrochloride .....................................................2337Marek’s disease vaccine (live).................................................. 930Marshmallow leaf .....................................................................2338Marshmallow root ....................................................................2339Mass spectrometry (2.2.43.)....................................................... 68Mass spectrometry, inductively coupled plasma- (2.2.58.).. 98Mass uniformity of delivered doses from multidose containers(2.9.27.) ...................................................................................... 309

Mass uniformity of single-dose preparations (2.9.5.) ......... 278Mastic..........................................................................................2340

General Notices (1) apply to all monographs and other texts 3279

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Materials based on non-plasticised poly(vinyl chloride) forcontainers for dry dosage forms for oral administration(3.1.11.)....................................................................................... 362

Materials based on non-plasticised poly(vinyl chloride)for containers for non-injectable, aqueous solutions(3.1.10.) ...................................................................................... 360

Materials based on plasticised poly(vinyl chloride) forcontainers for aqueous solutions for intravenous infusion(3.1.14.) ...................................................................................... 366

Materials based on plasticised poly(vinyl chloride) forcontainers for human blood and blood components(3.1.1.1.) ..................................................................................... 339

Materials based on plasticised poly(vinyl chloride) fortubing used in sets for the transfusion of blood and bloodcomponents (3.1.1.2.).............................................................. 342

Materials for containers for human blood and bloodcomponents (3.1.1.) ................................................................. 339

Materials used for the manufacture of containers (3.1.) ... 339Matricaria flower ......................................................................2340Matricaria liquid extract ......................................................... 2341Matricaria oil .............................................................................2342Meadowsweet ............................................................................2344Measles immunoglobulin, human ........................................2069Measles, mumps and rubella vaccine (live) .......................... 812Measles vaccine (live) ................................................................ 813Measurement of consistency by penetrometry (2.9.9.) ...... 279Mebendazole .............................................................................2345Meclozine hydrochloride ........................................................2346Medicated chewing gum (2.9.25.)........................................... 304Medicated chewing gums ......................................................... 719Medicated feeding stuffs for veterinary use, premixes for.. 739Medicated foams......................................................................... 723Medicated plasters ..................................................................... 747Medicated tampons.................................................................... 751Medicated vaginal tampons ..................................................... 752Medicinal air.............................................................................. 1118Medicinal air, synthetic........................................................... 1121Medium-chain triglycerides.................................................... 3122Medroxyprogesterone acetate ...............................................2347Mefenamic acid .........................................................................2349Mefloquine hydrochloride......................................................2350Megestrol acetate .....................................................................2352Meglumine.................................................................................2353Melilot.........................................................................................2354Melissa leaf ................................................................................2355Melting point - capillary method (2.2.14.)............................... 32Melting point - instantaneous method (2.2.16.) .................... 33Melting point - open capillary method (2.2.15.) .................... 32Menadione .................................................................................2356Meningococcal group C conjugate vaccine...........................814Meningococcal polysaccharide vaccine..................................816Menthol, racemic......................................................................2356Mepivacaine hydrochloride....................................................2357Meprobamate ............................................................................2359Mepyramine maleate ...............................................................2360Mercaptopurine ........................................................................ 2361Mercuric chloride..................................................................... 2361Mesalazine .................................................................................2362Mesna..........................................................................................2364Mesterolone...............................................................................2366Mestranol ...................................................................................2367Metacresol .................................................................................2368Metamizole sodium .................................................................2369Metformin hydrochloride .......................................................2370Methacrylate copolymer, basic butylated ...........................1254Methacrylic acid - ethyl acrylate copolymer (1:1) .............2371Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion30 per cent ..............................................................................2372

Methacrylic acid - methyl methacrylate copolymer (1:1) ..2373Methacrylic acid - methyl methacrylate copolymer (1:2) .. 2374Methadone hydrochloride...................................................... 2374Methanol .................................................................................... 2376Methanol and 2-propanol, test for (2.9.11.) .......................... 282Methaqualone ...........................................................................2377Methenamine ............................................................................2378Methionine ................................................................................2379Methionine ([11C]methyl) injection, L-.................................. 1001Methionine, DL- .........................................................................2380Methods in pharmacognosy (2.8.) .......................................... 249Methods of preparation of homoeopathic stocks andpotentisation........................................................................... 1066

Methods of preparation of sterile products (5.1.1.) ............ 525Methotrexate .............................................................................2380Methylatropine bromide .........................................................2383Methylatropine nitrate ............................................................2383Methylcellulose.........................................................................2384Methyldopa................................................................................2386Methylene blue .........................................................................2402Methylene chloride ..................................................................2387Methylergometrine maleate...................................................2388Methylhydroxyethylcellulose .................................................2390Methyl nicotinate .....................................................................2390Methyl parahydroxybenzoate ................................................ 2391Methylpentoses in polysaccharide vaccines (2.5.21.) ......... 143Methylphenobarbital ...............................................................2392Methylprednisolone.................................................................2393Methylprednisolone acetate...................................................2395Methylprednisolone hydrogen succinate ............................2397Methylpyrrolidone, N- .............................................................2399Methylrosanilinium chloride .................................................2400Methyl salicylate....................................................................... 2401Methyltestosterone ..................................................................2402Methylthioninium chloride ....................................................2402Metixene hydrochloride ..........................................................2404Metoclopramide........................................................................2405Metoclopramide hydrochloride.............................................2407Metolazone ................................................................................2407Metoprolol succinate...............................................................2409Metoprolol tartrate .................................................................. 2410Metrifonate ................................................................................ 2412Metronidazole ........................................................................... 2414Metronidazole benzoate ......................................................... 2415Mexiletine hydrochloride........................................................ 2416Mianserin hydrochloride ........................................................ 2417Miconazole ................................................................................ 2418Miconazole nitrate ...................................................................2420Microbial enumeration tests (microbiological examination ofnon-sterile products) (2.6.12.) ............................................... 166

Microbiological assay of antibiotics (2.7.2.)...........................210Microbiological control of cellular products (2.6.27.) ........ 205Microbiological examination of non-sterile products : test forspecified micro-organisms (2.6.13.) ..................................... 173

Microbiological examination of non-sterile products : totalviable aerobic count (2.6.12.) ................................................ 166

Microbiological quality, alternative methods for control of(5.1.6.)......................................................................................... 532

Microbiological quality of pharmaceutical preparations(5.1.4.)......................................................................................... 529

Microbiology, general texts on (5.1.) ..................................... 525Microcrystalline cellulose....................................................... 1469Microcrystalline cellulose and carmellose sodium...........2422Micro determination of water (2.5.32.).................................. 147Microscopy, optical (2.9.37.) .................................................... 323Midazolam .................................................................................2422Milk thistle dry extract, refined and standardised............2426Milk-thistle fruit........................................................................2425

3280 See the information section on general monographs (cover pages)

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Minimising the risk of transmitting animal spongiformencephalopathy agents via human and veterinary medicinalproducts (5.2.8.) ....................................................................... 558

Minocycline hydrochloride dihydrate ..................................2427Minoxidil ....................................................................................2429Mint oil, partly dementholised ..............................................2430Mirtazapine ............................................................................... 2431Misoprostol................................................................................2433Mitomycin ..................................................................................2434Mitoxantrone hydrochloride..................................................2436Modafinil ....................................................................................2437Modified-release capsules......................................................... 718Modified-release granules ........................................................ 724Modified-release tablets ............................................................ 750Molecular mass distribution in dextrans (2.2.39.) ................ 60Molgramostim concentrated solution .................................2438Mometasone furoate................................................................ 2441Monoclonal antibodies for human use.................................. 690Morantel hydrogen tartrate for veterinary use .................2443Morphine hydrochloride.........................................................2444Morphine sulphate...................................................................2446Moss, Iceland ............................................................................ 2121Mother tinctures for homoeopathic preparations ............ 1072Motherwort ...............................................................................2447Mouthwashes .............................................................................. 733Moxidectin for veterinary use ...............................................2448Moxifloxacin hydrochloride ................................................... 2451Moxonidine ................................................................................2453Mucoadhesive preparations ..................................................... 735Mullein flower...........................................................................2454Multidose containers, uniformity of mass of delivered doses(2.9.27.) ...................................................................................... 309

Mumps vaccine (live) ..................................................................818Mupirocin...................................................................................2454Mupirocin calcium ...................................................................2456Mycobacteria (2.6.2.) ................................................................. 159Mycophenolate mofetil............................................................2458Mycoplasma gallisepticum vaccine (inactivated)................. 932Mycoplasmas (2.6.7.).................................................................. 159myo-Inositol ..............................................................................2460Myrrh .......................................................................................... 2461Myrrh tincture .......................................................................... 2461Myxomatosis vaccine (live) for rabbits .................................. 933

NNabumetone ..............................................................................2465N-Acetyltryptophan.................................................................. 1104N-Acetyltyrosine ....................................................................... 1106Nadolol .......................................................................................2466Nadroparin calcium .................................................................2467Naftidrofuryl hydrogen oxalate.............................................2470Nalidixic acid.............................................................................2472Naloxone hydrochloride dihydrate.......................................2473Naltrexone hydrochloride....................................................... 2474Nandrolone decanoate ............................................................ 2476Naphazoline hydrochloride....................................................2478Naphazoline nitrate .................................................................2479Naproxen....................................................................................2480Naproxen sodium .....................................................................2482Narrow-leaved coneflower root .............................................2483Nasal drops and liquid nasal sprays....................................... 731Nasal powders............................................................................. 732Nasal preparations ..................................................................... 730Nasal preparations, semi-solid................................................. 732Nasal sprays (liquid) and nasal drops .................................... 730Nasal sticks.................................................................................. 732Nasal washes ............................................................................... 732Near-infrared spectrophotometry (2.2.40.) ............................. 62Neohesperidin-dihydrochalcone ...........................................2485

Neomycin sulphate ..................................................................2487Neonatal piglet colibacillosis vaccine (inactivated) ............ 934Neonatal ruminant colibacillosis vaccine (inactivated) ..... 936Neostigmine bromide ..............................................................2489Neostigmine metilsulfate........................................................2490Neroli oil ....................................................................................2490Netilmicin sulphate..................................................................2492Nettle leaf...................................................................................2493Neurovirulence test for poliomyelitis vaccine (oral)(2.6.19.) ...................................................................................... 193

Neurovirulence test of live viral vaccines (2.6.18.) ............. 193Nevirapine, anhydrous ............................................................2495Newcastle disease vaccine (inactivated) ................................ 937Newcastle disease vaccine (live).............................................. 939Nicergoline ................................................................................2496Nickel in hydrogenated vegetable oils (2.4.31.)....................131Nickel in polyols (2.4.15.) ..........................................................116Niclosamide, anhydrous .........................................................2497Niclosamide monohydrate .....................................................2498Nicotinamide .............................................................................2499Nicotine ......................................................................................2500Nicotine resinate ...................................................................... 2501Nicotinic acid ............................................................................2502Nifedipine...................................................................................2503Nifuroxazide ..............................................................................2504Nikethamide ..............................................................................2505Nimesulide.................................................................................2506Nimodipine ................................................................................2507Nitrazepam ................................................................................2508Nitrendipine ..............................................................................2509Nitric acid .................................................................................. 2510Nitric oxide ................................................................................ 2511Nitrofural ................................................................................... 2512Nitrofurantoin........................................................................... 2513Nitrogen ..................................................................................... 2513Nitrogen determination by sulphuric acid digestion(2.5.9.) ........................................................................................ 139

Nitrogen determination, primary aromatic amino(2.5.8.) ........................................................................................ 139

Nitrogen, low-oxygen............................................................... 2514Nitrogen monoxide and nitrogen dioxide in gases(2.5.26.) ...................................................................................... 146

Nitrous oxide............................................................................. 2515Nitrous oxide in gases (2.5.35.)............................................... 152Nizatidine................................................................................... 2516N-Methylpyrrolidone................................................................2399N,N-Dimethylaniline (2.4.26.) .................................................. 127Nomegestrol acetate................................................................ 2518Nonoxinol 9............................................................................... 2519Non-sterile products, microbiological examination of (test forspecified micro-organisms) (2.6.13.) .................................... 173

Non-sterile products, microbiological examination of (totalviable aerobic count) (2.6.12.)............................................... 166

Noradrenaline hydrochloride ................................................2520Noradrenaline tartrate ............................................................ 2521Norcholesterol injection, iodinated (131I) ............................ 1003Norepinephrine hydrochloride..............................................2520Norepinephrine tartrate ......................................................... 2521Norethisterone..........................................................................2523Norethisterone acetate ...........................................................2524Norfloxacin................................................................................2525Norgestimate .............................................................................2526Norgestrel ..................................................................................2527Normal immunoglobulin for intravenous administration,human ......................................................................................2072

Normal immunoglobulin, human .........................................2070Nortriptyline hydrochloride...................................................2528Noscapine ..................................................................................2529Noscapine hydrochloride........................................................2530

General Notices (1) apply to all monographs and other texts 3281

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Notoginseng root ..................................................................... 2531Nuclear magnetic resonance spectrometry (2.2.33.)............ 54Nucleated cell count and viability (2.7.29.) .......................... 243Nucleic acid amplification techniques (2.6.21.) ................... 195Nucleic acids in polysaccharide vaccines (2.5.17.) .............. 142Numeration of CD34/CD45+ cells in haematopoieticproducts (2.7.23.) ..................................................................... 238

Nutmeg oil .................................................................................2533Nystatin ......................................................................................2534

OO-Acetyl in polysaccharide vaccines (2.5.19.) ...................... 143Oak bark ....................................................................................2539Octoxinol 10 ..............................................................................2539Octyldodecanol .........................................................................2540Octyl gallate ..............................................................................2539Odour (2.3.4.).............................................................................. 107Odour and taste of essential oils (2.8.8.) .............................. 250Ofloxacin.................................................................................... 2541Oils, essential .............................................................................. 680Oils, fatty, vegetable .................................................................. 712Oils rich in omega-3 acids, composition of fatty acids in(2.4.29.) ...................................................................................... 130

Oils rich in omega-3 acids, total cholesterol in (2.4.32.) ... 132Ointments .................................................................................... 747Oleic acid ...................................................................................2543Oleoyl macrogolglycerides.....................................................2543Oleyl alcohol .............................................................................2544Olive leaf ....................................................................................2545Olive oil, refined .......................................................................2546Olive oil, virgin .........................................................................2547Olsalazine sodium....................................................................2548Omega-3 acid ethyl esters 60.................................................2550Omega-3-acid ethyl esters 90.................................................2552Omega-3 acids, composition of fatty acids in oils rich in(2.4.29.) ...................................................................................... 130

Omega-3 acids, fish oil rich in ...............................................1893Omega-3 acids, total cholesterol in oils rich in (2.4.32.) ... 132Omega-3 acid triglycerides.....................................................2554Omeprazole ...............................................................................2557Omeprazole sodium.................................................................2558Ondansetron hydrochloride dihydrate ................................2560Opalescence of liquids, clarity and degree of (2.2.1.)............21Ophthalmic inserts .................................................................... 722Opium dry extract, standardised ..........................................2562Opium, prepared.......................................................................2563Opium, raw ................................................................................2564Opium tincture, standardised................................................2565Optical microscopy (2.9.37.) .................................................... 323Optical rotation (2.2.7.)............................................................... 26Oral drops .................................................................................... 730Oral lyophilisates........................................................................ 748Oral powders............................................................................... 738Oral solutions, emulsions and suspensions ......................... 729Oral use, liquid preparations for............................................. 728Orciprenaline sulphate............................................................2567Oregano......................................................................................2568Organ preservation, solutions for.........................................2929Oriental cashew for homoeopathic preparations..............1082Orodispersible tablets ............................................................... 750Oromucosal capsules ................................................................ 734Oromucosal drops, oromucosal sprays and sublingualsprays.......................................................................................... 733

Oromucosal preparations......................................................... 732Oromucosal preparations, semi-solid..................................... 733Oromucosal solutions and oromucosal suspensions ......... 733Oromucosal sprays, oromucosal drops and sublingualsprays.......................................................................................... 732

Oromucosal suspensions and oromucosal solutions ......... 732

Orphenadrine citrate...............................................................2569Orphenadrine hydrochloride.................................................2570Osmolality (2.2.35.)...................................................................... 57Ouabain......................................................................................2571Oxacillin sodium monohydrate .............................................2572Oxaliplatin ................................................................................. 2574Oxazepam ..................................................................................2577Oxeladin hydrogen citrate......................................................2578Oxfendazole for veterinary use .............................................2580Oxidising substances (2.5.30.)................................................. 147Oxitropium bromide ................................................................ 2581Oxolinic acid..............................................................................2582Oxprenolol hydrochloride ......................................................2583Oxybuprocaine hydrochloride...............................................2584Oxybutynin hydrochloride .....................................................2585Oxycodone hydrochloride ......................................................2587Oxygen........................................................................................2588Oxygen (15O) .............................................................................. 1004Oxygen-flask method (2.5.10.)................................................. 140Oxygen in gases (2.5.27.).......................................................... 146Oxymetazoline hydrochloride ...............................................2589Oxytetracycline dihydrate ......................................................2590Oxytetracycline hydrochloride .............................................. 2591Oxytocin .....................................................................................2593Oxytocin concentrated solution............................................2594

PPaclitaxel....................................................................................2599Pale coneflower root ...............................................................2602Palmitic acid..............................................................................2604Pamidronate disodium pentahydrate ..................................2604Pancreas powder ......................................................................2605Pancuronium bromide ............................................................2608Pansy, wild (flowering aerial parts) ..................................... 3217Papaverine hydrochloride ......................................................2609Paper chromatography (2.2.26.) ............................................... 43Paracetamol .............................................................................. 2611Paraffin, hard ............................................................................ 2612Paraffin, light liquid ................................................................ 2612Paraffin, liquid .......................................................................... 2613Paraffin, white soft .................................................................. 2614Paraffin, yellow soft................................................................. 2615Parainfluenza virus vaccine (live), bovine............................ 878Parainfluenza virus vaccine (live), canine ............................ 890Paraldehyde............................................................................... 2615Paramyxovirus 1 (Newcastle disease) vaccine (inactivated),avian ........................................................................................... 937

Parenteral preparations............................................................ 735Parenteral preparations, test for extractable volume of(2.9.17.)....................................................................................... 287

Parnaparin sodium .................................................................. 2616Paroxetine hydrochloride, anhydrous ................................. 2616Paroxetine hydrochloride hemihydrate............................... 2619Particles, fine, aerodynamic assessment of in preparationsfor inhalation (2.9.18.) ............................................................ 287

Particle size analysis by laser light diffraction (2.9.31.) .....311Particle-size distribution estimation by analytical sieving(2.9.38.) ...................................................................................... 325

Particulate contamination : sub-visible particles(2.9.19.) ...................................................................................... 300

Particulate contamination : visible particles (2.9.20.)........ 302Parvovirosis vaccine (inactivated), canine ............................ 891Parvovirosis vaccine (inactivated), porcine .......................... 946Parvovirosis vaccine (live), canine.......................................... 892Passion flower .......................................................................... 2621Passion flower dry extract .....................................................2622Pastes............................................................................................ 747Pasteurella vaccine (inactivated) for sheep .......................... 941Pastilles and lozenges ............................................................... 734

3282 See the information section on general monographs (cover pages)

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Patches, transdermal................................................................. 737Patches, transdermal, dissolution test for (2.9.4.) .............. 275Pefloxacin mesilate dihydrate ...............................................2623Pelargonium root .....................................................................2625Penbutolol sulphate ................................................................2625Penetrometry, measurement of consistency (2.9.9.) .......... 279Penicillamine.............................................................................2626Pentaerythrityl tetranitrate, diluted ....................................2628Pentamidine diisetionate........................................................2630Pentazocine............................................................................... 2631Pentazocine hydrochloride ....................................................2632Pentazocine lactate .................................................................2632Pentobarbital ............................................................................2633Pentobarbital sodium..............................................................2634Pentoxifylline ............................................................................2635Pentoxyverine hydrogen citrate ............................................2637Peppermint leaf ........................................................................2638Peppermint oil ..........................................................................2639Pepsin powder ..........................................................................2640Peptide mapping (2.2.55.) .......................................................... 86Peptides, synthetic, acetic acid in (2.5.34.)........................... 151Pergolide mesilate.................................................................... 2641Perindopril tert-butylamine....................................................2643Peritoneal dialysis, solutions for...........................................2646Peroxide value (2.5.5.)............................................................... 138Perphenazine ............................................................................2648Pertussis (acellular, component), diphtheria and tetanusvaccine (adsorbed)................................................................... 767

Pertussis (acellular, component), diphtheria, tetanus andhaemophilus type b conjugate vaccine (adsorbed) .......... 771

Pertussis (acellular, component), diphtheria, tetanus andhepatitis B (rDNA) vaccine (adsorbed) ............................... 774

Pertussis (acellular, component), diphtheria, tetanus andpoliomyelitis (inactivated) vaccine (adsorbed) .................. 775

Pertussis (acellular, component), diphtheria, tetanus andpoliomyelitis (inactivated) vaccine (adsorbed, reducedantigen(s) content) .................................................................. 778

Pertussis (acellular, component), diphtheria, tetanus,hepatitis B (rDNA), poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) .......... 780

Pertussis (acellular, component), diphtheria, tetanus,poliomyelitis (inactivated) and haemophilus type bconjugate vaccine (adsorbed)................................................ 783

Pertussis, diphtheria, tetanus and poliomyelitis (inactivated)vaccine (adsorbed)................................................................... 785

Pertussis, diphtheria, tetanus, poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) .......... 787

Pertussis vaccine .........................................................................819Pertussis vaccine (acellular), assay of (2.7.16.) .................... 233Pertussis vaccine (acellular, component, adsorbed) .......... 820Pertussis vaccine (acellular, co-purified, adsorbed) ........... 822Pertussis vaccine (adsorbed) ................................................... 824Pertussis vaccine, assay of (2.7.7.) .......................................... 222Peru balsam...............................................................................2649Pessaries....................................................................................... 751Pessaries and suppositories, disintegration of (2.9.2.) ...... 265Pesticide residues (2.8.13.)....................................................... 252Pethidine hydrochloride.........................................................2650Pharmaceutical technical procedures (2.9.)......................... 263Pharmacognosy, methods in (2.8.)......................................... 249Pharmacopoeial harmonisation (5.8.) ................................... 645Phenazone................................................................................. 2651Pheniramine maleate ..............................................................2652Phenobarbital ...........................................................................2653Phenobarbital sodium.............................................................2654Phenol ........................................................................................2655Phenol in immunosera and vaccines (2.5.15.) ..................... 142Phenolphthalein.......................................................................2656Phenolsulfonphthalein ...........................................................2657

Phenothiazines, identification by thin-layer chromatography(2.3.3.) ........................................................................................ 107

Phenoxyethanol........................................................................2657Phenoxymethylpenicillin ........................................................2658Phenoxymethylpenicillin potassium....................................2660Phentolamine mesilate ...........................................................2662Phenylalanine ...........................................................................2663Phenylbutazone .......................................................................2664Phenylephrine...........................................................................2665Phenylephrine hydrochloride................................................2667Phenylmercuric acetate ..........................................................2668Phenylmercuric borate ...........................................................2669Phenylmercuric nitrate ...........................................................2669Phenylpropanolamine hydrochloride ..................................2670Phenytoin...................................................................................2671Phenytoin sodium....................................................................2672Phloroglucinol, anhydrous ....................................................2672Phloroglucinol dihydrate .......................................................2673Pholcodine................................................................................. 2674Phosphates (2.4.11.) ...................................................................116Phosphoric acid, concentrated .............................................2675Phosphoric acid, dilute ...........................................................2676Phosphorus in polysaccharide vaccines (2.5.18.) ............... 142pH, potentiometric determination of (2.2.3.) ......................... 24Phthalylsulfathiazole .............................................................. 2676Physical and physicochemical methods (2.2.) ........................21Physostigmine salicylate.........................................................2677Physostigmine sulphate..........................................................2678Phytomenadione ......................................................................2679Phytosterol ................................................................................2680Picotamide monohydrate .......................................................2682Pilocarpine hydrochloride......................................................2682Pilocarpine nitrate ...................................................................2684Pimobendan ..............................................................................2685Pimozide ....................................................................................2686Pindolol ......................................................................................2688Pine (dwarf) oil ......................................................................... 1766Pine sylvestris oil .....................................................................2689Pinus pinaster type turpentine oil ....................................... 3151Pipemidic acid trihydrate .......................................................2690Piperacillin ................................................................................ 2691Piperacillin sodium..................................................................2692Piperazine adipate ...................................................................2694Piperazine citrate .....................................................................2695Piperazine hydrate...................................................................2696Piracetam...................................................................................2697Pirenzepine dihydrochloride monohydrate .......................2698Piretanide ..................................................................................2699Piroxicam ...................................................................................2700Pivampicillin..............................................................................2702Pivmecillinam hydrochloride.................................................2704Plasma for fractionation, human..........................................2073Plasma (pooled and treated for virus inactivation),human ......................................................................................2075

Plasmid vectors for human use............................................... 674Plasmid vectors for human use, bacterial cells used for themanufacture of ......................................................................... 676

Plasters, medicated.................................................................... 746Plastic additives (3.1.13.).......................................................... 364Plastic containers and closures for pharmaceutical use(3.2.2.) ........................................................................................ 378

Plastic containers for aqueous solutions for infusion(3.2.2.1.) ..................................................................................... 379

Plastic containers for human blood and blood components,sterile (3.2.3.) ............................................................................ 379

Plastic syringes, single-use, sterile (3.2.8.) ........................... 384Pneumococcal polysaccharide conjugate vaccine(adsorbed).................................................................................. 825

Pneumococcal polysaccharide vaccine ................................. 827

General Notices (1) apply to all monographs and other texts 3283

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Poliomyelitis (inactivated), diphtheria and tetanus vaccine(adsorbed, reduced antigen(s) content) .............................. 770

Poliomyelitis (inactivated), diphtheria, tetanus and pertussis(acellular, component) vaccine (adsorbed) ........................ 775

Poliomyelitis (inactivated), diphtheria, tetanus and pertussis(acellular, component) vaccine (adsorbed, reducedantigen(s) content) .................................................................. 778

Poliomyelitis (inactivated), diphtheria, tetanus and pertussisvaccine (adsorbed)................................................................... 785

Poliomyelitis (inactivated), diphtheria, tetanus, pertussis(acellular, component) and haemophilus type b conjugatevaccine (adsorbed)................................................................... 783

Poliomyelitis (inactivated), diphtheria, tetanus, pertussis(acellular, component), hepatitis B (rDNA) and haemophilustype b conjugate vaccine (adsorbed) ................................... 780

Poliomyelitis (inactivated), diphtheria, tetanus, pertussis andhaemophilus type b conjugate vaccine (adsorbed) .......... 787

Poliomyelitis vaccine (inactivated) ......................................... 829Poliomyelitis vaccine (inactivated), in vivo assay of(2.7.20.) ...................................................................................... 235

Poliomyelitis vaccine (oral) ...................................................... 832Poliomyelitis vaccine (oral), test for neurovirulence(2.6.19.) ...................................................................................... 193

Poloxamers ................................................................................2705Polyacrylate dispersion 30 per cent.....................................2706Polyamide 6/6 suture, sterile, in distributor for veterinaryuse ............................................................................................ 1059

Polyamide 6 suture, sterile, in distributor for veterinary use................................................................................................... 1058

Polyethyleneglycols .................................................................2308Polyethylene terephthalate for containers for preparationsnot for parenteral use (3.1.15.) ............................................. 369

Poly(ethylene terephthalate) suture, sterile, in distributor forveterinary use ........................................................................ 1059

Poly(ethylene - vinyl acetate) for containers and tubing fortotal parenteral nutrition preparations (3.1.7.) ................. 356

Polyethylene with additives for containers for parenteralpreparations and for ophthalmic preparations (3.1.5.) ... 349

Polyethylene without additives for containers for parenteralpreparations and for ophthalmic preparations (3.1.4.) ... 348

Polymorphism (5.9.) .................................................................. 649Polymyxin B sulphate .............................................................2707Polyolefines (3.1.3.) ................................................................... 344Polyoxyl castor oil....................................................................2304Polyoxyl hydrogenated castor oil .........................................2303Polypropylene for containers and closures for parenteralpreparations and ophthalmic preparations (3.1.6.).......... 352

Polysaccharide vaccines, hexosamines in (2.5.20.)............. 143Polysaccharide vaccines, methylpentoses in (2.5.21.)........ 143Polysaccharide vaccines, nucleic acids in (2.5.17.) ............. 142Polysaccharide vaccines, O-acetyl in (2.5.19.)...................... 143Polysaccharide vaccines, phosphorus in (2.5.18.)............... 142Polysaccharide vaccines, protein in (2.5.16.) ....................... 142Polysaccharide vaccines, ribose in (2.5.31.) ......................... 147Polysaccharide vaccines, sialic acid in (2.5.23.) .................. 144Polysaccharide vaccines, uronic acids in (2.5.22.) .............. 144Polysorbate 20 ..........................................................................2709Polysorbate 40 .......................................................................... 2710Polysorbate 60 .......................................................................... 2710Polysorbate 80 .......................................................................... 2711Poly(vinyl acetate).................................................................... 2712Poly(vinyl acetate) dispersion 30 per cent ......................... 2713Poly(vinyl alcohol) ................................................................... 2715Poly(vinyl chloride), non-plasticised, materials based on forcontainers for dry dosage forms for oral administration(3.1.11.)....................................................................................... 362

Poly(vinyl chloride), non-plasticised, materials based onfor containers for non-injectable aqueous solutions(3.1.10.) ...................................................................................... 360

Poly(vinyl chloride), plasticised, empty sterile containers offor human blood and blood components (3.2.4.) ............. 381

Poly(vinyl chloride), plasticised, materials based on forcontainers for aqueous solutions for intravenous infusion(3.1.14.) ...................................................................................... 366

Poly(vinyl chloride), plasticised, materials based on forcontainers for human blood and blood components(3.1.1.1.) ..................................................................................... 339

Poly(vinyl chloride), plasticised, materials based on fortubing used in sets for the transfusion of blood and bloodcomponents (3.1.1.2.).............................................................. 342

Poly(vinyl chloride), plasticised, sterile containers offor human blood containing anticoagulant solution(3.2.5.) ........................................................................................ 382

Poppy petals, red...................................................................... 2811Porcine actinobacillosis vaccine (inactivated) ..................... 943Porcine influenza vaccine (inactivated) ................................ 944Porcine insulin.......................................................................... 2144Porcine parvovirosis vaccine (inactivated) ........................... 946Porcine progressive atrophic rhinitis vaccine(inactivated) .............................................................................. 947

Porosity of sintered-glass filters (2.1.2.) ...................................15Potassium (2.4.12.) .....................................................................116Potassium acetate .................................................................... 2716Potassium bromide .................................................................. 2716Potassium carbonate............................................................... 2717Potassium chloride .................................................................. 2717Potassium citrate ..................................................................... 2718Potassium clavulanate ............................................................ 2719Potassium clavulanate, diluted ............................................. 2721Potassium dihydrogen phosphate ........................................2723Potassium hydrogen aspartate hemihydrate .....................2723Potassium hydrogen carbonate ............................................2724Potassium hydrogen tartrate.................................................2725Potassium hydroxide ...............................................................2726Potassium iodide......................................................................2726Potassium metabisulphite......................................................2727Potassium nitrate .....................................................................2728Potassium perchlorate ............................................................2728Potassium permanganate.......................................................2729Potassium sodium tartrate tetrahydrate.............................2729Potassium sorbate....................................................................2730Potassium sulphate ................................................................. 2731Potato starch............................................................................. 2731Potentiometric determination of ionic concentration usingion-selective electrodes (2.2.36.)............................................. 58

Potentiometric determination of pH (2.2.3.).......................... 24Potentiometric titration (2.2.20.).............................................. 35Potentisation, methods of preparation of homoeopathicstocks and................................................................................ 1066

Poultices....................................................................................... 747Pour-on preparations ................................................................ 753Povidone ....................................................................................2732Povidone, iodinated .................................................................2734Powdered cellulose .................................................................. 1473Powder flow (2.9.36.) ................................................................ 320Powders and granules for oral solutions andsuspensions............................................................................... 729

Powders and granules for syrups ........................................... 730Powders and tablets for rectal solutions and suspensions.. 746Powders, ear................................................................................ 720Powders, effervescent................................................................ 739Powders for cutaneous application........................................ 738Powders for eye drops and powders for eye lotions........... 722Powders for inhalation.............................................................. 742Powders for injections or infusions ....................................... 736Powders for oral drops.............................................................. 730Powders, nasal ............................................................................ 732Powders, oral .............................................................................. 738

3284 See the information section on general monographs (cover pages)

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Poxvirus vectors for human use ............................................. 672Pravastatin sodium..................................................................2735Prazepam ...................................................................................2736Praziquantel ..............................................................................2737Prazosin hydrochloride ..........................................................2738Prednicarbate............................................................................ 2740Prednisolone ............................................................................. 2741Prednisolone acetate............................................................... 2742Prednisolone pivalate.............................................................. 2744Prednisolone sodium phosphate .......................................... 2745Prednisone................................................................................. 2746Prekallikrein activator (2.6.15.) .............................................. 189Premixes for medicated feeding stuffs for veterinary use.. 739Preparations for inhalation...................................................... 739Preparations for inhalation : aerodynamic assessment of fineparticles (2.9.18.) ..................................................................... 287

Preparations for irrigation....................................................... 743Pressurised pharmaceutical preparations ............................ 744Prilocaine................................................................................... 2748Prilocaine hydrochloride........................................................2750Primaquine diphosphate ........................................................ 2751Primary aromatic amino-nitrogen, determination of(2.5.8.) ........................................................................................ 139

Primary standards for volumetric solutions (4.2.1.)............514Primidone ..................................................................................2752Primula root ..............................................................................2753Probenecid.................................................................................2754Procainamide hydrochloride .................................................2755Procaine benzylpenicillin .......................................................1287Procaine hydrochloride ..........................................................2756Prochlorperazine maleate ......................................................2756Products of fermentation ......................................................... 693Products of recombinant DNA technology .......................... 701Products with risk of transmitting agents of animalspongiform encephalopathies............................................... 694

Progenitor cells, human haematopoietic, colony-forming cellassay for (2.7.28.) ..................................................................... 242

Progesterone .............................................................................2757Proguanil hydrochloride ........................................................2758Proline ........................................................................................ 2760Promazine hydrochloride....................................................... 2761Promethazine hydrochloride................................................. 2761Propacetamol hydrochloride ................................................. 2763Propafenone hydrochloride ................................................... 2764Propanol.....................................................................................2766Propanol and methanol, 2-, test for (2.9.11.) ....................... 282Propantheline bromide........................................................... 2767Propofol...................................................................................... 2768Propranolol hydrochloride.....................................................2770Propylene glycol.......................................................................2773Propylene glycol dicaprylocaprate....................................... 2774Propylene glycol dilaurate ..................................................... 2774Propylene glycol monolaurate ..............................................2775Propylene glycol monopalmitostearate............................... 2776Propylene glycol monostearate............................................. 2776Propyl gallate ............................................................................2771Propyl parahydroxybenzoate.................................................2772Propylthiouracil .......................................................................2777Propyphenazone ......................................................................2778Protamine hydrochloride .......................................................2779Protamine sulphate .................................................................2780Protein in polysaccharide vaccines (2.5.16.) ........................ 142Protein, total (2.5.33.) ............................................................... 148Prothrombin complex, human .............................................. 2076Protirelin .................................................................................... 2781Proxyphylline ............................................................................2783Pseudoephedrine hydrochloride ..........................................2784Psyllium seed ............................................................................2785Purified water ........................................................................... 3213

Purified water, highly ............................................................. 3212Purple coneflower herb..........................................................2785Purple coneflower root...........................................................2787Pycnometric density of solids (2.9.23.) ................................. 304Pygeum africanum bark .........................................................2789Pyrantel embonate...................................................................2790Pyrazinamide ............................................................................ 2791Pyridostigmine bromide .........................................................2792Pyridoxine hydrochloride.......................................................2793Pyrimethamine .........................................................................2794Pyrogens (2.6.8.)......................................................................... 164Pyrrolidone................................................................................2794

QQuality of pharmaceutical preparations, microbiological(5.1.4.)......................................................................................... 529

Quantified hawthorn leaf and flower liquid extract.........2037Quinidine sulphate ..................................................................2799Quinine hydrochloride............................................................2800Quinine sulphate......................................................................2802

RRabbit haemorrhagic disease vaccine (inactivated) ........... 949Rabies immunoglobulin, human ..........................................2078Rabies vaccine for human use prepared in cell cultures... 836Rabies vaccine (inactivated) for veterinary use................... 950Rabies vaccine (live, oral) for foxes ........................................ 952Racemic camphor..................................................................... 1401Racemic ephedrine hydrochloride ....................................... 1792Racemic menthol .....................................................................2356Raclopride ([11C]methoxy) injection..................................... 1005Radionuclides, table of physical characteristics (5.7.) ....... 633Radiopharmaceutical preparations ........................................ 695Radiopharmaceutical preparations, iobenguane sulphatefor .............................................................................................. 1000

Raman spectrometry (2.2.48.) ................................................... 82Ramipril......................................................................................2807Ramon assay, flocculation value (Lf) of diphtheria andtetanus toxins and toxoids (2.7.27.) ..................................... 241

Ranitidine hydrochloride........................................................2809Rapeseed oil, refined............................................................... 2811Reagents (4.) ............................................................................... 391Reagents (4.1.1.) ......................................................................... 391Reagents, standard solutions, buffer solutions (4.1.)......... 391Recombinant DNA technology, products of......................... 701Rectal capsules ........................................................................... 745Rectal foams................................................................................ 746Rectal preparations.................................................................... 744Rectal preparations, semi-solid ............................................... 746Rectal solutions and suspensions, powders and tabletsfor ................................................................................................ 744

Rectal solutions, emulsions and suspensions...................... 745Rectal tampons........................................................................... 746Red poppy petals...................................................................... 2811Reference standards (5.12.) ..................................................... 663Refractive index (2.2.6.) .............................................................. 26Relationship between reaction of solution, approximate pHand colour of certain indicators (2.2.4.) ............................... 25

Relative density (2.2.5.)............................................................... 25Repaglinide................................................................................ 2812Reserpine ................................................................................... 2814Residual solvents (5.4.) ............................................................. 603Residual solvents, identification and control (2.4.24.) ...... 121Residue on evaporation of essential oils (2.8.9.)................. 250Resistance to crushing of tablets (2.9.8.) ............................. 279Resorcinol .................................................................................. 2815Restharrow root ....................................................................... 2815Rhatany root ............................................................................. 2816

General Notices (1) apply to all monographs and other texts 3285

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Rhatany tincture ...................................................................... 2817Rhinotracheitis vaccine (inactivated), viral, feline ...............916Rhinotracheitis vaccine (live), viral, feline.............................917Rhubarb ..................................................................................... 2817Ribavirin..................................................................................... 2818Riboflavin...................................................................................2820Riboflavin sodium phosphate................................................ 2821Ribose in polysaccharide vaccines (2.5.31.) ......................... 147Ribwort plantain ......................................................................2823Rice starch.................................................................................2824Rifabutin ....................................................................................2825Rifampicin..................................................................................2826Rifamycin sodium.....................................................................2827Rilmenidine dihydrogen phosphate .....................................2829Risperidone ...............................................................................2830Ritonavir ....................................................................................2832Rocuronium bromide ..............................................................2835Roman chamomile flower ...................................................... 1487Ropivacaine hydrochloride monohydrate...........................2837Roselle ........................................................................................2838Rosemary leaf ...........................................................................2839Rosemary oil .............................................................................2840Rotating viscometer method - viscosity (2.2.10.) .................. 28Rotation, optical (2.2.7.) ............................................................. 26Roxithromycin...........................................................................2842RRR-α-Tocopherol ...................................................................3088RRR-α-Tocopheryl acetate .....................................................3090RRR-α-Tocopheryl hydrogen succinate ..............................3095Rubber closures for containers for aqueous parenteralpreparations, for powders and for freeze-dried powders(3.2.9.) ........................................................................................ 386

Rubella immunoglobulin, human.........................................2079Rubella vaccine (live) ................................................................ 838Rutoside trihydrate..................................................................2844

SSaccharin ...................................................................................2849Saccharin sodium ....................................................................2850Safety, viral (5.1.7.) .................................................................... 543Safflower flower ....................................................................... 2851Safflower oil, refined...............................................................2852Saffron for homoeopathic preparations.............................. 1084Sage leaf (salvia officinalis)....................................................2853Sage leaf, three-lobed..............................................................2854Sage tincture.............................................................................2854Salbutamol ................................................................................2855Salbutamol sulphate ...............................................................2857Salicylic acid..............................................................................2859Salmeterol xinafoate................................................................2860Salmonella Enteritidis vaccine (inactivated) for chickens.. 953Salmonella Typhimurium vaccine (inactivated) forchickens ..................................................................................... 954

Salmon oil, farmed...................................................................2862Saponification value (2.5.6.) .................................................... 139Saw palmetto fruit ...................................................................2864Scopolamine.............................................................................. 2108Scopolamine butylbromide .................................................... 2109Scopolamine hydrobromide................................................... 2110Selegiline hydrochloride ........................................................2866Selenium disulphide................................................................2867Semi-micro determination of water (2.5.12.) ........................141Semi-solid ear preparations ..................................................... 720Semi-solid eye preparations ..................................................... 722Semi-solid intrauterine preparations ..................................... 726Semi-solid nasal preparations.................................................. 732Semi-solid oromucosal preparations...................................... 733Semi-solid preparations for cutaneous application ............ 746Semi-solid rectal preparations................................................. 746Semi-solid vaginal preparations.............................................. 752

Senega root ...............................................................................2867Senna leaf ..................................................................................2868Senna leaf dry extract, standardised ...................................2869Senna pods, Alexandrian........................................................2870Senna pods, Tinnevelly ...........................................................2871Separation techniques, chromatographic (2.2.46.) .............. 72Serine..........................................................................................2872Sertaconazole nitrate..............................................................2873Sesame oil, refined .................................................................. 2874Sets for the transfusion of blood and blood components(3.2.6.) ........................................................................................ 383

Shampoos .................................................................................... 728Shellac ....................................................................................... 2876Sialic acid in polysaccharide vaccines (2.5.23.)................... 144Siam benzoin tincture.............................................................1278Sieves (2.1.4.) .................................................................................16Sieve test (2.9.12.)...................................................................... 283Sieving, analytical, particle-size distribution estimation by(2.9.38.) ...................................................................................... 325

SI (International System) units (1.) ........................................... 3Silica, colloidal anhydrous .....................................................2877Silica, colloidal hydrated ........................................................2877Silica, dental type.....................................................................2878Silica, hydrophobic colloidal .................................................2878Silicone elastomer for closures and tubing (3.1.9.) ............ 358Silicone oil used as a lubricant (3.1.8.) ................................. 358Silk suture, sterile, braided, in distributor for veterinary use................................................................................................... 1059

Silver, colloidal, for external use ..........................................2879Silver nitrate .............................................................................2880Simeticone .................................................................................2880Simvastatin................................................................................ 2881Single-dose preparations, uniformity of content (2.9.6.)... 278Single-dose preparations, uniformity of mass (2.9.5.)........ 278Sintered-glass filters (2.1.2.) .......................................................15Size-exclusion chromatography (2.2.30.)................................ 47(S)-Lactic acid............................................................................2229Smallpox vaccine (live) ............................................................. 839Sodium acetate ([1-11C]) injection......................................... 1006Sodium acetate trihydrate .....................................................2883Sodium alendronate ................................................................2884Sodium alginate .......................................................................2885Sodium amidotrizoate.............................................................2886Sodium aminosalicylate dihydrate .......................................2887Sodium ascorbate ....................................................................2888Sodium aurothiomalate ..........................................................2889Sodium benzoate .....................................................................2890Sodium bromide....................................................................... 2891Sodium calcium edetate .........................................................2892Sodium caprylate .....................................................................2893Sodium carbonate, anhydrous ..............................................2894Sodium carbonate decahydrate ............................................2894Sodium carbonate monohydrate ..........................................2895Sodium carboxymethylcellulose ........................................... 1423Sodium carboxymethylcellulose, cross-linked ................... 1626Sodium carboxymethylcellulose, low-substituted............. 1424Sodium cetostearyl sulphate .................................................2895Sodium chloride .......................................................................2897Sodium chromate (51Cr) sterile solution ............................. 1007Sodium citrate ..........................................................................2898Sodium cromoglicate ..............................................................2899Sodium cyclamate....................................................................2900Sodium dihydrogen phosphate dihydrate .......................... 2901Sodium fluoride .......................................................................2902Sodium fluoride (18F) injection ............................................. 1008Sodium fusidate .......................................................................2902Sodium glycerophosphate, hydrated ...................................2903Sodium hyaluronate ................................................................2904Sodium hydrogen carbonate .................................................2906

3286 See the information section on general monographs (cover pages)

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Sodium hydroxide....................................................................2907Sodium iodide...........................................................................2907Sodium iodide (123I) injection ................................................ 1009Sodium iodide (123I) solution for radiolabelling ................ 1010Sodium iodide (131I) capsules for diagnostic use................1011Sodium iodide (131I) capsules for therapeutic use ............ 1012Sodium iodide (131I) solution ................................................. 1013Sodium iodide (131I) solution for radiolabelling .................1014Sodium iodohippurate (123I) injection ..................................1014Sodium iodohippurate (131I) injection ................................. 1015Sodium lactate solution..........................................................2908Sodium laurilsulfate ................................................................ 2910Sodium metabisulphite........................................................... 2911Sodium methyl parahydroxybenzoate................................. 2911Sodium molybdate (99Mo) solution (fission) ...................... 1016Sodium molybdate dihydrate ................................................ 2912Sodium nitrite........................................................................... 2913Sodium nitroprusside ............................................................. 2913Sodium perborate, hydrated.................................................. 2914Sodium pertechnetate (99mTc) injection (fission) .............. 1018Sodium pertechnetate (99mTc) injection (non-fission) ......1020Sodium phosphate (32P) injection ........................................ 1020Sodium picosulfate ................................................................. 2915Sodium polystyrene sulphonate ........................................... 2916Sodium propionate .................................................................. 2917Sodium propyl parahydroxybenzoate.................................. 2918Sodium salicylate ..................................................................... 2919Sodium selenite pentahydrate .............................................. 2919Sodium (S)-lactate solution ...................................................2909Sodium starch glycolate (type A) .........................................2920Sodium starch glycolate (type B) ......................................... 2921Sodium starch glycolate (type C) .........................................2922Sodium stearate .......................................................................2923Sodium stearyl fumarate ........................................................2924Sodium sulphate, anhydrous.................................................2924Sodium sulphate decahydrate...............................................2925Sodium sulphite, anhydrous..................................................2926Sodium sulphite heptahydrate..............................................2926Sodium thiosulphate...............................................................2927Sodium valproate .....................................................................2927Soft capsules ............................................................................... 718Softening time determination of lipophilic suppositories(2.9.22.) ...................................................................................... 302

Soft extracts ................................................................................ 684Solid dosage forms, dissolution test for (2.9.3.) .................. 266Solids, density of (2.2.42.) .......................................................... 67Solids, pycnometric density of (2.9.23.) ................................ 304Solubility in alcohol of essential oils (2.8.10.) ..................... 250Soluble tablets ............................................................................ 750Solutions, emulsions and suspensions, oral ........................ 729Solutions for haemodialysis...................................................2022Solutions for haemodialysis, concentrated, water fordiluting..................................................................................... 2021

Solutions for haemofiltration and for haemodiafiltra-tion............................................................................................2025

Solutions for organ preservation..........................................2929Solutions for peritoneal dialysis ...........................................2646Solutions, suspensions, intrauterine ..................................... 726Solvents, residual (5.4.) ............................................................ 603Solvents, residual, identification and control (2.4.24.) ...... 121Somatostatin .............................................................................2930Somatropin................................................................................ 2931Somatropin concentrated solution ......................................2933Somatropin for injection ........................................................2935Sorbic acid.................................................................................2937Sorbitan laurate .......................................................................2938Sorbitan oleate .........................................................................2938Sorbitan palmitate ...................................................................2939Sorbitan sesquioleate..............................................................2939

Sorbitan stearate......................................................................2940Sorbitan trioleate .....................................................................2940Sorbitol....................................................................................... 2941Sorbitol, liquid (crystallising)................................................2942Sorbitol, liquid (non-crystallising)........................................2943Sorbitol, liquid, partially dehydrated...................................2944Sotalol hydrochloride .............................................................2944Soya-bean oil, hydrogenated..................................................2946Soya-bean oil, refined..............................................................2946Specific surface area by air permeability (2.9.14.).............. 283Specific surface area by gas adsorption (2.9.26.) ............... 306Spectinomycin dihydrochloride pentahydrate ..................2947Spectinomycin sulphate tetrahydrate for veterinary use ..2949Spectrometry, atomic absorption (2.2.23.) ............................. 37Spectrometry, atomic emission (2.2.22.)................................. 36Spectrometry, mass (2.2.43.) ..................................................... 68Spectrometry, nuclear magnetic resonance (2.2.33.) .......... 54Spectrometry, Raman (2.2.48.) ................................................. 82Spectrometry, X-ray fluorescence (2.2.37.)............................. 59Spectrophotometry, infrared absorption (2.2.24.)................ 39Spectrophotometry, near-infrared (2.2.40.)............................ 62Spectrophotometry, ultraviolet and visible absorption(2.2.25.) .........................................................................................41

SPF chicken flocks for the production and quality control ofvaccines (5.2.2.) ........................................................................ 547

Spheroids and granules, friability of (2.9.41.)...................... 330Spiramycin................................................................................. 2951Spirapril hydrochloride monohydrate.................................2954Spironolactone .........................................................................2955Spot-on preparations................................................................. 753Sprays ........................................................................................... 753Sprays (liquid nasal) and drops (nasal) ................................. 731Squalane ....................................................................................2956Standard solutions for limit tests (4.1.2.) ............................. 504Standards, reference (5.12.)..................................................... 663Stannous chloride dihydrate .................................................2959Stanozolol..................................................................................2960Star anise ...................................................................................2960Star anise oil .............................................................................2962Starch glycolate (type A), sodium ........................................2920Starch glycolate (type B), sodium ........................................ 2921Starch glycolate (type C), sodium ........................................2922Starch, maize ............................................................................2326Starch, potato ........................................................................... 2731Starch, pregelatinised .............................................................2964Starch, rice ................................................................................2824Starch, wheat ............................................................................ 3215Starflower (borage) oil, refined.............................................1326Statistical analysis of results of biological assays and tests(5.3.) ............................................................................................ 571

Stavudine...................................................................................2964Steam sterilisation of aqueous preparations, application ofthe F0 concept (5.1.5.)............................................................. 531

Stearic acid................................................................................2966Stearoyl macrogolglycerides .................................................2967Stearyl alcohol..........................................................................2968Stem cells, human haematopoietic ......................................2067Sterile braided silk suture in distributor for veterinaryuse............................................................................................. 1059

Sterile catgut............................................................................. 1045Sterile catgut in distributor for veterinary use ................. 1057Sterile containers of plasticised poly(vinyl chloride)for human blood containing anticoagulant solution(3.2.5.) ........................................................................................ 382

Sterile linen thread in distributor for veterinary use.......1058Sterile non-absorbable strands in distributor for veterinaryuse............................................................................................. 1060

Sterile non-absorbable sutures ............................................. 1046

General Notices (1) apply to all monographs and other texts 3287

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Sterile plastic containers for human blood and bloodcomponents (3.2.3.) ................................................................. 379

Sterile polyamide 6/6 suture in distributor for veterinaryuse............................................................................................. 1059

Sterile polyamide 6 suture in distributor for veterinaryuse............................................................................................. 1058

Sterile poly(ethylene terephthalate) suture in distributor forveterinary use ......................................................................... 1059

Sterile products, methods of preparation (5.1.1.) ............... 525Sterile single-use plastic syringes (3.2.8.) ............................. 384Sterile synthetic absorbable braided sutures .................... 1050Sterile synthetic absorbable monofilament sutures......... 1052Sterilisation procedures, biological indicators (5.1.2.) ...... 527Sterility (2.6.1.) ........................................................................... 155Sterols in fatty oils (2.4.23.)..................................................... 120Sticks ............................................................................................ 748Sticks, intrauterine .................................................................... 726Sticks, nasal................................................................................. 732St. John’s wort..........................................................................2958Stomata and stomatal index (2.8.3.) ...................................... 249Stramonium leaf.......................................................................2968Stramonium, prepared ............................................................2970Strands, sterile non-absorbable, in distributor for veterinaryuse ............................................................................................ 1060

Streptokinase bulk solution ..................................................2971Streptomycin sulphate ............................................................2972Strontium (89Sr) chloride injection ...................................... 1021Subdivision of tablets................................................................ 748Sublingual sprays, oromucosal drops and oromucosalsprays.......................................................................................... 732

Sublingual tablets and buccal tablets ................................... 734Substances for pharmaceutical use ....................................... 703Substances for pharmaceutical use, control of impurities in(5.10.).......................................................................................... 653

Substances of animal origin for the production of veterinaryvaccines (5.2.5.) ........................................................................ 555

Sub-visible particles, particulate contamination (2.9.19.) .. 300Succinylsulfathiazole .............................................................. 2974Sucrose.......................................................................................2975Sufentanil ..................................................................................2977Sufentanil citrate .....................................................................2978Sugars, lead in (2.4.10.) ............................................................ 115Sugar spheres ...........................................................................2979Sulbactam sodium ...................................................................2980Sulfacetamide sodium.............................................................2982Sulfadiazine...............................................................................2983Sulfadimidine............................................................................2984Sulfadoxine................................................................................2984Sulfafurazole.............................................................................2985Sulfaguanidine..........................................................................2986Sulfamerazine...........................................................................2987Sulfamethizole..........................................................................2988Sulfamethoxazole ....................................................................2989Sulfamethoxypyridazine for veterinary use .......................2990Sulfanilamide ............................................................................ 2991Sulfasalazine .............................................................................2992Sulfathiazole .............................................................................2994Sulfinpyrazone .........................................................................2995Sulfisomidine ............................................................................2996Sulindac .....................................................................................2996Sulphated ash (2.4.14.) ..............................................................116Sulphates (2.4.13.) ......................................................................116Sulphur dioxide (2.5.29.).......................................................... 146Sulphur for external use ........................................................2998Sulphuric acid...........................................................................2998Sulpiride.....................................................................................2999Sultamicillin ..............................................................................3000Sultamicillin tosilate dihydrate.............................................3003Sumatra benzoin......................................................................1278

Sumatra benzoin tincture ......................................................1279Sumatriptan succinate............................................................3005Sunflower oil, refined .............................................................3007Supercritical fluid chromatography (2.2.45.) .........................71Suppositories .............................................................................. 745Suppositories and pessaries, disintegration of (2.9.2.)...... 265Suppositories, lipophilic, softening time determination(2.9.22.) ...................................................................................... 302

Suspensions, solutions and emulsions, oral ........................ 729Suspensions, solutions, intrauterine ..................................... 726Sutures, sterile non-absorbable ............................................ 1046Sutures, sterile synthetic absorbable braided .................. 1050Sutures, sterile synthetic absorbable monofilament ......1052Suxamethonium chloride.......................................................3007Suxibuzone................................................................................3008Sweet fennel .............................................................................. 1874Sweet orange oil.......................................................................3009Swelling index (2.8.4.)............................................................... 249Swine erysipelas vaccine (inactivated) .................................. 955Swine-fever vaccine (live), classical, freeze-dried ................ 956Symbols and abbreviations (1.) ................................................... 3Synthetic absorbable braided sutures, sterile ................... 1050Synthetic absorbable monofilament sutures, sterile........ 1052Syringes, plastic, sterile single-use (3.2.8.) ........................... 384Syrups........................................................................................... 730

TTable of physical characteristics of radionuclides mentionedin the European Pharmacopoeia (5.7.) ............................... 633

Tablets .......................................................................................... 748Tablets and capsules, disintegration of (2.9.1.) ................... 263Tablets, buccal ............................................................................ 734Tablets, coated............................................................................ 749Tablets, dispersible .................................................................... 750Tablets, effervescent .................................................................. 749Tablets for intrauterine solutions and suspensions ........... 726Tablets for use in the mouth ................................................... 750Tablets for vaginal solutions and suspensions .................... 752Tablets, gastro-resistant............................................................ 750Tablets, intrauterine .................................................................. 726Tablets, modified-release .......................................................... 750Tablets, orodispersible .............................................................. 750Tablets, resistance to crushing (2.9.8.) ................................. 279Tablets, soluble........................................................................... 750Tablets, subdivision of .............................................................. 748Tablets, sublingual..................................................................... 734Tablets, uncoated ....................................................................... 749Tablets, uncoated, friability of (2.9.7.) ................................... 278Tablets, vaginal........................................................................... 752Talc.............................................................................................. 3013Tamoxifen citrate ..................................................................... 3014Tampons, ear............................................................................... 720Tampons, medicated ................................................................. 751Tampons, rectal .......................................................................... 746Tampons, vaginal, medicated .................................................. 752Tamsulosin hydrochloride ..................................................... 3016Tannic acid ................................................................................ 3018Tannins in herbal drugs, determination of (2.8.14.) .......... 255Tartaric acid .............................................................................. 3018Teat dips....................................................................................... 753Tea tree oil ................................................................................. 3019Teat sprays................................................................................... 753Technetium (99mTc) bicisate injection .................................. 1022Technetium (99mTc) colloidal rhenium sulphide injection................................................................................................... 1023

Technetium (99mTc) colloidal sulphur injection ................. 1024Technetium (99mTc) colloidal tin injection .......................... 1025Technetium (99mTc) etifenin injection .................................. 1026Technetium (99mTc) exametazime injection ........................ 1027

3288 See the information section on general monographs (cover pages)

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Technetium (99mTc) gluconate injection .............................. 1028Technetium (99mTc) human albumin injection ................... 1029Technetium (99mTc) macrosalb injection.............................. 1030Technetium (99mTc) medronate injection............................. 1031Technetium (99mTc) mertiatide injection ............................. 1033Technetium (99mTc) microspheres injection........................ 1034Technetium (99mTc) pentetate injection............................... 1035Technetium (99mTc) sestamibi injection ............................... 1036Technetium (99mTc) succimer injection................................ 1037Technetium (99mTc) tin pyrophosphate injection............... 1038Temazepam................................................................................3020Tenosynovitis avian viral vaccine (live) ................................. 875Tenoxicam.................................................................................. 3021Terazosin hydrochloride dihydrate ......................................3022Terbinafine hydrochloride......................................................3024Terbutaline sulphate ...............................................................3025Terconazole ...............................................................................3027Terfenadine................................................................................3028Terminology used in monographs on biological products(5.2.1.)......................................................................................... 547

Test for anticomplementary activity of immunoglobulin(2.6.17.)........................................................................................191

Test for anti-D antibodies in human immunoglobulin forintravenous administration (2.6.26.) ................................... 205

Test for extractable volume of parenteral preparations(2.9.17.)....................................................................................... 287

Test for Fc function of immunoglobulin (2.7.9.) ................. 227Test for methanol and 2-propanol (2.9.11.) .......................... 282Test for neurovirulence of live virus vaccines (2.6.18.) ..... 193Test for neurovirulence of poliomyelitis vaccine (oral)(2.6.19.) ...................................................................................... 193

Test for specified micro-organisms (microbiologicalexamination of non-sterile products) (2.6.13.) .................. 173

Testosterone..............................................................................3030Testosterone decanoate .......................................................... 3031Testosterone enantate.............................................................3033Testosterone isocaproate........................................................3034Testosterone propionate.........................................................3035Tests for extraneous agents in viral vaccines for human use(2.6.16.) ...................................................................................... 190

Tetanus and diphtheria toxins and toxoids, flocculation value(Lf) of, (Ramon assay) (2.7.27.) ............................................. 241

Tetanus and diphtheria vaccine (adsorbed, reducedantigen(s) content) .................................................................. 764

Tetanus antitoxin for human use ........................................... 969Tetanus antitoxin for veterinary use...................................... 976Tetanus, diphtheria and hepatitis B (rDNA) vaccine(adsorbed).................................................................................. 765

Tetanus, diphtheria and pertussis (acellular, component)vaccine (adsorbed)................................................................... 767

Tetanus, diphtheria and poliomyelitis (inactivated) vaccine(adsorbed, reduced antigen(s) content) .............................. 770

Tetanus, diphtheria, pertussis (acellular, component) andhaemophilus type b conjugate vaccine (adsorbed) .......... 771

Tetanus, diphtheria, pertussis (acellular, component) andhepatitis B (rDNA) vaccine (adsorbed) ............................... 774

Tetanus, diphtheria, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed) .................. 775

Tetanus, diphtheria, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed, reducedantigen(s) content) .................................................................. 778

Tetanus, diphtheria, pertussis (acellular, component),hepatitis B (rDNA), poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) .......... 780

Tetanus, diphtheria, pertussis (acellular, component),poliomyelitis (inactivated) and haemophilus type bconjugate vaccine (adsorbed)................................................ 783

Tetanus, diphtheria, pertussis and poliomyelitis (inactivated)vaccine (adsorbed)................................................................... 785

Tetanus, diphtheria, pertussis, poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) .......... 787

Tetanus immunoglobulin, human ........................................2079Tetanus vaccine (adsorbed) ..................................................... 844Tetanus vaccine (adsorbed), assay of (2.7.8.) ....................... 223Tetanus vaccine for veterinary use ........................................ 957Tetracaine hydrochloride .......................................................3036Tetracosactide ...........................................................................3037Tetracycline ...............................................................................3040Tetracycline hydrochloride .................................................... 3041Tetrazepam................................................................................3043Tetryzoline hydrochloride......................................................3044Thallous (201Tl) chloride injection......................................... 1039Theobromine.............................................................................3045Theophylline .............................................................................3046Theophylline-ethylenediamine ..............................................3048Theophylline-ethylenediamine hydrate ...............................3049Theophylline monohydrate....................................................3047Thermal analysis (2.2.34.). ......................................................... 55Thermogravimetry (2.2.34.). ...................................................... 55Thiamazole ................................................................................3050Thiamine hydrochloride ......................................................... 3051Thiamine nitrate.......................................................................3053Thiamphenicol ..........................................................................3054Thin-layer chromatography (2.2.27.)........................................ 43Thioctic acid ..............................................................................3055Thiomersal .................................................................................3056Thiopental sodium and sodium carbonate.........................3057Thioridazine ..............................................................................3058Thioridazine hydrochloride ...................................................3059Three-lobed sage leaf...............................................................2854Threonine...................................................................................3060Thyme ......................................................................................... 3061Thyme oil ..................................................................................3063Thyme, wild ............................................................................... 3219Thymol........................................................................................3064Tiabendazole .............................................................................3064Tiamulin for veterinary use ...................................................3065Tiamulin hydrogen fumarate for veterinary use ...............3068Tianeptine sodium ...................................................................3070Tiapride hydrochloride ...........................................................3071Tiaprofenic acid ........................................................................3072Tibolone ..................................................................................... 3074Ticarcillin sodium.....................................................................3075Tick-borne encephalitis vaccine (inactivated) ...................... 845Ticlopidine hydrochloride ......................................................3077Tilidine hydrochloride hemihydrate ....................................3079Timolol maleate ........................................................................3080Tinctures ...................................................................................... 683Tinidazole .................................................................................. 3081Tinnevelly senna pods.............................................................2871Tinzaparin sodium...................................................................3082Tioconazole ...............................................................................3083Titanium dioxide ......................................................................3084Titration, amperometric (2.2.19.).............................................. 35Titration, potentiometric (2.2.20.) ............................................ 35Titrations, complexometric (2.5.11.) ...................................... 140Tobramycin ................................................................................3085Tocopherol, all-rac-α- ..............................................................3086Tocopherol, RRR-α- .................................................................3088Tocopheryl acetate, all-rac-α- ................................................3089α-Tocopheryl acetate concentrate (powder form) ............ 3091Tocopheryl acetate, RRR-α-...................................................3090Tocopheryl hydrogen succinate, DL-α- ................................3093Tocopheryl hydrogen succinate, RRR-α- ............................3095Tolbutamide ..............................................................................3097Tolfenamic acid.........................................................................3097Tolnaftate ..................................................................................3099Tolu balsam ...............................................................................3099

General Notices (1) apply to all monographs and other texts 3289

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Torasemide, anhydrous........................................................... 3100Tormentil ....................................................................................3101Tormentil tincture.................................................................... 3102Tosylchloramide sodium......................................................... 3103Total ash (2.4.16.)........................................................................116Total cholesterol in oils rich in omega-3 acids (2.4.32.) .... 132Total organic carbon in water for pharmaceutical use(2.2.44.) .........................................................................................71

Total protein (2.5.33.) ............................................................... 148Total viable aerobic count (microbiological examination ofnon-sterile products) (2.6.12.) ............................................... 166

Toxicity, abnormal (2.6.9.)........................................................ 165Toxin, botulinum type A for injection..................................1327Tragacanth ................................................................................ 3103Tramadol hydrochloride ......................................................... 3104Tramazoline hydrochloride monohydrate .......................... 3106Trandolapril............................................................................... 3107Tranexamic acid ....................................................................... 3108Transdermal patches ................................................................. 737Transdermal patches, dissolution test for (2.9.4.) .............. 275Trapidil ....................................................................................... 3110Tretinoin .....................................................................................3111Triacetin ..................................................................................... 3112Triamcinolone........................................................................... 3112Triamcinolone acetonide.........................................................3114Triamcinolone hexacetonide ................................................. 3115Triamterene ............................................................................... 3116Tribenoside.................................................................................3117Tributyl acetylcitrate ............................................................... 3118Trichloroacetic acid ................................................................. 3119Triethanolamine ....................................................................... 3133Triethyl citrate .......................................................................... 3120Trifluoperazine hydrochloride .............................................. 3121Triflusal ...................................................................................... 3121Triglycerides, medium-chain.................................................. 3122Triglycerides, omega-3 acid ...................................................2554Triglycerol diisostearate ......................................................... 3124Trihexyphenidyl hydrochloride............................................. 3125Trimetazidine dihydrochloride.............................................. 3126Trimethadione .......................................................................... 3127Trimethoprim............................................................................ 3128Trimipramine maleate ............................................................. 3130Tri-n-butyl phosphate .............................................................. 3132Tritiated (3H) water injection................................................. 1040Trolamine................................................................................... 3133Trometamol ............................................................................... 3135Tropicamide............................................................................... 3135Tropisetron hydrochloride ..................................................... 3136Trospium chloride.................................................................... 3138Troxerutin.................................................................................. 3139Trypsin ........................................................................................3141Tryptophan................................................................................ 3142TSE, animal, minimising the risk of transmitting via humanand veterinary medicinal products (5.2.8.) ........................ 558

TSE, animal, products with risk of transmitting agentsof.................................................................................................. 694

Tuberculin for human use, old.............................................. 3144Tuberculin purified protein derivative, avian .................... 3146Tuberculin purified protein derivative, bovine.................. 3147Tuberculin purified protein derivative for human use .... 3147Tubes for comparative tests (2.1.5.) ..........................................17Tubing and closures, silicone elastomer for (3.1.9.)........... 358Tubing and containers for total parenteral nutritionpreparations, poly(ethylene - vinyl acetate) for (3.1.7.) ... 356

Tubing used in sets for the transfusion of blood and bloodcomponents, materials based on plasticised poly(vinylchloride) for (3.1.1.2.) ............................................................. 342

Tubocurarine chloride ............................................................ 3150Turmeric, Javanese .................................................................. 3150

Turpentine oil, Pinus pinaster type ..................................... 3151Tylosin for veterinary use ...................................................... 3152Tylosin phosphate bulk solution for veterinary use ........ 3154Tylosin tartrate for veterinary use ....................................... 3156Typhoid polysaccharide vaccine ............................................. 847Typhoid vaccine.......................................................................... 849Typhoid vaccine, freeze-dried.................................................. 849Typhoid vaccine (live, oral, strain Ty 21a)............................ 849Tyrosine...................................................................................... 3157Tyrothricin................................................................................. 3158

UUbidecarenone.......................................................................... 3163Udder-washes .............................................................................. 753Ultraviolet and visible absorption spectrophotometry(2.2.25.) .........................................................................................41

Ultraviolet ray lamps for analytical purposes (2.1.3.)............15Uncoated tablets......................................................................... 749Undecylenic acid ...................................................................... 3164Uniformity of content of single-dose preparations(2.9.6.) ........................................................................................ 278

Uniformity of dosage units (2.9.40.) ...................................... 327Uniformity of mass of delivered doses from multidosecontainers (2.9.27.) .................................................................. 309

Uniformity of mass of single-dose preparations (2.9.5.) .... 278Units of the International System (SI) used in thePharmacopoeia and equivalence with other units (1.)........ 3

Unsaponifiable matter (2.5.7.) ................................................. 139Urea............................................................................................. 3165Urofollitropin ............................................................................ 3166Urokinase................................................................................... 3167Uronic acids in polysaccharide vaccines (2.5.22.)............... 144Ursodeoxycholic acid ............................................................. 3168

VVaccines, adsorbed, aluminium in (2.5.13.)...........................141Vaccines, adsorbed, calcium in (2.5.14.)................................ 142Vaccines and immunosera, phenol in (2.5.15.) .................... 142Vaccines and immunosera, veterinary, evaluation of efficacy(5.2.7.)......................................................................................... 557

Vaccines and immunosera, veterinary, evaluation of safety(5.2.6.) ........................................................................................ 556

Vaccines and immunosera, veterinary, evaluation of thesafety of each batch (5.2.9.) ................................................... 567

Vaccines for human use............................................................ 705Vaccines for human use, cell substrates for the production of(5.2.3.) ........................................................................................ 550

Vaccines for human use, viral, extraneous agents in(2.6.16.) ...................................................................................... 190

Vaccines for veterinary use...................................................... 707Vaccines, polysaccharide, hexosamines in (2.5.20.)............ 143Vaccines, polysaccharide, methylpentoses in (2.5.21.)....... 143Vaccines, polysaccharide, nucleic acids in (2.5.17.) ............ 142Vaccines, polysaccharide, O-acetyl in (2.5.19.)..................... 143Vaccines, polysaccharide, phosphorus in (2.5.18.) ............. 142Vaccines, polysaccharide, protein in (2.5.16.) ...................... 142Vaccines, polysaccharide, ribose in (2.5.31.) ........................ 147Vaccines, polysaccharide, sialic acid in (2.5.23.) ................. 144Vaccines, polysaccharide, uronic acids in (2.5.22.)............. 144Vaccines, SPF chicken flocks for the production and qualitycontrol of (5.2.2.) .................................................................... 547

Vaccines, veterinary, cell cultures for the production of(5.2.4.) ........................................................................................ 553

Vaccines, veterinary, substances of animal origin for theproduction of (5.2.5.) .............................................................. 555

Vaccines, viral live, test for neurovirulence (2.6.18.).......... 193Vaginal capsules ......................................................................... 752Vaginal foams.............................................................................. 752

3290 See the information section on general monographs (cover pages)

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Vaginal preparations ................................................................. 751Vaginal preparations, semi-solid ............................................. 752Vaginal solutions and suspensions, tablets for.................... 752Vaginal solutions, emulsions and suspensions.................... 752Vaginal tablets ............................................................................ 752Vaginal tampons, medicated.................................................... 752Valerian dry hydroalcoholic extract..................................... 3173Valerian root...............................................................................3174Valerian tincture....................................................................... 3175Valine ...........................................................................................3176Valnemulin hydrochloride for veterinary use ................... 3177Valproic acid.............................................................................. 3178Vancomycin hydrochloride .................................................... 3180Vanillin ....................................................................................... 3182Varicella immunoglobulin for intravenous administration,human ...................................................................................... 2081

Varicella immunoglobulin, human.......................................2080Varicella vaccine (live)............................................................... 850Vectors for human use, adenovirus ....................................... 670Vectors for human use, plasmid ............................................. 674Vectors for human use, plasmid, bacterial cells used for themanufacture of ......................................................................... 676

Vectors for human use, poxvirus ............................................ 672Vecuronium bromide............................................................... 3183Vegetable fatty oils..................................................................... 712Venlafaxine hydrochloride ..................................................... 3184Verapamil hydrochloride ........................................................ 3186Verbena herb............................................................................. 3188Veterinary liquid preparations for cutaneous application.. 752Viability, nucleated cell count and (2.7.29.) ......................... 243Vibriosis (cold-water) vaccine (inactivated) for salmonids.. 959Vibriosis vaccine (inactivated) for salmonids....................... 960VICH (5.8.) ................................................................................... 645Vinblastine sulphate ................................................................ 3189Vincristine sulphate................................................................. 3190Vindesine sulphate .................................................................. 3192Vinorelbine tartrate ................................................................. 3194Vinpocetine................................................................................ 3196Viper venom antiserum, European ........................................ 970Viral rhinotracheitis vaccine (inactivated), feline.................916Viral rhinotracheitis vaccine (live), feline ..............................917Viral safety (5.1.7.) ..................................................................... 543Viscometer method, capillary (2.2.9.) ...................................... 27Viscometer method, falling ball (2.2.49.) ................................ 84Viscose wadding, absorbent .................................................. 3197Viscosity (2.2.8.) ........................................................................... 27Viscosity - rotating viscometer method (2.2.10.) ................... 28Visible and ultraviolet absorption spectrophotometry(2.2.25.) .........................................................................................41

Visible particles, particulate contamination (2.9.20.) ........ 302Vitamin A ................................................................................... 3199Vitamin A concentrate (oily form), synthetic .....................3200Vitamin A concentrate (powder form), synthetic .............. 3201Vitamin A concentrate (solubilisate/emulsion),synthetic ..................................................................................3203

Volumetric analysis (4.2.) ..........................................................514Volumetric solutions (4.2.2.).....................................................514Volumetric solutions, primary standards for (4.2.1.) ..........514von Willebrand factor, human .............................................. 2081von Willebrand factor, human, assay of (2.7.21.) ................ 237

WWarfarin sodium.......................................................................3207

Warfarin sodium clathrate .....................................................3208Washes, nasal .............................................................................. 732Water (15O) injection................................................................ 1040Water, determination by distillation (2.2.13.) .........................31Water for diluting concentrated haemodialysissolutions .................................................................................. 2021

Water for injections .................................................................3209Water for pharmaceutical use, total organic carbon in(2.2.44.) .........................................................................................71

Water, highly purified ............................................................. 3212Water in essential oils (2.8.5.) ................................................. 249Water in gases (2.5.28.) ............................................................ 146Water : micro determination (2.5.32.).................................... 147Water, purified.......................................................................... 3213Water : semi-micro determination (2.5.12.) ...........................141Wheat-germ oil, refined .......................................................... 3215Wheat-germ oil, virgin............................................................. 3216Wheat starch ............................................................................. 3215White beeswax ..........................................................................1260White horehound..................................................................... 3216White soft paraffin................................................................... 2614Wild pansy (flowering aerial parts)...................................... 3217Wild thyme ................................................................................ 3219Willow bark ...............................................................................3220Wool alcohols............................................................................ 3221Wool fat ......................................................................................3222Wool fat, hydrogenated...........................................................3226Wool fat, hydrous.....................................................................3227Wormwood ................................................................................3228

XXanthan gum ............................................................................3233Xenon (133Xe) injection............................................................ 1042X-ray fluorescence spectrometry (2.2.37.)............................... 59X-ray powder diffraction (XRPD), characterisation ofcrystalline and partially crystalline solids by (2.9.33.) .....314

Xylazine hydrochloride for veterinary use .........................3234Xylitol ..........................................................................................3235Xylometazoline hydrochloride ..............................................3237Xylose..........................................................................................3238

YYarrow ........................................................................................3243Yellow beeswax ......................................................................... 1261Yellow fever vaccine (live) ........................................................ 852Yellow soft paraffin.................................................................. 2615Yohimbine hydrochloride .......................................................3244

ZZidovudine.................................................................................3249Zinc acetate dihydrate.............................................................3250Zinc acexamate ......................................................................... 3251Zinc chloride .............................................................................3253Zinc oxide...................................................................................3253Zinc stearate..............................................................................3254Zinc sulphate heptahydrate ...................................................3254Zinc sulphate hexahydrate.....................................................3255Zinc sulphate monohydrate ...................................................3255Zinc undecylenate ....................................................................3256Zolpidem tartrate .....................................................................3256Zopiclone ...................................................................................3257Zuclopenthixol decanoate ......................................................3259

General Notices (1) apply to all monographs and other texts 3291

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3292 See the information section on general monographs (cover pages)

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AAbsinthii herba ........................................................................3228Acaciae gummi ........................................................................ 1087Acaciae gummi dispersione desiccatum........................... 1087Acamprosatum calcicum....................................................... 1088Acarbosum ................................................................................ 1089Acebutololi hydrochloridum ................................................ 1091Aceclofenacum ......................................................................... 1093Acesulfamum kalicum ........................................................... 1095Acetazolamidum...................................................................... 1096Acetonum .................................................................................. 1098Acetylcholini chloridum ........................................................ 1099Acetylcysteinum ...................................................................... 1100β-Acetyldigoxinum ...................................................................1101Aciclovirum .............................................................................. 1107Acidi methacrylici et ethylis acrylatis polymerisati 1:1dispersio 30 per centum .....................................................2372

Acidi methacrylici et ethylis acrylatis polymerisatum1:1 .............................................................................................2371

Acidi methacrylici et methylis methacrylatis polymerisatum1:1 .............................................................................................2373

Acidi methacrylici et methylis methacrylatis polymerisatum1:2 ............................................................................................. 2374

Acidum 4-aminobenzoicum ................................................. 1164Acidum aceticum glaciale..................................................... 1097Acidum acetylsalicylicum ..................................................... 1103Acidum adipicum .................................................................... 1113Acidum alginicum................................................................... 1131Acidum amidotrizoicum dihydricum ................................ 1158Acidum aminocaproicum ..................................................... 1166Acidum ascorbicum ................................................................ 1221Acidum asparticum ................................................................1225Acidum benzoicum ................................................................. 1276Acidum boricum ......................................................................1327Acidum caprylicum ................................................................ 1402Acidum chenodeoxycholicum.............................................. 1489Acidum citricum anhydricum .............................................1554Acidum citricum monohydricum .......................................1555Acidum edeticum .................................................................... 1774Acidum etacrynicum ..............................................................1826Acidum folicum .......................................................................1938Acidum fusidicum ...................................................................1954Acidum glutamicum ...............................................................1984Acidum hydrochloridum concentratum............................2085Acidum hydrochloridum dilutum .......................................2085Acidum iopanoicum ............................................................... 2162Acidum iotalamicum .............................................................. 2163Acidum ioxaglicum................................................................. 2167Acidum lacticum .....................................................................2228Acidum lactobionicum........................................................... 2231Acidum maleicum ...................................................................2328Acidum malicum .....................................................................2329Acidum mefenamicum...........................................................2349Acidum nalidixicum ...............................................................2472Acidum nicotinicum...............................................................2502Acidum nitricum ..................................................................... 2510Acidum oleicum.......................................................................2543Acidum oxolinicum ................................................................2582Acidum palmiticum ................................................................2604Acidum phosphoricum concentratum ...............................2675Acidum phosphoricum dilutum .......................................... 2676Acidum pipemidicum trihydricum .....................................2690Acidum salicylicum ................................................................2859Acidum (S)-lacticum ...............................................................2229Acidum sorbicum ....................................................................2937Acidum stearicum ...................................................................2966Acidum sulfuricum .................................................................2998Acidum tartaricum ................................................................. 3018Acidum thiocticum..................................................................3055

Acidum tiaprofenicum ...........................................................3072Acidum tolfenamicum............................................................3097Acidum tranexamicum .......................................................... 3108Acidum trichloraceticum ...................................................... 3119Acidum undecylenicum ........................................................ 3164Acidum ursodeoxycholicum................................................. 3168Acidum valproicum ................................................................ 3178Acitretinum ............................................................................... 1109Adeninum.................................................................................. 1110Adenosinum ..............................................................................1111Adeps lanae ..............................................................................3222Adeps lanae cum aqua...........................................................3227Adeps lanae hydrogenatus ...................................................3226Adeps solidus............................................................................2034Adrenalini tartras.....................................................................1114Aer medicinalis........................................................................ 1118Aer medicinalis artificiosus ................................................. 1121Aether ......................................................................................... 1833Aether anaestheticus .............................................................. 1834Aetherolea ................................................................................... 680Agar ............................................................................................ 1115Agni casti fructus .................................................................... 1116Agrimoniae herba ....................................................................1117Alaninum................................................................................... 1121Albendazolum .......................................................................... 1122Albumini humani solutio ......................................................2057Alchemillae herba ................................................................... 1123Alcohol benzylicus .................................................................. 1281Alcohol cetylicus...................................................................... 1485Alcohol cetylicus et stearylicus ........................................... 1480Alcohol cetylicus et stearylicus emulsificans A .............. 1481Alcohol cetylicus et stearylicus emulsificans B .............. 1482Alcoholes adipis lanae ........................................................... 3221Alcohol isopropylicus............................................................. 2182Alcohol oleicus .........................................................................2544Alcohol stearylicus..................................................................2968Alcuronii chloridum ............................................................... 1124Alfacalcidolum ......................................................................... 1126Alfadexum ................................................................................. 1127Alfentanili hydrochloridum.................................................. 1128Alfuzosini hydrochloridum .................................................. 1130Allantoinum.............................................................................. 1131Allii sativi bulbi pulvis ........................................................... 1961Allium sativum ad praeparationes homoeopathicas ..... 1077Allopurinolum.......................................................................... 1132Almagatum................................................................................ 1134Aloe barbadensis ..................................................................... 1137Aloe capensis............................................................................ 1138Aloes extractum siccum normatum.................................... 1139Alprazolamum ......................................................................... 1139Alprenololi hydrochloridum..................................................1141Alprostadilum........................................................................... 1143Alteplasum ad iniectabile...................................................... 1145Althaeae folium........................................................................2338Althaeae radix ..........................................................................2339Alumen....................................................................................... 1149Aluminii chloridum hexahydricum ................................... 1149Aluminii hydroxidum hydricum ad adsorptionem ........ 1150Aluminii magnesii silicas ..................................................... 1151Aluminii oxidum hydricum .................................................. 1152Aluminii phosphas hydricus ................................................ 1153Aluminii phosphatis liquamen ............................................ 1152Aluminii sulfas......................................................................... 1154Alverini citras ........................................................................... 1154Amantadini hydrochloridum ............................................... 1156Ambroxoli hydrochloridum .................................................. 1156Amfetamini sulfas ................................................................... 1158Amikacini sulfas ...................................................................... 1161Amikacinum ............................................................................. 1159

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Amiloridi hydrochloridum.................................................... 1163Aminoglutethimidum ............................................................. 1167Amiodaroni hydrochloridum ............................................... 1168Amisulpridum .......................................................................... 1170Amitriptylini hydrochloridum ............................................. 1172Amlodipini besilas .................................................................. 1173Ammoniae (13N) solutio iniectabilis ..................................... 981Ammoniae solutio concentrata ........................................... 1175Ammonii bromidum ............................................................... 1177Ammonii chloridum ............................................................... 1178Ammonii glycyrrhizas ........................................................... 1179Ammonii hydrogenocarbonas ............................................. 1180Ammonio methacrylatis copolymerum A......................... 1175Ammonio methacrylatis copolymerum B .........................1176Amobarbitalum ........................................................................ 1180Amobarbitalum natricum ..................................................... 1181Amoxicillinum natricum ....................................................... 1182Amoxicillinum trihydricum.................................................. 1184Amphotericinum B ................................................................. 1187Ampicillinum anhydricum ................................................... 1188Ampicillinum natricum ......................................................... 1190Ampicillinum trihydricum.................................................... 1193Amygdalae oleum raffinatum .............................................. 1136Amygdalae oleum virginale ................................................. 1136Amylum pregelificatum .........................................................2964Angelicae radix ........................................................................ 1196Anisi aetheroleum ................................................................... 1197Anisi fructus ............................................................................. 1199Anisi stellati aetheroleum .....................................................2962Anisi stellati fructus................................................................2960Antazolini hydrochloridum.................................................. 1199Anticorpora monoclonalia ad usum humanum ............... 690Antithrombinum III humanum densatum .......................2060Apis mellifera ad praeparationes homoeopathicas........ 1079Apomorphini hydrochloridum ............................................1207Aprotinini solutio concentrata ............................................1209Aprotininum .............................................................................1208Aqua ad dilutionem solutionum concentratarum adhaemodialysim ...................................................................... 2021

Aqua ad iniectabilia ...............................................................3209Aquae (15O) solutio iniectabilis ............................................ 1040Aquae tritiatae (3H) solutio iniectabilis ............................. 1040Aqua purificata ........................................................................ 3213Aqua valde purificata............................................................. 3212Arachidis oleum hydrogenatum.......................................... 1211Arachidis oleum raffinatum ................................................. 1211Argenti nitras ...........................................................................2880Argentum colloidale ad usum externum ..........................2879Arginini aspartas .................................................................... 1213Arginini hydrochloridum...................................................... 1214Argininum................................................................................. 1212Arnicae flos............................................................................... 1215Arnicae tinctura ...................................................................... 1216Arsenii trioxidumad praeparationes homoeopathicas .. 1073Articaini hydrochloridum ..................................................... 1217Ascorbylis palmitas.................................................................1222Asparaginum monohydricum..............................................1223Aspartamum .............................................................................1224Astemizolum .............................................................................1226Atenololum................................................................................1228Atracurii besilas.......................................................................1230Atropini sulfas..........................................................................1234Atropinum .................................................................................1232Aurantii amari epicarpii et mesocarpii tinctura ............1320Aurantii amari epicarpium et mesocarpium................... 1319Aurantii amari flos .................................................................1320Aurantii dulcis aetheroleum.................................................3009Auricularia.................................................................................. 719Azaperonum ad usum veterinarium..................................1234

Azathioprinum.........................................................................1236Azelastini hydrochloridum ...................................................1236Azithromycinum......................................................................1238

BBacampicillini hydrochloridum ..........................................1243Bacitracinum............................................................................1245Bacitracinum zincum ............................................................1247Baclofenum...............................................................................1250Ballotae nigrae herba ............................................................ 1321Balsamum peruvianum.........................................................2649Balsamum tolutanum ............................................................3099Bambuteroli hydrochloridum .............................................. 1251Barbitalum ................................................................................1252Barii chloridum dihydricum ad praeparationeshomoeopathicas .................................................................... 1073

Barii sulfas ................................................................................1253BCG ad immunocurationem .................................................. 758Beclometasoni dipropionas anhydricus ...........................1256Beclometasoni dipropionas monohydricus .....................1258Belladonnae folii extractum siccum normatum .............1263Belladonnae folii tinctura normata ...................................1264Belladonnae folium ................................................................ 1261Belladonnae pulvis normatus..............................................1265Bendroflumethiazidum .........................................................1266Benfluorexi hydrochloridum ...............................................1267Benperidolum ..........................................................................1269Benserazidi hydrochloridum ...............................................1270Bentonitum ............................................................................... 1271Benzalkonii chloridi solutio ................................................1273Benzalkonii chloridum..........................................................1272Benzbromaronum ...................................................................1273Benzethonii chloridum .........................................................1275Benzocainum ........................................................................... 1276Benzoe sumatranus ................................................................1278Benzoe tonkinensis ................................................................1277Benzois sumatrani tinctura..................................................1279Benzois tonkinensis tinctura ...............................................1278Benzoylis peroxidum cum aqua .........................................1280Benzylis benzoas.....................................................................1283Benzylpenicillinum benzathinum......................................1283Benzylpenicillinum kalicum................................................1285Benzylpenicillinum natricum .............................................1288Benzylpenicillinum procainum ..........................................1287Betacarotenum ........................................................................1290Betadexum ................................................................................ 1291Betahistini dihydrochloridum .............................................1292Betahistini mesilas .................................................................1293Betamethasoni acetas ............................................................1297Betamethasoni dipropionas .................................................1298Betamethasoni natrii phosphas ..........................................1300Betamethasoni valeras........................................................... 1301Betamethasonum ....................................................................1295Betaxololi hydrochloridum...................................................1303Betulae folium.......................................................................... 1311Bezafibratum ............................................................................1304Bifonazolum .............................................................................1306Biotinum ...................................................................................1308Biperideni hydrochloridum .................................................1309Bisacodylum ............................................................................. 1312Bismuthi subcarbonas ........................................................... 1313Bismuthi subgallas ................................................................. 1314Bismuthi subnitras ponderosus........................................... 1315Bismuthi subsalicylas ............................................................ 1316Bistortae rhizoma ................................................................... 1317Bleomycini sulfas ....................................................................1322Boldi folium ..............................................................................1324Boragonis officinalis oleum raffinatum............................1326Borax ..........................................................................................1326

3294 See the information section on general monographs (cover pages)

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Bromazepamum ...................................................................... 1331Bromhexini hydrochloridum ...............................................1332Bromocriptini mesilas ...........................................................1333Bromperidoli decanoas .........................................................1337Bromperidolum .......................................................................1335Brompheniramini maleas ....................................................1339Brotizolamum ..........................................................................1340Budesonidum ...........................................................................1342Bufexamacum ..........................................................................1344Buflomedili hydrochloridum ...............................................1345Bumetanidum ..........................................................................1346Bupivacaini hydrochloridum...............................................1347Buprenorphini hydrochloridum .........................................1350Buprenorphinum ...................................................................1349Buserelinum ............................................................................. 1351Buspironi hydrochloridum...................................................1353Busulfanum ..............................................................................1355Butylhydroxyanisolum ..........................................................1357Butylhydroxytoluenum..........................................................1357Butylis parahydroxybenzoas................................................1358

CCabergolinum ..........................................................................1363Cadmii sulfas hydricusad praeparationes homoeopathicas................................. 1074

Calcifediolum ...........................................................................1366Calcii acetas ............................................................................. 1376Calcii ascorbas .........................................................................1377Calcii carbonas ........................................................................1378Calcii chloridum dihydricum ..............................................1378Calcii chloridum hexahydricum .........................................1379Calcii dobesilas monohydricus ...........................................1380Calcii folinas ............................................................................1380Calcii glucoheptonas..............................................................1383Calcii gluconas ........................................................................1384Calcii gluconas ad iniectabile .............................................1385Calcii glycerophosphas..........................................................1386Calcii hydrogenophosphas anhydricus.............................1387Calcii hydrogenophosphas dihydricus..............................1388Calcii hydroxidum ..................................................................1389Calcii iodidum tetrahydricum ad praeparationeshomoeopathicas .................................................................... 1074

Calcii lactas anhydricus ........................................................1389Calcii lactas monohydricus ..................................................1390Calcii lactas pentahydricus ..................................................1390Calcii lactas trihydricus ........................................................ 1391Calcii laevulinas dihydricus.................................................1394Calcii levofolinas pentahydricus ........................................1392Calcii pantothenas ..................................................................1395Calcii stearas ............................................................................1397Calcii sulfas dihydricus .........................................................1398Calcipotriolum anhydricum.................................................1367Calcipotriolum monohydricum...........................................1370Calcitoninum salmonis .........................................................1372Calcitriolum..............................................................................1375Calendulae flos ........................................................................1398Camphora racemica ............................................................... 1401Capsici fructus ......................................................................... 1404Capsici oleoresina raffinata et quantificata .................... 1405Capsici tinctura normata ...................................................... 1406Capsulae .......................................................................................717Captoprilum ............................................................................. 1407Carbacholum ............................................................................ 1410Carbamazepinum ....................................................................1411Carbasalatum calcicum ......................................................... 1412Carbidopum .............................................................................. 1413Carbimazolum ..........................................................................1414Carbo activatus ........................................................................ 1488Carbocisteinum ....................................................................... 1415

Carbomera ................................................................................ 1416Carbonei dioxidum ..................................................................1417Carbonei monoxidum (15O) .................................................... 982Carboplatinum ......................................................................... 1419Carboprostum trometamolum ............................................. 1420Carboxymethylamylum natricum A...................................2920Carboxymethylamylum natricum B................................... 2921Carboxymethylamylum natricum C...................................2922Carisoprodolum....................................................................... 1421Carmellosum calcicum .......................................................... 1422Carmellosum natricum ......................................................... 1423Carmellosum natricum conexum ....................................... 1626Carmellosum natricum, substitutum humile................... 1424Carmustinum ........................................................................... 1425Carteololi hydrochloridum ................................................... 1426Carthami flos ........................................................................... 2851Carthami oleum raffinatum .................................................2852Carvedilolum ............................................................................ 1427Carvi aetheroleum .................................................................. 1408Carvi fructus............................................................................. 1408Caryophylli floris aetheroleum ...........................................1588Caryophylli flos .......................................................................1587Cefaclorum ............................................................................... 1435Cefadroxilum monohydricum ............................................. 1436Cefalexinum monohydricum ............................................... 1438Cefalotinum natricum ........................................................... 1440Cefamandoli nafas .................................................................. 1441Cefapirinum natricum........................................................... 1443Cefatrizinum propylen glycolum........................................ 1444Cefazolinum natricum........................................................... 1445Cefepimi dihydrochloridum monohydricum................... 1448Cefiximum................................................................................. 1450Cefoperazonum natricum..................................................... 1451Cefotaximum natricum ......................................................... 1453Cefoxitinum natricum ........................................................... 1455Cefradinum ............................................................................... 1457Ceftazidimum........................................................................... 1459Ceftriaxonum natricum......................................................... 1461Cefuroximum axetili............................................................... 1462Cefuroximum natricum ......................................................... 1464Celiprololi hydrochloridum.................................................. 1465Cellulae stirpes haematopoieticae humanae...................2067Cellulosi acetas ........................................................................ 1467Cellulosi acetas butyras ......................................................... 1468Cellulosi acetas phthalas....................................................... 1468Cellulosi pulvis ........................................................................ 1473Cellulosum microcristallinum ............................................. 1469Cellulosum microcristallinum et carmellosumnatricum..................................................................................2422

Centaurii herba ....................................................................... 1477Centellae asiaticae herba ...................................................... 1477Cera alba ...................................................................................1260Cera carnauba ......................................................................... 1425Cera flava .................................................................................. 1261Cetirizini dihydrochloridum ................................................ 1479Cetobemidoni hydrochloridum ........................................... 2215Cetostearylis isononanoas.................................................... 1484Cetrimidum............................................................................... 1484Cetylis palmitas ....................................................................... 1486Cetylpyridinii chloridum ...................................................... 1486Chamomillae romanae flos .................................................. 1487Chelidonii herba...................................................................... 2010Chinidini sulfas .......................................................................2799Chinini hydrochloridum .......................................................2800Chinini sulfas ...........................................................................2802Chitosani hydrochloridum ................................................... 1490Chlorali hydras ........................................................................ 1491Chlorambucilum...................................................................... 1492Chloramphenicoli natrii succinas ...................................... 1495

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Chloramphenicoli palmitas .................................................. 1493Chloramphenicolum............................................................... 1492Chlorcyclizini hydrochloridum ........................................... 1496Chlordiazepoxidi hydrochloridum ..................................... 1498Chlordiazepoxidum ................................................................ 1497Chlorhexidini diacetas........................................................... 1499Chlorhexidini digluconatis solutio.....................................1500Chlorhexidini dihydrochloridum........................................1502Chlorobutanolum anhydricum............................................1503Chlorobutanolum hemihydricum .......................................1504Chlorocresolum .......................................................................1504Chloroquini phosphas ...........................................................1505Chloroquini sulfas...................................................................1506Chlorothiazidum .....................................................................1507Chlorphenamini maleas........................................................1508Chlorpromazini hydrochloridum .......................................1509Chlorpropamidum .................................................................. 1510Chlorprothixeni hydrochloridum ....................................... 1511Chlortalidonum ....................................................................... 1513Chlortetracyclini hydrochloridum...................................... 1514Cholecalciferoli pulvis ........................................................... 1519Cholecalciferolum ................................................................... 1516Cholecalciferolum densatum oleosum .............................. 1517Cholecalciferolum in aqua dispergibile ............................ 1521Cholesterolum ..........................................................................1524Chondroitini natrii sulfas .....................................................1525Chorda resorbilis sterilis ....................................................... 1045Chorda resorbilis sterilis in fusoad usum veterinarium ......................................................... 1057

Chromii (51Cr) edetatis solutio iniectabilis ......................... 983Chymotrypsinum ....................................................................1527Ciclopirox olaminum .............................................................1530Ciclopiroxum............................................................................1528Ciclosporinum ......................................................................... 1531Cilastatinum natricum ..........................................................1533Cilazaprilum ............................................................................1534Cimetidini hydrochloridum .................................................1537Cimetidinum ............................................................................1536Cinchocaini hydrochloridum ..............................................1538Cinchonae cortex ....................................................................1539Cinchonae extractum fluidum normatum .......................1540Cineolum ................................................................................... 1541Cinnamomi cassiae aetheroleum ....................................... 1431Cinnamomi cortex ..................................................................1542Cinnamomi corticis tinctura................................................1545Cinnamomi zeylanici folii aetheroleum ...........................1544Cinnamomi zeylanicii corticis aetheroleum ...................1543Cinnarizinum ..........................................................................1545Ciprofibratum...........................................................................1547Ciprofloxacini hydrochloridum ..........................................1550Ciprofloxacinum .....................................................................1548Cisapridi tartras ......................................................................1552Cisapridum monohydricum ................................................. 1551Cisplatinum ..............................................................................1554Citri reticulatae aetheroleum ...............................................2333Citronellae aetheroleum........................................................1556Cladribinum .............................................................................1557Clarithromycinum ..................................................................1559Clazurilum ad usum veterinarium.....................................1562Clebopridi malas .....................................................................1564Clemastini fumaras ................................................................1566Clenbuteroli hydrochloridum ..............................................1567Clindamycini hydrochloridum ............................................1568Clindamycini phosphas.........................................................1570Clioquinolum ........................................................................... 1571Clobazamum ............................................................................1572Clobetasoli propionas ............................................................1573Clobetasoni butyras ................................................................1575Clofaziminum ..........................................................................1577

Clofibratum ...............................................................................1578Clomifeni citras .......................................................................1579Clomipramini hydrochloridum ...........................................1580Clonazepamum .......................................................................1582Clonidini hydrochloridum....................................................1583Closantelum natricum dihydricumad usum veterinarium .........................................................1584

Clotrimazolum .........................................................................1586Cloxacillinum natricum ........................................................1589Clozapinum ..............................................................................1590Cocaini hydrochloridum .......................................................1592Cocois oleum raffinatum.......................................................1593Cocoylis caprylocapras..........................................................1594Codeini hydrochloridum dihydricum................................1596Codeini phosphas hemihydricus ........................................1598Codeini phosphas sesquihydricus ......................................1599Codeinum ..................................................................................1594Codergocrini mesilas ............................................................. 1601Coffeinum..................................................................................1364Coffeinum monohydricum ...................................................1365Colae semen ............................................................................. 1611Colchicinum ............................................................................. 1612Colestyraminum ...................................................................... 1613Colistimethatum natricum ................................................... 1614Colistini sulfas ......................................................................... 1615Colophonium ............................................................................1617Compressi.................................................................................... 748Copolymerum methacrylatis butylati basicum ...............1254Copovidonum ............................................................................1617Coriandri aetheroleum .......................................................... 1621Coriandri fructus .................................................................... 1620Corpora ad usum pharmaceuticum ..................................... 703Cortisoni acetas ....................................................................... 1622Crataegi folii cum floreextractum fluidum quantificatum ....................................2037

Crataegi folii cum flore extractum siccum .......................2036Crataegi folium cum flore.....................................................2035Crataegi fructus .......................................................................2034Cresolum crudum ................................................................... 1626Croci stigma ad praeparationes homoeopathicas .......... 1084Crospovidonum ....................................................................... 1628Crotamitonum.......................................................................... 1629Cupri acetas monohydricus ad praeparationeshomoeopathicas .................................................................... 1075

Cupri sulfas anhydricus ........................................................ 1619Cupri sulfas pentahydricus .................................................. 1620Cuprum ad praeparationes homoeopathicas .................. 1076Curcumae xanthorrhizae rhizoma..................................... 3150Cyamopsidis seminis pulvis ................................................. 2016Cyanocobalamini (57Co) capsulae ........................................ 983Cyanocobalamini (57Co) solutio ............................................ 984Cyanocobalamini (58Co) capsulae ........................................ 985Cyanocobalamini (58Co) solutio ............................................ 986Cyanocobalaminum ............................................................... 1630Cyclizini hydrochloridum..................................................... 1631Cyclopentolati hydrochloridum .......................................... 1632Cyclophosphamidum ............................................................. 1633Cynarae folium ........................................................................ 1219Cyproheptadini hydrochloridum ........................................ 1634Cyproteroni acetas.................................................................. 1635Cysteini hydrochloridum monohydricum ........................ 1636Cystinum ................................................................................... 1637Cytarabinum............................................................................. 1638

DDacarbazinum ......................................................................... 1641Dalteparinum natricum ........................................................ 1642Danaparoidum natricum ...................................................... 1644Dapsonum ................................................................................. 1646

3296 See the information section on general monographs (cover pages)

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Daunorubicini hydrochloridum..........................................1647D-Camphora .............................................................................. 1400Decylis oleas ............................................................................. 1648Deferoxamini mesilas ............................................................ 1649Dembrexini hydrochloridum monohydricum ad usumveterinarium .......................................................................... 1650

Demeclocyclini hydrochloridum ........................................ 1651Deptropini citras ..................................................................... 1653Dequalinii chloridum............................................................. 1654Desipramini hydrochloridum .............................................. 1655Deslanosidum .......................................................................... 1656Desmopressinum..................................................................... 1657Desogestrelum.......................................................................... 1658Desoxycortoni acetas ............................................................. 1659Detomidini hydrochloridum ad usum veterinarium ..... 1660Dexamethasoni acetas ........................................................... 1665Dexamethasoni isonicotinas ................................................ 1666Dexamethasoni natrii phosphas ......................................... 1667Dexamethasonum ................................................................... 1663Dexchlorpheniramini maleas .............................................. 1669Dexpanthenolum..................................................................... 1670Dextranomerum ...................................................................... 1675Dextranum 1 ad iniectabile ................................................. 1671Dextranum 40 ad iniectabile ............................................... 1672Dextranum 60 ad iniectabile ............................................... 1673Dextranum 70 ad iniectabile ............................................... 1674Dextrinum ................................................................................. 1675Dextromethorphani hydrobromidum ................................ 1676Dextromoramidi tartras......................................................... 1677Dextropropoxypheni hydrochloridum............................... 1678Diazepamum ............................................................................ 1679Diazoxidum .............................................................................. 1680Dibrompropamidini diisetionas .......................................... 1681Dibutylis phthalas ................................................................... 1682Diclazurilum ad usum veterinarium ................................. 1683Diclofenacum kalicum........................................................... 1685Diclofenacum natricum ........................................................ 1686Dicloxacillinum natricum..................................................... 1687Dicycloverini hydrochloridum ............................................ 1689Didanosinum............................................................................ 1689Dienestrolum ............................................................................ 1691Diethylcarbamazini citras .................................................... 1693Diethylenglycoli aether monoethilicus ............................. 1694Diethylenglycoli palmitostearas.......................................... 1695Diethylis phthalas ................................................................... 1692Diethylstilbestrolum ............................................................... 1696Diflunisalum ............................................................................ 1697Digitalis purpureae folium ................................................... 1698Digitoxinum.............................................................................. 1700Digoxinum ................................................................................ 1701Dihydralazini sulfas hydricus.............................................. 1703Dihydrocodeini hydrogenotartras ...................................... 1704Dihydroergocristini mesilas ................................................. 1705Dihydroergotamini mesilas .................................................. 1708Dihydroergotamini tartras.................................................... 1709Dihydrostreptomycini sulfas ad usum veterinarium..... 1710Dihydrotachysterolum ........................................................... 1712Dikalii clorazepas ................................................................... 1728Dikalii phosphas...................................................................... 1729Diltiazemi hydrochloridum .................................................. 1714Dimenhydrinatum .................................................................. 1715Dimercaprolum........................................................................ 1716Dimethylacetamidum..............................................................1717Dimethylis sulfoxidum ........................................................... 1716Dimeticonum............................................................................ 1718Dimetindeni maleas ............................................................... 1719Dinatrii edetas ......................................................................... 1734Dinatrii etidronas ...................................................................1844Dinatrii pamidronas pentahydricus ..................................2604

Dinatrii phosphas anhydricus............................................. 1735Dinatrii phosphas dihydricus .............................................. 1735Dinatrii phosphas dodecahydricus .................................... 1736Dinitrogenii oxidum............................................................... 2515Dinoprostonum........................................................................ 1722Dinoprostum trometamolum ............................................... 1720Diosminum ............................................................................... 1723Diphenhydramini hydrochloridum .................................... 1725Diphenoxylati hydrochloridum ........................................... 1726Dipivefrini hydrochloridum ................................................. 1727Diprophyllinum ....................................................................... 1730Dipyridamolum ....................................................................... 1731Dirithromycinum .................................................................... 1732Disopyramidi phosphas......................................................... 1738Disopyramidum ....................................................................... 1737Disulfiramum ........................................................................... 1739Dithranolum ............................................................................. 1740DL-Methioninum ......................................................................2380DL-α-Tocopherylis hydrogenosuccinas..............................3093Dobutamini hydrochloridum ................................................1741Dodecylis gallas ....................................................................... 1744Domperidoni maleas .............................................................. 1747Domperidonum ....................................................................... 1745Dopamini hydrochloridum................................................... 1749Dopexamini dihydrochloridum........................................... 1750Dorzolamidi hydrochloridum .............................................. 1752Dosulepini hydrochloridum ................................................. 1753Doxaprami hydrochloridum ................................................ 1754Doxazosini mesilas................................................................. 1756Doxepini hydrochloridum .................................................... 1757Doxorubicini hydrochloridum............................................. 1759Doxycyclini hyclas .................................................................. 1760Doxycyclinum monohydricum ............................................ 1762Doxylamini hydrogenosuccinas ......................................... 1763Droperidolum........................................................................... 1765

EEbastinum ................................................................................. 1771Echinaceae angustifoliae radix...........................................2483Echinaceae pallidae radix ....................................................2602Echinaceae purpureae herba...............................................2785Echinaceae purpureae radix................................................2787Econazoli nitras ...................................................................... 1773Econazolum.............................................................................. 1772Edrophonii chloridum ........................................................... 1775Eleutherococci radix .............................................................. 1777Emedastini difumaras............................................................ 1779Emetini hydrochloridum heptahydricum......................... 1780Emetini hydrochloridum pentahydricum ........................ 1781Emplastra transcutanea .......................................................... 737Enalaprilatum dihydricum................................................... 1784Enalaprili maleas.................................................................... 1782Enilconazolum ad usum veterinarium ............................. 1785Enoxaparinum natricum ...................................................... 1787Enoxolonum ............................................................................. 1788Ephedrini hydrochloridum .................................................. 1791Ephedrini racemici hydrochloridum ................................. 1792Ephedrinum anhydricum ..................................................... 1789Ephedrinum hemihydricum ................................................ 1790Epirubicini hydrochloridum ................................................ 1793Equiseti herba .......................................................................... 1794Ergocalciferolum ..................................................................... 1795Ergometrini maleas ................................................................ 1797Ergotamini tartras .................................................................. 1798Erythritolum............................................................................. 1800Erythromycini estolas............................................................ 1803Erythromycini ethylsuccinas ............................................... 1806Erythromycini lactobionas ................................................... 1808Erythromycini stearas ........................................................... 1810

General Notices (1) apply to all monographs and other texts 3297

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Erythromycinum ..................................................................... 1801Erythropoietini solutio concentrata................................... 1813Eserini salicylas ......................................................................2677Eserini sulfas............................................................................2678Esketamini hydrochloridum .................................................1817Estradioli benzoas................................................................... 1818Estradioli valeras..................................................................... 1821Estradiolum hemihydricum ................................................. 1819Estriolum ...................................................................................1822Estrogeni coniuncti ................................................................1824Etamsylatum ............................................................................1827Ethacridini lactas monohydricus .......................................1828Ethambutoli hydrochloridum ..............................................1829Ethanolum (96 per centum) .................................................1829Ethanolum anhydricum ........................................................ 1831Ethinylestradiolum .................................................................1834Ethionamidum .........................................................................1835Ethosuximidum .......................................................................1836Ethylcellulosum ....................................................................... 1841Ethylendiaminum ...................................................................1843Ethylenglycoli monopalmitostearas...................................1842Ethylis acetas ...........................................................................1838Ethylis oleas..............................................................................1838Ethylis parahydroxybenzoas................................................1839Ethylis parahydroxybenzoas natricus ...............................1840Ethylmorphini hydrochloridum ..........................................1843Etilefrini hydrochloridum.....................................................1845Etodolacum...............................................................................1847Etofenamatum .........................................................................1849Etofyllinum ...............................................................................1850Etomidatum .............................................................................. 1851Etoposidum...............................................................................1852Eucalypti aetheroleum ..........................................................1858Eucalypti folium ......................................................................1857Eugenolum................................................................................1859Extracta........................................................................................ 682

FFactor humanus von Willebrandi ....................................... 2081Factor IX coagulationis humanus ......................................2064Factor VII coagulationis humanus .................................... 2061Factor VIII coagulationis humanus...................................2062Factor VIII coagulationis humanus (ADNr) ....................2063Factor XI coagulationis humanus ......................................2065Fagopyri herba ........................................................................ 1341Famotidinum............................................................................1865Febantelum ad usum veterinarium....................................1870Felbinacum ...............................................................................1866Felodipinum .............................................................................1867Felypressinum..........................................................................1869Fenbendazolum ad usum veterinarium............................ 1871Fenbufenum..............................................................................1872Fenofibratum ............................................................................1875Fenoteroli hydrobromidum .................................................. 1876Fentanyli citras ........................................................................1879Fentanylum...............................................................................1878Fenticonazoli nitras ...............................................................1880Ferri chloridum hexahydricum...........................................1882Ferrosi fumaras .......................................................................1883Ferrosi gluconas ......................................................................1884Ferrosi sulfas desiccatus .......................................................1885Ferrosi sulfas heptahydricus ................................................1886Ferrum ad praeparationes homoeopathicas ................... 1081Fexofenadini hydrochloridum .............................................1888Fibrini glutinum......................................................................1890Fibrinogenum humanum .....................................................2066Fila non resorbilia sterilia .................................................... 1046Fila non resorbilia sterilia in fuso ad usumveterinarium .......................................................................... 1060

Fila resorbilia synthetica monofilamenta sterilia .......... 1052Fila resorbilia synthetica torta sterilia .............................. 1050Filipendulae ulmariae herba ...............................................2344Filum bombycis tortum sterile in fuso ad usumveterinarium .......................................................................... 1059

Filum ethyleni polyterephthalici sterile in fuso ad usumveterinarium .......................................................................... 1059

Filum lini sterile in fuso ad usum veterinarium ............ 1058Filum polyamidicum-6/6 sterile in fuso ad usumveterinarium .......................................................................... 1059

Filum polyamidicum-6 sterile in fuso ad usumveterinarium .......................................................................... 1058

Finasteridum ............................................................................ 1891Flavoxati hydrochloridum .................................................... 1895Flecainidi acetas ..................................................................... 1896Flubendazolum ........................................................................ 1898Flucloxacillinum natricum................................................... 1899Fluconazolum ..........................................................................1900Flucytosinum ...........................................................................1902Fludarabini phosphas ............................................................1903Fludeoxyglucosi (18F) solutio iniectabilis ........................... 986Fludrocortisoni acetas ...........................................................1906Flumazenili (N-[11C]methyl) solutio iniectabilis ............... 989Flumazenilum..........................................................................1908Flumequinum...........................................................................1909Flumetasoni pivalas ............................................................... 1910Flunarizini dihydrochloridum ............................................ 1911Flunitrazepamum ................................................................... 1913Flunixini megluminum ad usum veterinarium.............. 1914Fluocinoloni acetonidum ..................................................... 1915Fluocortoloni pivalas ............................................................. 1916Fluoresceinum ......................................................................... 1918Fluoresceinum natricum ...................................................... 1919Fluorodopae (18F) ab electrophila substitutione solutioiniectabilis ................................................................................ 990

Fluorouracilum........................................................................1920Fluoxetini hydrochloridum ..................................................1922Flupentixoli dihydrochloridum ...........................................1924Fluphenazini decanoas .........................................................1926Fluphenazini dihydrochloridum ........................................1928Fluphenazini enantas............................................................1927Flurazepami monohydrochloridum...................................1930Flurbiprofenum ....................................................................... 1931Fluspirilenum ..........................................................................1932Flutamidum ..............................................................................1933Fluticasoni propionas ............................................................1934Flutrimazolum .........................................................................1936Foeniculi amari fructus......................................................... 1873Foeniculi amari fructus aetheroleum................................ 1318Foeniculi dulcis fructus......................................................... 1874Formaldehydi solutio (35 per centum)..............................1939Formoteroli fumaras dihydricus .........................................1940Foscarnetum natricum hexahydricum..............................1942Fosfomycinum calcicum .......................................................1943Fosfomycinum natricum.......................................................1945Fosfomycinum trometamolum ............................................1946Framycetini sulfas ..................................................................1947Frangulae cortex .....................................................................1949Frangulae corticis extractum siccum normatum ...........1950Fraxini folium ..........................................................................1222Fructosum ................................................................................. 1951Fucus vel Ascophyllum .......................................................... 2213Fumariae herba .......................................................................1952Furosemidum ...........................................................................1953

GGalactosum ...............................................................................1959Gallamini triethiodidum .......................................................1959Gallii (67Ga) citratis solutio iniectabilis ............................... 992

3298 See the information section on general monographs (cover pages)

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Gelatina ..................................................................................... 1961Gemcitabini hydrochloridum...............................................1963Gemfibrozilum .........................................................................1964Gentamicini sulfas ..................................................................1965Gentianae radix .......................................................................1967Gentianae tinctura..................................................................1968Ginkgonis folium.....................................................................1969Ginseng radix ........................................................................... 1971Glibenclamidum ......................................................................1972Gliclazidum............................................................................... 1974Glimepiridum ...........................................................................1975Glipizidum ................................................................................1977Glucagonum humanum ........................................................1979Glucosum anhydricum .......................................................... 1981Glucosum liquidum ................................................................1982Glucosum liquidum dispersione desiccatum...................1982Glucosum monohydricum ....................................................1983Glutathionum ...........................................................................1985Glyceroli dibehenas ................................................................1990Glyceroli distearas .................................................................. 1991Glyceroli monocaprylas ........................................................1992Glyceroli monocaprylocapras..............................................1993Glyceroli monolinoleas ........................................................1994Glyceroli mono-oleas..............................................................1995Glyceroli monostearas 40-55................................................1996Glyceroli trinitratis solutio ...................................................1997Glycerolum................................................................................1987Glycerolum (85 per centum) ................................................1988Glycinum ...................................................................................1998Gonadorelini acetas ...............................................................2003Gonadotropinum chorionicum ...........................................2004Gonadotropinum sericum equinum ad usumveterinarium ..........................................................................2005

Goserelinum .............................................................................2005Gossypii oleum hydrogenatum............................................ 1625Gramicidinum ..........................................................................2007Graminis rhizoma................................................................... 1625Granisetroni hydrochloridum..............................................2009Granulata .................................................................................... 723Griseofulvinum ........................................................................ 2011Guaiacolum .............................................................................. 2012Guaifenesinum ........................................................................ 2014Guanethidini monosulfas ..................................................... 2015Guar galactomannanum ....................................................... 2016

HHalofantrini hydrochloridum ..............................................2027Haloperidoli decanoas...........................................................2030Haloperidolum .........................................................................2028Halothanum.............................................................................. 2031Hamamelidis folium ...............................................................2033Harpagophyti extractum siccum......................................... 1662Harpagophyti radix ................................................................ 1662Hederae folium ........................................................................ 2198Hedera helix ad praeparationes homoeopathicas.......... 1078Helianthi annui oleum raffinatum.....................................3007Helium .......................................................................................2038Heparina massae molecularis minoris ............................. 2041Heparinum calcicum .............................................................2039Heparinum natricum .............................................................2040Heptaminoli hydrochloridum ..............................................2043Hexamidini diisetionas .........................................................2044Hexetidinum .............................................................................2045Hexobarbitalum .......................................................................2047Hexylresorcinolum .................................................................2047Hibisci sabdariffae flos ..........................................................2838Histamini dihydrochloridum ...............................................2049Histamini phosphas................................................................2049Histidini hydrochloridum monohydricum....................... 2051

Histidinum ................................................................................2050Homatropini hydrobromidum .............................................2052Homatropini methylbromidum ...........................................2053Hyaluronidasum .....................................................................2082Hydralazini hydrochloridum ...............................................2083Hydrargyri dichloridum ........................................................ 2361Hydrastis rhizoma .................................................................. 2001Hydrochlorothiazidum ..........................................................2086Hydrocodoni hydrogenotartras 2.5-hydricus ..................2087Hydrocortisoni acetas ............................................................ 2091Hydrocortisoni hydrogenosuccinas ...................................2092Hydrocortisonum ....................................................................2089Hydrogenii peroxidum 30 per centum..............................2094Hydrogenii peroxidum 3 per centum ................................2094Hydromorphoni hydrochloridum .......................................2095Hydroxocobalamini acetas ...................................................2096Hydroxocobalamini chloridum ...........................................2098Hydroxocobalamini sulfas ....................................................2099Hydroxycarbamidum ............................................................. 2100Hydroxyethylcellulosum........................................................ 2102Hydroxyethylis salicylas........................................................ 2101Hydroxypropylbetadexum .................................................... 2103Hydroxypropylcellulosum .................................................... 2105Hydroxyzini hydrochloridum .............................................. 2106Hymecromonum...................................................................... 2107Hyoscini butylbromidum ...................................................... 2109Hyoscini hydrobromidum..................................................... 2110Hyoscinum ................................................................................ 2108Hyoscyamini sulfas ................................................................ 2112Hyoscyamus nigerad praeparationes homoeopathicas................................. 1079

Hyperici herba .........................................................................2958Hypericum perforatumad praeparationes homoeopathicas................................. 1080

Hypromellosi phthalas........................................................... 2115Hypromellosum ....................................................................... 2113

IIbuprofenum............................................................................. 2119Ichthammolum ........................................................................ 2122Idoxuridinum ........................................................................... 2122Iecoris aselli oleum A............................................................. 1603Iecoris aselli oleum B ............................................................ 1607Ifosfamidum ............................................................................. 2123Imipenemum ............................................................................ 2125Imipramini hydrochloridum ................................................ 2126Immunoglobulinum anti-T lymphocytorum ex animale adusum humanum ....................................................................1203

Immunoglobulinum humanum anti-D..............................2058Immunoglobulinum humanum anti-D ad usumintravenosum .........................................................................2059

Immunoglobulinum humanum hepatitidis A .................2068Immunoglobulinum humanum hepatitidis B .................2069Immunoglobulinum humanum hepatitidis B ad usumintravenosum .........................................................................2069

Immunoglobulinum humanum morbillicum ..................2069Immunoglobulinum humanum normale .........................2070Immunoglobulinum humanum normale ad usumintravenosum .........................................................................2072

Immunoglobulinum humanum rabicum..........................2078Immunoglobulinum humanum rubellae ..........................2079Immunoglobulinum humanum tetanicum ......................2079Immunoglobulinum humanum varicellae .......................2080Immunoglobulinum humanum varicellae ad usumintravenosum ......................................................................... 2081

Immunosera ad usum veterinarium .................................... 687Immunosera ex animali ad usum humanum.................... 685Immunoserum botulinicum ................................................... 965

General Notices (1) apply to all monographs and other texts 3299

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Immunoserum Clostridii novyi alpha ad usumveterinarium ............................................................................ 973

Immunoserum Clostridii perfringentis beta ad usumveterinarium ............................................................................ 974

Immunoserum Clostridii perfringentis epsilon ad usumveterinarium ............................................................................ 975

Immunoserum contra venena viperarumeuropaearum ........................................................................... 970

Immunoserum diphthericum ................................................ 965Immunoserum gangraenicum (Clostridium novyi) ........ 966Immunoserum gangraenicum(Clostridium perfringens)..................................................... 967

Immunoserum gangraenicum (Clostridium septicum) .. 968Immunoserum gangraenicum mixtum ............................... 966Immunoserum tetanicum ad usum humanum................. 969Immunoserum tetanicum ad usum veterinarium............ 976Indapamidum .......................................................................... 2127Indii (111In) chloridi solutio .................................................... 994Indii (111In) oxini solutio ......................................................... 995Indii (111In) pentetatis solutio iniectabilis .......................... 996Indinaviri sulfas ...................................................................... 2130Indometacinum ....................................................................... 2132Inhalanda.................................................................................... 739Insulini zinci amorphi suspensio iniectabilis................. 2149Insulini zinci cristallini suspensio iniectabilis............... 2149Insulini zinci suspensio iniectabilis .................................. 2148Insulinum aspartum .............................................................. 2133Insulinum biphasicum iniectabile ..................................... 2140Insulinum bovinum ................................................................ 2135Insulinum humanum............................................................. 2137Insulinum isophanum biphasicum iniectabile ............... 2140Insulinum isophanum iniectabile .......................................2141Insulinum lisprum...................................................................2141Insulinum porcinum .............................................................. 2144Insulinum solubile iniectabile ..............................................2141Interferoni alfa-2 solutio concentrata................................ 2150Interferoni gamma-1b solutio concentrata ...................... 2153int-rac-α-Tocopherolum .........................................................3086int-rac-α-Tocopherylis acetas ...............................................3089Iobenguani (123I) solutio iniectabilis .................................... 997Iobenguani (131I) solutio iniectabilis ad usumdiagnosticum ........................................................................... 998

Iobenguani (131I) solutio iniectabilis ad usumtherapeuticum.......................................................................... 999

Iobenguani sulfas ad radiopharmaceutica ...................... 1000Iodinati (125I) humani albumini solutio iniectabilis ........ 993Iodum ......................................................................................... 2156Iohexolum ................................................................................. 2157Iopamidolum ............................................................................ 2160Iotrolanum ................................................................................ 2164Ipecacuanhae extractum fluidum normatum ................. 2168Ipecacuanhae pulvis normatus ........................................... 2169Ipecacuanhae radix ................................................................ 2170Ipecacuanhae tinctura normata ......................................... 2171Ipratropii bromidum .............................................................. 2172Isoconazoli nitras ................................................................... 2175Isoconazolum........................................................................... 2173Isofluranum...............................................................................2176Isoleucinum .............................................................................. 2177Isomaltum ................................................................................. 2178Isoniazidum ............................................................................. 2180Isoprenalini hydrochloridum .............................................. 2181Isoprenalini sulfas .................................................................. 2182Isopropylis myristas ............................................................... 2183Isopropylis palmitas ............................................................... 2184Isosorbidi dinitras dilutus..................................................... 2185Isosorbidi mononitras dilutus ............................................. 2186Isotretinoinum ......................................................................... 2188Isoxsuprini hydrochloridum ................................................ 2189

Isradipinum .............................................................................. 2192Itraconazolum.......................................................................... 2194Iuniperi aetheroleum .............................................................2207Iuniperi pseudo-fructus .........................................................2206Ivermectinum ........................................................................... 2196

JJosamycini propionas ............................................................2205Josamycinum ...........................................................................2204

KKalii acetas ............................................................................... 2716Kalii bromidum........................................................................ 2716Kalii carbonas .......................................................................... 2717Kalii chloridum........................................................................ 2717Kalii citras ................................................................................. 2718Kalii clavulanas ....................................................................... 2719Kalii clavulanas dilutus ......................................................... 2721Kalii dihydrogenophosphas .................................................2723Kalii hydrogenoaspartas hemihydricus ............................2723Kalii hydrogenocarbonas......................................................2724Kalii hydrogenotartras...........................................................2725Kalii hydroxidum ....................................................................2726Kalii iodidum ...........................................................................2726Kalii metabisulfis ....................................................................2727Kalii natrii tartras tetrahydricus.........................................2729Kalii nitras ................................................................................2728Kalii perchloras .......................................................................2728Kalii permanganas .................................................................2729Kalii sorbas ...............................................................................2730Kalii sulfas ................................................................................ 2731Kanamycini monosulfas ....................................................... 2212Kanamycini sulfas acidus ..................................................... 2211Kaolinum ponderosum.......................................................... 2213Ketamini hydrochloridum .................................................... 2214Ketoconazolum ........................................................................ 2216Ketoprofenum .......................................................................... 2218Ketorolacum trometamolum ................................................2220Ketotifeni hydrogenofumaras .............................................. 2221Kryptonum (81mKr) ad inhalationem ................................ 1000

LLabetaloli hydrochloridum ...................................................2227Lacca .......................................................................................... 2876Lactitolum monohydricum...................................................2229Lactosum anhydricum...........................................................2232Lactosum monohydricum.....................................................2233Lactulosum ...............................................................................2234Lactulosum liquidum .............................................................2236Lamivudinum ..........................................................................2238Lansoprazolum........................................................................2240Lanugo cellulosi absorbens.................................................. 3197Lanugo gossypii absorbens .................................................. 1624Lavandulae aetheroleum ......................................................2244Lavandulae flos .......................................................................2243Leflunomidum .........................................................................2245Leonuri cardiacae herba.......................................................2447Letrozolum................................................................................2249Leucinum ..................................................................................2250Leuprorelinum......................................................................... 2251Levamisoli hydrochloridum .................................................2254Levamisolum ad usum veterinarium ................................2253Levistici radix...........................................................................2290Levocabastini hydrochloridum ...........................................2255Levocarnitinum .......................................................................2257Levodopum ...............................................................................2258Levodropropizinum................................................................2260Levomentholum....................................................................... 2261

3300 See the information section on general monographs (cover pages)

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Levomepromazini hydrochloridum ...................................2262Levomepromazini maleas ....................................................2263Levomethadoni hydrochloridum ........................................2264Levonorgestrelum ...................................................................2266Levothyroxinum natricum ...................................................2267Lichen islandicus .................................................................... 2121Lidocaini hydrochloridum ...................................................2269Lidocainum ..............................................................................2268Limonis aetheroleum .............................................................2246Lincomycini hydrochloridum..............................................2271Lindanum .................................................................................2272Lini oleum virginale .............................................................. 2274Lini semen ................................................................................2273Liothyroninum natricum ..................................................... 2274Liquiritiae extractum fluidumethanolicum normatum ......................................................2275

Liquiritiae radix ...................................................................... 2276Lisinoprilum dihydricum .....................................................2277Lithii carbonas.........................................................................2279Lithii citras ...............................................................................2279L-Methionini ([11C]methyl) solutio iniectabilis ................ 1001Lobelini hydrochloridum ......................................................2280Lomustinum ............................................................................. 2281Loperamidi hydrochloridum................................................2283Loperamidi oxidum monohydricum..................................2285Loratadinum ............................................................................2286Lorazepamum ..........................................................................2288Lovastatinum ........................................................................... 2291Lupuli flos .................................................................................2056Lymecyclinum .........................................................................2292Lynestrenolum .........................................................................2294Lysini acetas.............................................................................2295Lysini hydrochloridum..........................................................2296Lythri herba..............................................................................2283

MMacrogol 20 glyceroli monostearas ...................................2304Macrogol 40 sorbitoli heptaoleas ........................................ 2310Macrogol 6 glyceroli caprylocapras ...................................2302Macrogola..................................................................................2308Macrogolglyceridorum caprylocaprates ........................... 1403Macrogolglyceridorum laurates ..........................................2242Macrogolglyceridorum linoleates .......................................2273Macrogolglyceridorum oleates ............................................2543Macrogolglyceridorum stearates.........................................2967Macrogolglyceroli cocoates ..................................................2302Macrogolglyceroli hydroxystearas......................................2303Macrogolglyceroli ricinoleas................................................2304Macrogoli 15 hydroxystearas ...............................................2305Macrogoli aether cetostearylicus ........................................ 2301Macrogoli aether laurilicus ..................................................2306Macrogoli aether oleicus .......................................................2308Macrogoli aether stearylicus................................................ 2312Macrogoli oleas........................................................................2307Macrogoli stearas .................................................................... 2311Magaldratum ............................................................................ 2312Magnesii acetas tetrahydricus ............................................. 2313Magnesii aspartas dihydricus .............................................. 2314Magnesii chloridum 4.5-hydricum ..................................... 2317Magnesii chloridum hexahydricum ................................... 2316Magnesii citras anhydricus .................................................. 2318Magnesii glycerophosphas ................................................... 2318Magnesii hydroxidum ............................................................ 2319Magnesii lactas dihydricus ...................................................2320Magnesii oxidum leve ............................................................ 2321Magnesii oxidum ponderosum ............................................2320Magnesii peroxidum............................................................... 2321Magnesii pidolas .....................................................................2322Magnesii stearas ......................................................................2323

Magnesii subcarbonas levis.................................................. 2316Magnesii subcarbonas ponderosus .................................... 2315Magnesii sulfas heptahydricus ............................................2325Magnesii trisilicas ...................................................................2325Malathionum ............................................................................2327Maltitolum .................................................................................2330Maltitolum liquidum...............................................................2332Maltodextrinum .......................................................................2333Malvae sylvestris flos .............................................................2330Mangani glycerophosphas hydricus ..................................2334Mangani sulfas monohydricus ............................................2335Mannitolum ..............................................................................2336Maprotilini hydrochloridum ................................................2337Marrubii herba......................................................................... 3216Masticabilia gummis medicata.............................................. 719Mastix .........................................................................................2340Matricariae aetheroleum.......................................................2342Matricariae extractum fluidum ........................................... 2341Matricariae flos .......................................................................2340Maydis amylum .......................................................................2326Maydis oleum raffinatum......................................................2326Mebendazolum.........................................................................2345Meclozini hydrochloridum ...................................................2346Medroxyprogesteroni acetas ................................................2347Mefloquini hydrochloridum .................................................2350Megestroli acetas .....................................................................2352Megluminum ............................................................................2353Mel...............................................................................................2055Melaleucae aetheroleum ....................................................... 3019Meliloti herba ...........................................................................2354Melissae folium ........................................................................2355Menadionum ............................................................................2356Menthae arvensis aetheroleum partim mentholumdepletum..................................................................................2430

Menthae piperitae aetheroleum ..........................................2639Menthae piperitae folium .....................................................2638Mentholum racemicum .........................................................2356Menyanthidis trifoliatae folium ..........................................1323Mepivacaini hydrochloridum ..............................................2357Meprobamatum........................................................................2359Mepyramini maleas ................................................................2360Mercaptopurinum ................................................................... 2361Mesalazinum ............................................................................2362Mesnum .....................................................................................2364Mesterolonum ..........................................................................2366Mestranolum.............................................................................2367Metacresolum ...........................................................................2368Metamizolum natricum .........................................................2369Metformini hydrochloridum ................................................2370Methadoni hydrochloridum ................................................. 2374Methanolum.............................................................................. 2376Methaqualonum ......................................................................2377Methenaminum .......................................................................2378Methioninum............................................................................2379Methotrexatum .........................................................................2380Methylatropini bromidum.....................................................2383Methylatropini nitras .............................................................2383Methylcellulosum ....................................................................2384Methyldopum ...........................................................................2386Methyleni chloridum ..............................................................2387Methylergometrini maleas ....................................................2388Methylhydroxyethylcellulosum............................................2390Methylis nicotinas ...................................................................2390Methylis parahydroxybenzoas ............................................. 2391Methylis parahydroxybenzoas natricus ............................ 2911Methylis salicylas .................................................................... 2401Methylphenobarbitalum ........................................................2392Methylprednisoloni acetas....................................................2395Methylprednisoloni hydrogenosuccinas ...........................2397

General Notices (1) apply to all monographs and other texts 3301

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Index EUROPEAN PHARMACOPOEIA 6.0

Methylprednisolonum ............................................................2393Methylrosanilinii chloridum ................................................2400Methyltestosteronum ..............................................................2402Methylthioninii chloridum ...................................................2402Metixeni hydrochloridum .....................................................2404Metoclopramidi hydrochloridum ........................................2407Metoclopramidum ...................................................................2405Metolazonum............................................................................2407Metoprololi succinas ..............................................................2409Metoprololi tartras .................................................................. 2410Metrifonatum............................................................................ 2412Metronidazoli benzoas .......................................................... 2415Metronidazolum ...................................................................... 2414Mexiletini hydrochloridum................................................... 2416Mianserini hydrochloridum ................................................. 2417Miconazoli nitras ....................................................................2420Miconazolum............................................................................ 2418Midazolamum ..........................................................................2422Millefolii herba.........................................................................3243Minocyclini hydrochloridum dihydricum ........................2427Minoxidilum .............................................................................2429Mirtazapinum .......................................................................... 2431Misoprostolum .........................................................................2433Mitomycinum ...........................................................................2434Mitoxantroni hydrochloridum .............................................2436Modafinilum .............................................................................2437Molgramostimi solutio concentrata ...................................2438Mometasoni furoas ................................................................. 2441Moranteli hydrogenotartras ad usum veterinarium ......2443Morphini hydrochloridum ....................................................2444Morphini sulfas........................................................................2446Moxidectinum ad usum veterinarium ...............................2448Moxifloxacini hydrochloridum ........................................... 2451Moxonidinum ...........................................................................2453Mupirocinum............................................................................2454Mupirocinum calcicum .........................................................2456Musci medicati........................................................................... 723Mycophenolas mofetil ............................................................2458myo-Inositolum........................................................................2460Myristicae fragrantis aetheroleum .....................................2533Myrrha ....................................................................................... 2461Myrrhae tinctura ..................................................................... 2461Myrtilli fructus recens............................................................1307Myrtilli fructus siccus.............................................................1307

NNabumetonum .........................................................................2465N-Acetyltryptophanum........................................................... 1104N-Acetyltyrosinum .................................................................. 1106Nadololum.................................................................................2466Nadroparinum calcicum .......................................................2467Naftidrofuryli hydrogenooxalas ..........................................2470Naloxoni hydrochloridum dihydricum .............................2473Naltrexoni hydrochloridum .................................................. 2474Nandroloni decanoas ............................................................. 2476Naphazolini hydrochloridum ..............................................2478Naphazolini nitras ..................................................................2479Naproxenum .............................................................................2480Naproxenum natricum ..........................................................2482Nasalia ......................................................................................... 730Natrii acetas trihydricus .......................................................2883Natrii acetatis ([1-11C]) solutio iniectabilis ....................... 1006Natrii alendronas ....................................................................2884Natrii alginas ...........................................................................2885Natrii amidotrizoas ................................................................2886Natrii aminosalicylas dihydricus........................................2887Natrii ascorbas .........................................................................2888Natrii aurothiomalas..............................................................2889Natrii benzoas ..........................................................................2890

Natrii bromidum...................................................................... 2891Natrii calcii edetas ..................................................................2892Natrii caprylas .........................................................................2893Natrii carbonas anhydricus..................................................2894Natrii carbonas decahydricus..............................................2894Natrii carbonas monohydricus............................................2895Natrii cetylo- et stearylosulfas. ............................................2895Natrii chloridum......................................................................2897Natrii chromatis (51Cr) solutio sterilis ............................... 1007Natrii citras ...............................................................................2898Natrii cromoglicas ..................................................................2899Natrii cyclamas ........................................................................2900Natrii dihydrogenophosphas dihydricus .......................... 2901Natrii docusas .......................................................................... 1743Natrii fluoridi (18F) solutio iniectabilis.............................. 1008Natrii fluoridum ......................................................................2902Natrii fusidas ............................................................................2902Natrii glycerophosphas hydricus ........................................2903Natrii hyaluronas ....................................................................2904Natrii hydrogenocarbonas....................................................2906Natrii hydroxidum ..................................................................2907Natrii iodidi (123I) solutioad radio-signandum ................ 1010Natrii iodidi (123I) solutio iniectabilis ................................ 1009Natrii iodidi (131I) capsulae ad usum diagnosticum........1011Natrii iodidi (131I) capsulae ad usum therapeuticum..... 1012Natrii iodidi (131I) solutio....................................................... 1013Natrii iodidi (131I) solutio ad radio-signandum ................1014Natrii iodidum .........................................................................2907Natrii iodohippurati (123I) solutio iniectabilis ..................1014Natrii iodohippurati (131I) solutio iniectabilis.................. 1015Natrii lactatis solutio ..............................................................2908Natrii laurilsulfas .................................................................... 2910Natrii metabisulfis .................................................................. 2911Natrii molybdas dihydricus .................................................. 2912Natrii molybdatis (99Mo) fissione formati solutio ........... 1016Natrii nitris ............................................................................... 2913Natrii nitroprussias ................................................................ 2913Natrii perboras hydricus ....................................................... 2914Natrii pertechnetatis (99mTc) fissione formati solutioiniectabilis .............................................................................. 1018

Natrii pertechnetatis (99mTc) sine fissione formati solutioiniectabilis .............................................................................. 1020

Natrii phosphatis (32P) solutio iniectabilis ....................... 1020Natrii picosulfas ...................................................................... 2915Natrii polystyrenesulfonas.................................................... 2916Natrii propionas ...................................................................... 2917Natrii salicylas ......................................................................... 2919Natrii selenis pentahydricus ................................................ 2919Natrii (S)-lactatis solutio .......................................................2909Natrii stearas ............................................................................2923Natrii stearylis fumaras .........................................................2924Natrii sulfas anhydricus ........................................................2924Natrii sulfas decahydricus ....................................................2925Natrii sulfis anhydricus .........................................................2926Natrii sulfis heptahydricus ...................................................2926Natrii thiosulfas .......................................................................2927Natrii valproas .........................................................................2927Neohesperidin-dihydrochalconum .....................................2485Neomycini sulfas .....................................................................2487Neostigmini bromidum..........................................................2489Neostigmini metilsulfas .........................................................2490Neroli aetheroleum .................................................................2490Netilmicini sulfas ....................................................................2492Nevirapinum anhydricum ....................................................2495Nicergolinum ...........................................................................2496Nicethamidum .........................................................................2505Niclosamidum anhydricum..................................................2497Niclosamidum monohydricum............................................2498Nicotinamidum........................................................................2499

3302 See the information section on general monographs (cover pages)

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EUROPEAN PHARMACOPOEIA 6.0 Index

Nicotini resinas ....................................................................... 2501Nicotinum .................................................................................2500Nifedipinum..............................................................................2503Nifuroxazidum .........................................................................2504Nimesulidum ............................................................................2506Nimodipinum ...........................................................................2507Nitrazepamum .........................................................................2508Nitrendipinum .........................................................................2509Nitrofuralum............................................................................. 2512Nitrofurantoinum.................................................................... 2513Nitrogenii oxidum................................................................... 2511Nitrogenium ............................................................................. 2513Nitrogenium oxygenio depletum ........................................ 2514Nizatidinum.............................................................................. 2516N-Methylpyrrolidonum ..........................................................2399Nomegestroli acetas................................................................ 2518Nonoxinolum 9 ........................................................................ 2519Noradrenalini hydrochloridum ...........................................2520Noradrenalini tartras ............................................................. 2521Norcholesteroli iodinati (131I) solutio iniectabilis ........... 1003Norethisteroni acetas .............................................................2524Norethisteronum .....................................................................2523Norfloxacinum.........................................................................2525Norgestimatum ........................................................................2526Norgestrelum ............................................................................2527Nortriptylini hydrochloridum..............................................2528Noscapini hydrochloridum...................................................2530Noscapinum..............................................................................2529Notoginseng radix................................................................... 2531Nystatinum ...............................................................................2534

OOctoxinolum 10 .......................................................................2539Octyldodecanolum ..................................................................2540Octylis gallas ............................................................................2539Oenotherae oleum raffinatum .............................................1860Ofloxacinum............................................................................. 2541Oleae folium .............................................................................2545Olea herbaria ............................................................................ 712Olibanum indicum.................................................................. 2128Olivae oleum raffinatum .......................................................2546Olivae oleum virginale ..........................................................2547Olsalazinum natricum...........................................................2548Omega-3 acidorum esteri ethylici 60.................................2550Omega-3 acidorum esteri ethylici 90.................................2552Omega-3 acidorum triglycerida ..........................................2554Omeprazolum...........................................................................2557Omeprazolum natricum ........................................................2558Ondansetroni hydrochloridum dihydricum ....................2560Ononidis radix ......................................................................... 2815Ophthalmica ............................................................................... 721Opii extractum siccum normatum......................................2562Opii pulvis normatus .............................................................2563Opii tinctura normata............................................................2565Opium crudum ........................................................................2564Orciprenalini sulfas ................................................................2567Origani herba ...........................................................................2568Orphenadrini citras ................................................................2569Orphenadrini hydrochloridum............................................2570Orthosiphonis folium .............................................................2203Oryzae amylum .......................................................................2824Ouabainum ...............................................................................2571Oxacillinum natricum monohydricum .............................2572Oxaliplatinum .......................................................................... 2574Oxazepamum ...........................................................................2577Oxeladini hydrogenocitras ...................................................2578Oxfendazolum ad usum veterinarium ..............................2580Oxitropii bromidum................................................................ 2581Oxprenololi hydrochloridum ..............................................2583

Oxybuprocaini hydrochloridum .........................................2584Oxybutynini hydrochloridum ..............................................2585Oxycodoni hydrochloridum .................................................2587Oxygenium................................................................................2588Oxygenium (15O) ...................................................................... 1004Oxymetazolini hydrochloridum ..........................................2589Oxytetracyclini hydrochloridum ......................................... 2591Oxytetracyclinum dihydricum.............................................2590Oxytocini solutio concentrata..............................................2594Oxytocinum ..............................................................................2593

PPaclitaxelum .............................................................................2599Pancreatis pulvis .....................................................................2605Pancuronii bromidum ...........................................................2608Papaverini hydrochloridum .................................................2609Papaveris rhoeados flos ........................................................ 2811Paracetamolum........................................................................ 2611Paraffinum liquidum.............................................................. 2613Paraffinum perliquidum ....................................................... 2612Paraffinum solidum................................................................ 2612Paraldehydum .......................................................................... 2615Parenteralia ................................................................................ 735Parnaparinum natricum....................................................... 2616Paroxetini hydrochloridum anhydricum.......................... 2616Paroxetini hydrochloridum hemihydricum ..................... 2619Passiflorae herba..................................................................... 2621Passiflorae herbae extractum siccum ................................2622Pefloxacini mesilas dihydricus ...........................................2623Pelargonii radix .......................................................................2625Penbutololi sulfas ....................................................................2625Penicillaminum .......................................................................2626Pentaerythrityli tetranitras dilutus.....................................2628Pentamidini diisetionas ........................................................2630Pentazocini hydrochloridum ...............................................2632Pentazocini lactas ...................................................................2632Pentazocinum .......................................................................... 2631Pentobarbitalum ......................................................................2633Pentobarbitalum natricum ...................................................2634Pentoxifyllinum .......................................................................2635Pentoxyverini hydrogenocitras ...........................................2637Pepsini pulvis ...........................................................................2640Pergolidi mesilas ..................................................................... 2641Perphenazinum .......................................................................2648Pethidini hydrochloridum ....................................................2650Phenazonum ............................................................................ 2651Pheniramini maleas ...............................................................2652Phenobarbitalum.....................................................................2653Phenobarbitalum natricum ..................................................2654Phenolphthaleinum................................................................2656Phenolsulfonphthaleinum ....................................................2657Phenolum ..................................................................................2655Phenoxyethanolum ................................................................2657Phenoxymethylpenicillinum................................................2658Phenoxymethylpenicillinum kalicum ...............................2660Phentolamini mesilas ............................................................2662Phenylalaninum......................................................................2663Phenylbutazonum...................................................................2664Phenylephrini hydrochloridum ..........................................2667Phenylephrinum .....................................................................2665Phenylhydrargyri acetas .......................................................2668Phenylhydrargyri boras.........................................................2669Phenylhydrargyri nitras ........................................................2669Phenylpropanolamini hydrochloridum ............................2670Phenytoinum............................................................................2671Phenytoinum natricum .........................................................2672Phloroglucinolum anhydricum...........................................2672Phloroglucinolum dihydricum ............................................2673Pholcodinum ............................................................................ 2674

General Notices (1) apply to all monographs and other texts 3303

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Index EUROPEAN PHARMACOPOEIA 6.0

Phthalylsulfathiazolum ......................................................... 2676Physostigmini salicylas .........................................................2677Physostigmini sulfas ..............................................................2678Phytomenadionum .................................................................2679Phytosterolum ..........................................................................2680Picotamidum monohydricum..............................................2682Pilocarpini hydrochloridum ................................................2682Pilocarpini nitras ....................................................................2684Pimobendanum .......................................................................2685Pimozidum ...............................................................................2686Pindololum ...............................................................................2688Pini pumilionis aetheroleum ............................................... 1766Pini sylvestris aetheroleum ..................................................2689Piperacillinum ........................................................................ 2691Piperacillinum natricum ......................................................2692Piperazini adipas ....................................................................2694Piperazini citras ......................................................................2695Piperazinum hydricum .........................................................2696Piracetamum ............................................................................2697Pirenzepini dihydrochloridum monohydricum .............2698Piretanidum..............................................................................2699Piroxicamum ............................................................................2700Piscis oleum omega-3 acidis abundans ............................1893Pivampicillinum ......................................................................2702Pivmecillinami hydrochloridum ........................................2704Plantae ad ptisanam ................................................................ 685Plantae medicinales ................................................................. 684Plantae medicinales ad praeparationeshomoeopathicas .................................................................... 1065

Plantae medicinales praeparatae ......................................... 684Plantaginis lanceolatae folium ...........................................2823Plantaginis ovatae semen ..................................................... 2192Plantaginis ovatae seminis tegumentum ......................... 2191Plasma humanum ad separationem ..................................2073Plasma humanum coagmentatum conditumque adexstinguendum virum .........................................................2075

Poloxamera ...............................................................................2705Polyacrylatis dispersio 30 per centum..............................2706Poly(alcohol vinylicus) .......................................................... 2715Polygalae radix ........................................................................2867Polygoni avicularis herba .....................................................2223Polymyxini B sulfas................................................................2707Polysorbatum 20 .....................................................................2709Polysorbatum 40 ..................................................................... 2710Polysorbatum 60 ..................................................................... 2710Polysorbatum 80 ..................................................................... 2711Poly(vinylis acetas) ................................................................. 2712Poly(vinylis acetas) dispersio 30 per centum .................. 2713Povidonum................................................................................2732Povidonum iodinatum ...........................................................2734Praeadmixta ad alimenta medicataad usum veterinarium ........................................................... 739

Praeparationes ad irrigationem............................................ 743Praeparationes buccales ......................................................... 732Praeparationes homoeopathicas ........................................ 1065Praeparationes insulini iniectabiles .................................. 2146Praeparationes intramammariaead usum veterinarium ........................................................... 725

Praeparationes intraruminales ............................................. 725Praeparationes intra-uterinae ad usum veterinarium .... 726Praeparationes liquidae ad usum dermicum .................... 728Praeparationes liquidae peroraliae...................................... 728Praeparationes liquidae veterinariae ad usum dermicum..................................................................................................... 752

Praeparationes molles ad usum dermicum ....................... 746Praeparationes pharmaceuticae in vasis cum pressu..... 744Pravastatinum natricum .......................................................2735Prazepamum ............................................................................2736Praziquantelum .......................................................................2737

Prazosini hydrochloridum ...................................................2738Prednicarbatum....................................................................... 2740Prednisoloni acetas ................................................................ 2742Prednisoloni natrii phosphas .............................................. 2745Prednisoloni pivalas............................................................... 2744Prednisolonum ........................................................................ 2741Prednisonum ............................................................................ 2746Prilocaini hydrochloridum...................................................2750Prilocainum.............................................................................. 2748Primaquini diphosphas ......................................................... 2751Primidonum .............................................................................2752Primulae radix .........................................................................2753Probenecidum ..........................................................................2754Procainamidi hydrochloridum............................................2755Procaini hydrochloridum .....................................................2756Prochlorperazini maleas.......................................................2756Producta ab arte ADN recombinandorum ......................... 701Producta ab fermentatione ..................................................... 693Producta allergenica ................................................................ 679Producta cum possibili transmissione vectoriumenkephalopathiarum spongiformium animalium ......... 694

Progesteronum ........................................................................2757Proguanili hydrochloridum .................................................2758Prolinum ................................................................................... 2760Promazini hydrochloridum.................................................. 2761Promethazini hydrochloridum............................................ 2761Propacetamoli hydrochloridum .......................................... 2763Propafenoni hydrochloridum .............................................. 2764Propanolum.............................................................................. 2766Propanthelini bromidum ...................................................... 2767Propofolum ............................................................................... 2768Propranololi hydrochloridum..............................................2770Propylenglycoli dicaprylocapras ........................................ 2774Propylenglycoli dilauras ....................................................... 2774Propylenglycoli monolauras ................................................2775Propylenglycoli monopalmitostearas ................................ 2776Propylenglycolum ...................................................................2773Propylis gallas..........................................................................2771Propylis parahydroxybenzoas .............................................2772Propylis parahydroxybenzoas natricus ............................ 2918Propylthiouracilum ................................................................2777Propyphenazonum .................................................................2778Protamini hydrochloridum ..................................................2779Protamini sulfas ......................................................................2780Prothrombinum multiplex humanum ............................... 2076Protirelinum ............................................................................. 2781Proxyphyllinum.......................................................................2783Pruni africanae cortex ..........................................................2789Pseudoephedrini hydrochloridum .....................................2784Psyllii semen ............................................................................2785Pulveres ad usum dermicum ................................................. 738Pulveres perorales..................................................................... 738Pyranteli embonas ..................................................................2790Pyrazinamidum....................................................................... 2791Pyridostigmini bromidum ....................................................2792Pyridoxini hydrochloridum .................................................2793Pyrimethaminum ....................................................................2794Pyrrolidonum...........................................................................2794

QQuercus cortex .........................................................................2539

RRaclopridi ([11C]methoxy) solutio iniectabilis ................. 1005Radiopharmaceutica ................................................................ 695Ramiprilum ..............................................................................2807Ranitidini hydrochloridum ..................................................2809Rapae oleum raffinatum ....................................................... 2811

3304 See the information section on general monographs (cover pages)

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Ratanhiae radix ....................................................................... 2816Ratanhiae tinctura .................................................................. 2817Rectalia ........................................................................................ 744Repaglinidum........................................................................... 2812Reserpinum .............................................................................. 2814Resorcinolum ........................................................................... 2815Rhamni purshianae cortex................................................... 1429Rhamni purshianae extractum siccum normatum........ 1430Rhei radix.................................................................................. 2817Rhenii sulfidi colloidalis et technetii (99mTc) solutioiniectabilis .............................................................................. 1023

Ribavirinum ............................................................................. 2818Riboflavini natrii phosphas ................................................. 2821Riboflavinum............................................................................2820Ricini oleum hydrogenatum ................................................ 1432Ricini oleum raffinatum........................................................ 1433Ricini oleum virginale ........................................................... 1434Rifabutinum..............................................................................2825Rifampicinum ..........................................................................2826Rifamycinum natricum .........................................................2827Rilmenidini dihydrogenophosphas....................................2829Risperidonum ..........................................................................2830Ritonavirum .............................................................................2832Rocuronii bromidum..............................................................2835Ropivacaini hydrochloridum monohydricum ................2837Rosae pseudo-fructus ............................................................. 1744Rosmarini aetheroleum.........................................................2840Rosmarini folium ....................................................................2839Roxithromycinum ...................................................................2842RRR-α-Tocopherolum ............................................................3088RRR-α-Tocopherylis acetas ..................................................3090RRR-α-Tocopherylis hydrogenosuccinas..........................3095Rusci rhizoma..........................................................................1355Rutosidum trihydricum .........................................................2844

SSabalis serrulatae fructus .....................................................2864Saccharinum ............................................................................2849Saccharinum natricum .........................................................2850Sacchari sphaerae ..................................................................2979Saccharum ................................................................................2975Salbutamoli sulfas .................................................................2857Salbutamolum ..........................................................................2855Salicis cortex ............................................................................3220Salmeteroli xinafoas ..............................................................2860Salmonis domestici oleum ...................................................2862Salviae officinalis folium ......................................................2853Salviae sclareae aetheroleum .............................................. 1561Salviae tinctura .......................................................................2854Salviae trilobae folium ..........................................................2854Sambuci flos ............................................................................. 1776Scopolamini butylbromidum ............................................... 2109Scopolamini hydrobromidum.............................................. 2110Scopolaminum......................................................................... 2108Selegilini hydrochloridum....................................................2866Selenii disulfidum...................................................................2867Semecarpus anacardiumad praeparationes homoeopathicas................................. 1082

Sennae folii extractum siccum normatum.......................2869Sennae folium..........................................................................2868Sennae fructus acutifoliae....................................................2870Sennae fructus angustifoliae ...............................................2871Serinum .....................................................................................2872Serpylli herba........................................................................... 3219Sertaconazoli nitras ...............................................................2873Serum bovinum .......................................................................1329Sesami oleum raffinatum ..................................................... 2874Silica ad usum dentalem.......................................................2878Silica colloidalis anhydrica..................................................2877

Silica colloidalis hydrica.......................................................2877Silica hydrophobica colloidalis ...........................................2878Silybi mariani extractum siccum raffinatum etnormatum ...............................................................................2426

Silybi mariani fructus............................................................2425Simeticonum ............................................................................2880Simvastatinum ......................................................................... 2881Soiae oleum hydrogenatum .................................................2946Soiae oleum raffinatum ........................................................2946Solani amylum ........................................................................ 2731Solidaginis herba ....................................................................1999Solidaginis virgaureae herba...............................................2000Solutiones ad conservationem partium corporis ...........2929Solutiones ad haemocolaturamhaemodiacolaturamque ......................................................2025

Solutiones ad haemodialysim .............................................2022Solutiones ad peritonealem dialysim ................................2646Solutiones anticoagulantes et sanguinem humanumconservantes ..........................................................................1200

Somatostatinum ......................................................................2930Somatropini solutio concentrata ........................................2933Somatropinum ......................................................................... 2931Somatropinum iniectabile ....................................................2935Sorbitani lauras .......................................................................2938Sorbitani oleas .........................................................................2938Sorbitani palmitas ..................................................................2939Sorbitani sesquioleas .............................................................2939Sorbitani stearas .....................................................................2940Sorbitani trioleas ....................................................................2940Sorbitolum ................................................................................ 2941Sorbitolum liquidum cristallisabile....................................2942Sorbitolum liquidum non cristallisabile ...........................2943Sorbitolum liquidum partim deshydricum ......................2944Sotaloli hydrochloridum .......................................................2944Spectinomycini dihydrochloridum pentahydricum ......2947Spectinomycini sulfas tetrahydricus ad usumveterinarium ..........................................................................2949

Spiramycinum ......................................................................... 2951Spiraprili hydrochloridum monohydricum .....................2954Spironolactonum ....................................................................2955Squalanum................................................................................2956Stanni colloidalis et technetii (99mTc)solutio iniectabilis ................................................................ 1025

Stanni pyrophosphatis et technetii (99mTc) solutioiniectabilis .............................................................................. 1038

Stannosi chloridum dihydricum.........................................2959Stanozololum ...........................................................................2960Stavudinum ..............................................................................2964Stramonii folium .....................................................................2968Stramonii pulvis normatus...................................................2970Streptokinasi solutio ad praeparationem .........................2971Streptomycini sulfas...............................................................2972Strontii (89Sr) chloridi solutio iniectabilis ........................ 1021Styli ............................................................................................... 748Succinylsulfathiazolum ......................................................... 2974Sufentanili citras .....................................................................2978Sufentanilum............................................................................2977Sulbactamum natricum.........................................................2980Sulfacetamidum natricum ....................................................2982Sulfadiazinum .........................................................................2983Sulfadimidinum.......................................................................2984Sulfadoxinum...........................................................................2984Sulfafurazolum ........................................................................2985Sulfaguanidinum ....................................................................2986Sulfamerazinum......................................................................2987Sulfamethizolum .....................................................................2988Sulfamethoxazolum................................................................2989Sulfamethoxypyridazinum ad usum veterinarium .......2990Sulfanilamidum....................................................................... 2991

General Notices (1) apply to all monographs and other texts 3305

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Sulfasalazinum ........................................................................2992Sulfathiazolum ........................................................................2994Sulfinpyrazonum ....................................................................2995Sulfisomidinum .......................................................................2996Sulfur ad usum externum .....................................................2998Sulfuris colloidalis et technetii (99mTc) solutioiniectabilis .............................................................................. 1024

Sulindacum ..............................................................................2996Sulpiridum ................................................................................2999Sultamicillini tosilas dihydricus .........................................3003Sultamicillinum.......................................................................3000Sumatriptani succinas...........................................................3005Suxamethonii chloridum ......................................................3007Suxibuzonum ...........................................................................3008

TTalcum ....................................................................................... 3013Tamoxifeni citras..................................................................... 3014Tamponae medicatae ............................................................... 751Tamsulosini hydrochloridum .............................................. 3016Tanaceti parthenii herba ......................................................1887Tanninum ................................................................................. 3018Technetii (99mTc) bicisati solutio iniectabilis.................... 1022Technetii (99mTc) et etifenini solutio iniectabilis ............. 1026Technetii (99mTc) exametazimi solutio iniectabilis ......... 1027Technetii (99mTc) gluconatis solutio iniectabilis.............. 1028Technetii (99mTc) humani albumini solutio iniectabilis .. 1029Technetii (99mTc) macrosalbi suspensio iniectabilis....... 1030Technetii (99mTc) medronati solutio iniectabilis.............. 1031Technetii (99mTc) mertiatidi solutio iniectabilis............... 1033Technetii (99mTc) microsphaerarum suspensioiniectabilis .............................................................................. 1034

Technetii (99mTc) pentetatis solutio iniectabilis ............... 1035Technetii (99mTc) sestamibi solutio iniectabilis................ 1036Technetii (99mTc) succimeri solutio iniectabilis ............... 1037Temazepamum ........................................................................3020Tenoxicamum .......................................................................... 3021Terazosini hydrochloridum dihydricum...........................3022Terbinafini hydrochloridum ................................................3024Terbutalini sulfas ....................................................................3025Terconazolum ..........................................................................3027Terebinthinae aetheroleum a Pino pinastro.................... 3151Terfenadinum...........................................................................3028tert-Butylamini perindoprilum............................................2643Testosteroni decanoas............................................................ 3031Testosteroni enantas ..............................................................3033Testosteroni isocaproas .........................................................3034Testosteroni propionas ..........................................................3035Testosteronum..........................................................................3030Tetracaini hydrochloridum ..................................................3036Tetracosactidum ......................................................................3037Tetracyclini hydrochloridum ............................................... 3041Tetracyclinum ..........................................................................3040Tetrazepamum .........................................................................3043Tetryzolini hydrochloridum .................................................3044Thallosi (201Tl) chloridi solutio iniectabilis....................... 1039Theobrominum ........................................................................3045Theophyllinum.........................................................................3046Theophyllinum et ethylenediaminum ...............................3048Theophyllinum et ethylenediaminum hydricum............3049Theophyllinum monohydricum ..........................................3047Thiamazolum ...........................................................................3050Thiamini hydrochloridum .................................................... 3051Thiamini nitras ........................................................................3053Thiamphenicolum...................................................................3054Thiomersalum ..........................................................................3056Thiopentalum natricum et natrii carbonas .....................3057Thioridazini hydrochloridum ..............................................3059Thioridazinum .........................................................................3058

Threoninum..............................................................................3060Thymi aetheroleum ................................................................3063Thymi herba ............................................................................. 3061Thymolum .................................................................................3064Tiabendazolum ........................................................................3064Tiamulini hydrogenofumaras ad usum veterinarium ..3068Tiamulinum ad usum veterinarium ..................................3065Tianeptinum natricum ..........................................................3070Tiapridi hydrochloridum ......................................................3071Tibolonum ................................................................................. 3074Ticarcillinum natricum .........................................................3075Ticlopidini hydrochloridum .................................................3077Tiliae flos...................................................................................2270Tilidini hydrochloridum hemihydricum...........................3079Timololi maleas .......................................................................3080Tincturae maternaead praeparationes homoeopathicas................................. 1072

Tinidazolum ............................................................................. 3081Tinzaparinum natricum .......................................................3082Tioconazolum ..........................................................................3083Titanii dioxidum......................................................................3084Tobramycinum.........................................................................3085α-Tocopherylis acetatis pulvis ............................................. 3091Tolbutamidum ..........................................................................3097Tolnaftatum ..............................................................................3099Torasemidum anhydricum ................................................... 3100Tormentillae rhizoma .............................................................3101Tormentillae tinctura ............................................................. 3102Tosylchloramidum natricum ............................................... 3103Toxinum botulinicum typum A ad iniectabile ................1327Tragacantha.............................................................................. 3103Tramadoli hydrochloridum .................................................. 3104Tramazolini hydrochloridum monohydricum ................ 3106Trandolaprilum ....................................................................... 3107Trapidilum ................................................................................ 3110Tretinoinum...............................................................................3111Triacetinum .............................................................................. 3112Triamcinoloni acetonidum....................................................3114Triamcinoloni hexacetonidum ............................................ 3115Triamcinolonum ..................................................................... 3112Triamterenum .......................................................................... 3116Tribenosidum ............................................................................3117Tributylis acetylcitras............................................................. 3118Tricalcii phosphas...................................................................1396Triethylis citras ........................................................................ 3120Trifluoperazini hydrochloridum......................................... 3121Triflusalum ............................................................................... 3121Triglycerida saturata media ................................................. 3122Triglyceroli diisostearas ........................................................ 3124Trigonellae foenugraeci semen ........................................... 1882Trihexyphenidyli hydrochloridum ..................................... 3125Trimetazidini dihydrochloridum ........................................ 3126Trimethadionum ..................................................................... 3127Trimethoprimum..................................................................... 3128Trimipramini maleas ............................................................. 3130Tri-n-butylis phosphas............................................................ 3132Tritici aestivi oleum raffinatum .......................................... 3215Tritici aestivi oleum virginale.............................................. 3216Tritici amylum ......................................................................... 3215Trolaminum.............................................................................. 3133Trometamolum ........................................................................ 3135Tropicamidum ......................................................................... 3135Tropisetroni hydrochloridum .............................................. 3136Trospii chloridum ................................................................... 3138Troxerutinum ........................................................................... 3139Trypsinum..................................................................................3141Tryptophanum ......................................................................... 3142Tuberculini aviarii derivatum proteinosumpurificatum............................................................................. 3146

3306 See the information section on general monographs (cover pages)

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Tuberculini bovini derivatum proteinosumpurificatum............................................................................. 3147

Tuberculini derivatum proteinosum purificatum ad usumhumanum ............................................................................... 3147

Tuberculinum pristinum ad usum humanum ................ 3144Tubocurarini chloridum........................................................ 3150Tylosini phosphatis solutio ad usum veterinarium ....... 3154Tylosini tartras ad usum veterinarium ............................. 3156Tylosinum ad usum veterinarium ...................................... 3152Tyrosinum................................................................................. 3157Tyrothricinum.......................................................................... 3158

UUbidecarenonum ..................................................................... 3163Ureum......................................................................................... 3165Urofollitropinum ..................................................................... 3166Urokinasum .............................................................................. 3167Urtica dioica ad praeparationes homoeopathicas .........1075Urticae folium ..........................................................................2493Uvae ursi folium ......................................................................1255

VVaccina ad usum humanum .................................................. 705Vaccina ad usum veterinarium ............................................. 707Vaccinum actinobacillosidis inactivatum ad suem.......... 943Vaccinum adenovirosidis caninae vivum........................... 886Vaccinum adenovirosis caninae inactivatum ................... 885Vaccinum anaemiae infectivae pulli vivum....................... 925Vaccinum anthracis adsorbatum ab colato culturarum adusum humanum ...................................................................... 757

Vaccinum anthracis vivum ad usum veterinarium.......... 859Vaccinum aphtharum epizooticarum inactivatum adruminantes ................................................................................918

Vaccinum bronchitidis infectivae aviariae inactivatum .. 864Vaccinum bronchitidis infectivae aviariae vivum ............ 865Vaccinum brucellosis (Brucella melitensis stirpe Rev. 1)vivum ad usum veterinarium .............................................. 881

Vaccinum bursitidis infectivae aviariae inactivatum...... 867Vaccinum bursitidis infectivae aviariae vivum ................. 869Vaccinum calicivirosis felinae inactivatum ....................... 909Vaccinum calicivirosis felinae vivum ...................................910Vaccinum chlamydiosidis felinae inactivatum ..................911Vaccinum cholerae ....................................................................761Vaccinum cholerae aviariae inactivatum ........................... 920Vaccinum cholerae cryodesiccatum......................................761Vaccinum cholerae perorale inactivatum........................... 762Vaccinum Clostridii botulini ad usum veterinarium ...... 894Vaccinum Clostridii chauvoei ad usum veterinarium .... 894Vaccinum Clostridii novyi B ad usum vete rinari um ...... 895Vaccinum Clostridii perfringentisad usum veterinarium ........................................................... 897

Vaccinum Clostridii septici ad usum veterinarium ......... 899Vaccinum colibacillosis fetus a partu recentis inactivatumad ruminantes ......................................................................... 936

Vaccinum colibacillosis fetus a partu recentis inactivatumad suem ..................................................................................... 934

Vaccinum diarrhoeae viralis bovinae inactivatum .......... 880Vaccinum diphtheriae adsorbatum ...................................... 789Vaccinum diphtheriae, antigeniis minutum,adsorbatum............................................................................... 791

Vaccinum diphtheriae et tetani adsorbatum ..................... 763Vaccinum diphtheriae et tetani, antigeni-o(-is) minutum,adsorbatum............................................................................... 764

Vaccinum diphtheriae, tetani et hepatitidis B (ADNr)adsorbatum............................................................................... 765

Vaccinum diphtheriae, tetani et pertussis adsorbatum .. 768Vaccinum diphtheriae, tetani et pertussis sine cellulis exelementis praeparatum adsorbatum.................................. 767

Vaccinum diphtheriae, tetani et poliomyelitidisinactivatum, antigeni-o(-is) minutum, adsorbatum....... 770

Vaccinum diphtheriae, tetani, pertussis et poliomyelitidisinactivatum adsorbatum ....................................................... 785

Vaccinum diphtheriae, tetani, pertussis, poliomyelitidisinactivatum et haemophili stirpi b coniugatumadsorbatum............................................................................... 787

Vaccinum diphtheriae, tetani, pertussis sine cellulis exelementis praeparatum cumque haemophili stirpi bconiugatum adsorbatum ....................................................... 771

Vaccinum diphtheriae, tetani, pertussis sine cellulisex elementis praeparatum et hepatitidis B (ADNr)adsorbatum............................................................................... 774

Vaccinum diphtheriae, tetani, pertussis sine cellulis exelementis praeparatum et poliomyelitidis inactivatumadsorbatum............................................................................... 775

Vaccinum diphtheriae, tetani, pertussis sine cellulis exelementis praeparatum et poliomyelitidis inactivatum,antigeni-o(-is) minutum, adsorbatum................................ 778

Vaccinum diphtheriae, tetani, pertussis sine cellulisex elementis praeparatum, hepatitidis B (ADNr),poliomyelitidis inactivatum et haemophili stirpi bconiugatum adsorbatum ....................................................... 780

Vaccinum diphtheriae, tetani, pertussis sine cellulis exelementis praeparatum, poliomyelitidis inactivatum ethaemophili stirpi b coniugatum adsorbatum.................. 783

Vaccinum encephalitidis ixodibus advectaeinactivatum .............................................................................. 845

Vaccinum encephalomyelitidis infectivae aviariaevivum.......................................................................................... 871

Vaccinum erysipelatis suillae inactivatum ........................ 955Vaccinum febris flavae vivum................................................ 852Vaccinum febris typhoidi ........................................................ 849Vaccinum febris typhoidi cryodesiccatum ......................... 849Vaccinum febris typhoidis polysaccharidicum ................. 847Vaccinum febris typhoidis vivum perorale (stirpeTy 21a) ....................................................................................... 849

Vaccinum furunculosidis ad salmonidas inactivatum cumadiuvatione oleosa ad iniectionem .................................... 922

Vaccinum haemophili stirpi b coniugatum........................ 792Vaccinum hepatitidis A inactivatum adsorbatum ............ 795Vaccinum hepatitidis A inactivatum et hepatitidis B (ADNr)adsorbatum............................................................................... 794

Vaccinum hepatitidis A inactivatum virosomale .............. 797Vaccinum hepatitidis B (ADNr)............................................. 800Vaccinum hepatitidis viralis anatis stirpe I vivum .......... 902Vaccinum herpesviris equini inactivatum ......................... 905Vaccinum inactivatum diarrhoeae vituli coronaviroillatae ......................................................................................... 882

Vaccinum inactivatum diarrhoeae vituli rotaviroillatae ......................................................................................... 884

Vaccinum influenzae equi inactivatum .............................. 907Vaccinum influenzae inactivatum ad suem ...................... 944Vaccinum influenzae inactivatum ex cellulis corticisqueantigeniis praeparatum......................................................... 804

Vaccinum influenzae inactivatum ex cellulis virisqueintegris praeparatum ..............................................................810

Vaccinum influenzae inactivatum ex corticis antigeniispraeparatum............................................................................. 803

Vaccinum influenzae inactivatum ex corticis antigeniispraeparatum virosomale....................................................... 806

Vaccinum influenzae inactivatum ex viris integrispraeparatum............................................................................. 808

Vaccinum influenzae inactivatum ex virorum fragmentispraeparatum............................................................................. 801

Vaccinum laryngotracheitidis infectivae aviariaevivum.......................................................................................... 872

Vaccinum leptospirosis bovinae inactivatum .................... 876Vaccinum leptospirosis caninae inactivatum ................... 888

General Notices (1) apply to all monographs and other texts 3307

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Vaccinum leucosis felinae inactivatum................................914Vaccinum mannheimiae inactivatum ad bovinas............ 927Vaccinum mannheimiae inactivatum ad ovem ................ 928Vaccinum meningococcale classis C coniugatum ............814Vaccinum meningococcale polysaccharidicum.................816Vaccinum morbi Aujeszkyi ad suem inactivatum ............ 859Vaccinum morbi Aujeszkyi ad suem vivum ad usumparenteralem ............................................................................ 861

Vaccinum morbi Carrei vivum ad canem........................... 887Vaccinum morbi Carrei vivum ad mustelidas ................... 900Vaccinum morbi haemorrhagici cuniculi inactivatum .. 949Vaccinum morbillorum, parotitidis et rubellae vivum .... 812Vaccinum morbillorum vivum............................................... 813Vaccinum morbi Marek vivum .............................................. 930Vac ci num m orbi p artus dim inutio nis M CM LXXVI

inactivatumad pullum ........................................................... 904Vaccinum Mycoplasmatis galliseptici inactivatum .......... 932Vaccinum myxomatosidis vivum ad cuniculum ............... 933Vaccinum panleucopeniae felinae infectivaeinactivatum .............................................................................. 912

Vaccinum panleucopeniae felinae infectivae vivum ........913Vaccinum parainfluenzae viri canini vivum..................... 890Vaccinum paramyxoviris 3 aviarii inactivatum ............... 874Vaccinum parotitidis vivum ....................................................818Vaccinum parvovirosis caninae inactivatum .................... 891Vaccinum parvovirosis caninae vivum ............................... 892Vaccinum parvovirosis inactivatum ad suem ................... 946Vaccinum pasteurellae inactivatum ad ovem.................... 941Vaccinum pertussis....................................................................819Vaccinum pertussis adsorbatum ........................................... 824Vaccinum pertussis sine cellulis copurificatumadsorbatum............................................................................... 822

Vaccinum pertussis sine cellulis ex elementis praeparatumadsorbatum............................................................................... 820

Vaccinum pestis anatis vivum ............................................... 901Vaccinum pestis classicae suillae vivumcryodesiccatum ....................................................................... 956

Vaccinum pneumococcale polysaccharidicum ................. 827Vaccinum pneumococcale polysaccharidicum coniugatumadsorbatum............................................................................... 825

Vaccinum poliomyelitidis inactivatum ............................... 829Vaccinum poliomyelitidis perorale ...................................... 832Vaccinum pseudopestis aviariae inactivatum ................... 937Vaccinum pseudopestis aviariae vivum .............................. 939Vaccinum rabiei ex cellulis ad usum humanum .............. 836Vaccinum rabiei inactivatum ad usum veterinarium ..... 950Vaccinum rabiei perorale vivum ad vulpem ...................... 952Vaccinum rhinitidis atrophicantis ingravescentis suillaeinactivatum .............................................................................. 947

Vaccinum rhinotracheitidis infectivae bovinae vivum ... 924Vaccinum rhinotracheitidis viralis felinae inactivatum ..916Vaccinum rhinotracheitidis viralis felinae vivum .............917Vaccinum rubellae vivum ....................................................... 838Vaccinum Salmonellae Enteritidis inactivatum adpullum........................................................................................ 953

Vaccinum Salmonellae Typhimurium inactivatum adpullum........................................................................................ 954

Vaccinum tenosynovitidis viralis aviariae vivum ............ 875Vaccinum tetani adsorbatum ................................................. 844Vaccinum tetani ad usum veterinarium ............................. 957Vaccinum tuberculosis (BCG) cryodesiccatum ................. 759Vaccinum varicellae vivum .................................................... 850Vaccinum variolae gallinaceae vivum ............................... 921Vaccinum variolae vivum ....................................................... 839Vaccinum vibriosidis ad salmonidas inactivatum ........... 960Vaccinum vibriosidis aquae frigidae inactivatum adsalmonidas................................................................................ 959

Vaccinum viri parainfluenzae bovini vivum ..................... 878Vaccinum viri syncytialis meatus spiritus bovinivivum.......................................................................................... 879

Vaginalia ..................................................................................... 751Valerianae extractum hydroalcoholicum siccum ........... 3173Valerianae radix .......................................................................3174Valerianae tinctura ................................................................. 3175Valinum ......................................................................................3176Valnemulini hydrochloridum ad usum veterinarium ... 3177Vancomycini hydrochloridum ............................................. 3180Vanillinum ................................................................................ 3182Vaselinum album..................................................................... 2614Vaselinum flavum ................................................................... 2615Vecuronii bromidum .............................................................. 3183Venlafaxini hydrochloridum ................................................ 3184Verapamili hydrochloridum ................................................. 3186Verbasci flos..............................................................................2454Verbenae citriodoratae folium .............................................2248Verbenae herba ........................................................................ 3188Via praeparandi stirpes homoeopathicas etpotentificandi......................................................................... 1066

Vinblastini sulfas ..................................................................... 3189Vincristini sulfas ..................................................................... 3190Vindesini sulfas ....................................................................... 3192Vinorelbini tartras................................................................... 3194Vinpocetinum........................................................................... 3196Violae herba cum flore .......................................................... 3217Vitamini synthetici densati A pulvis .................................. 3201Vitaminum A ............................................................................ 3199Vitaminum A syntheticum densatum oleosum ...............3200Vitaminum A syntheticum, solubilisatum densatum inaqua dispergibile...................................................................3203

WWarfarinum natricum............................................................3207Warfarinum natricum clathratum ......................................3208

XXanthani gummi .....................................................................3233Xenoni (133Xe) solutio iniectabilis ....................................... 1042Xylazini hydrochloridum ad usum veterinarium ..........3234Xylitolum ...................................................................................3235Xylometazolini hydrochloridum .........................................3237Xylosum .....................................................................................3238

YYohimbini hydrochloridum ..................................................3244

ZZidovudinum ............................................................................3249Zinci acetas dihydricus .........................................................3250Zinci acexamas ........................................................................ 3251Zinci chloridum .......................................................................3253Zinci oxidum ............................................................................3253Zinci stearas .............................................................................3254Zinci sulfas heptahydricus....................................................3254Zinci sulfas hexahydricus .....................................................3255Zinci sulfas monohydricus ...................................................3255Zinci undecylenas...................................................................3256Zingiberis rhizoma .................................................................1969Zolpidemi tartras.....................................................................3256Zopiclonum...............................................................................3257Zuclopenthixoli decanoas .....................................................3259

3308 See the information section on general monographs (cover pages)