EUROPEAN PHARMACOPOEIA 7.0 Monographs deleted from the

EUROPEAN PHARMACOPOEIA 7.0

INDEXMonographs deleted from the 6th Edition are not included in the index; a list of deleted texts is found in the Contents ofVolume 1, page xxii.

English index ........................................................................ 3267 Latin index ................................................................................. 3295

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

EUROPEAN PHARMACOPOEIA 7.0

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

EUROPEAN PHARMACOPOEIA 7.0 Index

Numerics1. General notices .................................................................................32.1.1. Droppers ................................................................................... 152.1.2. Comparative table of porosity of sintered-glass filters ... 152.1.3. 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........................................312.2.15. Melting point - open capillary method ............................ 322.2.16. Melting point - instantaneous method ............................ 322.2.17. Drop point .............................................................................. 322.2.18. Freezing point....................................................................... 342.2.19. Amperometric titration ....................................................... 342.2.1. Clarity and degree of opalescence of liquids.....................212.2.20. Potentiometric titration ...................................................... 342.2.21. Fluorimetry............................................................................ 352.2.22. Atomic emission spectrometry .......................................... 352.2.23. Atomic absorption spectrometry ...................................... 362.2.24. Absorption spectrophotometry, infrared ........................ 382.2.25. Absorption spectrophotometry, ultraviolet andvisible.................................................................................................. 40

2.2.26. Paper chromatography ........................................................412.2.27. Thin-layer chromatography ................................................ 422.2.28. Gas chromatography ........................................................... 432.2.29. Liquid chromatography ...................................................... 452.2.2. Degree of coloration of liquids............................................ 222.2.30. Size-exclusion chromatography ........................................ 462.2.31. Electrophoresis ..................................................................... 462.2.31. Electrophoresis (5.8.)......................................................... 6212.2.32. Loss on drying .......................................................................512.2.33. Nuclear magnetic resonance spectrometry .................... 522.2.34. Thermal analysis................................................................... 542.2.35. Osmolality .............................................................................. 572.2.36. Potentiometric determination of ionicconcentration using ion-selective electrodes............................. 57

2.2.37. X-ray fluorescence spectrometry....................................... 582.2.38. Conductivity .......................................................................... 592.2.39. Molecular mass distribution in dextrans ........................ 602.2.3. Potentiometric determination of pH.................................. 242.2.40. Near-infrared spectrophotometry ......................................612.2.41. Circular dichroism................................................................ 652.2.42. Density of solids ................................................................... 662.2.43. Mass spectrometry ............................................................... 672.2.44. Total organic carbon in water for pharmaceuticaluse....................................................................................................... 69

2.2.45. Supercritical fluid chromatography................................. 702.2.46. Chromatographic separation techniques........................ 702.2.47. Capillary electrophoresis .................................................... 772.2.47. Capillary electrophoresis (5.8.)........................................ 6212.2.48. Raman spectrometry ........................................................... 822.2.49. Falling ball viscometer method......................................... 832.2.4. Relationship between reaction of solution, approximate pHand colour of certain indicators ................................................... 25

2.2.54. Isoelectric focusing.............................................................. 832.2.54. Isoelectric focusing (5.8.) ................................................. 6212.2.55. Peptide mapping................................................................... 852.2.55. Peptide mapping (5.8.) ...................................................... 6212.2.56. Amino acid analysis ............................................................. 882.2.56. Amino acid analysis (5.8.)................................................. 6212.2.57. Inductively coupled plasma-atomic emissionspectrometry ..................................................................................... 94

2.2.58. Inductively coupled plasma-mass spectrometry ............ 962.2.59. Glycan analysis of glycoproteins....................................... 972.2.5. Relative density....................................................................... 252.2.60. Melting point - instrumental method............................. 1022.2.6. Refractive index ...................................................................... 26

2.2.7. Optical rotation ....................................................................... 262.2.8. Viscosity.................................................................................... 272.2.9. Capillary viscometer method ............................................... 272.2. Physical and physicochemical methods.................................212.3.1. Identification reactions of ions and functional groups.. 1072.3.2. Identification of fatty oils by thin-layer chromato-graphy .............................................................................................. 110

2.3.3. Identification of phenothiazines by thin-layerchromatography............................................................................. 110

2.3.4. Odour ...................................................................................... 1102.3. Identification............................................................................. 1072.4.10. Lead in sugars......................................................................1172.4.11. Phosphates............................................................................1172.4.12. Potassium..............................................................................1172.4.13. Sulfates................................................................................. 1182.4.14. Sulfated ash......................................................................... 1182.4.14. Sulfated ash (5.8.) .............................................................. 6222.4.15. Nickel in polyols ................................................................. 1182.4.16. Total ash............................................................................... 1182.4.17. Aluminium............................................................................ 1182.4.18. Free formaldehyde ............................................................. 1182.4.19. Alkaline impurities in fatty oils ....................................... 1192.4.1. Ammonium............................................................................. 1132.4.21. Foreign oils in fatty oils by thin-layer chromato-graphy .............................................................................................. 119

2.4.22. Composition of fatty acids by gas chromatography ... 1192.4.23. Sterols in fatty oils ............................................................. 1212.4.24. Identification and control of residual solvents............ 1232.4.25. Ethylene oxide and dioxan............................................... 1272.4.26. N,N-Dimethylaniline .......................................................... 1282.4.27. Heavy metals in herbal drugs and fatty oils ................. 1292.4.28. 2-Ethylhexanoic acid ......................................................... 1302.4.29. Composition of fatty acids in oils rich in omega-3acids.................................................................................................. 130

2.4.2. Arsenic .................................................................................... 1132.4.30. Ethylene glycol and diethylene glycol in ethoxylatedsubstances ....................................................................................... 132

2.4.31. Nickel in hydrogenated vegetable oils ........................... 1322.4.32. Total cholesterol in oils rich in omega-3 acids ............ 1332.4.3. Calcium................................................................................... 1132.4.4. Chlorides ................................................................................ 1132.4.5. Fluorides .................................................................................1142.4.6. Magnesium..............................................................................1142.4.7. Magnesium and alkaline-earth metals ..............................1142.4.8. Heavy metals ..........................................................................1142.4.9. Iron ...........................................................................................1172.4. Limit tests .................................................................................. 1132.5.10. Oxygen-flask method......................................................... 1392.5.11. Complexometric titrations................................................ 1402.5.12. Water : semi-micro determination ................................... 1402.5.13. Aluminium in adsorbed vaccines.....................................1412.5.14. Calcium in adsorbed vaccines ..........................................1412.5.15. Phenol in immunosera and vaccines ..............................1412.5.16. Protein in polysaccharide vaccines .................................1412.5.17. Nucleic acids in polysaccharide vaccines ...................... 1422.5.18. Phosphorus in polysaccharide vaccines........................ 1422.5.19. O-Acetyl in polysaccharide vaccines............................... 1422.5.1. Acid value............................................................................... 1372.5.20. Hexosamines in polysaccharide vaccines...................... 1422.5.21. Methylpentoses in polysaccharide vaccines ................. 1432.5.22. Uronic acids in polysaccharide vaccines ....................... 1432.5.23. Sialic acid in polysaccharide vaccines ........................... 1432.5.24. Carbon dioxide in gases.................................................... 1432.5.25. Carbon monoxide in gases............................................... 1442.5.26. Nitrogen monoxide and nitrogen dioxide in gases ..... 1452.5.27. Oxygen in gases .................................................................. 1452.5.28. Water in gases..................................................................... 1452.5.29. Sulfur dioxide ..................................................................... 1452.5.2. Ester value ............................................................................. 1372.5.30. Oxidising substances......................................................... 1462.5.31. Ribose in polysaccharide vaccines.................................. 1462.5.32. Water : micro determination ............................................ 1462.5.33. Total protein........................................................................ 147


Index EUROPEAN PHARMACOPOEIA 7.0

2.5.34. Acetic acid in synthetic peptides .................................... 1502.5.35. Nitrous oxide in gases ....................................................... 1502.5.36. Anisidine value ................................................................... 1502.5.3. 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 aromatic amino-nitrogen .... 1392.5.9. Determination of nitrogen by sulfuric acid digestion .. 1392.5. Assays ......................................................................................... 1372.6.10. Histamine ............................................................................. 1622.6.11. Depressor substances........................................................ 1622.6.12. Microbiological examination of non-sterile products :microbial enumeration tests........................................................ 163

2.6.12. Microbiological examination of non-sterile products :microbial enumeration tests (5.8.) ............................................. 622

2.6.13. Microbiological examination of non-sterile products : testfor specified micro-organisms ..................................................... 167

2.6.13. Microbiological examination of non-sterile products : testfor specified micro-organisms (5.8.)........................................... 622

2.6.14. Bacterial endotoxins .......................................................... 1712.6.15. Prekallikrein activator....................................................... 1752.6.16. Tests for extraneous agents in viral vaccines for humanuse .................................................................................................... 176

2.6.17. Test for anticomplementary activity ofimmunoglobulin............................................................................. 177

2.6.18. Test for neurovirulence of live virus vaccines.............. 1792.6.19. Test for neurovirulence of poliomyelitis vaccine(oral) ................................................................................................. 179

2.6.1. Sterility ................................................................................... 1532.6.20. Anti-A and anti-B haemagglutinins (indirect meth-od) ..................................................................................................... 180

2.6.21. Nucleic acid amplification techniques ........................... 1812.6.22. Activated coagulation factors .......................................... 1852.6.24. Avian viral vaccines : tests for extraneous agents inseed lots ........................................................................................... 185

2.6.25. Avian live virus vaccines : tests for extraneous agents inbatches of finished product......................................................... 188

2.6.26. Test for anti-D antibodies in human immunoglobulin forintravenous administration ......................................................... 191

2.6.27. Microbiological control of cellular products ................ 1912.6.2. Mycobacteria ......................................................................... 1562.6.30. Monocyte-activation test ................................................... 1922.6.31. Microbiological examination of herbal medicinalproducts for oral use..................................................................... 197

2.6.7. Mycoplasmas.......................................................................... 1562.6.8. Pyrogens................................................................................. 1612.6.9. Abnormal toxicity ................................................................. 1622.6. Biological tests ......................................................................... 1532.7.10. Assay of human coagulation factor VII ......................... 2192.7.11. Assay of human coagulation factor IX ........................... 2192.7.12. Assay of heparin in coagulation factors ........................ 2202.7.13. Assay of human anti-D immunoglobulin....................... 2202.7.14. Assay of hepatitis A vaccine ............................................. 2222.7.15. Assay of hepatitis B vaccine (rDNA)............................... 2232.7.16. Assay of pertussis vaccine (acellular)............................. 2232.7.17. Assay of human antithrombin III .................................... 2242.7.18. Assay of human coagulation factor II ............................ 2242.7.19. Assay of human coagulation factor X ............................ 2252.7.19. Assay of human coagulation factor X (2.7.19.)............. 2252.7.1. Immunochemical methods ................................................. 2012.7.20. In vivo assay of poliomyelitis vaccine (inactivated).... 2252.7.21. Assay of human von Willebrand factor.......................... 2262.7.22. Assay of human coagulation factor XI........................... 2272.7.23. Numeration of CD34/CD45+ cells in haemato-poietic products ............................................................................. 228

2.7.24. Flow cytometry ................................................................... 2292.7.25. Assay of human plasmin inhibitor .................................. 2302.7.27. Flocculation value (Lf) of diphtheria and tetanus toxinsand toxoids (Ramon assay) .......................................................... 231

2.7.28. Colony-forming cell assay for human haematopoietic pro-genitor cells..................................................................................... 232

2.7.29. Nucleated cell count and viability................................... 2332.7.2. Microbiological assay of antibiotics .................................. 2022.7.30. Assay of human protein C ................................................ 2342.7.31. Assay of human protein S................................................. 2352.7.32. Assay of human α-1-proteinase inhibitor ...................... 2362.7.4. Assay of human coagulation factor VIII .......................... 2072.7.5. Assay of heparin.................................................................... 2082.7.6. Assay of diphtheria vaccine (adsorbed) ........................... 2092.7.7. Assay of pertussis vaccine................................................... 2132.7.8. Assay of tetanus vaccine (adsorbed)................................. 2142.7.9. Test for Fc function of immunoglobulin ..........................2172.7. Biological assays ...................................................................... 2012.8.10. Solubility in alcohol of essential oils ............................. 2402.8.11. Assay of 1,8-cineole in essential oils .............................. 2402.8.12. Determination of essential oils in herbal drugs .......... 2412.8.13. Pesticide residues............................................................... 2422.8.14. Determination of tannins in herbal drugs .................... 2432.8.15. Bitterness value .................................................................. 2442.8.16. Dry residue of extracts...................................................... 2442.8.17. Loss on drying of extracts ................................................ 2442.8.18. Determination of aflatoxin B1 in herbal drugs ............ 2442.8.1. Ash insoluble in hydrochloric acid ................................... 2392.8.20. Herbal drugs : sampling and sample preparation........ 2462.8.21. Test for aristolochic acids in herbal drugs ................... 2472.8.22. Determination of ochratoxin A in herbal drugs.......... 2492.8.23. Microscopic examination of herbal drugs .................... 2502.8.2. Foreign matter ...................................................................... 2392.8.3. Stomata and stomatal index .............................................. 2392.8.4. Swelling index....................................................................... 2392.8.5. Water in essential oils.......................................................... 2392.8.6. Foreign esters in essential oils .......................................... 2392.8.7. Fatty oils and resinified essential oils in essential oils .. 2392.8.8. Odour and taste of essential oils....................................... 2402.8.9. Residue on evaporation of essential oils ......................... 2402.8. Methods in pharmacognosy .................................................. 2392.9.10. Ethanol content and alcoholimetric tables .................. 2682.9.11. Test for methanol and 2-propanol .................................. 2702.9.12. Sieve test .............................................................................. 2702.9.14. Specific surface area by air permeability ...................... 2712.9.16. Flowability............................................................................ 2722.9.17. Test for extractable volume of parenteralpreparations .................................................................................... 273

2.9.17. Test for extractable volume of parenteral preparations(5.8.).................................................................................................. 622

2.9.18. Preparations for inhalation : aerodynamic assessment offine particles ................................................................................... 274

2.9.19. Particulate contamination : sub-visible particles ......... 2852.9.1. Disintegration of tablets and capsules............................. 2532.9.20. Particulate contamination: visible particles ................ 2872.9.22. Softening time determination of lipophilicsuppositories................................................................................... 288

2.9.23. Gas pycnometric density of solids .................................. 2882.9.25. Dissolution test for medicated chewing gums............. 2892.9.26. Specific surface area by gas adsorption........................ 2912.9.26. Specific surface area by gas adsorption (5.8.) ............. 6222.9.27. Uniformity of mass of delivered doses from multidosecontainers........................................................................................ 294

2.9.29. Intrinsic dissolution........................................................... 2942.9.2. Disintegration of suppositories and pessaries ............... 2552.9.31. Particle size analysis by laser light diffraction ............ 2952.9.32. Porosity and pore-size distribution of solids by mercuryporosimetry ..................................................................................... 299

2.9.33. Characterisation of crystalline and partially crystallinesolids by X-ray powder diffraction (XRPD)............................... 301

2.9.34. Bulk density and tapped density of powders............... 3052.9.35. Powder fineness ................................................................. 3082.9.36. Powder flow......................................................................... 3082.9.36. Powder flow (5.8.) .............................................................. 6222.9.37. Optical microscopy..............................................................3112.9.37. Optical microscopy (5.8.) .................................................. 6222.9.38. Particle-size distribution estimation by analyticalsieving .............................................................................................. 313



2.9.38. Particle-size distribution estimation by analytical sieving(5.8.).................................................................................................. 623

2.9.3. Dissolution test for solid dosage forms ........................... 2562.9.40. Uniformity of dosage units............................................... 3152.9.41. Friability of granules and spheroids .............................. 3182.9.42. Dissolution test for lipophilic solid dosage forms....... 3192.9.43. Apparent dissolution ......................................................... 3202.9.45. Wettability of porous solids including powders .......... 3212.9.4. Dissolution test for transdermal patches ........................ 2632.9.5. Uniformity of mass of single-dose preparations............. 2652.9.6. Uniformity of content of single-dose preparations........ 2662.9.7. Friability of uncoated tablets ............................................. 2662.9.7. Friability of uncoated tablets (5.8.)................................... 6222.9.8. Resistance to crushing of tablets...................................... 2672.9.9. Measurement of consistency by penetrometry .............. 2672.9. Pharmaceutical technical procedures ................................. 2533.1.10. Materials based on non-plasticised poly(vinyl chloride)for containers for non-injectable, aqueous solutions ............ 349

3.1.11. Materials based on non-plasticised poly(vinyl chloride) forcontainers for dry dosage forms for oral administration...... 350

3.1.1.1. Materials based on plasticised poly(vinyl chloride) forcontainers for human blood and blood components............. 329

3.1.1.2. Materials based on plasticised poly(vinyl chloride) fortubing used in sets for the transfusion of blood and bloodcomponents..................................................................................... 332

3.1.13. Plastic additives .................................................................. 3523.1.14. Materials based on plasticised poly(vinyl chloride) forcontainers for aqueous solutions for intravenous infusion ..355

3.1.15. Polyethylene terephthalate for containers forpreparations not for parenteral use........................................... 357

3.1.1. Materials for containers for human blood and bloodcomponents..................................................................................... 329

3.1.3. Polyolefines............................................................................ 3343.1.4. Polyethylene without additives for containers forparenteral preparations and for ophthalmic preparations ...337

3.1.5. Polyethylene with additives for containers for parenteralpreparations and for ophthalmic preparations ....................... 338

3.1.6. Polypropylene for containers and closures for parenteralpreparations and ophthalmic preparations.............................. 342

3.1.7. Poly(ethylene - vinyl acetate) for containers and tubing fortotal parenteral nutrition preparations..................................... 345

3.1.8. Silicone oil used as a lubricant ......................................... 3473.1.9. Silicone elastomer for closures and tubing .................... 3473.1. Materials used for the manufacture of containers ........... 3293.2.1. Glass containers for pharmaceutical use ........................ 3633.2.2.1. Plastic containers for aqueous solutions forinfusion ............................................................................................ 368

3.2.2. Plastic containers and closures for pharmaceuticaluse..................................................................................................... 368

3.2.3. Sterile plastic containers for human blood andblood components ......................................................................... 369

3.2.4. Empty sterile containers of plasticised poly(vinyl chloride)for human blood and blood components ................................. 370

3.2.5. Sterile containers of plasticised poly(vinyl chloride) forhuman blood containing anticoagulant solution ................... 371

3.2.6. Sets for the transfusion of blood and bloodcomponents..................................................................................... 371

3.2.8. Sterile single-use plastic syringes ..................................... 3733.2.9. Rubber closures for containers for aqueousparenteral preparations, for powders and forfreeze-dried powders ..................................................................... 374

3.2. Containers ................................................................................. 3634.1.1. Reagents ................................................................................. 3794.1.2. Standard solutions for limit tests...................................... 4854.1.3. Buffer solutions .................................................................... 4894.1. Reagents, standard solutions, buffer solutions ................. 3794.2.1. Primary standards for volumetric solutions................... 4944.2.2. Volumetric solutions............................................................ 4944.2. Volumetric analysis.................................................................. 4944-Aminobenzoic acid .....................................................................13714. Reagents........................................................................................ 3795.10. Control of impurities in substances for pharmaceuticaluse..................................................................................................... 631

5.1.10. Guidelines for using the test for bacterial endotoxins .. 5205.11. Characters section in monographs .................................... 6375.1.1. Methods of preparation of sterile products .................... 5035.1.2. Biological indicators of sterilisation................................. 5045.12. Reference standards.............................................................. 6415.1.3. Efficacy of antimicrobial preservation ............................. 5055.14. Gene transfer medicinal products for human use .......... 6475.1.4. Microbiological quality of non-sterile pharmaceuticalpreparations and substances for pharmaceutical use ........... 507

5.1.4. Microbiological quality of non-sterile pharmaceuticalpreparations and substances for pharmaceutical use (5.8.) .. 623

5.1.5. Application of the F0 concept to steam sterilisation ofaqueous preparations ................................................................... 508

5.15. Functionality-related characteristics of excipients......... 6615.1.6. Alternative methods for control of microbiologicalquality............................................................................................... 508

5.17.1. Recommendations on dissolution testing ..................... 6655.17. Recommendations on methods for dosage formstesting............................................................................................... 665

5.1.7. Viral safety.............................................................................. 5185.1.8. Microbiological quality of herbal medicinal products fororal use ............................................................................................ 519

5.1.9. Guidelines for using the test for sterility ........................ 5195.1. General texts on microbiology .............................................. 5035.2.1. Terminology used in monographs on biologicalproducts ........................................................................................... 527

5.2.2. Chicken flocks free from specified pathogens for theproduction and quality control of vaccines ............................. 527

5.2.3. Cell substrates for the production of vaccines for humanuse..................................................................................................... 530

5.2.4. Cell cultures for the production of veterinaryvaccines............................................................................................ 533

5.2.5. Substances of animal origin for the production ofimmunological veterinary medicinal products........................ 535

5.2.6. Evaluation of safety of veterinary vaccines andimmunosera ................................................................................... 536

5.2.7. Evaluation of efficacy of veterinary vaccines andimmunosera .................................................................................... 538

5.2.8. Minimising the risk of transmitting animal spongiformencephalopathy agents via human and veterinary medicinalproducts ........................................................................................... 539

5.2.9. Evaluation of safety of each batch of veterinary vaccinesand immunosera ............................................................................ 547

5.2. General texts on biological products................................... 5275.3. Statistical analysis of results of biological assays andtests................................................................................................... 551

5.4. Residual solvents ..................................................................... 5835.5. Alcoholimetric tables .............................................................. 5935.6. Assay of interferons................................................................. 6075.7. Table of physical characteristics of radionuclides mentionedin the European Pharmacopoeia ............................................... 611

5.8. Pharmacopoeial harmonisation ........................................... 6215.9. Polymorphism........................................................................... 627

AAbbreviations and symbols (1.) ..........................................................3Abnormal toxicity (2.6.9.)............................................................... 162Absorption spectrophotometry, infrared (2.2.24.) ...................... 38Absorption spectrophotometry, ultraviolet and visible(2.2.25.) .............................................................................................. 40

Acacia................................................................................................1043Acacia, spray-dried ......................................................................... 1301Acamprosate calcium .................................................................... 1301Acarbose...........................................................................................1302Acebutolol hydrochloride.............................................................1304Aceclofenac......................................................................................1306Acemetacin ......................................................................................1307Acesulfame potassium ..................................................................1309Acetate trihydrate, sodium...........................................................2908Acetazolamide................................................................................. 1310Acetic acid, glacial ......................................................................... 1311Acetic acid in synthetic peptides (2.5.34.) .................................. 150



Acetone............................................................................................. 1312Acetylcholine chloride .................................................................. 1313Acetylcysteine ................................................................................. 1313β-Acetyldigoxin ............................................................................... 1315Acetylsalicylic acid ......................................................................... 1317Acetyltryptophan, N- ..................................................................... 1319Acetyltyrosine, N- ...........................................................................1320Aciclovir ........................................................................................... 1321Acid value (2.5.1.)............................................................................. 137Acitretin............................................................................................1323Actinobacillosis vaccine (inactivated), porcine .......................... 926Activated charcoal..........................................................................1649Activated coagulation factors (2.6.22.)........................................ 185Adapalene ........................................................................................1324Additives, plastic (3.1.13.)............................................................... 352Adenine ............................................................................................1326Adeno-associated-virus vectors for human use ......................... 656Adenosine ........................................................................................1327Adipic acid .......................................................................................1328Adrenaline .......................................................................................1329Adrenaline tartrate ........................................................................1330Adsorption, gas, specific surface area by (2.9.26.).................... 291Adsorption, gas, specific surface area by (2.9.26.) (5.8.)......... 622Aerodynamic assessment of fine particles in preparations forinhalation (2.9.18.) ........................................................................ 274

Aflatoxin B1 in herbal drugs, determination of (2.8.18.)......... 244Agar...................................................................................................1044Agnus castus fruit..........................................................................1044Agrimony .........................................................................................1046Air, medicinal .................................................................................. 1331Air, synthetic medicinal ................................................................1333Alanine .............................................................................................1334Albendazole.....................................................................................1335Albumin solution, human............................................................. 2165Alchemilla ........................................................................................1047Alcoholimetric tables (2.9.10.) ...................................................... 268Alcoholimetric tables (5.5.) ............................................................ 593Alcuronium chloride......................................................................1336Alendronate, sodium .....................................................................2908Alexandrian senna pods ...............................................................1238Alfacalcidol ......................................................................................1337Alfadex..............................................................................................1338Alfentanil hydrochloride...............................................................1339Alfuzosin hydrochloride ............................................................... 1341Alginate, sodium.............................................................................2909Alginic acid ......................................................................................1342Alkaline-earth metals and magnesium (2.4.7.) ...........................114Alkaline impurities in fatty oils (2.4.19.)..................................... 119Allantoin...........................................................................................1342Allergen products............................................................................. 671Allopurinol.......................................................................................1343all-rac-α-Tocopherol....................................................................... 3104all-rac-α-Tocopheryl acetate ........................................................ 3106Almagate ..........................................................................................1345Almond oil, refined ........................................................................1346Almond oil, virgin ..........................................................................1347Aloes, Barbados..............................................................................1047Aloes, Cape ......................................................................................1048Aloes dry extract, standardised...................................................1049Alphacyclodextrin ..........................................................................1338Alprazolam ......................................................................................1347Alprenolol hydrochloride .............................................................1349Alprostadil .......................................................................................1350Alteplase for injection ...................................................................1352Alternative methods for control of microbiological quality(5.1.6.)............................................................................................... 508

Altizide .............................................................................................1356Alum..................................................................................................1357Aluminium (2.4.17.) ......................................................................... 118Aluminium chloride hexahydrate ...............................................1357Aluminium hydroxide, hydrated, for adsorption.....................1357Aluminium in adsorbed vaccines (2.5.13.)...................................141Aluminium magnesium silicate...................................................1358

Aluminium oxide, hydrated..........................................................1359Aluminium phosphate gel ............................................................1360Aluminium phosphate, hydrated ................................................ 1361Aluminium sodium silicate .......................................................... 1361Aluminium sulfate..........................................................................1362Alverine citrate ...............................................................................1363Amantadine hydrochloride ..........................................................1364Ambroxol hydrochloride...............................................................1365Amfetamine sulfate........................................................................1366Amidotrizoate, sodium.................................................................. 2910Amidotrizoic acid dihydrate.........................................................1366Amikacin ..........................................................................................1367Amikacin sulfate.............................................................................1369Amiloride hydrochloride...............................................................1370Amino acid analysis (2.2.56.) ........................................................... 88Amino acid analysis (2.2.56.) (5.8.) .............................................. 621Aminobenzoic acid, 4- ...................................................................1371Aminocaproic acid .........................................................................1373Aminoglutethimide........................................................................1373Aminophylline, anhydrous ...........................................................3068Aminophylline hydrate..................................................................3069Aminosalicylate dihydrate, sodium ............................................ 2911Amiodarone hydrochloride ..........................................................1375Amisulpride .....................................................................................1376Amitriptyline hydrochloride ........................................................1377Amlodipine besilate .......................................................................1379Ammonia (13N) injection ................................................................. 965Ammonia solution, concentrated ...............................................1380Ammonio methacrylate copolymer (type A) ............................ 1381Ammonio methacrylate copolymer (type B) ............................1382Ammonium (2.4.1.) .......................................................................... 113Ammonium bromide......................................................................1382Ammonium chloride......................................................................1383Ammonium glycyrrhizate.............................................................1384Ammonium hydrogen carbonate ................................................1385Amobarbital.....................................................................................1385Amobarbital sodium ......................................................................1386Amoxicillin sodium ........................................................................1386Amoxicillin trihydrate ...................................................................1389Amperometric titration (2.2.19.) ..................................................... 34Amphotericin B .............................................................................. 1391Ampicillin, anhydrous ..................................................................1393Ampicillin sodium ..........................................................................1395Ampicillin trihydrate .....................................................................1397Amylmetacresol ..............................................................................1399Anaemia vaccine (live), chicken, infectious ................................ 910Anaesthetic ether ...........................................................................1968Analysis, thermal (2.2.34.)................................................................ 54Analytical sieving, particle-size distribution estimation by(2.9.38.) ............................................................................................ 313

Analytical sieving, particle-size distribution estimation by(2.9.38.) (5.8.) ................................................................................. 623

Angelica root ...................................................................................1049Animal anti-T lymphocyte immunoglobulin for human use ..1404Animal immunosera for human use............................................. 678Animal spongiform encephalopathies, products with risk oftransmitting agents of................................................................... 686

Animal spongiform encephalopathy agents, minimising the riskof transmitting via human and veterinary medicinal products(5.2.8.) .............................................................................................. 539

Aniseed .............................................................................................1052Anise oil............................................................................................1050Anisidine value (2.5.36.) ................................................................. 150Antazoline hydrochloride............................................................. 1401Anthrax spore vaccine (live) for veterinary use......................... 847Anthrax vaccine for human use (adsorbed, prepared fromculture filtrates) ............................................................................. 745

Anti-A and anti-B haemagglutinins (indirect method)(2.6.20.) ............................................................................................ 180

Antibiotics, microbiological assay of (2.7.2.) .............................. 202Antibodies (anti-D) in human immunoglobulin for intravenousadministration, test for (2.6.26.) ................................................. 191

Antibodies for human use, monoclonal ...................................... 682



Anticoagulant and preservative solutions for human blood......................................................................................................... 1401

Anticomplementary activity of immunoglobulin (2.6.17.)....... 177Anti-D antibodies in human immunoglobulin for intravenousadministration, test for (2.6.26.) ................................................. 191

Anti-D immunoglobulin for intravenous administration,human ............................................................................................ 2167

Anti-D immunoglobulin, human ................................................. 2166Anti-D immunoglobulin, human, assay of (2.7.13.)................... 220Antimicrobial preservation, efficacy of (5.1.3.) .......................... 505Antiserum, European viper venom .............................................. 953Antithrombin III concentrate, human ....................................... 2168Antithrombin III, human, assay of (2.7.17.) ................................ 224Anti-T lymphocyte immunoglobulin for human use, animal ..1404Apomorphine hydrochloride .......................................................1407Apparatus (2.1.) .................................................................................. 15Apparent dissolution (2.9.43.) ....................................................... 320Application of the F0 concept to steam sterilisation of aqueouspreparations (5.1.5.) ...................................................................... 508

Aprotinin ..........................................................................................1408Aprotinin concentrated solution................................................. 1411Arachis oil, hydrogenated ............................................................ 1413Arachis oil, refined......................................................................... 1413Arginine............................................................................................ 1414Arginine aspartate ......................................................................... 1415Arginine hydrochloride................................................................. 1415Argon ................................................................................................ 1416Aristolochic acids in herbal drugs, test for (2.8.21) ................. 247Arnica flower...................................................................................1053Arnica tincture................................................................................1055Arsenic (2.4.2.) .................................................................................. 113Arsenious trioxide for homoeopathic preparations................1286Articaine hydrochloride................................................................ 1417Artichoke leaf..................................................................................1056Artichoke leaf dry extract ............................................................1058Ascorbate, calcium.........................................................................1548Ascorbate, sodium ......................................................................... 2912Ascorbic acid ................................................................................... 1418Ascorbyl palmitate .........................................................................1420Ash insoluble in hydrochloric acid (2.8.1.)................................. 239Ash leaf.............................................................................................1059Ash, sulfated (2.4.14.)...................................................................... 118Ash, sulfated (2.4.14.) (5.8.) ........................................................... 622Asparagine monohydrate ............................................................. 1421Aspartame........................................................................................ 1421Aspartic acid....................................................................................1423Assay of 1,8-cineole in essential oils (2.8.11.) ............................ 240Assay of diphtheria vaccine (adsorbed) (2.7.6.) ......................... 209Assay of heparin (2.7.5.) ................................................................. 208Assay of heparin in coagulation factors (2.7.12.) ...................... 220Assay of hepatitis A vaccine (2.7.14.) ........................................... 222Assay of hepatitis B vaccine (rDNA) (2.7.15.) ............................ 223Assay of human anti-D immunoglobulin (2.7.13.)..................... 220Assay of human antithrombin III (2.7.17.) .................................. 224Assay of human coagulation factor II (2.7.18.).......................... 224Assay of human coagulation factor IX (2.7.11.)......................... 219Assay of human coagulation factor VII (2.7.10.) ....................... 219Assay of human coagulation factor VIII (2.7.4.)........................ 207Assay of human coagulation factor X (2.7.19.) .......................... 225Assay of human coagulation factor XI (2.7.22.) ........................ 227Assay of human plasmin inhibitor (2.7.25.)................................ 230Assay of human protein C (2.7.30.) .............................................. 234Assay of human protein S (2.7.31.)............................................... 235Assay of human von Willebrand factor (2.7.21.) ....................... 226Assay of interferons (5.6.) .............................................................. 607Assay of pertussis vaccine (2.7.7.)................................................. 213Assay of pertussis vaccine (acellular) (2.7.16.) .......................... 223Assay of poliomyelitis vaccine (inactivated), in vivo (2.7.20.) .. 225Assay of tetanus vaccine (adsorbed) (2.7.8.) .............................. 214Assays (2.5.) ....................................................................................... 137Astragalus mongholicus root ......................................................1060Atenolol ............................................................................................1424Atomic absorption spectrometry (2.2.23.) .................................... 36

Atomic emission spectrometry (2.2.22.)........................................ 35Atomic emission spectrometry, inductively coupled plasma-(2.2.57.) .............................................................................................. 94

Atracurium besilate .......................................................................1425Atropine ...........................................................................................1427Atropine sulfate ..............................................................................1429Aujeszky’s disease vaccine (inactivated) for pigs...................... 847Aujeszky’s disease vaccine (live) for pigs for parenteraladministration ................................................................................ 849

Avian infectious bronchitis vaccine (inactivated)...................... 851Avian infectious bronchitis vaccine (live) ................................... 852Avian infectious bursal disease vaccine (inactivated) .............. 854Avian infectious bursal disease vaccine (live) ............................ 856Avian infectious encephalomyelitis vaccine (live) ..................... 857Avian infectious laryngotracheitis vaccine (live)....................... 859Avian live virus vaccines : tests for extraneous agents in batchesof finished product (2.6.25.) ........................................................ 188

Avian paramyxovirus 1 (Newcastle disease) vaccine(inactivated) .................................................................................... 921

Avian paramyxovirus 3 vaccine (inactivated)............................. 860Avian tuberculin purified protein derivative............................ 3161Avian viral tenosynovitis vaccine (live)........................................ 861Avian viral vaccines : tests for extraneous agents in seed lots(2.6.24.) ............................................................................................ 185

Azaperone for veterinary use ......................................................1430Azathioprine.................................................................................... 1431Azelastine hydrochloride..............................................................1433Azithromycin...................................................................................1434

BB19 virus (B19V), validation of nucleic acid amplificationtechniques for the quantification of B19V DNA in plasmapools : guidelines............................................................................ 181

Bacampicillin hydrochloride........................................................1439Bacitracin.........................................................................................1440Bacitracin zinc ................................................................................1443Baclofen ...........................................................................................1445Bacterial endotoxins (2.6.14.)........................................................ 171Bacterial endotoxins, guidelines for using the test for(5.1.10.) ............................................................................................ 520

Bambuterol hydrochloride...........................................................1446Barbados aloes ...............................................................................1047Barbital.............................................................................................1447Barium chloride dihydrate for homoeopathic preparations ..1287Barium sulfate ................................................................................1448Basic butylated methacrylate copolymer..................................1448BCG for immunotherapy ................................................................ 746BCG vaccine, freeze-dried .............................................................. 747Bearberry leaf ................................................................................. 1061Beclometasone dipropionate, anhydrous .................................1449Beclometasone dipropionate monohydrate ............................. 1451Bee for homoeopathic preparations, honey.............................1292Beeswax, white ...............................................................................1453Beeswax, yellow..............................................................................1454Belladonna leaf...............................................................................1062Belladonna leaf dry extract, standardised ................................1064Belladonna leaf tincture, standardised .....................................1065Belladonna, prepared ....................................................................1066Benazepril hydrochloride.............................................................1454Bendroflumethiazide ....................................................................1456Benfluorex hydrochloride ............................................................1457Benperidol .......................................................................................1458Benserazide hydrochloride ..........................................................1459Bentonite .........................................................................................1460Benzalkonium chloride................................................................. 1461Benzalkonium chloride solution ................................................1463Benzathine benzylpenicillin ........................................................ 1471Benzbromarone..............................................................................1465Benzethonium chloride ................................................................1466Benzocaine ......................................................................................1466Benzoic acid ....................................................................................1467Benzoin, Siam.................................................................................1067



Benzoin, Sumatra ..........................................................................1068Benzoin tincture, Siam .................................................................1069Benzoin tincture, Sumatra...........................................................1069Benzoyl peroxide, hydrous ..........................................................1468Benzyl alcohol ................................................................................1469Benzyl benzoate .............................................................................1470Benzylpenicillin, benzathine ....................................................... 1471Benzylpenicillin potassium..........................................................1473Benzylpenicillin, procaine............................................................ 1474Benzylpenicillin sodium ............................................................... 1476Betacarotene ...................................................................................1477Betacyclodextrin ............................................................................1478Betacyclodextrin, poly(hydroxypropyl) ether .......................... 2210Betadex ............................................................................................1478Betahistine dihydrochloride ........................................................1479Betahistine mesilate ......................................................................1480Betamethasone............................................................................... 1481Betamethasone acetate ................................................................1483Betamethasone dipropionate ......................................................1485Betamethasone sodium phosphate............................................1486Betamethasone valerate ...............................................................1488Betaxolol hydrochloride ...............................................................1489Bezafibrate ......................................................................................1490Bifonazole........................................................................................ 1491Bilberry fruit, dried .......................................................................1070Bilberry fruit dry extract, fresh, refined and standardised...1130Bilberry fruit, fresh........................................................................1070Biological assays (2.7.) .................................................................... 201Biological assays and tests, statistical analysis of results of(5.3.).................................................................................................. 551

Biological indicators of sterilisation (5.1.2.) .............................. 504Biological products, general texts on (5.2.)................................ 527Biological products, terminology used in monographs on(5.2.1.)............................................................................................... 527

Biological tests (2.6.) ....................................................................... 153Biotin ................................................................................................1492Biperiden hydrochloride...............................................................1493Biphasic insulin injection.............................................................2243Biphasic isophane insulin injection ...........................................2244Birch leaf..........................................................................................1071Bisacodyl..........................................................................................1495Bismuth subcarbonate..................................................................1496Bismuth subgallate........................................................................1497Bismuth subnitrate, heavy ...........................................................1498Bismuth subsalicylate ...................................................................1498Bisoprolol fumarate.......................................................................1499Bistort rhizome ..............................................................................1072Bitter fennel ....................................................................................1124Bitter-fennel fruit oil......................................................................1073Bitter-fennel herb oil .....................................................................1075Bitterness value (2.8.15.)................................................................ 244Bitter-orange epicarp and mesocarp..........................................1077Bitter-orange-epicarp and mesocarp tincture ..........................1078Bitter-orange flower ......................................................................1078Bitter-orange-flower oil ................................................................. 1194Black horehound ...........................................................................1079Bleomycin sulfate...........................................................................1502Blood and blood components, empty sterile containers ofplasticised poly(vinyl chloride) for (3.2.4.) ............................... 370

Blood and blood components, materials for containers for(3.1.1.)............................................................................................... 329

Blood and blood components, sets for the transfusion of(3.2.6.) .............................................................................................. 371

Blood and blood components, sterile plastic containers for(3.2.3.) .............................................................................................. 369

Blood, anticoagulant and preservative solutions for ............. 1401Blood, sterile containers of plasticised poly(vinyl chloride)containing anticoagulant solution (3.2.5.) ............................... 371

Bogbean leaf ...................................................................................1080Boiling point (2.2.12.) ........................................................................31Boldo leaf......................................................................................... 1081Boldo leaf dry extract....................................................................1083Borage (starflower) oil, refined...................................................1503

Borax ................................................................................................1503Boric acid.........................................................................................1504Botulinum antitoxin ........................................................................ 949Botulinum toxin type A for injection.........................................1504Bovine infectious rhinotracheitis vaccine (live) ........................ 908Bovine insulin.................................................................................2239Bovine leptospirosis vaccine (inactivated).................................. 862Bovine parainfluenza virus vaccine (live)................................... 864Bovine respiratory syncytial virus vaccine (live)....................... 865Bovine serum..................................................................................1506Bovine tuberculin purified protein derivative ......................... 3161Bovine viral diarrhoea vaccine (inactivated).............................. 866Bromazepam ...................................................................................1507Bromhexine hydrochloride ..........................................................1508Bromocriptine mesilate ................................................................1509Bromperidol .................................................................................... 1511Bromperidol decanoate ................................................................ 1512Brompheniramine maleate........................................................... 1514Brotizolam ....................................................................................... 1515Brucellosis vaccine (live) (Brucella melitensis Rev. 1 strain) forveterinary use ................................................................................. 867

Buccal tablets and sublingual tablets.......................................... 723Buckwheat herb .............................................................................1084Budesonide...................................................................................... 1516Bufexamac ....................................................................................... 1518Buffer solutions (4.1.3.) .................................................................. 489Buflomedil hydrochloride ............................................................ 1519Bulk density and tapped density of powders (2.9.34.)............. 305Bumetanide .....................................................................................1520Bupivacaine hydrochloride .......................................................... 1521Buprenorphine ...............................................................................1523Buprenorphine hydrochloride ....................................................1524Buserelin..........................................................................................1526Buspirone hydrochloride..............................................................1527Busulfan...........................................................................................1529Butcher’s broom.............................................................................1085Butylated methacrylate copolymer, basic.................................1448Butylhydroxyanisole...................................................................... 1531Butylhydroxytoluene..................................................................... 1531Butyl parahydroxybenzoate.........................................................1530

CCabergoline .....................................................................................1535Cachets ............................................................................................... 709Cadmium sulfate hydrate for homoeopathic preparations...1287Caffeine ............................................................................................1536Caffeine monohydrate...................................................................1537Calcifediol ........................................................................................1538Calcipotriol, anhydrous ................................................................1539Calcipotriol monohydrate ............................................................1542Calcitonin (salmon)........................................................................1544Calcitriol...........................................................................................1546Calcium (2.4.3.)................................................................................. 113Calcium acetate, anhydrous.........................................................1547Calcium ascorbate..........................................................................1548Calcium carbonate .........................................................................1549Calcium carboxymethylcellulose ................................................1589Calcium chloride dihydrate..........................................................1550Calcium chloride hexahydrate ....................................................1550Calcium dobesilate monohydrate ............................................... 1551Calcium edetate, sodium .............................................................. 2916Calcium folinate .............................................................................1552Calcium glucoheptonate...............................................................1554Calcium gluconate .........................................................................1555Calcium gluconate, anhydrous ...................................................1555Calcium gluconate for injection..................................................1556Calcium glycerophosphate...........................................................1557Calcium hydrogen phosphate, anhydrous ................................1558Calcium hydrogen phosphate dihydrate ...................................1559Calcium hydroxide .........................................................................1560Calcium in adsorbed vaccines (2.5.14.) ........................................141



Calcium iodide tetrahydrate for homoeopathic prepara-tions ................................................................................................1288

Calcium lactate, anhydrous ......................................................... 1561Calcium lactate monohydrate ..................................................... 1561Calcium lactate pentahydrate .....................................................1562Calcium lactate trihydrate............................................................1562Calcium levofolinate pentahydrate ............................................1563Calcium levulinate dihydrate.......................................................1565Calcium pantothenate...................................................................1566Calcium pentetate (sodium) for radiopharmaceuticalpreparations.................................................................................... 987

Calcium phosphate ........................................................................1567Calcium stearate.............................................................................1567Calcium sulfate dihydrate ............................................................1569Calendula flower ............................................................................1086Calf coronavirus diarrhoea vaccine (inactivated)...................... 868Calf rotavirus diarrhoea vaccine (inactivated)........................... 869Calicivirosis vaccine (inactivated), feline..................................... 895Calicivirosis vaccine (live), feline .................................................. 896Camphor, D- .....................................................................................1569Camphor, racemic ..........................................................................1571Canine adenovirus vaccine (inactivated) .................................... 870Canine adenovirus vaccine (live) .................................................. 871Canine distemper vaccine (live) .................................................... 872Canine leptospirosis vaccine (inactivated).................................. 874Canine parainfluenza virus vaccine (live)................................... 875Canine parvovirosis vaccine (inactivated)................................... 876Canine parvovirosis vaccine (live) ................................................ 877Cape aloes........................................................................................1048Capillary electrophoresis (2.2.47.).................................................. 77Capillary electrophoresis (2.2.47.) (5.8.) ..................................... 621Capillary viscometer method (2.2.9.)............................................. 27Caprylate, sodium .......................................................................... 2917Caprylic acid....................................................................................1571Caprylocaproyl macrogolglycerides...........................................1572Capsicum..........................................................................................1087Capsicum oleoresin, refined and quantified ............................1089Capsicum tincture, standardised ................................................1090Capsules ............................................................................................. 707Capsules and tablets, disintegration of (2.9.1.) ......................... 253Capsules, gastro-resistant............................................................... 708Capsules, hard .................................................................................. 708Capsules, intrauterine..................................................................... 715Capsules, modified-release ............................................................. 708Capsules, oromucosal ..................................................................... 723Capsules, rectal................................................................................. 733Capsules, soft .................................................................................... 708Capsules, vaginal.............................................................................. 739Captopril ..........................................................................................1573Caraway fruit...................................................................................1090Caraway oil ...................................................................................... 1091Carbachol.........................................................................................1575Carbamazepine ...............................................................................1576Carbasalate calcium.......................................................................1577Carbidopa ........................................................................................1579Carbimazole ....................................................................................1580Carbocisteine .................................................................................. 1581Carbomers ....................................................................................... 1581Carbon dioxide ...............................................................................1583Carbon dioxide in gases (2.5.24.) ................................................. 143Carbon monoxide...........................................................................1584Carbon monoxide (15O) ................................................................... 965Carbon monoxide in gases (2.5.25.)............................................. 144Carboplatin......................................................................................1585Carboprost trometamol ................................................................1586Carboxymethylcellulose................................................................1588Carboxymethylcellulose calcium ................................................1589Carboxymethylcellulose sodium.................................................1589Carboxymethylcellulose sodium, cross-linked .........................1770Carboxymethylcellulose sodium, low-substituted...................1590Carisoprodol....................................................................................1587Carmellose.......................................................................................1588Carmellose calcium........................................................................1589

Carmellose sodium ........................................................................1589Carmellose sodium and microcrystalline cellulose ................2507Carmellose sodium, low-substituted ..........................................1590Carmustine ...................................................................................... 1591Carnauba wax .................................................................................1592Carprofen for veterinary use .......................................................1592Carrageenan....................................................................................1593Carteolol hydrochloride................................................................1594Carvedilol.........................................................................................1595Cascara .............................................................................................1092Cascara dry extract, standardised ..............................................1094Cassia oil ..........................................................................................1095Castor oil, hydrogenated ..............................................................1596Castor oil, polyoxyl ........................................................................2398Castor oil, polyoxyl hydrogenated..............................................2397Castor oil, refined ..........................................................................1597Castor oil, virgin.............................................................................1598Catgut, sterile..................................................................................1027Catgut, sterile, in distributor for veterinary use .....................1037CD34/CD45+ cells in haematopoietic products, numeration of(2.7.23.) ............................................................................................ 228

Cefaclor ............................................................................................1599Cefadroxil monohydrate ...............................................................1600Cefalexin monohydrate.................................................................1602Cefalotin sodium ............................................................................1603Cefamandole nafate .......................................................................1605Cefapirin sodium............................................................................1606Cefatrizine propylene glycol........................................................1607Cefazolin sodium............................................................................1608Cefepime dihydrochloride monohydrate .................................. 1610Cefixime ........................................................................................... 1612Cefoperazone sodium ................................................................... 1613Cefotaxime sodium ........................................................................ 1615Cefoxitin sodium ............................................................................ 1617Cefpodoxime proxetil .................................................................... 1618Cefradine..........................................................................................1620Ceftazidime pentahydrate ............................................................1622Ceftazidime pentahydrate with sodium carbonate forinjection .........................................................................................1624

Ceftriaxone sodium........................................................................1626Cefuroxime axetil ...........................................................................1627Cefuroxime sodium........................................................................1629Celiprolol hydrochloride...............................................................1630Cell count and viability, nucleated (2.7.29.) ............................... 233Cell cultures for the production of veterinary vaccines(5.2.4.) .............................................................................................. 533

Cell substrates for the production of vaccines for human use(5.2.3.) .............................................................................................. 530

Cellular products, microbiological control of (2.6.27.) ............ 191Cellulose acetate ............................................................................ 1631Cellulose acetate butyrate............................................................1632Cellulose acetate phthalate..........................................................1633Cellulose, microcrystalline...........................................................1634Cellulose (microcrystalline) and carmellose sodium..............2507Cellulose, powdered ......................................................................1638Centaury ..........................................................................................1095Centella ............................................................................................1096Cetirizine dihydrochloride ........................................................... 1641Cetostearyl alcohol ........................................................................1643Cetostearyl alcohol (type A), emulsifying .................................1643Cetostearyl alcohol (type B), emulsifying.................................1645Cetostearyl isononanoate.............................................................1646Cetostearyl sulfate, sodium .........................................................2920Cetrimide .........................................................................................1646Cetyl alcohol ...................................................................................1647Cetyl palmitate................................................................................1648Cetylpyridinium chloride..............................................................1648Ceylon cinnamon bark oil ............................................................ 1101Ceylon cinnamon leaf oil.............................................................. 1102CFC assay for human haematopoietic progenitor cells(2.7.28.) ............................................................................................ 232

Chamomile flower, Roman...........................................................1098



Characterisation of crystalline and partially crystalline solidsby X-ray powder diffraction (XRPD) (2.9.33.) .......................... 301

Characters section in monographs (5.11.).................................. 637Charcoal, activated ........................................................................1649Chenodeoxycholic acid ................................................................1650Chewing gums, medicated ............................................................. 709Chewing gums, medicated, dissolution test for (2.9.25.) ........ 289Chicken anaemia vaccine (live), infectious................................. 910Chicken flocks free from specified pathogens for the productionand quality control of vaccines (5.2.2.) ..................................... 527

Chitosan hydrochloride ................................................................ 1651Chlamydiosis vaccine (inactivated), feline ................................. 897Chloral hydrate...............................................................................1652Chlorambucil...................................................................................1653Chloramine ...................................................................................... 3118Chloramphenicol............................................................................1653Chloramphenicol palmitate .........................................................1654Chloramphenicol sodium succinate...........................................1655Chlorcyclizine hydrochloride ......................................................1656Chlordiazepoxide ...........................................................................1657Chlordiazepoxide hydrochloride ................................................1658Chlorhexidine diacetate................................................................1659Chlorhexidine digluconate solution ..........................................1660Chlorhexidine dihydrochloride ...................................................1662Chlorides (2.4.4.) .............................................................................. 113Chlorobutanol, anhydrous ...........................................................1663Chlorobutanol hemihydrate ........................................................1663Chlorocresol ....................................................................................1664Chloroquine phosphate ................................................................1665Chloroquine sulfate .......................................................................1665Chlorothiazide ................................................................................1666Chlorphenamine maleate .............................................................1667Chlorpromazine hydrochloride...................................................1668Chlorpropamide..............................................................................1669Chlorprothixene hydrochloride ..................................................1670Chlortalidone ..................................................................................1671Chlortetracycline hydrochloride.................................................1673Cholecalciferol ................................................................................ 1674Cholecalciferol concentrate (oily form).....................................1675Cholecalciferol concentrate (powder form)..............................1677Cholecalciferol concentrate (water-dispersible form).............1678Cholera vaccine ................................................................................ 748Cholera vaccine, freeze-dried ........................................................ 749Cholera vaccine (inactivated, oral) ............................................... 749Cholesterol ......................................................................................1680Cholesterol in oils rich in omega-3 acids, total (2.4.32.) ......... 133Chondroitin sulfate sodium ......................................................... 1681Chromatographic separation techniques (2.2.46.) ..................... 70Chromatography, gas (2.2.28.)........................................................ 43Chromatography, liquid (2.2.29.) ................................................... 45Chromatography, paper (2.2.26.).....................................................41Chromatography, size-exclusion (2.2.30.)..................................... 46Chromatography, supercritical fluid (2.2.45.) ............................. 70Chromatography, thin-layer (2.2.27.) ............................................. 42Chromium (51Cr) edetate injection ............................................... 966Chymotrypsin..................................................................................1683Ciclopirox.........................................................................................1684Ciclopirox olamine .........................................................................1686Ciclosporin ......................................................................................1687Cilastatin sodium ...........................................................................1688Cilazapril ..........................................................................................1690Cimetidine........................................................................................ 1691Cimetidine hydrochloride.............................................................1693Cinchocaine hydrochloride..........................................................1694Cinchona bark ................................................................................1098Cinchona liquid extract, standardised....................................... 1100Cineole..............................................................................................1695Cineole in essential oils, 1,8-, assay of (2.8.11.) ......................... 240Cinnamon ........................................................................................ 1101Cinnamon bark oil, Ceylon .......................................................... 1101Cinnamon leaf oil, Ceylon ............................................................ 1102Cinnamon tincture......................................................................... 1103Cinnarizine ......................................................................................1696

Ciprofibrate .....................................................................................1697Ciprofloxacin...................................................................................1698Ciprofloxacin hydrochloride........................................................1700Circular dichroism (2.2.41.) ............................................................. 65Cisplatin ........................................................................................... 1701Citalopram hydrobromide ............................................................1703Citalopram hydrochloride ............................................................1704Citric acid, anhydrous ...................................................................1705Citric acid monohydrate ...............................................................1706Citronella oil.................................................................................... 1103Cladribine ........................................................................................1707Clarithromycin................................................................................1708Clarity and degree of opalescence of liquids (2.2.1.)...................21Clary sage oil................................................................................... 1104Classical swine-fever vaccine (live, prepared in cell cultures) .. 940Clazuril for veterinary use ........................................................... 1710Clebopride malate .......................................................................... 1712Clemastine fumarate ..................................................................... 1713Clenbuterol hydrochloride........................................................... 1715Clindamycin hydrochloride.......................................................... 1716Clindamycin phosphate ................................................................ 1717Clioquinol ........................................................................................ 1718Clobazam ......................................................................................... 1719Clobetasol propionate...................................................................1720Clobetasone butyrate ....................................................................1722Clodronate disodium tetrahydrate .............................................1723Clofazimine......................................................................................1724Clofibrate .........................................................................................1725Clomifene citrate ............................................................................1726Clomipramine hydrochloride.......................................................1727Clonazepam.....................................................................................1729Clonidine hydrochloride...............................................................1730Clopamide........................................................................................ 1731Clorazepate, dipotassium.............................................................1869Closantel sodium dihydrate for veterinary use .......................1732Clostridium botulinum vaccine for veterinary use ................... 878Clostridium chauvoei vaccine for veterinary use...................... 879Clostridium novyi alpha antitoxin for veterinary use .............. 957Clostridium novyi (type B) vaccine for veterinary use............. 879Clostridium perfringens beta antitoxin for veterinary use .... 958Clostridium perfringens epsilon antitoxin for veterinary use........................................................................................................... 959

Clostridium perfringens vaccine for veterinary use ................. 881Clostridium septicum vaccine for veterinary use...................... 883Closures and containers for parenteral preparations andophthalmic preparations, polypropylene for (3.1.6.).............. 342

Closures and containers for pharmaceutical use, plastic(3.2.2.) .............................................................................................. 368

Closures and tubing, silicone elastomer for (3.1.9.) ................. 347Closures for containers for aqueous parenteral preparations, forpowders and for freeze-dried powders, rubber (3.2.9.) ......... 374

Clotrimazole....................................................................................1734Clove ................................................................................................. 1105Clove oil ........................................................................................... 1106Cloxacillin sodium..........................................................................1735Clozapine .........................................................................................1737Coagulation factor II, assay of (2.7.18.)....................................... 224Coagulation factor IX, human..................................................... 2172Coagulation factor IX, human, assay of (2.7.11.)....................... 219Coagulation factors, activated (2.6.22.)....................................... 185Coagulation factors, assay of heparin (2.7.12.) ......................... 220Coagulation factor VII, human ................................................... 2169Coagulation factor VII, human, assay of (2.7.10.)..................... 219Coagulation factor VIII, human.................................................. 2170Coagulation factor VIII, human, assay of (2.7.4.)...................... 207Coagulation factor VIII (rDNA), human ................................... 2171Coagulation factor X, assay of (2.7.19.) ....................................... 225Coagulation factor XI, human..................................................... 2173Coagulation factor XI, human, assay of (2.7.22.) ...................... 227Coated granules ............................................................................... 714Coated tablets ................................................................................... 737Cocaine hydrochloride..................................................................1738Coccidiosis vaccine (live) for chickens ........................................ 884



Coconut oil, refined.......................................................................1739Cocoyl caprylocaprate................................................................... 1740Codeine ............................................................................................ 1740Codeine hydrochloride dihydrate............................................... 1742Codeine phosphate hemihydrate................................................ 1743Codeine phosphate sesquihydrate ............................................. 1745Codergocrine mesilate .................................................................. 1747Cod-liver oil, farmed ...................................................................... 1748Cod-liver oil (type A)......................................................................1752Cod-liver oil (type B)......................................................................1756Cola ................................................................................................... 1107Colchicine ........................................................................................1759Cold-water vibriosis vaccine (inactivated) for salmonids......... 943Colestyramine ................................................................................. 1761Colibacillosis vaccine (inactivated), neonatal piglet................. 918Colibacillosis vaccine (inactivated), neonatal ruminant .......... 920Colistimethate sodium .................................................................. 1762Colistin sulfate................................................................................ 1763Colloidal anhydrous silica ............................................................2901Colloidal hydrated silica ...............................................................2902Colloidal silica, hydrophobic .......................................................2903Colloidal silver, for external use .................................................2904Colony-forming cell assay for human haematopoietic progenitorcells (2.7.28.) ................................................................................... 232

Colophony ....................................................................................... 1107Coloration of liquids (2.2.2.)............................................................ 22Common stinging nettle for homoeopathic preparations.....1288Comparative table of porosity of sintered-glass filters (2.1.2.).. 15Complexometric titrations (2.5.11.).............................................. 140Composition of fatty acids by gas chromatography (2.4.22.).. 119Composition of fatty acids in oils rich in omega-3 acids(2.4.29.) ............................................................................................ 130

Compressed lozenges...................................................................... 723Concentrated solutions for haemodialysis ............................... 2136Concentrates for injections or infusions..................................... 725Concentrates for intrauterine solutions...................................... 715Conductivity (2.2.38.) ........................................................................ 59Coneflower herb, purple .............................................................. 1218Coneflower root, narrow-leaved.................................................. 1193Coneflower root, pale....................................................................1208Coneflower root, purple ............................................................... 1219Conjugated estrogens ...................................................................1958Consistency by penetrometry, measurement of (2.9.9.) .......... 267Containers (3.2.)............................................................................... 363Containers and closures for parenteral preparations andophthalmic preparations, polypropylene for (3.1.6.).............. 342

Containers and closures for pharmaceutical use, plastic(3.2.2.) .............................................................................................. 368

Containers and tubing for total parenteral nutritionpreparations, poly(ethylene - vinyl acetate) for (3.1.7.) ......... 345

Containers for aqueous solutions for infusion, plastic(3.2.2.1.) ........................................................................................... 368

Containers for aqueous solutions for intravenous infusion,materials based on plasticised poly(vinyl chloride) for(3.1.14.) ............................................................................................ 355

Containers for dry dosage forms for oral administration,materials based on non-plasticised poly(vinyl chloride) for(3.1.11.)............................................................................................. 350

Containers for human blood and blood components, materialsbased on plasticised poly(vinyl chloride) for (3.1.1.1.) .......... 329

Containers for human blood and blood components, materialsfor (3.1.1.) ........................................................................................ 329

Containers for human blood and blood components, plastic,sterile (3.2.3.) .................................................................................. 369

Containers for non-injectable aqueous solutions, materialsbased on non-plasticised poly(vinyl chloride) for (3.1.10.) ... 349

Containers for parenteral preparations and for ophthalmicpreparations, polyethylene with additives for (3.1.5.) ........... 338

Containers for parenteral preparations and for ophthalmicpreparations, polyethylene without additives for (3.1.4.) ..... 337

Containers for pharmaceutical use, glass (3.2.1.)..................... 363Containers for preparations not for parenteral use, polyethyleneterephthalate for (3.1.15) ............................................................. 357

Containers of plasticised poly(vinyl chloride) for human bloodand blood components, empty sterile (3.2.4.) ......................... 370

Containers of plasticised poly(vinyl chloride) for human bloodcontaining anticoagulant solution, sterile (3.2.5.) ................. 371

Contamination, microbial : microbial enumeration tests(2.6.12.) ............................................................................................ 163

Contamination, microbial : microbial enumeration tests (2.6.12.)(5.8.).................................................................................................. 622

Contamination, microbial : test for specified micro-organisms(2.6.13.) ............................................................................................ 167

Contamination, microbial : test for specified micro-organisms(2.6.13.) (5.8.) ................................................................................. 622

Content uniformity of single-dose preparations (2.9.6.).......... 266Control of impurities in substances for pharmaceutical use(5.10.)................................................................................................ 631

Control of microbiological quality, alternative methods for(5.1.6.)............................................................................................... 508

Copolymer, basic butylated methacrylate ................................1448Copolymer, grafted, macrogol poly(vinyl alcohol)..................2401Copolymer, methacrylic acid - ethyl acrylate (1:1) .................2459Copolymer, methacrylic acid - ethyl acrylate (1:1) dispersion30 per cent ....................................................................................2460

Copolymer (type A), ammonio methacrylate ........................... 1381Copolymer (type B), ammonio methacrylate ...........................1382Copovidone...................................................................................... 1764Copper acetate monohydrate for homoeopathic prepara-tions ................................................................................................1289

Copper for homoeopathic preparations....................................1289Copper sulfate, anhydrous ........................................................... 1766Copper sulfate pentahydrate ....................................................... 1766Coriander ......................................................................................... 1108Coriander oil ................................................................................... 1108Cortisone acetate ........................................................................... 1767Cotton, absorbent .......................................................................... 1768Cottonseed oil, hydrogenated .................................................... 1769Couch grass rhizome .................................................................... 1109Creams................................................................................................ 735Cresol, crude ...................................................................................1770Cromoglicate, sodium ...................................................................2923Croscarmellose sodium.................................................................1770Crospovidone .................................................................................. 1771Crotamiton ......................................................................................1773Crystalline and partially crystalline solids, characterisationby X-ray powder diffraction (XRPD) of (2.9.33.) ..................... 301

Cutaneous application, liquid preparations for......................... 717Cutaneous application, powders for ............................................ 726Cutaneous application, semi-solid preparations for ................. 734Cutaneous application, veterinary liquid preparations for..... 740Cutaneous foams.............................................................................. 717Cutaneous patches .......................................................................... 734Cyanocobalamin ............................................................................. 1774Cyanocobalamin (57Co) capsules .................................................. 967Cyanocobalamin (57Co) solution ................................................... 968Cyanocobalamin (58Co) capsules .................................................. 968Cyanocobalamin (58Co) solution ................................................... 969Cyclamate, sodium.........................................................................2924Cyclizine hydrochloride................................................................1775Cyclopentolate hydrochloride ..................................................... 1776Cyclophosphamide.........................................................................1777Cyproheptadine hydrochloride ...................................................1778Cyproterone acetate ......................................................................1779Cysteine hydrochloride monohydrate ....................................... 1781Cystine..............................................................................................1782Cytarabine .......................................................................................1783

DDacarbazine.....................................................................................1787Dalteparin sodium .........................................................................1788Danaparoid sodium .......................................................................1789Dandelion herb with root............................................................. 1110Dandelion root................................................................................ 1111Dapsone ...........................................................................................1792



Daunorubicin hydrochloride .......................................................1792D-Camphor .......................................................................................1569Decyl oleate .....................................................................................1794Deferoxamine mesilate..................................................................1794Degree of coloration of liquids (2.2.2.).......................................... 22Dembrexine hydrochloride monohydrate for veteri-nary use .........................................................................................1795

Demeclocycline hydrochloride....................................................1796Density of powders, bulk density and tapped (2.9.34.) ........... 305Density of solids (2.2.42.) ................................................................. 66Density of solids, gas pycnometric (2.9.23.)............................... 288Density, relative (2.2.5.) .................................................................... 25Dental type silica............................................................................2903Depressor substances (2.6.11.)...................................................... 162Deptropine citrate..........................................................................1797Dequalinium chloride....................................................................1798Desflurane .......................................................................................1800Desipramine hydrochloride ......................................................... 1801Deslanoside .....................................................................................1802Desmopressin..................................................................................1803Desogestrel ......................................................................................1804Desoxycortone acetate..................................................................1805Detector tubes, gas (2.1.6.) ...............................................................17Determination of aflatoxin B1 in herbal drugs (2.8.18.).......... 244Determination of essential oils in herbal drugs (2.8.12.)........ 241Determination of nitrogen by sulfuric acid digestion (2.5.9.) .. 139Determination of primary aromatic amino-nitrogen (2.5.8.) .. 139Determination of tannins in herbal drugs (2.8.14.).................. 243Determination of water by distillation (2.2.13.) ...........................31Detomidine hydrochloride for veterinary use .........................1806Devil’s claw dry extract................................................................. 1112Devil’s claw root ............................................................................. 1113Dexamethasone ..............................................................................1807Dexamethasone acetate................................................................1809Dexamethasone isonicotinate ..................................................... 1811Dexamethasone sodium phosphate ........................................... 1812Dexchlorpheniramine maleate .................................................... 1814Dexpanthenol.................................................................................. 1815Dextran 1 for injection.................................................................. 1816Dextran 40 for injection ............................................................... 1817Dextran 60 for injection ............................................................... 1818Dextran 70 for injection ............................................................... 1819Dextranomer ................................................................................... 1819Dextrans, molecular mass distribution in (2.2.39.) .................... 60Dextrin..............................................................................................1820Dextromethorphan hydrobromide ............................................. 1821Dextromoramide tartrate .............................................................1822Dextropropoxyphene hydrochloride..........................................1823Diazepam .........................................................................................1824Diazoxide .........................................................................................1825Dibrompropamidine diisetionate ................................................1826Dibutyl phthalate ...........................................................................1827Dichloromethane............................................................................2474Diclazuril for veterinary use........................................................1828Diclofenac potassium ....................................................................1829Diclofenac sodium .........................................................................1830Dicloxacillin sodium ...................................................................... 1831Dicycloverine hydrochloride........................................................1833Didanosine.......................................................................................1833Dienestrol ........................................................................................1835Diethylcarbamazine citrate ..........................................................1836Diethylene glycol and ethylene glycol in ethoxylated substances(2.4.30.) ............................................................................................ 132

Diethylene glycol monoethyl ether............................................1837Diethylene glycol palmitostearate..............................................1839Diethyl phthalate ...........................................................................1835Diethylstilbestrol ............................................................................1839Diffraction, laser light, particle size analysis by (2.9.31.) ....... 295Diflunisal..........................................................................................1840Digitalis leaf .................................................................................... 1114Digitoxin........................................................................................... 1841Digoxin .............................................................................................1842Dihydralazine sulfate, hydrated..................................................1844

Dihydrocodeine hydrogen tartrate.............................................1845Dihydroergocristine mesilate ......................................................1846Dihydroergotamine mesilate .......................................................1849Dihydroergotamine tartrate ........................................................1850Dihydrostreptomycin sulfate for veterinary use...................... 1851Dihydrotachysterol ........................................................................1853Diltiazem hydrochloride ...............................................................1855Dimenhydrinate..............................................................................1856Dimercaprol.....................................................................................1858Dimethylacetamide ........................................................................1859Dimethylaniline, N,N- (2.4.26.)...................................................... 128Dimethyl sulfoxide .........................................................................1858Dimeticone ......................................................................................1860Dimetindene maleate ....................................................................1860Dinoprostone ..................................................................................1863Dinoprost trometamol...................................................................1862Diosmin ............................................................................................1864Dioxan and ethylene oxide (2.4.25.) ............................................ 127Dip concentrates .............................................................................. 740Diphenhydramine hydrochloride................................................1866Diphenoxylate hydrochloride ......................................................1867Diphtheria and tetanus toxins and toxoids, flocculation value(Lf) of, (Ramon assay) (2.7.27.) ................................................... 231

Diphtheria and tetanus vaccine (adsorbed) ............................... 751Diphtheria and tetanus vaccine (adsorbed, reduced antigen(s)content)............................................................................................ 752

Diphtheria antitoxin ........................................................................ 949Diphtheria, tetanus and hepatitis B (rDNA) vaccine(adsorbed)........................................................................................ 753

Diphtheria, tetanus and pertussis (acellular, component)vaccine (adsorbed)......................................................................... 754

Diphtheria, tetanus and pertussis vaccine (adsorbed) ........... 755Diphtheria, tetanus and poliomyelitis (inactivated) vaccine(adsorbed, reduced antigen(s) content) .................................... 756

Diphtheria, tetanus, pertussis (acellular, component) andhaemophilus type b conjugate vaccine (adsorbed) ................ 758

Diphtheria, tetanus, pertussis (acellular, component) andhepatitis B (rDNA) vaccine (adsorbed) ..................................... 760

Diphtheria, tetanus, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed) ........................ 762

Diphtheria, tetanus, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed, reducedantigen(s) content) ........................................................................ 763

Diphtheria, tetanus, pertussis (acellular, component), hepatitis B(rDNA), poliomyelitis (inactivated) and haemophilus type bconjugate vaccine (adsorbed)...................................................... 765

Diphtheria, tetanus, pertussis (acellular, component),poliomyelitis (inactivated) and haemophilus type b conjugatevaccine (adsorbed)......................................................................... 768

Diphtheria, tetanus, pertussis and poliomyelitis (inactivated)vaccine (adsorbed)......................................................................... 771

Diphtheria, tetanus, pertussis, poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) ................ 772

Diphtheria vaccine (adsorbed) ...................................................... 774Diphtheria vaccine (adsorbed), assay of (2.7.6.) ........................ 209Diphtheria vaccine (adsorbed, reduced antigen content) ....... 776Dipivefrine hydrochloride ............................................................1867Dipotassium clorazepate ..............................................................1869Dipotassium phosphate ................................................................1870Diprophylline ..................................................................................1870Dipyridamole...................................................................................1871Dirithromycin..................................................................................1872Disintegration of suppositories and pessaries (2.9.2.) ............. 255Disintegration of tablets and capsules (2.9.1.) .......................... 253Disodium clodronate tetrahydrate .............................................1723Disodium edetate ........................................................................... 1874Disodium etidronate......................................................................1979Disodium pamidronate pentahydrate........................................2660Disodium phosphate, anhydrous................................................1875Disodium phosphate dihydrate...................................................1875Disodium phosphate dodecahydrate ......................................... 1876Disopyramide .................................................................................. 1876Disopyramide phosphate..............................................................1877



Dispersible tablets ........................................................................... 737Dissolution, apparent (2.9.43.)...................................................... 320Dissolution, intrinsic (2.9.29.) ....................................................... 294Dissolution test for lipophilic solid dosage forms (2.9.42.) .... 319Dissolution test for medicated chewing gums (2.9.25.) .......... 289Dissolution test for solid dosage forms (2.9.3.) ......................... 256Dissolution test for transdermal patches (2.9.4.)...................... 263Dissolution testing, recommendations on (5.17.1.) .................. 665Distemper vaccine (live), canine ................................................... 872Distemper vaccine (live) for mustelids ........................................ 887Distillation range (2.2.11.)................................................................ 30Distribution estimation by analytical sieving, particle-size(2.9.38.) ............................................................................................ 313

Distribution estimation by analytical sieving, particle-size(2.9.38.) (5.8.) ................................................................................. 623

Disulfiram ........................................................................................1878Dithranol..........................................................................................1879DL-Methionine .................................................................................2466DL-α-Tocopheryl hydrogen succinate......................................... 3110Dobesilate monohydrate, calcium .............................................. 1551Dobutamine hydrochloride..........................................................1880Docetaxel trihydrate...................................................................... 1881Docusate sodium............................................................................1883Dodecyl gallate ...............................................................................1884Dog rose ........................................................................................... 1115Domperidone ..................................................................................1885Domperidone maleate ...................................................................1886Dopamine hydrochloride..............................................................1887Dopexamine dihydrochloride ......................................................1889Dorzolamide hydrochloride .........................................................1890Dosage forms (glossary) ................................................................. 707Dosage units, uniformity of (2.9.40.) ........................................... 315Dosulepin hydrochloride..............................................................1892Doxapram hydrochloride..............................................................1893Doxazosin mesilate ........................................................................1894Doxepin hydrochloride .................................................................1895Doxorubicin hydrochloride..........................................................1897Doxycycline hyclate .......................................................................1898Doxycycline monohydrate............................................................1899Doxylamine hydrogen succinate................................................. 1901Droperidol........................................................................................1902Droppers (2.1.1.)................................................................................. 15Drop point (2.2.17.)............................................................................ 32Drops (nasal) and sprays (liquid nasal) ....................................... 720Drops, oral ......................................................................................... 719Drospirenone ..................................................................................1903Dry extracts ....................................................................................... 676Dry residue of extracts (2.8.16.).................................................... 244Duck plague vaccine (live) ............................................................. 888Duck viral hepatitis type I vaccine (live)..................................... 889Dwarf pine oil ................................................................................. 1116Dydrogesterone ..............................................................................1905

EEar drops and ear sprays................................................................ 710Ear powders ...................................................................................... 710Ear preparations............................................................................... 709Ear preparations, semi-solid .......................................................... 710Ear sprays and ear drops................................................................ 710Ear tampons...................................................................................... 710Ear washes......................................................................................... 710Ebastine ...........................................................................................1909Econazole ........................................................................................ 1910Econazole nitrate ........................................................................... 1911Edetate, disodium .......................................................................... 1874Edetate, sodium calcium .............................................................. 2916Edetic acid ....................................................................................... 1912Edrophonium chloride.................................................................. 1913Effervescent granules...................................................................... 714Effervescent powders ...................................................................... 727Effervescent tablets ......................................................................... 737Efficacy of antimicrobial preservation (5.1.3.) ........................... 505

Efficacy of veterinary vaccines and immunosera, evaluation of(5.2.7.)............................................................................................... 538

Egg drop syndrome ′76 vaccine (inactivated)............................ 891Elder flower..................................................................................... 1117Electrophoresis (2.2.31.) ................................................................... 46Electrophoresis (2.2.31.) (5.8.) ...................................................... 621Electrophoresis, capillary (2.2.47.) ................................................. 77Electrophoresis, capillary (2.2.47.) (5.8.) .................................... 621Eleutherococcus............................................................................. 1118Emedastine difumarate................................................................. 1913Emetine hydrochloride heptahydrate........................................ 1914Emetine hydrochloride pentahydrate........................................ 1915Empty sterile containers of plasticised poly(vinyl chloride) forhuman blood and blood components (3.2.4.).......................... 370

Emulsifying cetostearyl alcohol (type A) ..................................1643Emulsifying cetostearyl alcohol (type B)..................................1645Emulsions, solutions and suspensions, oral .............................. 718Enalaprilat dihydrate .................................................................... 1918Enalapril maleate ........................................................................... 1916Encephalitis vaccine (inactivated), tick-borne ........................... 834Endotoxins, bacterial (2.6.14.)....................................................... 171Endotoxins, bacterial, guidelines for using the test for(5.1.10.) ............................................................................................ 520

Enilconazole for veterinary use.................................................. 1919Enoxaparin sodium........................................................................1920Enoxolone........................................................................................ 1921Enrofloxacin for veterinary use ..................................................1922Entacapone......................................................................................1924Enzootic pneumonia vaccine (inactivated), porcine................. 927Ephedra herb ..................................................................................1120Ephedrine, anhydrous...................................................................1925Ephedrine hemihydrate ................................................................1926Ephedrine hydrochloride .............................................................1927Ephedrine hydrochloride, racemic.............................................1928Epinastine hydrochloride .............................................................1928Epinephrine.....................................................................................1329Epinephrine tartrate .....................................................................1330Epirubicin hydrochloride .............................................................1929Equine herpesvirus vaccine (inactivated) ................................... 892Equine influenza vaccine (inactivated) ....................................... 893Equisetum stem.............................................................................. 1121Ergocalciferol.................................................................................. 1931Ergometrine maleate.....................................................................1933Ergotamine tartrate.......................................................................1934Erysipelas vaccine (inactivated), swine ....................................... 939Erythritol .........................................................................................1935Erythromycin ..................................................................................1936Erythromycin estolate...................................................................1938Erythromycin ethylsuccinate.......................................................1940Erythromycin lactobionate ..........................................................1942Erythromycin stearate ..................................................................1944Erythropoietin concentrated solution.......................................1946Eserine salicylate ...........................................................................2726Eserine sulfate ................................................................................2727Esketamine hydrochloride ...........................................................1950Esomeprazole magnesium trihydrate........................................ 1951Essential oils ..................................................................................... 673Essential oils, assay of 1,8-cineole in (2.8.11.) ........................... 240Essential oils, fatty oils and resinified essential oils in(2.8.7.)............................................................................................... 239

Essential oils, foreign esters in (2.8.6.) ....................................... 239Essential oils in herbal drugs, determination of (2.8.12.)....... 241Essential oils, odour and taste (2.8.8.) ........................................ 240Essential oils, residue on evaporation (2.8.9.) ........................... 240Essential oils, solubility in alcohol (2.8.10.)............................... 240Essential oils, water in (2.8.5.) ...................................................... 239Ester value (2.5.2.) ........................................................................... 137Estradiol benzoate .........................................................................1953Estradiol hemihydrate...................................................................1954Estradiol valerate ...........................................................................1955Estriol ...............................................................................................1956Estrogens, conjugated ..................................................................1958Etacrynic acid .................................................................................1960



Etamsylate ....................................................................................... 1961Ethacridine lactate monohydrate...............................................1962Ethambutol hydrochloride...........................................................1963Ethanol (96 per cent) ....................................................................1964Ethanol, anhydrous .......................................................................1966Ethanol content and alcoholimetric tables (2.9.10.) ................ 268Ether .................................................................................................1968Ether, anaesthetic ..........................................................................1968Ethinylestradiol ..............................................................................1969Ethionamide....................................................................................1970Ethosuximide ..................................................................................1971Ethoxylated substances, ethylene glycol and diethylene glycolin (2.4.30.) ....................................................................................... 132

Ethyl acetate ...................................................................................1972Ethyl acrylate - methacrylic acid copolymer (1:1) ..................2459Ethyl acrylate - methacrylic acid copolymer (1:1) dispersion30 per cent ....................................................................................2460

Ethylcellulose .................................................................................1975Ethylenediamine ............................................................................1977Ethylene glycol and diethylene glycol in ethoxylated substances(2.4.30.) ............................................................................................ 132

Ethylene glycol monopalmitostearate....................................... 1976Ethylene glycol monostearate..................................................... 1976Ethylene oxide and dioxan (2.4.25.) ............................................ 127Ethylhexanoic acid, 2- (2.4.28.) ..................................................... 130Ethylmorphine hydrochloride.....................................................1978Ethyl oleate .....................................................................................1973Ethyl parahydroxybenzoate.........................................................1973Ethyl parahydroxybenzoate sodium .......................................... 1974Etidronate disodium......................................................................1979Etilefrine hydrochloride ...............................................................1979Etodolac ........................................................................................... 1981Etofenamate ....................................................................................1982Etofylline..........................................................................................1984Etomidate ........................................................................................1985Etoposide .........................................................................................1986Eucalyptus leaf ...............................................................................1122Eucalyptus oil .................................................................................1123Eugenol ............................................................................................1990European goldenrod ..................................................................... 1142European viper venom antiserum................................................ 953Evaluation of efficacy of veterinary vaccines and immunosera(5.2.7.)............................................................................................... 538

Evaluation of safety of each batch of veterinary vaccines andimmunosera (5.2.9.) ...................................................................... 547

Evaluation of safety of veterinary vaccines and immunosera(5.2.6.) .............................................................................................. 536

Evening primrose oil, refined...................................................... 1991Extractable volume of parenteral preparations, test for(2.9.17.)............................................................................................. 273

Extractable volume of parenteral preparations, test for (2.9.17.)(5.8.).................................................................................................. 622

Extracts .............................................................................................. 674Extracts, dry ...................................................................................... 676Extracts, dry residue of (2.8.16.)................................................... 244Extracts, liquid.................................................................................. 675Extracts, loss on drying of (2.8.17.).............................................. 244Extracts, soft ..................................................................................... 676Extraneous agents in viral vaccines for human use, tests for(2.6.16.) ............................................................................................ 176

Extraneous agents : tests in batches of finished product of avianlive virus vaccines (2.6.25.).......................................................... 188

Extraneous agents : tests in seed lots of avian viral vaccines(2.6.24.) ............................................................................................ 185

Eye drops ........................................................................................... 711Eye lotions......................................................................................... 711Eye preparations .............................................................................. 710Eye preparations, semi-solid .......................................................... 712

FF0 concept to steam sterilisation of aqueous preparations,application of (5.1.5.) .................................................................... 508

Factor II, human coagulation, assay of (2.7.18.) ....................... 224Factor IX, human coagulation .................................................... 2172Factor IX, human coagulation, assay of (2.7.11.) ...................... 219Factor VII, human coagulation................................................... 2169Factor VII, human coagulation, assay of (2.7.10.) .................... 219Factor VIII, human coagulation ................................................. 2170Factor VIII, human coagulation, assay of (2.7.4.) ..................... 207Factor VIII (rDNA), human coagulation ................................... 2171Factor X, human coagulation, assay of (2.7.19.) ....................... 225Factor XI, human coagulation .................................................... 2173Factor XI, human coagulation, assay of (2.7.22.)...................... 227Falling ball viscometer method (2.2.49.) ...................................... 83Famotidine.......................................................................................1995Fat, hard........................................................................................... 2146Fatty acids, composition by gas chromatography (2.4.22.) .... 119Fatty acids in oils rich in omega-3 acids, composition of(2.4.29.) ............................................................................................ 130

Fatty oils, alkaline impurities in (2.4.19.) ................................... 119Fatty oils and herbal drugs, heavy metals in (2.4.27.) ............. 129Fatty oils and resinified essential oils in essential oils(2.8.7.)............................................................................................... 239

Fatty oils, foreign oils in, by thin-layer chromatography(2.4.21.) ............................................................................................ 119

Fatty oils, identification by thin-layer chromatography(2.3.2.) .............................................................................................. 110

Fatty oils, sterols in (2.4.23.) ......................................................... 121Fatty oils, vegetable......................................................................... 703Fc function of immunoglobulin, test for (2.7.9.) ........................217Febantel for veterinary use..........................................................1996Felbinac ............................................................................................1997Feline calicivirosis vaccine (inactivated) ..................................... 895Feline calicivirosis vaccine (live)................................................... 896Feline chlamydiosis vaccine (inactivated)................................... 897Feline infectious enteritis (feline panleucopenia) vaccine(inactivated) .................................................................................... 898

Feline infectious enteritis (feline panleucopenia) vaccine(live) .................................................................................................. 899

Feline leukaemia vaccine (inactivated)........................................ 900Feline panleucopenia vaccine (inactivated)................................ 898Feline panleucopenia vaccine (live) ............................................. 899Feline viral rhinotracheitis vaccine (inactivated) ...................... 901Feline viral rhinotracheitis vaccine (live).................................... 902Felodipine ........................................................................................1998Felypressin.......................................................................................1999Fenbendazole for veterinary use ................................................2000Fenbufen ..........................................................................................2001Fennel, bitter...................................................................................1124Fennel, sweet...................................................................................1125Fenofibrate ......................................................................................2002Fenoterol hydrobromide...............................................................2003Fentanyl ...........................................................................................2005Fentanyl citrate...............................................................................2006Fenticonazole nitrate ....................................................................2007Fenugreek........................................................................................1126Fermentation, products of ............................................................. 685Ferric chloride hexahydrate ........................................................2008Ferrous fumarate ...........................................................................2009Ferrous gluconate.......................................................................... 2010Ferrous sulfate, dried .................................................................... 2011Ferrous sulfate heptahydrate ...................................................... 2012Feverfew ...........................................................................................1126Fexofenadine hydrochloride ........................................................ 2013Fibrinogen, human ........................................................................ 2174Fibrin sealant kit ............................................................................ 2014Filgrastim concentrated solution ............................................... 2015Finasteride....................................................................................... 2018Fineness, powder (2.9.35.) ............................................................. 308Fish oil, rich in omega-3 acids..................................................... 2019Flavoxate hydrochloride ...............................................................2021Flecainide acetate ..........................................................................2022Flocculation value (Lf) of diphtheria and tetanus toxins andtoxoids (Ramon assay) (2.7.27.) .................................................. 231

Flowability (2.9.16.) ......................................................................... 272



Flow cytometry (2.7.24.) ................................................................. 229Flubendazole ..................................................................................2024Flucloxacillin magnesium octahydrate .....................................2025Flucloxacillin sodium ....................................................................2026Fluconazole .....................................................................................2028Flucytosine ......................................................................................2029Fludarabine phosphate.................................................................2031Fludeoxyglucose (18F) injection .................................................... 969Fludrocortisone acetate................................................................2033Flumazenil .......................................................................................2035Flumazenil (N-[11C]methyl) injection ........................................... 972Flumequine .....................................................................................2036Flumetasone pivalate ....................................................................2037Flunarizine dihydrochloride........................................................2038Flunitrazepam.................................................................................2039Flunixin meglumine for veterinary use.....................................2040Fluocinolone acetonide ................................................................2041Fluocortolone pivalate..................................................................2042Fluorescein ......................................................................................2044Fluorescein sodium .......................................................................2045Fluoride (18F) solution for radiolabelling.................................... 973Fluorides (2.4.5.) ...............................................................................114Fluorimetry (2.2.21.) ......................................................................... 35Fluorodopa (18F) (prepared by electrophilic substitution)injection ........................................................................................... 974

Fluorouracil.....................................................................................2046Fluoxetine hydrochloride .............................................................2048Flupentixol dihydrochloride ........................................................2049Fluphenazine decanoate ..............................................................2051Fluphenazine dihydrochloride....................................................2052Fluphenazine enantate .................................................................2054Flurazepam monohydrochloride ................................................2055Flurbiprofen ....................................................................................2056Fluspirilene .....................................................................................2057Flutamide.........................................................................................2058Fluticasone propionate .................................................................2059Flutrimazole ....................................................................................2061Fluvastatin sodium ........................................................................2062Fluvoxamine maleate ....................................................................2063Foams, cutaneous ............................................................................ 717Foams, intrauterine ......................................................................... 715Foams, medicated ............................................................................ 712Foams, rectal ..................................................................................... 733Foams, vaginal .................................................................................. 740Folic acid..........................................................................................2065Folinate, calcium ............................................................................1552Foot-and-mouth disease (ruminants) vaccine (inactivated) .... 904Foreign esters in essential oils (2.8.6.) ........................................ 239Foreign matter (2.8.2.) .................................................................... 239Foreign oils in fatty oils by thin-layer chromatography(2.4.21.) ............................................................................................ 119

Formaldehyde, free (2.4.18.) .......................................................... 118Formaldehyde solution (35 per cent) ........................................2066Formoterol fumarate dihydrate ..................................................2067Foscarnet sodium hexahydrate...................................................2069Fosfomycin calcium .......................................................................2070Fosfomycin sodium........................................................................2071Fosfomycin trometamol ................................................................2072Fosinopril sodium ..........................................................................2073Fourstamen stephania root..........................................................1127Fowl cholera vaccine (inactivated) ............................................... 905Fowl-pox vaccine (live) .................................................................... 906Framycetin sulfate .........................................................................2076Frangula bark .................................................................................1128Frangula bark dry extract, standardised ..................................1129Frankincense, Indian .................................................................... 1152Free formaldehyde (2.4.18.) ........................................................... 118Freezing point (2.2.18.) .................................................................... 34Fresh bilberry fruit dry extract, refined and standardised ...1130Friability of granules and spheroids (2.9.41.) ............................ 318Friability of uncoated tablets (2.9.7.)........................................... 266Friability of uncoated tablets (2.9.7.) (5.8.) ................................ 622Fructose ...........................................................................................2077

Fucus ................................................................................................ 1161Fumitory .......................................................................................... 1132Functional groups and ions, identification reactions of(2.3.1.)............................................................................................... 107

Furosemide......................................................................................2078Furunculosis vaccine (inactivated, oil-adjuvanted, injectable) forsalmonids......................................................................................... 907

Fusidate, sodium............................................................................2926Fusidic acid .....................................................................................2079

GGalactose..........................................................................................2083Galantamine hydrobromide .........................................................2083Gallium (67Ga) citrate injection ..................................................... 975Ganciclovir.......................................................................................2086Gargles................................................................................................ 722Garlic for homoeopathic preparations ......................................1290Garlic powder.................................................................................. 1133Gas adsorption, specific surface area by (2.9.26.)..................... 291Gas adsorption, specific surface area by (2.9.26.) (5.8.).......... 622Gas chromatography (2.2.28.) ......................................................... 43Gas detector tubes (2.1.6.) ................................................................17Gases, carbon dioxide in (2.5.24.)................................................. 143Gases, carbon monoxide in (2.5.25.) ............................................ 144Gases, nitrogen monoxide and nitrogen dioxide in (2.5.26.).. 145Gases, nitrous oxide in (2.5.35.).................................................... 150Gases, oxygen in (2.5.27.) ............................................................... 145Gases, water in (2.5.28.).................................................................. 145Gas-gangrene antitoxin, mixed ...................................................... 950Gas-gangrene antitoxin (novyi) ..................................................... 950Gas-gangrene antitoxin (perfringens) .......................................... 951Gas-gangrene antitoxin (septicum)............................................... 952Gas pycnometric density of solids (2.9.23.) ................................ 288Gastro-resistant capsules ................................................................ 708Gastro-resistant granules................................................................ 714Gastro-resistant tablets ................................................................... 738Gelatin ..............................................................................................2087Gels...................................................................................................... 735Gels for injections ............................................................................ 725Gemcitabine hydrochloride..........................................................2088Gemfibrozil ......................................................................................2090General notices (1.)...............................................................................3General texts on biological products (5.2.) ................................ 527General texts on microbiology (5.1.)............................................ 503Gene transfer medicinal products for human use (5.14.)........ 647Gentamicin sulfate .........................................................................2091Gentian root .................................................................................... 1133Gentian tincture ............................................................................. 1134Gestodene ........................................................................................2092Ginger ............................................................................................... 1135Gingival solutions ............................................................................ 722Ginkgo dry extract, refined and quantified.............................. 1136Ginkgo leaf ...................................................................................... 1138Ginseng............................................................................................. 1140Glass containers for pharmaceutical use (3.2.1.) ...................... 363Glibenclamide .................................................................................2094Gliclazide..........................................................................................2096Glimepiride ......................................................................................2097Glipizide ...........................................................................................2098Glossary (dosage forms) ................................................................. 707Glucagon, human........................................................................... 2100Glucoheptonate, calcium..............................................................1554Glucose, anhydrous ....................................................................... 2102Glucose, liquid ................................................................................ 2103Glucose, liquid, spray-dried.......................................................... 2103Glucose monohydrate ................................................................... 2104Glutamic acid .................................................................................. 2105Glutathione...................................................................................... 2106Glycan analysis of glycoproteins (2.2.59.)..................................... 97Glycerol ............................................................................................ 2108Glycerol (85 per cent).................................................................... 2109Glycerol dibehenate ....................................................................... 2110



Glycerol distearate ......................................................................... 2111Glycerol monocaprylate................................................................ 2112Glycerol monocaprylocaprate...................................................... 2113Glycerol monolinoleate ................................................................. 2114Glycerol mono-oleate..................................................................... 2115Glycerol monostearate 40-55....................................................... 2116Glycerol triacetate.......................................................................... 3127Glyceryl trinitrate solution........................................................... 2117Glycine .............................................................................................. 2118Glycoproteins, glycan analysis of (2.2.59.).................................... 97Glycyrrhizate ammonium.............................................................1384Goldenrod ........................................................................................ 1141Goldenrod, European.................................................................... 1142Goldenseal rhizome....................................................................... 1143Gonadorelin acetate ...................................................................... 2119Gonadotrophin, chorionic ............................................................2120Gonadotrophin, equine serum, for veterinary use.................. 2121Goserelin .......................................................................................... 2121Grafted copolymer, macrogol poly(vinyl alcohol) ...................2401Gramicidin .......................................................................................2123Granisetron hydrochloride...........................................................2124Granules ............................................................................................. 713Granules and powders for oral solutions and suspensions .... 718Granules and powders for syrups................................................. 719Granules and spheroids, friability of (2.9.41.)............................ 318Granules, coated............................................................................... 714Granules, effervescent..................................................................... 714Granules, gastro-resistant............................................................... 714Granules, modified-release............................................................. 714Greater celandine ........................................................................... 1145Griseofulvin .....................................................................................2126Guaiacol ...........................................................................................2127Guaifenesin......................................................................................2128Guanethidine monosulfate...........................................................2129Guar .................................................................................................. 1146Guar galactomannan ..................................................................... 2130Guidelines for using the test for bacterial endotoxins(5.1.10.) ............................................................................................ 520

Guidelines for using the test for sterility (5.1.9.) ...................... 519

HHaematopoietic products, numeration of CD34/CD45+ cells in(2.7.23.) ............................................................................................ 228

Haematopoietic progenitor cells, human, colony-forming cellassay for (2.7.28.) ........................................................................... 232

Haematopoietic stem cells, human ............................................ 2175Haemodiafiltration and haemofiltration, solutions for.......... 2138Haemodialysis, concentrated solutions for .............................. 2136Haemodialysis solutions, concentrated, water for diluting ..2135Haemodialysis, solutions for........................................................ 2136Haemofiltration and haemodiafiltration, solutions for.......... 2138Haemophilus type b (conjugate), diphtheria, tetanus andpertussis (acellular, component) vaccine (adsorbed)............. 758

Haemophilus type b (conjugate), diphtheria, tetanus, pertussis(acellular, component) and poliomyelitis (inactivated) vaccine(adsorbed)........................................................................................ 768

Haemophilus type b (conjugate), diphtheria, tetanus, pertussis(acellular, component), hepatitis B (rDNA) and poliomyelitis(inactivated) vaccine (adsorbed) ................................................. 765

Haemophilus type b (conjugate), diphtheria, tetanus, pertussisand poliomyelitis (inactivated) vaccine (adsorbed) ................ 772

Haemophilus type b conjugate vaccine....................................... 776Haemorrhagic disease vaccine (inactivated), rabbit ................. 933Halofantrine hydrochloride ......................................................... 2141Haloperidol...................................................................................... 2142Haloperidol decanoate.................................................................. 2143Halothane ........................................................................................ 2144Hamamelis leaf ............................................................................... 1146Hard capsules.................................................................................... 708Hard fat ............................................................................................ 2146Hard paraffin...................................................................................2668Harmonisation, pharmacopoeial (5.8.) ........................................ 621

Hawthorn berries ........................................................................... 1147Hawthorn leaf and flower ............................................................ 1148Hawthorn leaf and flower dry extract ....................................... 1149Hawthorn leaf and flower liquid extract, quantified.............. 1150Heavy bismuth subnitrate ............................................................1498Heavy kaolin.................................................................................... 2314Heavy magnesium carbonate ......................................................2409Heavy magnesium oxide............................................................... 2415Heavy metals (2.4.8.) ........................................................................114Heavy metals in herbal drugs and fatty oils (2.4.27.)............... 129Hedera helix for homoeopathic preparations.......................... 1291Helium .............................................................................................. 2146Heparin, assay of (2.7.5.) ................................................................ 208Heparin calcium ............................................................................. 2147Heparin in coagulation factors, assay of (2.7.12.)..................... 220Heparins, low-molecular-mass ..................................................... 2151Heparin sodium.............................................................................. 2149Hepatitis A immunoglobulin, human ........................................ 2176Hepatitis A (inactivated) and hepatitis B (rDNA) vaccine(adsorbed)........................................................................................ 779

Hepatitis A vaccine, assay of (2.7.14.) .......................................... 222Hepatitis A vaccine (inactivated, adsorbed) ............................... 780Hepatitis A vaccine (inactivated, virosome) ............................... 781Hepatitis B immunoglobulin for intravenous administration,human ............................................................................................ 2176

Hepatitis B immunoglobulin, human ........................................ 2176Hepatitis B (rDNA), diphtheria and tetanus vaccine(adsorbed)........................................................................................ 753

Hepatitis B (rDNA), diphtheria, tetanus and pertussis (acellular,component) vaccine (adsorbed).................................................. 760

Hepatitis B (rDNA), diphtheria, tetanus, pertussis (acellular,component), poliomyelitis (inactivated) and haemophilustype b conjugate vaccine (adsorbed) ......................................... 765

Hepatitis B vaccine (rDNA)............................................................ 784Hepatitis B vaccine (rDNA), assay of (2.7.15.) ........................... 223Hepatitis C virus (HCV), validation of nucleic acid amplificationtechniques for the detection of HCV RNA in plasma pools :guidelines ........................................................................................ 181

Heptaminol hydrochloride ........................................................... 2153Herbal drug preparations............................................................... 676Herbal drugs ..................................................................................... 676Herbal drugs and fatty oils, heavy metals in (2.4.27.).............. 129Herbal drugs, determination of aflatoxin B1 in (2.8.18.)......... 244Herbal drugs, determination of essential oils in herbal drugs(2.8.12.) ............................................................................................ 241

Herbal drugs, determination of tannins (2.8.14.) ..................... 243Herbal drugs for homoeopathic preparations .........................1275Herbal drugs, microscopic examination of (2.8.23) ................. 250Herbal drugs : sampling and sample preparation (2.8.20.) ..... 246Herbal drugs, test for aristolochic acids in (2.8.21) ................. 247Herbal medicinal products for oral use, microbial examination(2.6.31.) ............................................................................................ 197

Herbal medicinal products for oral use, microbiological quality(5.1.8.)............................................................................................... 519

Herbal preparations......................................................................... 676Herbal substances............................................................................ 676Herbal teas......................................................................................... 677Herpes zoster (shingles) vaccine (live) ........................................ 828Hexamidine diisetionate ............................................................... 2154Hexetidine........................................................................................ 2155Hexobarbital.................................................................................... 2156Hexosamines in polysaccharide vaccines (2.5.20.) ................... 142Hexylresorcinol............................................................................... 2157Highly purified water ....................................................................3222Histamine (2.6.10.)........................................................................... 162Histamine dihydrochloride .......................................................... 2158Histamine phosphate .................................................................... 2159Histidine........................................................................................... 2159Histidine hydrochloride monohydrate ...................................... 2160Homatropine hydrobromide ........................................................ 2161Homatropine methylbromide ...................................................... 2162Homoeopathic preparations ........................................................1275Homoeopathic preparations, arsenious trioxide for ..............1286



Homoeopathic preparations, calcium iodide tetrahydratefor ....................................................................................................1288

Homoeopathic preparations, common stinging nettle for....1288Homoeopathic preparations, copper acetate monohydratefor ....................................................................................................1289

Homoeopathic preparations, copper for...................................1289Homoeopathic preparations, garlic for .....................................1290Homoeopathic preparations, hedera helix for......................... 1291Homoeopathic preparations, herbal drugs for ........................1275Homoeopathic preparations, honey bee for.............................1292Homoeopathic preparations, hyoscyamus for .........................1292Homoeopathic preparations, hypericum for ............................1293Homoeopathic preparations, iron for ........................................1294Homoeopathic preparations, mother tinctures for.................1286Homoeopathic preparations, oriental cashew for...................1295Homoeopathic preparations, saffron for...................................1296Homoeopathic stocks (methods of preparation of) andpotentisation.................................................................................1277

Honey ............................................................................................... 2163Honey bee for homoeopathic preparations..............................1292Hop strobile..................................................................................... 1151Human α-1-proteinase inhibitor ................................................. 2184Human albumin injection, iodinated (125I).................................. 976Human albumin solution ............................................................. 2165Human anti-D immunoglobulin .................................................. 2166Human anti-D immunoglobulin, assay of (2.7.13.) ................... 220Human anti-D immunoglobulin for intravenousadministration .............................................................................. 2167

Human antithrombin III, assay of (2.7.17.) ................................. 224Human antithrombin III concentrate ........................................ 2168Human coagulation factor II, assay of (2.7.18.)......................... 224Human coagulation factor IX...................................................... 2172Human coagulation factor IX, assay of (2.7.11.)........................ 219Human coagulation factor VII .................................................... 2169Human coagulation factor VII, assay of (2.7.10.) ...................... 219Human coagulation factor VIII................................................... 2170Human coagulation factor VIII, assay of (2.7.4.)....................... 207Human coagulation factor VIII (rDNA)..................................... 2171Human coagulation factor X, assay of (2.7.19.) ......................... 225Human coagulation factor XI...................................................... 2173Human coagulation factor XI, assay of (2.7.22.) ....................... 227Human fibrinogen.......................................................................... 2174Human haematopoietic progenitor cells, colony-forming cellassay for (2.7.28.) ........................................................................... 232

Human haematopoietic stem cells ............................................. 2175Human hepatitis A immunoglobulin ......................................... 2176Human hepatitis B immunoglobulin ......................................... 2176Human hepatitis B immunoglobulin for intravenousadministration .............................................................................. 2176

Human insulin ................................................................................2241Human measles immunoglobulin............................................... 2177Human normal immunoglobulin................................................ 2177Human normal immunoglobulin for intravenousadministration .............................................................................. 2179

Human papillomavirus vaccine (rDNA) ...................................... 785Human plasma for fractionation................................................. 2181Human plasma (pooled and treated for virus inactivation) .. 2182Human plasmin inhibitor, assay of (2.7.25.)............................... 230Human protein C, assay of (2.7.30.) ............................................. 234Human protein S, assay of (2.7.31.) ............................................. 235Human prothrombin complex..................................................... 2185Human rabies immunoglobulin .................................................. 2186Human rubella immunoglobulin ................................................ 2187Human tetanus immunoglobulin ............................................... 2187Human varicella immunoglobulin.............................................. 2188Human varicella immunoglobulin for intravenousadministration .............................................................................. 2189

Human von Willebrand factor..................................................... 2189Human von Willebrand factor, assay of (2.7.21.) ...................... 226Hyaluronate, sodium.....................................................................2927Hyaluronidase ................................................................................ 2190Hydralazine hydrochloride .......................................................... 2191Hydrochloric acid, concentrated ................................................ 2192

Hydrochloric acid, dilute .............................................................. 2192Hydrochlorothiazide...................................................................... 2193Hydrocodone hydrogen tartrate 2.5-hydrate ........................... 2194Hydrocortisone............................................................................... 2196Hydrocortisone acetate................................................................. 2198Hydrocortisone hydrogen succinate ..........................................2200Hydrogenated arachis oil ............................................................. 1413Hydrogenated castor oil ...............................................................1596Hydrogenated cottonseed oil ...................................................... 1769Hydrogenated soya-bean oil.........................................................2968Hydrogenated vegetable oils, nickel in (2.4.31.)........................ 132Hydrogenated wool fat..................................................................3232Hydrogen peroxide solution (30 per cent) ...............................2202Hydrogen peroxide solution (3 per cent)..................................2201Hydromorphone hydrochloride ..................................................2202Hydrophobic colloidal silica ........................................................2903Hydrous wool fat ............................................................................3233Hydroxocobalamin acetate...........................................................2203Hydroxocobalamin chloride.........................................................2204Hydroxocobalamin sulfate ...........................................................2205Hydroxycarbamide .........................................................................2206Hydroxyethylcellulose...................................................................2208Hydroxyethylmethylcellulose ......................................................2476Hydroxyethyl salicylate.................................................................2207Hydroxyethyl starches...................................................................2984Hydroxyl value (2.5.3.) .................................................................... 137Hydroxypropylbetadex.................................................................. 2210Hydroxypropylcellulose ................................................................ 2211Hydroxypropylmethylcellulose.................................................... 2219Hydroxypropylmethylcellulose phthalate.................................2221Hydroxypropyl starch....................................................................2981Hydroxyzine hydrochloride .........................................................2212Hymecromone................................................................................. 2213Hyoscine........................................................................................... 2214Hyoscine butylbromide ................................................................. 2215Hyoscine hydrobromide................................................................ 2216Hyoscyamine sulfate...................................................................... 2217Hyoscyamus for homoeopathic preparations ..........................1292Hypericum .......................................................................................1241Hypericum for homoeopathic preparations.............................1293Hypromellose .................................................................................. 2219Hypromellose phthalate ...............................................................2221

IIbuprofen .........................................................................................2225Iceland moss.................................................................................... 1152ICH (5.8.)............................................................................................ 621Ichthammol .....................................................................................2227Identification (2.3.) .......................................................................... 107Identification and control of residual solvents (2.4.24.).......... 123Identification of fatty oils by thin-layer chromatography(2.3.2.) .............................................................................................. 110

Identification of phenothiazines by thin-layer chromatography(2.3.3.) .............................................................................................. 110

Identification reactions of ions and functional groups(2.3.1.)............................................................................................... 107

Idoxuridine ......................................................................................2227Ifosfamide ........................................................................................2228Imipenem .........................................................................................2230Imipramine hydrochloride ...........................................................2231Immunochemical methods (2.7.1.) ............................................... 201Immunoglobulin for human use, anti-T lymphocyte,animal.............................................................................................1404

Immunoglobulin for intravenous administration, humananti-D .............................................................................................. 2167

Immunoglobulin for intravenous administration, humanhepatitis B ..................................................................................... 2176

Immunoglobulin for intravenous administration, humannormal ............................................................................................ 2179

Immunoglobulin for intravenous administration, humanvaricella.......................................................................................... 2189

Immunoglobulin, human anti-D ................................................. 2166



Immunoglobulin, human anti-D, assay of (2.7.13.) ................... 220Immunoglobulin, human hepatitis A......................................... 2176Immunoglobulin, human hepatitis B ........................................ 2176Immunoglobulin, human measles .............................................. 2177Immunoglobulin, human normal ............................................... 2177Immunoglobulin, human rabies ................................................. 2186Immunoglobulin, human rubella ............................................... 2187Immunoglobulin, human tetanus............................................... 2187Immunoglobulin, human varicella ............................................. 2188Immunoglobulin, test for anticomplementary activity of(2.6.17.)............................................................................................. 177

Immunoglobulin, test for Fc function of (2.7.9.)........................217Immunological veterinary medicinal products, substances ofanimal origin for the production of (5.2.5.) ............................. 535

Immunosera and vaccines, phenol in (2.5.15.) ...........................141Immunosera and vaccines, veterinary, evaluation of efficacy of(5.2.7.)............................................................................................... 538

Immunosera and vaccines, veterinary, evaluation of safety(5.2.6.) .............................................................................................. 536

Immunosera and vaccines, veterinary, evaluation of the safetyof each batch (5.2.9.)..................................................................... 547

Immunosera for human use, animal............................................ 678Immunosera for veterinary use..................................................... 680Implants ............................................................................................. 725Impurities in substances for pharmaceutical use, control of(5.10.)................................................................................................ 631

Indapamide......................................................................................2232Indian frankincense....................................................................... 1152Indicators, relationship between approximate pH and colour(2.2.4.) ................................................................................................ 25

Indinavir sulfate .............................................................................2233Indium (111In) chloride solution .................................................... 977Indium (111In) oxine solution ......................................................... 978Indium (111In) pentetate injection................................................. 979Indometacin ....................................................................................2235Inductively coupled plasma-atomic emission spectrometry(2.2.57.) .............................................................................................. 94

Inductively coupled plasma-mass spectrometry (2.2.58.).......... 96Infectious bovine rhinotracheitis vaccine (live)......................... 908Infectious bronchitis vaccine (inactivated), avian ..................... 851Infectious bronchitis vaccine (live), avian................................... 852Infectious bursal disease vaccine (inactivated), avian.............. 854Infectious bursal disease vaccine (live), avian ........................... 856Infectious chicken anaemia vaccine (live) .................................. 910Infectious encephalomyelitis vaccine (live), avian .................... 857Infectious laryngotracheitis vaccine (live), avian ...................... 859Influenza vaccine (split virion, inactivated) ............................... 788Influenza vaccine (surface antigen, inactivated)....................... 789Influenza vaccine (surface antigen, inactivated, prepared in cellcultures) ........................................................................................... 791

Influenza vaccine (surface antigen, inactivated, virosome).... 793Influenza vaccine (whole virion, inactivated) ............................ 795Influenza vaccine (whole virion, inactivated, prepared in cellcultures) ........................................................................................... 796

Infrared absorption spectrophotometry (2.2.24.) ....................... 38Infusions ............................................................................................ 725Inhalation gas, krypton (81mKr) ..................................................... 983Inhalation, preparations for........................................................... 728Inhalation, preparations for : aerodynamic assessment of fineparticles (2.9.18.) ........................................................................... 274

Injectable insulin preparations ...................................................2249Injections ........................................................................................... 724Injections, gels for............................................................................ 725Injections or infusions, concentrates for .................................... 725Injections or infusions, powders for ............................................ 725Inositol, myo- ..................................................................................2236Inserts, ophthalmic.......................................................................... 712Insulin aspart ..................................................................................2237Insulin, bovine ................................................................................2239Insulin, human................................................................................2241Insulin injection, biphasic ............................................................2243Insulin injection, biphasic isophane ..........................................2244Insulin injection, isophane...........................................................2244

Insulin injection, soluble ..............................................................2244Insulin lispro ...................................................................................2245Insulin, porcine...............................................................................2247Insulin preparations, injectable ..................................................2249Insulin zinc injectable suspension .............................................2251Insulin zinc injectable suspension (amorphous) ....................2252Insulin zinc injectable suspension (crystalline) ......................2252Interferon alfa-2 concentrated solution ....................................2252Interferon beta-1a concentrated solution.................................2255Interferon gamma-1b concentrated solution ...........................2257Interferons, assay of (5.6.) .............................................................. 607International System (SI) units (1.) ..................................................3Intramammary preparations for veterinary use ........................ 714Intraruminal devices ....................................................................... 715Intrauterine capsules ...................................................................... 715Intrauterine foams ........................................................................... 715Intrauterine preparations for veterinary use ............................. 715Intrauterine solutions, suspensions............................................. 715Intrauterine sticks............................................................................ 715Intrauterine tablets.......................................................................... 715Intrinsic dissolution (2.9.29.) ........................................................ 294In vivo assay of poliomyelitis vaccine (inactivated) (2.7.20.) .. 225Iobenguane (123I) injection............................................................. 979Iobenguane (131I) injection for diagnostic use ........................... 980Iobenguane (131I) injection for therapeutic use ......................... 981Iobenguane sulfate for radiopharmaceutical preparations .... 982Iodinated (125I) human albumin injection ................................... 976Iodinated povidone........................................................................2778Iodine................................................................................................2261Iodine value (2.5.4.) ......................................................................... 137Iodixanol ..........................................................................................2261Iodomethylnorcholesterol (131I) injection ................................... 982Iohexol..............................................................................................2264Ionic concentration, potentiometric determination of usingion-selective electrodes (2.2.36.)................................................... 57

Ions and functional groups, identification reactions of(2.3.1.)............................................................................................... 107

Ion-selective electrodes, potentiometric determination of ionicconcentration (2.2.36.) ................................................................... 57

Iopamidol .........................................................................................2266Iopanoic acid...................................................................................2268Iopromide.........................................................................................2269Iotalamic acid..................................................................................2272Iotrolan.............................................................................................2273Ioxaglic acid ....................................................................................2275Ipecacuanha liquid extract, standardised ................................. 1153Ipecacuanha, prepared.................................................................. 1154Ipecacuanha root ........................................................................... 1155Ipecacuanha tincture, standardised........................................... 1156Ipratropium bromide.....................................................................2277Irbesartan ........................................................................................2278Iron (2.4.9.) .........................................................................................117Iron for homoeopathic preparations .........................................1294Irrigation, preparations for ............................................................ 731Isoconazole......................................................................................2279Isoconazole nitrate ........................................................................2281Isoelectric focusing (2.2.54.)............................................................ 83Isoelectric focusing (2.2.54.) (5.8.)............................................... 621Isoflurane.........................................................................................2282Isoleucine.........................................................................................2283Isomalt..............................................................................................2284Isoniazid...........................................................................................2285Isophane insulin injection............................................................2244Isoprenaline hydrochloride..........................................................2286Isoprenaline sulfate .......................................................................2287Isopropyl alcohol............................................................................2287Isopropyl myristate........................................................................2288Isopropyl palmitate........................................................................2289Isosorbide dinitrate, diluted .......................................................2289Isosorbide mononitrate, diluted ................................................2291Isotretinoin ......................................................................................2293Isoxsuprine hydrochloride ...........................................................2294Ispaghula husk ............................................................................... 1156



Ispaghula seed ................................................................................ 1157Isradipine .........................................................................................2296Itraconazole ....................................................................................2297Ivermectin........................................................................................2299Ivy leaf .............................................................................................. 1157

JJavanese turmeric ..........................................................................1257Java tea ............................................................................................. 1158Josamycin.........................................................................................2305Josamycin propionate....................................................................2307Juniper.............................................................................................. 1160Juniper oil ........................................................................................ 1160

KKanamycin acid sulfate ................................................................. 2313Kanamycin monosulfate ............................................................... 2313Kaolin, heavy................................................................................... 2314Kelp ................................................................................................... 1161Ketamine hydrochloride ............................................................... 2315Ketobemidone hydrochloride...................................................... 2316Ketoconazole .................................................................................. 2317Ketoprofen....................................................................................... 2318Ketorolac trometamol ...................................................................2320Ketotifen hydrogen fumarate ......................................................2321Knotgrass......................................................................................... 1162Krypton (81mKr) inhalation gas...................................................... 983

LLabetalol hydrochloride ...............................................................2327Lactic acid........................................................................................2328Lactic acid, (S)- ...............................................................................2328Lactitol monohydrate....................................................................2329Lactobionic acid .............................................................................2331Lactose, anhydrous........................................................................2331Lactose monohydrate....................................................................2333Lactulose..........................................................................................2334Lactulose, liquid .............................................................................2336Lamivudine......................................................................................2337Lamotrigine.....................................................................................2339Lansoprazole...................................................................................2341Laser light diffraction, particle size analysis by (2.9.31.) ....... 295Laurilsulfate, sodium ....................................................................2933Lauromacrogol 400 .......................................................................2342Lauroyl macrogolglycerides ........................................................2344Lavender flower.............................................................................. 1163Lavender oil..................................................................................... 1164Lavender oil, spike.........................................................................1240Lead in sugars (2.4.10.) ...................................................................117Leflunomide ....................................................................................2345Lemon oil ......................................................................................... 1165Lemon verbena leaf ....................................................................... 1166Leptospirosis vaccine (inactivated), bovine................................ 862Leptospirosis vaccine (inactivated), canine ................................ 874Letrozole ..........................................................................................2347Leucine.............................................................................................2348Leuprorelin......................................................................................2348Levamisole for veterinary use .....................................................2350Levamisole hydrochloride ............................................................2351Levetiracetam .................................................................................2352Levocabastine hydrochloride ......................................................2354Levocarnitine ..................................................................................2355Levodopa..........................................................................................2356Levodropropizine ...........................................................................2358Levofolinate pentahydrate, calcium...........................................1563Levomenthol ...................................................................................2359Levomepromazine hydrochloride...............................................2360Levomepromazine maleate ..........................................................2361Levomethadone hydrochloride ...................................................2362Levonorgestrel ................................................................................2363Levothyroxine sodium ..................................................................2364Levulinate dihydrate, calcium.....................................................1565

Lidocaine .........................................................................................2365Lidocaine hydrochloride...............................................................2366Light liquid paraffin ......................................................................2669Light magnesium carbonate........................................................2409Light magnesium oxide ................................................................ 2416Lime flower ..................................................................................... 1168Limit tests (2.4.)................................................................................ 113Limit tests, standard solutions for (4.1.2.).................................. 485Lincomycin hydrochloride ...........................................................2367Linen thread, sterile, in distributor for veterinary use .........1038Linoleoyl macrogolglycerides......................................................2368Linseed ............................................................................................. 1168Linseed oil, virgin ..........................................................................2369Liothyronine sodium.....................................................................2370Lipophilic solid dosage forms, dissolution test for (2.9.42.)... 319Liquid chromatography (2.2.29.) .................................................... 45Liquid extracts .................................................................................. 675Liquid glucose ................................................................................ 2103Liquid glucose, spray-dried.......................................................... 2103Liquid lactulose ..............................................................................2336Liquid maltitol ................................................................................2427Liquid paraffin ................................................................................2669Liquid preparations for cutaneous application ......................... 717Liquid preparations for cutaneous application, veterinary .... 740Liquid preparations for inhalation ............................................... 728Liquid preparations for oral use................................................... 718Liquids, clarity and degree of opalescence of (2.2.1.) .................21Liquid sorbitol (crystallising) ......................................................2965Liquid sorbitol (non-crystallising) ..............................................2965Liquid sorbitol, partially dehydrated .........................................2966Liquorice dry extract for flavouring purposes ........................ 1169Liquorice ethanolic liquid extract, standardised .................... 1170Liquorice root ................................................................................. 1171Lisinopril dihydrate .......................................................................2371Lithium carbonate .........................................................................2372Lithium citrate................................................................................2373L-Methionine ([11C]methyl) injection............................................ 985Lobeline hydrochloride.................................................................2373Lomustine........................................................................................2375Loosestrife ....................................................................................... 1172Loperamide hydrochloride...........................................................2376Loperamide oxide monohydrate.................................................2378Loratadine .......................................................................................2379Lorazepam.......................................................................................2381Losartan potassium.......................................................................2382Loss on drying (2.2.32.).....................................................................51Loss on drying of extracts (2.8.17.) .............................................. 244Lovage root...................................................................................... 1172Lovastatin ........................................................................................2384Low-molecular-mass heparins ..................................................... 2151Lozenges and pastilles .................................................................... 723Lozenges, compressed .................................................................... 723Lubricant, silicone oil (3.1.8.)........................................................ 347Lufenuron (anhydrous) for veterinary use ...............................2385Lymecycline.....................................................................................2387Lynestrenol......................................................................................2389Lyophilisates, oral ............................................................................ 736Lysine acetate .................................................................................2390Lysine hydrochloride.....................................................................2391

MMacrogol 15 hydroxystearate ......................................................2399Macrogol 20 glycerol monostearate ..........................................2397Macrogol 40 sorbitol heptaoleate ..............................................2404Macrogol 6 glycerol caprylocaprate...........................................2395Macrogol cetostearyl ether ..........................................................2395Macrogolglycerol cocoates...........................................................2396Macrogolglycerol hydroxystearate .............................................2397Macrogolglycerol ricinoleate .......................................................2398Macrogol lauryl ether ...................................................................2400Macrogol oleate ..............................................................................2400Macrogol oleyl ether .....................................................................2401



Macrogol poly(vinyl alcohol) grafted copolymer ....................2401Macrogols.........................................................................................2402Macrogol stearate...........................................................................2405Macrogol stearyl ether..................................................................2405Magaldrate.......................................................................................2406Magnesium (2.4.6.) ...........................................................................114Magnesium acetate tetrahydrate ................................................2407Magnesium aluminium silicate ...................................................1358Magnesium and alkaline-earth metals (2.4.7.) ............................114Magnesium aspartate dihydrate .................................................2408Magnesium carbonate, heavy ......................................................2409Magnesium carbonate, light ........................................................2409Magnesium chloride 4.5-hydrate ................................................ 2410Magnesium chloride hexahydrate .............................................. 2411Magnesium citrate, anhydrous.................................................... 2411Magnesium citrate dodecahydrate .............................................2412Magnesium citrate nonahydrate .................................................2412Magnesium gluconate................................................................... 2413Magnesium glycerophosphate..................................................... 2414Magnesium hydroxide ................................................................... 2414Magnesium lactate dihydrate ...................................................... 2415Magnesium oxide, heavy............................................................... 2415Magnesium oxide, light................................................................. 2416Magnesium peroxide ..................................................................... 2417Magnesium pidolate ...................................................................... 2417Magnesium stearate....................................................................... 2418Magnesium sulfate heptahydrate ...............................................2421Magnesium trisilicate ....................................................................2421Maize oil, refined............................................................................2422Maize starch ....................................................................................2422Malathion.........................................................................................2423Maleic acid .......................................................................................2424Malic acid .........................................................................................2424Mallow flower.................................................................................. 1173Mallow leaf....................................................................................... 1174Maltitol .............................................................................................2425Maltitol, liquid.................................................................................2427Maltodextrin....................................................................................2428Mandarin oil .................................................................................... 1175Manganese gluconate ...................................................................2428Manganese glycerophosphate, hydrated...................................2429Manganese sulfate monohydrate................................................2430Mannheimia vaccine (inactivated) for cattle ...............................911Mannheimia vaccine (inactivated) for sheep.............................. 913Mannitol ...........................................................................................2430Maprotiline hydrochloride ...........................................................2432Marbofloxacin for veterinary use ...............................................2433Marek’s disease vaccine (live).........................................................914Marshmallow leaf ........................................................................... 1176Marshmallow root .......................................................................... 1177Mass spectrometry (2.2.43.)............................................................. 67Mass spectrometry, inductively coupled plasma- (2.2.58.)........ 96Mass uniformity of delivered doses from multidose containers(2.9.27.) ............................................................................................ 294

Mass uniformity of single-dose preparations (2.9.5.) ............... 265Mastic................................................................................................ 1177Materials based on non-plasticised poly(vinyl chloride) forcontainers for dry dosage forms for oral administration(3.1.11.)............................................................................................. 350

Materials based on non-plasticised poly(vinyl chloride) forcontainers for non-injectable, aqueous solutions (3.1.10.)... 349

Materials based on plasticised poly(vinyl chloride) for containersfor aqueous solutions for intravenous infusion (3.1.14.) ...... 355

Materials based on plasticised poly(vinyl chloride) for containersfor human blood and blood components (3.1.1.1.) ................ 329

Materials based on plasticised poly(vinyl chloride) for tubingused in sets for the transfusion of blood and blood components(3.1.1.2.) ........................................................................................... 332

Materials for containers for human blood and blood components(3.1.1.)............................................................................................... 329

Materials used for the manufacture of containers (3.1.) ......... 329Matricaria flower ............................................................................ 1178Matricaria liquid extract ............................................................... 1179

Matricaria oil ................................................................................... 1180Meadowsweet .................................................................................. 1182Measles immunoglobulin, human .............................................. 2177Measles, mumps and rubella vaccine (live) ................................ 798Measles, mumps, rubella and varicella vaccine (live)............... 799Measles vaccine (live) ...................................................................... 800Measurement of consistency by penetrometry (2.9.9.) ............ 267Mebendazole ...................................................................................2434Meclozine dihydrochloride ..........................................................2435Medicated chewing gums............................................................... 709Medicated chewing gums, dissolution test for (2.9.25.) .......... 289Medicated feeding stuffs for veterinary use, premixes for ...... 727Medicated foams............................................................................... 712Medicated plasters ........................................................................... 735Medicated tampons.......................................................................... 738Medicated vaginal tampons ........................................................... 740Medicinal air.................................................................................... 1331Medicinal air, synthetic.................................................................1333Medium-chain triglycerides.......................................................... 3138Medronic acid for radiopharmaceutical preparations.............. 984Medroxyprogesterone acetate .....................................................2437Mefenamic acid ...............................................................................2438Mefloquine hydrochloride............................................................2440Megestrol acetate ...........................................................................2441Meglumine.......................................................................................2442Melilot............................................................................................... 1183Melissa leaf ...................................................................................... 1184Melissa leaf dry extract ................................................................. 1185Meloxicam........................................................................................2443Melting point - capillary method (2.2.14.)......................................31Melting point - instantaneous method (2.2.16.) .......................... 32Melting point - open capillary method (2.2.15.) .......................... 32Menadione .......................................................................................2444Meningococcal group C conjugate vaccine................................ 802Meningococcal polysaccharide vaccine....................................... 803Menthol, racemic............................................................................2445Mepivacaine hydrochloride..........................................................2446Meprobamate ..................................................................................2447Mepyramine maleate .....................................................................2448Mercaptopurine ..............................................................................2449Mercuric chloride...........................................................................2449Mercury porosimetry, porosity and pore-size distribution ofsolids by (2.9.32.) ........................................................................... 299

Meropenem trihydrate ..................................................................2450Mesalazine .......................................................................................2451Mesna................................................................................................2453Mesterolone.....................................................................................2454Mestranol .........................................................................................2455Metabisulfite, sodium....................................................................2933Metacresol .......................................................................................2456Metamizole sodium .......................................................................2457Metformin hydrochloride .............................................................2458Methacrylate copolymer, basic butylated .................................1448Methacrylic acid - ethyl acrylate copolymer (1:1) ...................2459Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion30 per cent ....................................................................................2460

Methacrylic acid - methyl methacrylate copolymer (1:1) ......2461Methacrylic acid - methyl methacrylate copolymer (1:2) ......2461Methadone hydrochloride............................................................2462Methanol ..........................................................................................2463Methanol and 2-propanol, test for (2.9.11.) ................................ 270Methaqualone .................................................................................2464Methenamine ..................................................................................2465Methionine ......................................................................................2466Methionine ([11C]methyl) injection, L-.......................................... 985Methionine, DL- ...............................................................................2466Methods in pharmacognosy (2.8.) ................................................ 239Methods of preparation of homoeopathic stocks andpotentisation.................................................................................1277

Methods of preparation of sterile products (5.1.1.) .................. 503Methotrexate ...................................................................................2467Methylatropine bromide ...............................................................2469Methylatropine nitrate ..................................................................2470



Methylcellulose...............................................................................2471Methyldopa......................................................................................2472Methylene blue ...............................................................................2490Methylene chloride ........................................................................2474Methylergometrine maleate.........................................................2475Methylhydroxyethylcellulose .......................................................2476Methyl nicotinate ...........................................................................2477Methyl parahydroxybenzoate ......................................................2477Methyl parahydroxybenzoate, sodium ......................................2934Methylpentoses in polysaccharide vaccines (2.5.21.) ............... 143Methylphenidate hydrochloride..................................................2479Methylphenobarbital .....................................................................2480Methylprednisolone.......................................................................2481Methylprednisolone acetate.........................................................2483Methylprednisolone hydrogen succinate ..................................2485Methylpyrrolidone, N- ...................................................................2486Methylrosanilinium chloride .......................................................2487Methyl salicylate.............................................................................2488Methyltestosterone ........................................................................2489Methylthioninium chloride ..........................................................2490Metixene hydrochloride................................................................2491Metoclopramide..............................................................................2492Metoclopramide hydrochloride...................................................2493Metolazone ......................................................................................2494Metoprolol succinate.....................................................................2495Metoprolol tartrate ........................................................................2497Metrifonate ......................................................................................2498Metronidazole .................................................................................2500Metronidazole benzoate ...............................................................2500Mexiletine hydrochloride..............................................................2502Mianserin hydrochloride ..............................................................2503Miconazole ......................................................................................2504Miconazole nitrate .........................................................................2506Microbial enumeration tests (microbiological examination ofnon-sterile products) (2.6.12.) ..................................................... 163

Microbial enumeration tests (microbiological examination ofnon-sterile products) (2.6.12.) (5.8.) .......................................... 622

Microbiological assay of antibiotics (2.7.2.)................................ 202Microbiological control of cellular products (2.6.27.).............. 191Microbiological examination of herbal medicinal products fororal use (2.6.31.)............................................................................. 197

Microbiological examination of non-sterile products : microbialenumeration tests (2.6.12.).......................................................... 163

Microbiological examination of non-sterile products : microbialenumeration tests (2.6.12.) (5.8.) ............................................... 622

Microbiological examination of non-sterile products : test forspecified micro-organisms (2.6.13.) ........................................... 167

Microbiological examination of non-sterile products : test forspecified micro-organisms (2.6.13.) (5.8.)................................. 622

Microbiological quality, alternative methods for control of(5.1.6.)............................................................................................... 508

Microbiological quality of herbal medicinal products for oral use(5.1.8.)............................................................................................... 519

Microbiological quality of non-sterile pharmaceuticalpreparations and substances for pharmaceutical use(5.1.4.)............................................................................................... 507

Microbiological quality of non-sterile pharmaceuticalpreparations and substances for pharmaceutical use (5.1.4.)(5.8.).................................................................................................. 623

Microbiology, general texts on (5.1.) ........................................... 503Microcrystalline cellulose.............................................................1634Microcrystalline cellulose and carmellose sodium.................2507Micro determination of water (2.5.32.)........................................ 146Microscopic examination of herbal drugs (2.8.23) ................... 250Microscopy, optical (2.9.37.) ...........................................................311Microscopy, optical (2.9.37.) (5.8.) ............................................... 622Midazolam .......................................................................................2508Milk thistle dry extract, refined and standardised.................. 1186Milk-thistle fruit.............................................................................. 1187Minimising the risk of transmitting animal spongiformencephalopathy agents via human and veterinary medicinalproducts (5.2.8.) ............................................................................. 539

Minocycline hydrochloride dihydrate ........................................ 2510

Minoxidil .......................................................................................... 2511Mint oil, partly dementholised .................................................... 1189Mirtazapine ..................................................................................... 2512Misoprostol...................................................................................... 2513Mitomycin ........................................................................................ 2515Mitoxantrone hydrochloride........................................................ 2517Modafinil .......................................................................................... 2518Modified-release capsules............................................................... 708Modified-release granules .............................................................. 714Modified-release tablets .................................................................. 738Mofetil mycophenolate..................................................................2536Molecular mass distribution in dextrans (2.2.39.) ...................... 60Molgramostim concentrated solution ....................................... 2519Molsidomine....................................................................................2521Molybdate dihydrate, sodium......................................................2935Mometasone furoate......................................................................2523Monoclonal antibodies for human use........................................ 682Monocyte-activation test (2.6.30.)................................................. 192Morantel hydrogen tartrate for veterinary use .......................2525Morphine hydrochloride...............................................................2526Morphine sulfate ............................................................................2527Moss, Iceland .................................................................................. 1152Mother tinctures for homoeopathic preparations ..................1286Motherwort ..................................................................................... 1190Mouthwashes .................................................................................... 722Moxidectin for veterinary use .....................................................2529Moxifloxacin hydrochloride .........................................................2531Moxonidine......................................................................................2532Mucoadhesive preparations ........................................................... 723Mullein flower................................................................................. 1191Multidose containers, uniformity of mass of delivered doses(2.9.27.) ............................................................................................ 294

Mumps, measles and rubella vaccine (live) ................................ 798Mumps, measles, rubella and varicella vaccine (live)............... 799Mumps vaccine (live) ....................................................................... 805Mupirocin.........................................................................................2533Mupirocin calcium .........................................................................2535Mycobacteria (2.6.2.) ....................................................................... 156Mycophenolate mofetil..................................................................2536Mycoplasma gallisepticum vaccine (inactivated)....................... 916Mycoplasmas (2.6.7.)........................................................................ 156myo-Inositol ....................................................................................2236Myrrh ................................................................................................ 1192Myrrh tincture ................................................................................ 1192Myxomatosis vaccine (live) for rabbits .........................................917

NNabumetone ....................................................................................2541N-Acetyltryptophan........................................................................ 1319N-Acetyltyrosine .............................................................................1320Nadolol .............................................................................................2542Nadroparin calcium .......................................................................2543Naftidrofuryl hydrogen oxalate...................................................2545Nalidixic acid...................................................................................2547Naloxone hydrochloride dihydrate.............................................2548Naltrexone hydrochloride.............................................................2549Nandrolone decanoate ..................................................................2551Naphazoline hydrochloride..........................................................2552Naphazoline nitrate .......................................................................2553Naproxen..........................................................................................2554Naproxen sodium ...........................................................................2556Narrow-leaved coneflower root ................................................... 1193Nasal drops and liquid nasal sprays............................................. 720Nasal powders................................................................................... 721Nasal preparations ........................................................................... 719Nasal preparations, semi-solid....................................................... 721Nasal sprays (liquid) and nasal drops .......................................... 719Nasal sticks........................................................................................ 721Nasal washes ..................................................................................... 721Near-infrared spectrophotometry (2.2.40.)....................................61Neohesperidin-dihydrochalcone .................................................2558Neomycin sulfate............................................................................2559



Neonatal piglet colibacillosis vaccine (inactivated) .................. 918Neonatal ruminant colibacillosis vaccine (inactivated) ........... 920Neostigmine bromide ....................................................................2560Neostigmine metilsulfate..............................................................2561Neroli oil .......................................................................................... 1194Netilmicin sulfate ...........................................................................2562Nettle leaf......................................................................................... 1196Neurovirulence test for poliomyelitis vaccine (oral) (2.6.19.).. 179Neurovirulence test of live viral vaccines (2.6.18.) ................... 179Nevirapine, anhydrous ..................................................................2563Newcastle disease vaccine (inactivated) ...................................... 921Newcastle disease vaccine (live).................................................... 923Nicergoline ......................................................................................2564Nickel in hydrogenated vegetable oils (2.4.31.)......................... 132Nickel in polyols (2.4.15.) ............................................................... 118Niclosamide, anhydrous ...............................................................2565Niclosamide monohydrate ...........................................................2566Nicotinamide ...................................................................................2567Nicotine ............................................................................................2567Nicotine resinate ............................................................................2568Nicotinic acid ..................................................................................2570Nifedipine.........................................................................................2571Niflumic acid ...................................................................................2572Nifuroxazide ....................................................................................2574Nikethamide ....................................................................................2575Nilutamide .......................................................................................2575Nimesulide.......................................................................................2577Nimodipine ......................................................................................2578Nitrazepam ......................................................................................2579Nitrendipine ....................................................................................2580Nitric acid ........................................................................................2581Nitric oxide ......................................................................................2581Nitrofural .........................................................................................2582Nitrofurantoin.................................................................................2583Nitrogen ...........................................................................................2584Nitrogen determination by sulfuric acid digestion (2.5.9.) ..... 139Nitrogen determination, primary aromatic amino (2.5.8.) ...... 139Nitrogen, low-oxygen.....................................................................2585Nitrogen monoxide and nitrogen dioxide in gases (2.5.26.)... 145Nitroprusside, sodium...................................................................2936Nitrous oxide...................................................................................2585Nitrous oxide in gases (2.5.35.)..................................................... 150Nizatidine.........................................................................................2586N-Methylpyrrolidone......................................................................2486NMR spectrometry (2.2.33.)............................................................. 52N,N-Dimethylaniline (2.4.26.) ........................................................ 128Nomegestrol acetate......................................................................2588Nonoxinol 9.....................................................................................2589Non-sterile pharmaceutical preparations and substances forpharmaceutical use, microbiological quality of (5.1.4.)......... 507

Non-sterile pharmaceutical preparations and substancesfor pharmaceutical use, microbiological quality of (5.1.4.)(5.8.).................................................................................................. 623

Non-sterile products, microbiological examination of (microbialenumeration tests) (2.6.12.)......................................................... 163

Non-sterile products, microbiological examination of (microbialenumeration tests) (2.6.12.) (5.8.).............................................. 622

Non-sterile products, microbiological examination of (test forspecified micro-organisms) (2.6.13.) .......................................... 167

Non-sterile products, microbiological examination of (test forspecified micro-organisms) (2.6.13.) (5.8.) ............................... 622

Noradrenaline hydrochloride ......................................................2589Noradrenaline tartrate ..................................................................2591Norepinephrine hydrochloride....................................................2589Norepinephrine tartrate ...............................................................2591Norethisterone................................................................................2592Norethisterone acetate .................................................................2594Norfloxacin......................................................................................2595Norgestimate ...................................................................................2596Norgestrel ........................................................................................2597Normal immunoglobulin for intravenous administration,human ............................................................................................ 2179

Normal immunoglobulin, human............................................... 2177

Nortriptyline hydrochloride.........................................................2598Noscapine ........................................................................................2599Noscapine hydrochloride..............................................................2600Notoginseng root ........................................................................... 1197Nuclear magnetic resonance spectrometry (2.2.33.).................. 52Nucleated cell count and viability (2.7.29.) ................................ 233Nucleic acid amplification techniques (2.6.21.) ......................... 181Nucleic acids in polysaccharide vaccines (2.5.17.) .................... 142Numeration of CD34/CD45+ cells in haematopoietic products(2.7.23.) ............................................................................................ 228

Nutmeg oil ....................................................................................... 1199Nystatin ............................................................................................2602

OO-Acetyl in polysaccharide vaccines (2.5.19.) ............................ 142Oak bark .......................................................................................... 1199Octoxinol 10 ....................................................................................2607Octyldodecanol ...............................................................................2608Octyl gallate ....................................................................................2607Odour (2.3.4.).................................................................................... 110Odour and taste of essential oils (2.8.8.) .................................... 240Ofloxacin..........................................................................................2609Oils, essential .................................................................................... 673Oils, fatty, identification by thin-layer chromatography(2.3.2.) .............................................................................................. 110

Oils, fatty, vegetable ........................................................................ 703Oils 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.) ......... 133Ointments .......................................................................................... 735Oleic acid ......................................................................................... 2610Oleoresins .......................................................................................... 676Oleoyl macrogolglycerides ........................................................... 2610Oleyl alcohol ................................................................................... 2611Olive leaf ..........................................................................................1200Olive leaf dry extract ..................................................................... 1201Olive oil, refined .............................................................................2612Olive oil, virgin ............................................................................... 2613Olsalazine sodium.......................................................................... 2613Omega-3-acid ethyl esters 60....................................................... 2616Omega-3-acid ethyl esters 90....................................................... 2617Omega-3 acids, composition of fatty acids in oils rich in(2.4.29.) ............................................................................................ 130

Omega-3 acids, fish oil rich in ..................................................... 2019Omega-3 acids, total cholesterol in oils rich in (2.4.32.) ......... 133Omega-3-acid triglycerides ........................................................... 2619Omeprazole .....................................................................................2621Omeprazole magnesium...............................................................2623Omeprazole sodium.......................................................................2624Ondansetron hydrochloride dihydrate ......................................2625Opalescence of liquids, clarity and degree of (2.2.1.)..................21Ophthalmic inserts .......................................................................... 712Opium dry extract, standardised ................................................1202Opium, prepared.............................................................................1203Opium, raw ......................................................................................1204Opium tincture, standardised......................................................1205Optical microscopy (2.9.37.) ...........................................................311Optical microscopy (2.9.37.) (5.8.)................................................ 622Optical rotation (2.2.7.)..................................................................... 26Oral drops .......................................................................................... 719Oral lyophilisates.............................................................................. 736Oral powders..................................................................................... 727Oral solutions, emulsions and suspensions ............................... 718Oral use, liquid preparations for................................................... 718Orbifloxacin for veterinary use ...................................................2627Orciprenaline sulfate .....................................................................2628Oregano............................................................................................1206Organ preservation, solutions for...............................................2952Oriental cashew for homoeopathic preparations....................1295Orodispersible tablets ..................................................................... 737Oromucosal capsules ...................................................................... 723



Oromucosal drops, oromucosal sprays and sublingualsprays................................................................................................ 722

Oromucosal preparations............................................................... 721Oromucosal preparations, semi-solid........................................... 722Oromucosal solutions and oromucosal suspensions ............... 722Oromucosal sprays, oromucosal drops and sublingualsprays................................................................................................ 721

Oromucosal suspensions and oromucosal solutions ............... 721Orphenadrine citrate.....................................................................2630Orphenadrine hydrochloride.......................................................2631Osmolality (2.2.35.)............................................................................ 57Ouabain............................................................................................2632Oxacillin sodium monohydrate ...................................................2633Oxaliplatin .......................................................................................2635Oxazepam ........................................................................................2638Oxeladin hydrogen citrate............................................................2639Oxfendazole for veterinary use...................................................2640Oxidising substances (2.5.30.)....................................................... 146Oxitropium bromide ......................................................................2641Oxolinic acid....................................................................................2642Oxprenolol hydrochloride ............................................................2643Oxybuprocaine hydrochloride.....................................................2644Oxybutynin hydrochloride ...........................................................2645Oxycodone hydrochloride ............................................................2646Oxygen..............................................................................................2648Oxygen (15O) ...................................................................................... 986Oxygen-flask method (2.5.10.)....................................................... 139Oxygen in gases (2.5.27.)................................................................ 145Oxymetazoline hydrochloride .....................................................2648Oxytetracycline dihydrate ............................................................2649Oxytetracycline hydrochloride ....................................................2651Oxytocin ...........................................................................................2653Oxytocin concentrated solution..................................................2654

PPaclitaxel..........................................................................................2657Pale coneflower root .....................................................................1208Palmitic acid....................................................................................2660Pamidronate disodium pentahydrate ........................................2660Pancreas powder ............................................................................2661Pancuronium bromide ..................................................................2663Pansy, wild (flowering aerial parts) ...........................................1266Pantoprazole sodium sesquihydrate..........................................2664Pantothenate, calcium ..................................................................1566Papaverine hydrochloride ............................................................2666Paper chromatography (2.2.26.) ......................................................41Paracetamol ....................................................................................2667Paraffin, hard ..................................................................................2668Paraffin, light liquid ......................................................................2669Paraffin, liquid ................................................................................2669Paraffin, white soft ........................................................................2670Paraffin, yellow soft.......................................................................2671Parahydroxybenzoate, butyl ........................................................1530Parahydroxybenzoate, ethyl ........................................................1973Parahydroxybenzoate, methyl.....................................................2477Parahydroxybenzoate, propyl...................................................... 2813Parahydroxybenzoate sodium, ethyl.......................................... 1974Parahydroxybenzoate, sodium methyl ......................................2934Parahydroxybenzoate, sodium propyl .......................................2942Parainfluenza virus vaccine (live), bovine.................................. 864Parainfluenza virus vaccine (live), canine .................................. 875Paraldehyde.....................................................................................2671Paramyxovirus 1 (Newcastle disease) vaccine (inactivated),avian ................................................................................................. 921

Parenteral preparations.................................................................. 723Parenteral preparations, test for extractable volume of(2.9.17.)............................................................................................. 273

Parenteral preparations, test for extractable volume of (2.9.17.)(5.8.).................................................................................................. 622

Parnaparin sodium ........................................................................2672Paroxetine hydrochloride, anhydrous .......................................2672Paroxetine hydrochloride hemihydrate.....................................2674

Particles, fine, aerodynamic assessment of in preparations forinhalation (2.9.18.) ........................................................................ 274

Particle size analysis by laser light diffraction (2.9.31.) .......... 295Particle-size distribution estimation by analytical sieving(2.9.38.) ............................................................................................ 313

Particle-size distribution estimation by analytical sieving(2.9.38.) (5.8.) ................................................................................. 623

Particulate contamination : sub-visible particles (2.9.19.)....... 285Particulate contamination : visible particles (2.9.20.) .............. 287Parvovirosis vaccine (inactivated), canine .................................. 876Parvovirosis vaccine (inactivated), porcine ................................ 930Parvovirosis vaccine (live), canine................................................ 877Passion flower ................................................................................1209Passion flower dry extract ........................................................... 1210Pastes.................................................................................................. 735Pasteurella vaccine (inactivated) for sheep ................................ 925Pastilles and lozenges..................................................................... 723Patches, cutaneous.......................................................................... 734Patches, transdermal....................................................................... 726Patches, transdermal, dissolution test for (2.9.4.) .................... 263Pea starch ........................................................................................2676Pefloxacin mesilate dihydrate .....................................................2677Pelargonium root ........................................................................... 1211Penbutolol sulfate..........................................................................2678Penetrometry, measurement of consistency by (2.9.9.)........... 267Penicillamine...................................................................................2679Pentaerythrityl tetranitrate, diluted ..........................................2681Pentamidine diisetionate..............................................................2683Pentazocine.....................................................................................2684Pentazocine hydrochloride ..........................................................2684Pentazocine lactate .......................................................................2685Pentetate sodium calcium for radiopharmaceuticalpreparations .................................................................................... 987

Pentobarbital ..................................................................................2685Pentobarbital sodium....................................................................2686Pentoxifylline ..................................................................................2687Pentoxyverine hydrogen citrate ..................................................2689Peppermint leaf .............................................................................. 1212Peppermint leaf dry extract ......................................................... 1213Peppermint oil ................................................................................ 1214Pepsin powder ................................................................................2690Peptide mapping (2.2.55.) ................................................................ 85Peptide mapping (2.2.55.) (5.8.) ................................................... 621Peptides, synthetic, acetic acid in (2.5.34.)................................. 150Perborate, hydrated sodium ........................................................2937Pergolide mesilate..........................................................................2691Perindopril tert-butylamine..........................................................2692Peritoneal dialysis, solutions for.................................................2695Peroxide value (2.5.5.)..................................................................... 138Perphenazine ..................................................................................2697Pertussis (acellular, component), diphtheria and tetanus vaccine(adsorbed)........................................................................................ 754

Pertussis (acellular, component), diphtheria, tetanus andhaemophilus type b conjugate vaccine (adsorbed) ................ 758

Pertussis (acellular, component), diphtheria, tetanus andhepatitis B (rDNA) vaccine (adsorbed) ..................................... 760

Pertussis (acellular, component), diphtheria, tetanus andpoliomyelitis (inactivated) vaccine (adsorbed) ........................ 762

Pertussis (acellular, component), diphtheria, tetanus andpoliomyelitis (inactivated) vaccine (adsorbed, reducedantigen(s) content) ........................................................................ 763

Pertussis (acellular, component), diphtheria, tetanus, hepatitis B(rDNA), poliomyelitis (inactivated) and haemophilus type bconjugate vaccine (adsorbed)...................................................... 765

Pertussis (acellular, component), diphtheria, tetanus,poliomyelitis (inactivated) and haemophilus type b conjugatevaccine (adsorbed)......................................................................... 768

Pertussis, diphtheria, tetanus and poliomyelitis (inactivated)vaccine (adsorbed)......................................................................... 771

Pertussis, diphtheria, tetanus, poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) ................ 772

Pertussis vaccine (acellular), assay of (2.7.16.).......................... 223Pertussis vaccine (acellular, component, adsorbed) ................ 806



Pertussis vaccine (acellular, co-purified, adsorbed) ................. 808Pertussis vaccine, assay of (2.7.7.) ................................................ 213Pertussis vaccine (whole cell, adsorbed)..................................... 810Peru balsam..................................................................................... 1215Pessaries............................................................................................. 739Pessaries and suppositories, disintegration of (2.9.2.) ............ 255Pesticide residues (2.8.13.)............................................................. 242Pethidine hydrochloride...............................................................2698Pharmaceutical technical procedures (2.9.)............................... 253Pharmacognosy, methods in (2.8.)............................................... 239Pharmacopoeial harmonisation (5.8.) ......................................... 621Phenazone.......................................................................................2699Pheniramine maleate ....................................................................2700Phenobarbital .................................................................................2702Phenobarbital sodium...................................................................2702Phenol ..............................................................................................2703Phenol in immunosera and vaccines (2.5.15.) ............................141Phenolphthalein.............................................................................2704Phenolsulfonphthalein .................................................................2704Phenothiazines, identification by thin-layer chromatography(2.3.3.) .............................................................................................. 110

Phenoxyethanol..............................................................................2705Phenoxymethylpenicillin ..............................................................2706Phenoxymethylpenicillin potassium..........................................2708Phentolamine mesilate .................................................................2709Phenylalanine ................................................................................. 2711Phenylbutazone ............................................................................. 2711Phenylbutyrate, sodium................................................................2938Phenylephrine.................................................................................2713Phenylephrine hydrochloride...................................................... 2714Phenylmercuric acetate ................................................................2715Phenylmercuric borate .................................................................2716Phenylmercuric nitrate .................................................................2716Phenylpropanolamine hydrochloride ........................................ 2717Phenytoin.........................................................................................2718Phenytoin sodium..........................................................................2719Phloroglucinol, anhydrous ..........................................................2720Phloroglucinol dihydrate .............................................................2722Pholcodine.......................................................................................2724Phosphates (2.4.11.) .........................................................................117Phosphoric acid, concentrated ...................................................2725Phosphoric acid, dilute .................................................................2725Phosphorus in polysaccharide vaccines (2.5.18.) ..................... 142pH, potentiometric determination of (2.2.3.) ............................... 24Phthalylsulfathiazole ....................................................................2726Physical and physicochemical methods (2.2.) ..............................21Physostigmine salicylate...............................................................2726Physostigmine sulfate ...................................................................2727Phytomenadione ............................................................................2728Phytosterol ......................................................................................2729Picosulfate, sodium .......................................................................2939Picotamide monohydrate .............................................................2730Pilocarpine hydrochloride............................................................2731Pilocarpine nitrate .........................................................................2732Pimobendan ....................................................................................2734Pimozide ..........................................................................................2734Pindolol ............................................................................................2736Pine (dwarf) oil ............................................................................... 1116Pine sylvestris oil ........................................................................... 1216Pinus pinaster type turpentine oil .............................................1258Pipemidic acid trihydrate .............................................................2737Piperacillin ......................................................................................2738Piperacillin sodium........................................................................2739Piperazine adipate ......................................................................... 2741Piperazine citrate...........................................................................2742Piperazine hydrate.........................................................................2743Piracetam.........................................................................................2743Pirenzepine dihydrochloride monohydrate .............................2744Piretanide ........................................................................................2746Piroxicam .........................................................................................2747Pivampicillin....................................................................................2748Pivmecillinam hydrochloride.......................................................2750Plasma for fractionation, human................................................ 2181

Plasma (pooled and treated for virus inactivation), human.. 2182Plasmid vectors for human use, bacterial cells used for themanufacture of ............................................................................... 649

Plasmin inhibitor, assay of human (2.7.25.) ............................... 230Plasters, medicated.......................................................................... 734Plastic additives (3.1.13.)................................................................ 352Plastic containers and closures for pharmaceutical use(3.2.2.) .............................................................................................. 368

Plastic containers for aqueous solutions for infusion(3.2.2.1.) ........................................................................................... 368

Plastic containers for human blood and blood components,sterile (3.2.3.) .................................................................................. 369

Plastic syringes, single-use, sterile (3.2.8.) ................................. 373Pneumococcal polysaccharide conjugate vaccine(adsorbed)........................................................................................ 812

Pneumococcal polysaccharide vaccine ....................................... 813Pneumonia vaccine (inactivated), porcine enzootic ................. 927Poliomyelitis (inactivated), diphtheria and tetanus vaccine(adsorbed, reduced antigen(s) content) .................................... 756

Poliomyelitis (inactivated), diphtheria, tetanus and pertussis(acellular, component) vaccine (adsorbed) .............................. 762

Poliomyelitis (inactivated), diphtheria, tetanus and pertussis(acellular, component) vaccine (adsorbed, reduced antigen(s)content)............................................................................................ 763

Poliomyelitis (inactivated), diphtheria, tetanus and pertussisvaccine (adsorbed)......................................................................... 771

Poliomyelitis (inactivated), diphtheria, tetanus, pertussis(acellular, component) and haemophilus type b conjugatevaccine (adsorbed)......................................................................... 768

Poliomyelitis (inactivated), diphtheria, tetanus, pertussis(acellular, component), hepatitis B (rDNA) and haemophilustype b conjugate vaccine (adsorbed) ......................................... 765

Poliomyelitis (inactivated), diphtheria, tetanus, pertussis andhaemophilus type b conjugate vaccine (adsorbed) ................ 772

Poliomyelitis vaccine (inactivated) ............................................... 815Poliomyelitis vaccine (inactivated), in vivo assay of (2.7.20.) .. 225Poliomyelitis vaccine (oral) ............................................................ 818Poliomyelitis vaccine (oral), test for neurovirulence (2.6.19.).. 179Poloxamers ......................................................................................2751Polyacrylate dispersion 30 per cent...........................................2752Polyamide 6/6 suture, sterile, in distributor for veterinary use.........................................................................................................1038

Polyamide 6 suture, sterile, in distributor for veterinary use.........................................................................................................1038

Polyethyleneglycols .......................................................................2402Polyethylene terephthalate for containers for preparations notfor parenteral use (3.1.15.) .......................................................... 357

Poly(ethylene terephthalate) suture, sterile, in distributor forveterinary use ..............................................................................1039

Poly(ethylene - vinyl acetate) for containers and tubing for totalparenteral nutrition preparations (3.1.7.)................................. 345

Polyethylene with additives for containers for parenteralpreparations and for ophthalmic preparations (3.1.5.) ......... 338

Polyethylene without additives for containers for parenteralpreparations and for ophthalmic preparations (3.1.4.) ......... 337

Polymorphism (5.9.) ........................................................................ 627Polymyxin B sulfate.......................................................................2753Polyolefines (3.1.3.) ......................................................................... 334Polyoxyl castor oil..........................................................................2398Polyoxyl hydrogenated castor oil ...............................................2397Polypropylene for containers and closures for parenteralpreparations and ophthalmic preparations (3.1.6.)................ 342

Polysaccharide vaccines, hexosamines in (2.5.20.)................... 142Polysaccharide vaccines, methylpentoses in (2.5.21.).............. 143Polysaccharide vaccines, nucleic acids in (2.5.17.) ................... 142Polysaccharide vaccines, O-acetyl in (2.5.19.)............................ 142Polysaccharide vaccines, phosphorus in (2.5.18.)..................... 142Polysaccharide vaccines, protein in (2.5.16.) ..............................141Polysaccharide vaccines, ribose in (2.5.31.) ............................... 146Polysaccharide vaccines, sialic acid in (2.5.23.) ........................ 143Polysaccharide vaccines, uronic acids in (2.5.22.) .................... 143Polysorbate 20 ................................................................................2754Polysorbate 40 ................................................................................2755



Polysorbate 60 ................................................................................2756Polysorbate 80 ................................................................................2756Polystyrene sulfonate, sodium ....................................................2940Poly(vinyl acetate)..........................................................................2758Poly(vinyl acetate) dispersion 30 per cent ...............................2759Poly(vinyl alcohol) .........................................................................2760Poly(vinyl alcohol) macrogol grafted copolymer ....................2401Poly(vinyl chloride) (non-plasticised) for containers for drydosage forms for oral administration, materials based on(3.1.11.)............................................................................................. 350

Poly(vinyl chloride), non-plasticised, materials based on forcontainers for non-injectable aqueous solutions (3.1.10.).... 349

Poly(vinyl chloride), plasticised, empty sterile containers of forhuman blood and blood components (3.2.4.).......................... 370

Poly(vinyl chloride), plasticised, materials based on forcontainers for aqueous solutions for intravenous infusion(3.1.14.) ............................................................................................ 355

Poly(vinyl chloride), plasticised, materials based on forcontainers for human blood and blood components(3.1.1.1.) ........................................................................................... 329

Poly(vinyl chloride), plasticised, materials based on for tubingused in sets for the transfusion of blood and blood components(3.1.1.2.) ........................................................................................... 332

Poly(vinyl chloride), plasticised, sterile containers of for humanblood containing anticoagulant solution (3.2.5.) ................... 371

Poppy petals, red............................................................................1222Porcine actinobacillosis vaccine (inactivated) ........................... 926Porcine enzootic pneumonia vaccine (inactivated) .................. 927Porcine influenza vaccine (inactivated) ...................................... 929Porcine insulin................................................................................2247Porcine parvovirosis vaccine (inactivated) ................................. 930Porcine progressive atrophic rhinitis vaccine (inactivated) .... 931Pore-size distribution of solids by mercury porosimetry, porosityand (2.9.32.) .................................................................................... 299

Porosimetry, mercury, porosity and pore-size distribution ofsolids by (2.9.32.) ........................................................................... 299

Porosity and pore-size distribution of solids by mercuryporosimetry (2.9.32.)..................................................................... 299

Porosity of sintered-glass filters (2.1.2.) ........................................ 15Porous solids including powders, wettability of (2.9.45.) ....... 321Potassium (2.4.12.) ...........................................................................117Potassium acetate .......................................................................... 2761Potassium bromide ........................................................................ 2761Potassium carbonate.....................................................................2762Potassium chloride ........................................................................2763Potassium citrate ...........................................................................2763Potassium clavulanate ..................................................................2764Potassium clavulanate, diluted ...................................................2766Potassium dihydrogen phosphate ..............................................2768Potassium hydrogen aspartate hemihydrate ...........................2768Potassium hydrogen carbonate ..................................................2769Potassium hydrogen tartrate.......................................................2769Potassium hydroxide .....................................................................2770Potassium iodide............................................................................2771Potassium metabisulfite ...............................................................2771Potassium nitrate ...........................................................................2772Potassium perchlorate ..................................................................2773Potassium permanganate.............................................................2773Potassium sodium tartrate tetrahydrate...................................2774Potassium sorbate..........................................................................2774Potassium sulfate ...........................................................................2775Potato starch...................................................................................2775Potentiometric determination of ionic concentration usingion-selective electrodes (2.2.36.)................................................... 57

Potentiometric determination of pH (2.2.3.)................................ 24Potentiometric titration (2.2.20.).................................................... 34Potentisation, methods of preparation of homoeopathic stocksand ..................................................................................................1277

Poultices............................................................................................. 735Pour-on preparations ...................................................................... 740Povidone ..........................................................................................2776Povidone, iodinated .......................................................................2778Powdered cellulose ........................................................................1638

Powder fineness (2.9.35.) ............................................................... 308Powder flow (2.9.36.) ...................................................................... 308Powder flow (2.9.36.) (5.8.) ........................................................... 622Powders and granules for oral solutions and suspensions .... 718Powders and granules for syrups ................................................. 719Powders and tablets for rectal solutions and suspensions..... 733Powders, bulk density and tapped density of (2.9.34.) ............ 305Powders, ear...................................................................................... 710Powders, effervescent...................................................................... 727Powders for cutaneous application.............................................. 726Powders for eye drops and powders for eye lotions................. 711Powders for inhalation.................................................................... 730Powders for injections or infusions ............................................. 725Powders for oral drops.................................................................... 719Powders, nasal .................................................................................. 721Powders, oral .................................................................................... 727Powders, wettability of porous solids including (2.9.45.) ....... 321Pramipexole dihydrochloride monohydrate ............................2779Pravastatin sodium........................................................................2780Prazepam .........................................................................................2782Praziquantel ....................................................................................2783Prazosin hydrochloride ................................................................2784Prednicarbate..................................................................................2785Prednisolone ...................................................................................2786Prednisolone acetate.....................................................................2787Prednisolone pivalate....................................................................2789Prednisolone sodium phosphate ................................................2790Prednisone.......................................................................................2791Pregelatinised starch.....................................................................2983Prekallikrein activator (2.6.15.) .................................................... 175Premixes for medicated feeding stuffs for veterinary use....... 727Preparations for inhalation............................................................ 728Preparations for inhalation: aerodynamic assessment of fineparticles (2.9.18.) ........................................................................... 274

Preparations for irrigation............................................................. 731Pressurised pharmaceutical preparations .................................. 732Prilocaine.........................................................................................2792Prilocaine hydrochloride..............................................................2794Primaquine diphosphate ..............................................................2795Primary aromatic amino-nitrogen, determination of (2.5.8.) .. 139Primary standards for volumetric solutions (4.2.1.)................. 494Primidone ........................................................................................2796Primula root .................................................................................... 1217Probenecid.......................................................................................2797Procainamide hydrochloride .......................................................2798Procaine benzylpenicillin ............................................................. 1474Procaine hydrochloride ................................................................2798Prochlorperazine maleate ............................................................2799Products of fermentation ............................................................... 685Products of recombinant DNA technology ................................ 692Products with risk of transmitting agents of animal spongiformencephalopathies ........................................................................... 686

Progenitor cells, human haematopoietic, colony-forming cellassay for (2.7.28.) ........................................................................... 232

Progesterone ...................................................................................2800Progressive atrophic rhinitis vaccine (inactivated), porcine... 931Proguanil hydrochloride ..............................................................2801Proline ..............................................................................................2802Promazine hydrochloride.............................................................2803Promethazine hydrochloride.......................................................2804Propacetamol hydrochloride .......................................................2805Propafenone hydrochloride .........................................................2806Propanol...........................................................................................2808Propanol and methanol, 2-, test for (2.9.11.) ............................. 270Propantheline bromide.................................................................2809Propofol............................................................................................ 2810Propranolol hydrochloride........................................................... 2811Propylene glycol............................................................................. 2814Propylene glycol dicaprylocaprate............................................. 2815Propylene glycol dilaurate ........................................................... 2815Propylene glycol monolaurate .................................................... 2816Propylene glycol monopalmitostearate..................................... 2817Propylene glycol monostearate................................................... 2817



Propyl gallate ..................................................................................2812Propyl parahydroxybenzoate....................................................... 2813Propyl parahydroxybenzoate, sodium.......................................2942Propylthiouracil ............................................................................. 2818Propyphenazone ............................................................................ 2819Protamine hydrochloride .............................................................2820Protamine sulfate...........................................................................2821Protein C, human, assay of (2.7.30.) ............................................ 234Protein in polysaccharide vaccines (2.5.16.) ...............................141Protein S, human, assay of (2.7.31.)............................................. 235Protein, total (2.5.33.) ..................................................................... 147Prothrombin complex, human .................................................... 2185Protirelin ..........................................................................................2822Proxyphylline ..................................................................................2823Pseudoephedrine hydrochloride ................................................2824Psyllium seed .................................................................................. 1217Purified water .................................................................................3224Purified water, highly ...................................................................3222Purple coneflower herb................................................................ 1218Purple coneflower root................................................................. 1219Pycnometric density of solids, gas (2.9.23.) ............................... 288Pygeum africanum bark ...............................................................1221Pyrantel embonate.........................................................................2825Pyrazinamide ..................................................................................2826Pyridostigmine bromide ...............................................................2827Pyridoxine hydrochloride.............................................................2827Pyrimethamine ...............................................................................2829Pyrogens (2.6.8.)............................................................................... 161Pyrrolidone......................................................................................2829

QQuality of non-sterile pharmaceutical preparations andsubstances for pharmaceutical use, microbiological(5.1.4.)............................................................................................... 507

Quality of non-sterile pharmaceutical preparations andsubstances for pharmaceutical use, microbiological (5.1.4.)(5.8.).................................................................................................. 623

Quantified hawthorn leaf and flower liquid extract............... 1150Quinidine sulfate............................................................................2833Quinine hydrochloride..................................................................2834Quinine sulfate ...............................................................................2835

RRabbit haemorrhagic disease vaccine (inactivated) ................. 933Rabies immunoglobulin, human ................................................ 2186Rabies vaccine for human use prepared in cell cultures......... 822Rabies vaccine (inactivated) for veterinary use......................... 934Rabies vaccine (live, oral) for foxes .............................................. 936Racecadotril ....................................................................................2841Racemic camphor...........................................................................1571Racemic ephedrine hydrochloride .............................................1928Racemic menthol ...........................................................................2445Raclopride ([11C]methoxy) injection............................................. 988Radionuclides, table of physical characteristics (5.7.) ............. 611Radiopharmaceutical preparations .............................................. 686Radiopharmaceutical preparations, iobenguane sulfate for ..982Radiopharmaceutical preparations, medronic acid for ........... 984Radiopharmaceutical preparations, pentetate sodium calciumfor ...................................................................................................... 987

Radiopharmaceutical preparations, tetra-O-acetyl-mannosetriflate for ......................................................................................1020

Raloxifene hydrochloride .............................................................2842Raman spectrometry (2.2.48.) ......................................................... 82Ramipril............................................................................................2843Ramon assay, flocculation value (Lf) of diphtheria and tetanustoxins and toxoids (2.7.27.) .......................................................... 231

Ranitidine hydrochloride..............................................................2845Rapeseed oil, refined.....................................................................2847Reagents (4.) ..................................................................................... 379Reagents (4.1.1.) ............................................................................... 379Reagents, standard solutions, buffer solutions (4.1.)............... 379Recombinant DNA technology, products of .............................. 692

Recommendations on dissolution testing (5.17.1.) ................... 665Recommendations on methods for dosage forms testing(5.17.) ................................................................................................ 665

Rectal capsules ................................................................................. 733Rectal foams...................................................................................... 733Rectal preparations.......................................................................... 732Rectal preparations, semi-solid ..................................................... 733Rectal solutions and suspensions, powders and tablets for ... 732Rectal solutions, emulsions and suspensions............................ 733Rectal tampons................................................................................. 734Red poppy petals............................................................................1222Reference standards (5.12.) ........................................................... 641Refractive index (2.2.6.) .................................................................... 26Relationship between reaction of solution, approximate pH andcolour of certain indicators (2.2.4.) ............................................. 25

Relative density (2.2.5.)..................................................................... 25Repaglinide......................................................................................2847Reserpine .........................................................................................2849Residual solvents (5.4.) ................................................................... 583Residual solvents, identification and control (2.4.24.) ............ 123Residue on evaporation of essential oils (2.8.9.)....................... 240Resistance to crushing of tablets (2.9.8.) ................................... 267Resorcinol ........................................................................................2850Restharrow root .............................................................................1223Retroviridae-derived vectors for human use .............................. 654Rhatany root ...................................................................................1223Rhatany tincture ............................................................................1224Rhinotracheitis vaccine (inactivated), viral, feline .................... 901Rhinotracheitis vaccine (live), viral, feline.................................. 902Rhubarb ...........................................................................................1224Ribavirin...........................................................................................2850Riboflavin.........................................................................................2852Riboflavin sodium phosphate......................................................2853Ribose in polysaccharide vaccines (2.5.31.) ............................... 146Ribwort plantain ............................................................................1225Rice starch.......................................................................................2855Rifabutin ..........................................................................................2855Rifampicin........................................................................................2856Rifamycin sodium...........................................................................2858Rifaximin..........................................................................................2859Rilmenidine dihydrogen phosphate...........................................2861Risperidone .....................................................................................2861Ritonavir ..........................................................................................2863Rocuronium bromide ....................................................................2866Roman chamomile flower ............................................................1098Ropivacaine hydrochloride monohydrate.................................2868Roselle ..............................................................................................1226Rosemary leaf .................................................................................1227Rosemary oil ...................................................................................1228Rotating viscometer method - viscosity (2.2.10.) ........................ 28Rotation, optical (2.2.7.) ................................................................... 26Rotavirus vaccine (live, oral) ......................................................... 824Roxithromycin.................................................................................2869RRR-α-Tocopherol ......................................................................... 3105RRR-α-Tocopheryl acetate ........................................................... 3108RRR-α-Tocopheryl hydrogen succinate .................................... 3111Rubber closures for containers for aqueous parenteralpreparations, for powders and for freeze-dried powders(3.2.9.) .............................................................................................. 374

Rubella immunoglobulin, human............................................... 2187Rubella, measles and mumps vaccine (live) ............................... 798Rubella, measles, mumps and varicella vaccine (live).............. 799Rubella vaccine (live) ...................................................................... 827Rutoside trihydrate........................................................................2871

SSaccharin .........................................................................................2877Saccharin sodium ..........................................................................2878Safety, viral (5.1.7.) .......................................................................... 518Safflower flower .............................................................................1229Safflower oil, refined.....................................................................2879Saffron for homoeopathic preparations....................................1296



Sage leaf (salvia officinalis)..........................................................1230Sage leaf, three-lobed.................................................................... 1231Sage oil, Spanish............................................................................1239Sage tincture................................................................................... 1231Salbutamol ......................................................................................2879Salbutamol sulfate.........................................................................2881Salicylic acid....................................................................................2884Salmeterol xinafoate......................................................................2885Salmonella Enteritidis vaccine (inactivated) for chickens ...... 937Salmonella Typhimurium vaccine (inactivated) for chickens ..938Salmon oil, farmed.........................................................................2886Sanguisorba root............................................................................1232Saponification value (2.5.6.) .......................................................... 139Saquinavir mesilate .......................................................................2889Saw palmetto fruit .........................................................................1233Schisandra fruit..............................................................................1234Scopolamine.................................................................................... 2214Scopolamine butylbromide .......................................................... 2215Scopolamine hydrobromide......................................................... 2216Selamectin for veterinary use .....................................................2890Selegiline hydrochloride ..............................................................2892Selenium disulfide .........................................................................2893Semi-micro determination of water (2.5.12.) ............................. 140Semi-solid ear preparations ........................................................... 710Semi-solid eye preparations ........................................................... 712Semi-solid intrauterine preparations ........................................... 715Semi-solid nasal preparations........................................................ 721Semi-solid oromucosal preparations............................................ 722Semi-solid preparations for cutaneous application .................. 734Semi-solid rectal preparations....................................................... 733Semi-solid vaginal preparations.................................................... 740Senega root .....................................................................................1235Senna leaf ........................................................................................1236Senna leaf dry extract, standardised .........................................1237Senna pods, Alexandrian..............................................................1238Senna pods, Tinnevelly.................................................................1238Separation techniques, chromatographic (2.2.46.) .................... 70Serine................................................................................................2893Sertaconazole nitrate....................................................................2894Sertraline hydrochloride ..............................................................2895Sesame oil, refined ........................................................................2898Sets for the transfusion of blood and blood components(3.2.6.) .............................................................................................. 371

Sevoflurane .....................................................................................2899Shampoos .......................................................................................... 717Shellac .............................................................................................2901Shingles (herpes zoster) vaccine (live) ........................................ 828Sialic acid in polysaccharide vaccines (2.5.23.)......................... 143Siam benzoin tincture...................................................................1069Sieves (2.1.4.) .......................................................................................16Sieve test (2.9.12.)............................................................................ 270Sieving, analytical, particle-size distribution estimation by(2.9.38.) ............................................................................................ 313

Sieving, analytical, particle-size distribution estimation by(2.9.38.) (5.8.) ................................................................................. 623

SI (International System) units (1.) ..................................................3Silica, colloidal anhydrous ...........................................................2901Silica, colloidal hydrated ..............................................................2902Silica, dental type...........................................................................2903Silica, hydrophobic colloidal .......................................................2903Silicate, aluminium magnesium..................................................1358Silicate, aluminium sodium ......................................................... 1361Silicone elastomer for closures and tubing (3.1.9.) .................. 347Silicone oil used as a lubricant (3.1.8.) ....................................... 347Silk suture, sterile, braided, in distributor for veterinary use.........................................................................................................1039

Silver, colloidal, for external use ................................................2904Silver nitrate ...................................................................................2905Simeticone.......................................................................................2905Simvastatin......................................................................................2906Single-dose preparations, uniformity of content (2.9.6.)......... 266Single-dose preparations, uniformity of mass (2.9.5.).............. 265Sintered-glass filters (2.1.2.) ............................................................ 15

Size-exclusion chromatography (2.2.30.)...................................... 46(S)-Lactic acid..................................................................................2328Smallpox vaccine (live) ................................................................... 829Sodium acetate ([1-11C]) injection ................................................ 990Sodium acetate trihydrate ...........................................................2908Sodium alendronate ......................................................................2908Sodium alginate .............................................................................2909Sodium aluminium silicate .......................................................... 1361Sodium amidotrizoate................................................................... 2910Sodium aminosalicylate dihydrate ............................................. 2911Sodium ascorbate .......................................................................... 2912Sodium aurothiomalate................................................................ 2914Sodium benzoate ........................................................................... 2915Sodium bromide............................................................................. 2915Sodium calcium edetate ............................................................... 2916Sodium calcium pentetate for radiopharmaceuticalpreparations .................................................................................... 987

Sodium caprylate ........................................................................... 2917Sodium carbonate, anhydrous .................................................... 2918Sodium carbonate decahydrate .................................................. 2919Sodium carbonate monohydrate ................................................ 2919Sodium carboxymethylcellulose .................................................1589Sodium carboxymethylcellulose, cross-linked .........................1770Sodium carboxymethylcellulose, low-substituted...................1590Sodium cetostearyl sulfate ..........................................................2920Sodium chloride .............................................................................2921Sodium chromate (51Cr) sterile solution ..................................... 991Sodium citrate ................................................................................2922Sodium cromoglicate ....................................................................2923Sodium cyclamate..........................................................................2924Sodium dihydrogen phosphate dihydrate ................................2925Sodium ethyl parahydroxybenzoate .......................................... 1974Sodium fluoride .............................................................................2925Sodium fluoride (18F) injection ..................................................... 991Sodium fusidate .............................................................................2926Sodium glycerophosphate, hydrated .........................................2927Sodium hyaluronate ......................................................................2927Sodium hydrogen carbonate .......................................................2929Sodium hydroxide..........................................................................2930Sodium iodide.................................................................................2930Sodium iodide (123I) injection ........................................................ 992Sodium iodide (123I) solution for radiolabelling ........................ 993Sodium iodide (131I) capsules for diagnostic use....................... 994Sodium iodide (131I) capsules for therapeutic use .................... 995Sodium iodide (131I) solution ......................................................... 996Sodium iodide (131I) solution for radiolabelling ........................ 996Sodium iodohippurate (123I) injection ......................................... 997Sodium iodohippurate (131I) injection ......................................... 998Sodium lactate solution................................................................2931Sodium laurilsulfate ......................................................................2933Sodium metabisulfite ....................................................................2933Sodium methyl parahydroxybenzoate.......................................2934Sodium molybdate (99Mo) solution (fission) .............................. 999Sodium molybdate dihydrate ......................................................2935Sodium nitrite.................................................................................2936Sodium nitroprusside ...................................................................2936Sodium perborate, hydrated........................................................2937Sodium pertechnetate (99mTc) injection (fission) .................... 1001Sodium pertechnetate (99mTc) injection (non-fission) ............1002Sodium phenylbutyrate ................................................................2938Sodium phosphate (32P) injection ..............................................1003Sodium picosulfate ........................................................................2939Sodium polystyrene sulfonate.....................................................2940Sodium propionate ........................................................................2941Sodium propyl parahydroxybenzoate........................................2942Sodium salicylate ...........................................................................2943Sodium selenite pentahydrate ....................................................2944Sodium (S)-lactate solution .........................................................2932Sodium starch glycolate (type A) ...............................................2944Sodium starch glycolate (type B) ...............................................2945Sodium starch glycolate (type C) ...............................................2946Sodium stearate .............................................................................2947Sodium stearyl fumarate ..............................................................2948



Sodium sulfate, anhydrous ..........................................................2948Sodium sulfate decahydrate ........................................................2949Sodium sulfite, anhydrous ...........................................................2950Sodium sulfite heptahydrate .......................................................2950Sodium thiosulfate ........................................................................2951Sodium valproate ...........................................................................2951Soft capsules ..................................................................................... 708Softening time determination of lipophilic suppositories(2.9.22.) ............................................................................................ 288

Soft extracts ...................................................................................... 676Solid dosage forms, dissolution test for (2.9.3.)........................ 256Solid dosage forms, recommendations on dissolution testing of(5.17.1.)............................................................................................. 665

Solids by mercury porosimetry, porosity and pore-sizedistribution of (2.9.32.)................................................................. 299

Solids, density of (2.2.42.) ................................................................ 66Solids, gas pycnometric density of (2.9.23.)............................... 288Solids (porous) including powders, wettability of (2.9.45.) .... 321Solubility in alcohol of essential oils (2.8.10.) ........................... 240Soluble tablets .................................................................................. 737Solutions, emulsions and suspensions, oral .............................. 718Solutions for haemodialysis......................................................... 2136Solutions for haemodialysis, concentrated, water fordiluting........................................................................................... 2135

Solutions for haemofiltration and haemodiafiltration........... 2138Solutions for organ preservation................................................2952Solutions for peritoneal dialysis .................................................2695Solutions, suspensions, intrauterine ........................................... 715Solvents, residual (5.4.) .................................................................. 583Solvents, residual, identification and control (2.4.24.) ............ 123Somatostatin ...................................................................................2953Somatropin......................................................................................2954Somatropin concentrated solution ............................................2956Somatropin for injection ..............................................................2958Sorbic acid.......................................................................................2960Sorbitan laurate .............................................................................2961Sorbitan oleate ...............................................................................2961Sorbitan palmitate .........................................................................2962Sorbitan sesquioleate....................................................................2962Sorbitan stearate............................................................................2962Sorbitan trioleate ...........................................................................2963Sorbitol.............................................................................................2963Sorbitol, liquid (crystallising)......................................................2965Sorbitol, liquid (non-crystallising)..............................................2965Sorbitol, liquid, partially dehydrated.........................................2966Sotalol hydrochloride ...................................................................2967Soya-bean oil, hydrogenated........................................................2968Soya-bean oil, refined....................................................................2969Spanish sage oil..............................................................................1239Specific surface area by air permeability (2.9.14.).................... 271Specific surface area by gas adsorption (2.9.26.) ..................... 291Specific surface area by gas adsorption (2.9.26.) (5.8.)........... 622Spectinomycin dihydrochloride pentahydrate ........................2969Spectinomycin sulfate tetrahydrate for veterinary use .........2971Spectrometry, atomic absorption (2.2.23.)................................... 36Spectrometry, atomic emission (2.2.22.)....................................... 35Spectrometry, mass (2.2.43.) ........................................................... 67Spectrometry, nuclear magnetic resonance (2.2.33.) ................ 52Spectrometry, Raman (2.2.48.) ....................................................... 82Spectrometry, X-ray fluorescence (2.2.37.)................................... 58Spectrophotometry, infrared absorption (2.2.24.)...................... 38Spectrophotometry, near-infrared (2.2.40.)...................................61Spectrophotometry, ultraviolet and visible absorption(2.2.25.) .............................................................................................. 40

SPF chicken flocks for the production and quality control ofvaccines (5.2.2.) .............................................................................. 527

Spheroids and granules, friability of (2.9.41.)............................ 318Spike lavender oil ..........................................................................1240Spiramycin.......................................................................................2973Spirapril hydrochloride monohydrate.......................................2975Spironolactone ...............................................................................2976Spot-on preparations....................................................................... 740Sprays ................................................................................................. 740

Sprays (liquid nasal) and drops (nasal) ....................................... 720Squalane ..........................................................................................2978Standard solutions for limit tests (4.1.2.) ................................... 485Standards, reference (5.12.)........................................................... 641Stannous chloride dihydrate .......................................................2980Stanozolol........................................................................................2981Star anise .........................................................................................1244Star anise oil ...................................................................................1245Starches, hydroxyethyl..................................................................2984Starch glycolate (type A), sodium ..............................................2944Starch glycolate (type B), sodium ..............................................2945Starch glycolate (type C), sodium ..............................................2946Starch, hydroxypropyl...................................................................2981Starch, maize ..................................................................................2422Starch, potato .................................................................................2775Starch, pregelatinised ...................................................................2983Starch, rice ......................................................................................2855Starch, wheat ..................................................................................3226Starflower (borage) oil, refined...................................................1503Statistical analysis of results of biological assays and tests(5.3.).................................................................................................. 551

Stavudine.........................................................................................2988Steam sterilisation of aqueous preparations, application of theF0 concept (5.1.5.).......................................................................... 508

Stearic acid......................................................................................2989Stearoyl macrogolglycerides .......................................................2990Stearyl alcohol................................................................................2991Stem cells, human haematopoietic ............................................ 2175Stephania root, fourstamen.........................................................1127Sterile braided silk suture in distributor for veterinary use ..1039Sterile catgut...................................................................................1027Sterile catgut in distributor for veterinary use .......................1037Sterile containers of plasticised poly(vinyl chloride) for humanblood containing anticoagulant solution (3.2.5.) ................... 371

Sterile linen thread in distributor for veterinary use ............1038Sterile non-absorbable strands in distributor for veterinaryuse...................................................................................................1039

Sterile non-absorbable sutures ...................................................1028Sterile plastic containers for human blood and bloodcomponents (3.2.3.) ....................................................................... 369

Sterile polyamide 6/6 suture in distributor for veterinaryuse...................................................................................................1038

Sterile polyamide 6 suture in distributor for veterinaryuse...................................................................................................1038

Sterile poly(ethylene terephthalate) suture in distributor forveterinary use ...............................................................................1039

Sterile products, methods of preparation (5.1.1.) ..................... 503Sterile single-use plastic syringes (3.2.8.) ................................... 373Sterile synthetic absorbable braided sutures .......................... 1031Sterile synthetic absorbable monofilament sutures...............1033Sterilisation procedures, biological indicators (5.1.2.) ............ 504Sterility (2.6.1.) ................................................................................. 153Sterility, guidelines for using the test for (5.1.9.) ..................... 519Sterols in fatty oils (2.4.23.)........................................................... 121Sticks .................................................................................................. 736Sticks, intrauterine .......................................................................... 715Sticks, nasal....................................................................................... 721St. John’s wort................................................................................1241St. John’s wort dry extract, quantified......................................1242Stomata and stomatal index (2.8.3.) ............................................ 239Stramonium leaf.............................................................................1247Stramonium, prepared ..................................................................1248Strands, sterile non-absorbable, in distributor for veterinary use.........................................................................................................1039

Streptokinase concentrated solution ........................................2991Streptomycin sulfate .....................................................................2993Strontium (89Sr) chloride injection ............................................1003Subdivision of tablets...................................................................... 736Sublingual sprays, oromucosal drops and oromucosalsprays................................................................................................ 721

Sublingual tablets and buccal tablets ......................................... 723Substances for pharmaceutical use ............................................. 694



Substances for pharmaceutical use, control of impurities in(5.10.)................................................................................................ 631

Substances of animal origin for the production of immunologicalveterinary medicinal products (5.2.5.) ...................................... 535

Sub-visible particles, particulate contamination (2.9.19.)....... 285Succinylsulfathiazole ....................................................................2994Sucralfate.........................................................................................2995Sucrose.............................................................................................2996Sucrose monopalmitate................................................................2998Sucrose stearate .............................................................................2999Sufentanil ........................................................................................3000Sufentanil citrate ...........................................................................3001Sugars, lead in (2.4.10.) ...................................................................117Sugar spheres .................................................................................3002Sulbactam sodium .........................................................................3003Sulfacetamide sodium...................................................................3005Sulfadiazine.....................................................................................3006Sulfadimidine..................................................................................3007Sulfadoxine......................................................................................3007Sulfafurazole...................................................................................3008Sulfaguanidine................................................................................3009Sulfamerazine................................................................................. 3010Sulfamethizole................................................................................ 3011Sulfamethoxazole .......................................................................... 3011Sulfamethoxypyridazine for veterinary use ............................. 3013Sulfanilamide .................................................................................. 3013Sulfasalazine ................................................................................... 3014Sulfated ash (2.4.14.)....................................................................... 118Sulfated ash (2.4.14.) (5.8.)............................................................ 622Sulfates (2.4.13.)............................................................................... 118Sulfathiazole ................................................................................... 3016Sulfinpyrazone ............................................................................... 3017Sulfisomidine .................................................................................. 3018Sulfur dioxide (2.5.29.) ................................................................... 145Sulfur for external use.................................................................. 3019Sulfuric acid .................................................................................... 3019Sulindac ...........................................................................................3020Sulpiride...........................................................................................3021Sultamicillin ....................................................................................3022Sultamicillin tosilate dihydrate...................................................3024Sumatra benzoin............................................................................1068Sumatra benzoin tincture ............................................................1069Sumatriptan succinate..................................................................3026Sunflower oil, refined ...................................................................3028Supercritical fluid chromatography (2.2.45.) .............................. 70Suppositories .................................................................................... 733Suppositories and pessaries, disintegration of (2.9.2.)............ 255Suppositories, lipophilic, softening time determination(2.9.22.) ............................................................................................ 288

Suspensions, solutions and emulsions, oral .............................. 718Suspensions, solutions, intrauterine ........................................... 715Sutures, sterile non-absorbable ..................................................1028Sutures, sterile synthetic absorbable braided ........................ 1031Sutures, sterile synthetic absorbable monofilament ............1033Suxamethonium chloride.............................................................3028Suxibuzone......................................................................................3029Sweet fennel ....................................................................................1125Sweet orange oil.............................................................................1249Swelling index (2.8.4.)..................................................................... 239Swine erysipelas vaccine (inactivated) ........................................ 939Swine-fever vaccine (live, prepared in cell cultures),classical ............................................................................................ 940

Symbols and abbreviations (1.) ..........................................................3Synthetic absorbable braided sutures, sterile ......................... 1031Synthetic absorbable monofilament sutures, sterile..............1033Syringes, plastic, sterile single-use (3.2.8.) ................................. 373Syrups................................................................................................. 719

TTable of physical characteristics of radionuclides mentioned inthe European Pharmacopoeia (5.7.).......................................... 611

Tablets ................................................................................................ 736

Tablets and capsules, disintegration of (2.9.1.) ......................... 253Tablets, buccal .................................................................................. 723Tablets, coated.................................................................................. 737Tablets, dispersible .......................................................................... 737Tablets, effervescent ........................................................................ 737Tablets for intrauterine solutions and suspensions ................. 715Tablets for use in the mouth ......................................................... 738Tablets for vaginal solutions and suspensions .......................... 739Tablets, gastro-resistant.................................................................. 738Tablets, intrauterine ........................................................................ 715Tablets, modified-release ................................................................ 738Tablets, orodispersible .................................................................... 737Tablets, resistance to crushing (2.9.8.) ....................................... 267Tablets, soluble................................................................................. 737Tablets, subdivision of .................................................................... 736Tablets, sublingual........................................................................... 723Tablets, uncoated ............................................................................. 737Tablets, uncoated, friability of (2.9.7.) ......................................... 266Tablets, uncoated, friability of (2.9.7.) (5.8.) .............................. 622Tablets, vaginal................................................................................. 739Talc....................................................................................................3033Tamoxifen citrate ...........................................................................3034Tampons, ear..................................................................................... 710Tampons, medicated ....................................................................... 738Tampons, rectal ................................................................................ 734Tampons, vaginal, medicated ........................................................ 740Tamsulosin hydrochloride ...........................................................3036Tannic acid ......................................................................................3037Tannins in herbal drugs, determination of (2.8.14.) ................ 243Tapped density of powders, bulk density and (2.9.34.) ........... 305Tartaric acid ....................................................................................3038Teat dips............................................................................................. 740Tea tree oil ....................................................................................... 1251Teat sprays..........................................................................................741Technetium (99mTc) bicisate injection ........................................1004Technetium (99mTc) colloidal rhenium sulfide injection .......1005Technetium (99mTc) colloidal sulfur injection...........................1006Technetium (99mTc) colloidal tin injection ................................1006Technetium (99mTc) etifenin injection ........................................1007Technetium (99mTc) exametazime injection ..............................1008Technetium (99mTc) gluconate injection ....................................1009Technetium (99mTc) human albumin injection ......................... 1010Technetium (99mTc) macrosalb injection.................................... 1011Technetium (99mTc) mebrofenin injection ................................. 1012Technetium (99mTc) medronate injection................................... 1013Technetium (99mTc) mertiatide injection ................................... 1014Technetium (99mTc) microspheres injection.............................. 1015Technetium (99mTc) pentetate injection..................................... 1016Technetium (99mTc) sestamibi injection ..................................... 1017Technetium (99mTc) succimer injection...................................... 1018Technetium (99mTc) tin pyrophosphate injection..................... 1019Teicoplanin ......................................................................................3038Telmisartan......................................................................................3040Temazepam......................................................................................3042Tenosynovitis avian viral vaccine (live) ....................................... 861Tenoxicam........................................................................................3043Terazosin hydrochloride dihydrate ............................................3045Terbinafine hydrochloride............................................................3047Terbutaline sulfate.........................................................................3048Terconazole .....................................................................................3049Terfenadine......................................................................................3050Terminology used in monographs on biological products(5.2.1.)............................................................................................... 527

Test for anticomplementary activity of immunoglobulin(2.6.17.)............................................................................................. 177

Test for anti-D antibodies in human immunoglobulin forintravenous administration (2.6.26.) ......................................... 191

Test for aristolochic acids in herbal drugs (2.8.21) .................. 247Test for extractable volume of parenteral preparations(2.9.17.)............................................................................................. 273

Test for extractable volume of parenteral preparations (2.9.17.)(5.8.).................................................................................................. 622

Test for Fc function of immunoglobulin (2.7.9.) ........................217



Test for methanol and 2-propanol (2.9.11.) ................................ 270Test for neurovirulence of live virus vaccines (2.6.18.) ........... 179Test for neurovirulence of poliomyelitis vaccine (oral)(2.6.19.) ............................................................................................ 179

Test for specified micro-organisms (microbiological examinationof non-sterile products) (2.6.13.) ................................................ 167

Test for specified micro-organisms (microbiological examinationof non-sterile products) (2.6.13.) (5.8.) ..................................... 622

Testosterone ....................................................................................3052Testosterone decanoate ................................................................3053Testosterone enantate...................................................................3054Testosterone isocaproate..............................................................3056Testosterone propionate...............................................................3057Tests for extraneous agents in viral vaccines for human use(2.6.16.) ............................................................................................ 176

Tetanus and diphtheria toxins and toxoids, flocculation value(Lf) of, (Ramon assay) (2.7.27.) ................................................... 231

Tetanus and diphtheria vaccine (adsorbed, reduced antigen(s)content)............................................................................................ 752

Tetanus antitoxin for human use ................................................. 953Tetanus antitoxin for veterinary use............................................ 960Tetanus, diphtheria and hepatitis B (rDNA) vaccine(adsorbed)........................................................................................ 753

Tetanus, diphtheria and pertussis (acellular, component)vaccine (adsorbed)......................................................................... 754

Tetanus, diphtheria and poliomyelitis (inactivated) vaccine(adsorbed, reduced antigen(s) content) .................................... 756

Tetanus, diphtheria, pertussis (acellular, component) andhaemophilus type b conjugate vaccine (adsorbed) ................ 758

Tetanus, diphtheria, pertussis (acellular, component) andhepatitis B (rDNA) vaccine (adsorbed) ..................................... 760

Tetanus, diphtheria, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed) ........................ 762

Tetanus, diphtheria, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed, reducedantigen(s) content) ........................................................................ 763

Tetanus, diphtheria, pertussis (acellular, component),hepatitis B (rDNA), poliomyelitis (inactivated) and haemophilustype b conjugate vaccine (adsorbed) ......................................... 765

Tetanus, diphtheria, pertussis (acellular, component),poliomyelitis (inactivated) and haemophilus type b conjugatevaccine (adsorbed)......................................................................... 768

Tetanus, diphtheria, pertussis and poliomyelitis (inactivated)vaccine (adsorbed)......................................................................... 771

Tetanus, diphtheria, pertussis, poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) ................ 772

Tetanus immunoglobulin, human .............................................. 2187Tetanus vaccine (adsorbed) ........................................................... 833Tetanus vaccine (adsorbed), assay of (2.7.8.) ............................. 214Tetanus vaccine for veterinary use .............................................. 941Tetracaine hydrochloride .............................................................3058Tetracosactide.................................................................................3059Tetracycline .....................................................................................3060Tetracycline hydrochloride ..........................................................3061Tetra-O-acetyl-mannose triflate for radiopharmaceuticalpreparations..................................................................................1020

Tetrazepam......................................................................................3063Tetryzoline hydrochloride............................................................3064Thallous (201Tl) chloride injection............................................... 1021Theobromine...................................................................................3065Theophylline ...................................................................................3065Theophylline-ethylenediamine, anhydrous...............................3068Theophylline-ethylenediamine hydrate .....................................3069Theophylline monohydrate..........................................................3066Thermal analysis (2.2.34.) ................................................................ 54Thermogravimetry (2.2.34.) ............................................................. 54Thiamazole ......................................................................................3071Thiamine hydrochloride ...............................................................3072Thiamine nitrate.............................................................................3073Thiamphenicol ................................................................................3074Thin-layer chromatography (2.2.27.).............................................. 42Thioctic acid ....................................................................................3075Thiomersal.......................................................................................3076

Thiopental sodium and sodium carbonate...............................3077Thioridazine ....................................................................................3078Thioridazine hydrochloride .........................................................3079Three-lobed sage leaf..................................................................... 1231Threonine.........................................................................................3080Thyme ...............................................................................................1252Thyme oil ........................................................................................1254Thyme, wild .....................................................................................1267Thymol..............................................................................................3081Tiabendazole ...................................................................................3081Tiamulin for veterinary use .........................................................3082Tiamulin hydrogen fumarate for veterinary use .....................3084Tianeptine sodium .........................................................................3086Tiapride hydrochloride .................................................................3087Tiaprofenic acid ..............................................................................3088Tibolone ...........................................................................................3090Ticarcillin sodium...........................................................................3091Tick-borne encephalitis vaccine (inactivated) ............................ 834Ticlopidine hydrochloride ............................................................3092Tilidine hydrochloride hemihydrate ..........................................3094Timolol maleate ..............................................................................3095Tinctures ............................................................................................ 675Tinidazole ........................................................................................3097Tinnevelly senna pods...................................................................1238Tinzaparin sodium.........................................................................3098Tioconazole .....................................................................................3099Tiotropium bromide monohydrate............................................. 3100Titanium dioxide ............................................................................ 3101Titration, amperometric (2.2.19.).................................................... 34Titration, potentiometric (2.2.20.) .................................................. 34Titrations, complexometric (2.5.11.) ............................................ 140Tobramycin ...................................................................................... 3103Tocopherol, all-rac-α- .................................................................... 3104Tocopherol, RRR-α- ....................................................................... 3105Tocopheryl acetate, all-rac-α- ...................................................... 3106α-Tocopheryl acetate concentrate (powder form) .................. 3109Tocopheryl acetate, RRR-α-......................................................... 3108Tocopheryl hydrogen succinate, DL-α- ...................................... 3110Tocopheryl hydrogen succinate, RRR-α- .................................. 3111Tolbutamide .................................................................................... 3113Tolfenamic acid............................................................................... 3114Tolnaftate......................................................................................... 3115Tolu balsam .....................................................................................1254Torasemide, anhydrous................................................................. 3117Tormentil .........................................................................................1255Tormentil tincture..........................................................................1256Tosylchloramide sodium............................................................... 3118Total ash (2.4.16.)............................................................................. 118Total cholesterol in oils rich in omega-3 acids (2.4.32.) .......... 133Total organic carbon in water for pharmaceutical use(2.2.44.) .............................................................................................. 69

Total protein (2.5.33.) ..................................................................... 147Toxicity, abnormal (2.6.9.).............................................................. 162Toxin, botulinum type A for injection .......................................1504Tragacanth ......................................................................................1256Tramadol hydrochloride ............................................................... 3118Tramazoline hydrochloride monohydrate ................................ 3120Trandolapril..................................................................................... 3120Tranexamic acid ............................................................................. 3122Transdermal patches ....................................................................... 726Transdermal patches, dissolution test for (2.9.4.) .................... 263Trapidil ............................................................................................. 3123Trehalose dihydrate....................................................................... 3124Tretinoin .......................................................................................... 3125Triacetin ........................................................................................... 3127Triamcinolone................................................................................. 3127Triamcinolone acetonide.............................................................. 3128Triamcinolone hexacetonide ....................................................... 3130Triamterene ..................................................................................... 3131Tribenoside...................................................................................... 3132Tributyl acetylcitrate ..................................................................... 3133Trichloroacetic acid ....................................................................... 3135Triethanolamine ............................................................................. 3148



Triethyl citrate ................................................................................ 3136Trifluoperazine hydrochloride .................................................... 3136Triflusal ............................................................................................ 3137Triglycerides, medium-chain........................................................ 3138Triglycerides, omega-3-acid.......................................................... 2619Triglycerol diisostearate ............................................................... 3140Trihexyphenidyl hydrochloride................................................... 3140Trimebutine maleate ..................................................................... 3141Trimetazidine dihydrochloride.................................................... 3142Trimethadione ................................................................................ 3144Trimethoprim.................................................................................. 3144Trimipramine maleate ................................................................... 3146Tri-n-butyl phosphate .................................................................... 3134Tritiated (3H) water injection.......................................................1022Trolamine......................................................................................... 3148Trometamol ..................................................................................... 3150Tropicamide..................................................................................... 3151Tropisetron hydrochloride ........................................................... 3152Trospium chloride.......................................................................... 3154Troxerutin........................................................................................ 3155Trypsin ............................................................................................. 3156Tryptophan...................................................................................... 3157TSE, animal, minimising the risk of transmitting via human andveterinary medicinal products (5.2.8.) ...................................... 539

TSE, animal, products with risk of transmitting agents of..... 686Tuberculin for human use, old.................................................... 3159Tuberculin purified protein derivative, avian .......................... 3161Tuberculin purified protein derivative, bovine........................ 3161Tuberculin purified protein derivative for human use .......... 3162Tubes for comparative tests (2.1.5.) ................................................17Tubing and closures, silicone elastomer for (3.1.9.)................. 347Tubing and containers for total parenteral nutritionpreparations, poly(ethylene - vinyl acetate) for (3.1.7.) ......... 345

Tubing used in sets for the transfusion of blood and bloodcomponents, materials based on plasticised poly(vinyl chloride)for (3.1.1.2.) ..................................................................................... 332

Tubocurarine chloride .................................................................. 3164Turmeric, Javanese ........................................................................1257Turpentine oil, Pinus pinaster type ...........................................1258Tylosin for veterinary use ............................................................ 3165Tylosin phosphate bulk solution for veterinary use .............. 3166Tylosin tartrate for veterinary use ............................................. 3168Typhoid polysaccharide vaccine ................................................... 836Typhoid vaccine................................................................................ 837Typhoid vaccine, freeze-dried........................................................ 837Typhoid vaccine (live, oral, strain Ty 21a).................................. 838Tyrosine............................................................................................ 3169Tyrothricin....................................................................................... 3170

UUbidecarenone................................................................................ 3175Udder-washes .....................................................................................741Ultraviolet and visible absorption spectrophotometry(2.2.25.) .............................................................................................. 40

Ultraviolet ray lamps for analytical purposes (2.1.3.)................. 15Uncoated tablets............................................................................... 737Undecylenic acid ............................................................................ 3176Uniformity of content of single-dose preparations (2.9.6.) ..... 266Uniformity of dosage units (2.9.40.) ............................................ 315Uniformity of mass of delivered doses from multidose containers(2.9.27.) ............................................................................................ 294

Uniformity of mass of single-dose preparations (2.9.5.) .......... 265Units of the International System (SI) used in the Pharmacopoeiaand equivalence with other units (1.).............................................3

Unsaponifiable matter (2.5.7.) ....................................................... 139Urea................................................................................................... 3176Urofollitropin .................................................................................. 3177Urokinase......................................................................................... 3178Uronic acids in polysaccharide vaccines (2.5.22.)..................... 143Ursodeoxycholic acid ................................................................... 3180

VVaccines, adsorbed, aluminium in (2.5.13.).................................141Vaccines, adsorbed, calcium in (2.5.14.).......................................141Vaccines and immunosera, phenol in (2.5.15.) ...........................141Vaccines and immunosera, veterinary, evaluation of efficacy of(5.2.7.)............................................................................................... 538

Vaccines and immunosera, veterinary, evaluation of safety(5.2.6.) .............................................................................................. 536

Vaccines and immunosera, veterinary, evaluation of the safetyof each batch (5.2.9.)..................................................................... 547

Vaccines for human use.................................................................. 695Vaccines for human use, cell substrates for the production of(5.2.3.) .............................................................................................. 530

Vaccines for human use, viral, tests for extraneous agents in(2.6.16.) ............................................................................................ 176

Vaccines for veterinary use............................................................ 698Vaccines, polysaccharide, hexosamines in (2.5.20.).................. 142Vaccines, polysaccharide, methylpentoses in (2.5.21.)............. 143Vaccines, polysaccharide, nucleic acids in (2.5.17.) .................. 142Vaccines, polysaccharide, O-acetyl in (2.5.19.)........................... 142Vaccines, polysaccharide, phosphorus in (2.5.18.) ................... 142Vaccines, polysaccharide, protein in (2.5.16.) .............................141Vaccines, polysaccharide, ribose in (2.5.31.) .............................. 146Vaccines, polysaccharide, sialic acid in (2.5.23.) ....................... 143Vaccines, polysaccharide, uronic acids in (2.5.22.)................... 143Vaccines, SPF chicken flocks for the production and qualitycontrol of (5.2.2.) .......................................................................... 527

Vaccines, veterinary, cell cultures for the production of(5.2.4.) .............................................................................................. 533

Vaccines, viral live, test for neurovirulence (2.6.18.)................ 179Vaginal capsules ............................................................................... 739Vaginal foams.................................................................................... 740Vaginal preparations ....................................................................... 738Vaginal preparations, semi-solid ................................................... 740Vaginal solutions and suspensions, tablets for ......................... 739Vaginal solutions, emulsions and suspensions.......................... 739Vaginal tablets .................................................................................. 739Vaginal tampons, medicated.......................................................... 740Valaciclovir hydrochloride, anhydrous...................................... 3185Valerian dry aqueous extract .....................................................1259Valerian dry hydroalcoholic extract...........................................1260Valerian root....................................................................................1261Valerian root, cut............................................................................1262Valerian tincture.............................................................................1263Validation of nucleic acid amplification techniques forthe detection of B19 virus (B19V) DNA in plasma pools :guidelines ........................................................................................ 181

Validation of nucleic acid amplification techniques for thedetection of hepatitis C virus (HCV) RNA in plasma pools :guidelines ........................................................................................ 181

Valine ................................................................................................ 3188Valnemulin hydrochloride for veterinary use ......................... 3188Valproate, sodium ..........................................................................2951Valproic acid.................................................................................... 3190Valsartan .......................................................................................... 3191Vancomycin hydrochloride .......................................................... 3192Vanillin ............................................................................................. 3194Varicella immunoglobulin for intravenous administration,human ............................................................................................ 2189

Varicella immunoglobulin, human............................................. 2188Varicella, measles, mumps and rubella vaccine (live) .............. 799Varicella vaccine (live)..................................................................... 839Vectors for human use, adenovirus ............................................. 650Vectors for human use, plasmid ................................................... 648Vectors for human use, plasmid, bacterial cells used for themanufacture of ............................................................................... 649

Vectors for human use, poxvirus .................................................. 652Vecuronium bromide..................................................................... 3195Vedaprofen for veterinary use..................................................... 3196Vegetable fatty oils........................................................................... 703Venlafaxine hydrochloride ........................................................... 3197Verapamil hydrochloride .............................................................. 3198

General Notices (1) apply to all monographs and other texts 3294a


Verbena herb...................................................................................1264Veterinary liquid preparations for cutaneous application ...... 740Veterinary medicinal products, immunological, substances ofanimal origin for the production of (5.2.5.) ............................. 535

Veterinary vaccines and immunosera, evaluation of efficacy of(5.2.7.)............................................................................................... 538

Viability, nucleated cell count and (2.7.29.) ............................... 233Vibriosis (cold-water) vaccine (inactivated) for salmonids ...... 943Vibriosis vaccine (inactivated) for salmonids............................. 944VICH (5.8.) ......................................................................................... 621Vinblastine sulfate .........................................................................3200Vincristine sulfate ..........................................................................3201Vindesine sulfate ............................................................................3202Vinorelbine tartrate .......................................................................3204Vinpocetine......................................................................................3206Viper venom antiserum, European .............................................. 953Viral rhinotracheitis vaccine (inactivated), feline...................... 901Viral rhinotracheitis vaccine (live), feline ................................... 902Viral safety (5.1.7.) ........................................................................... 518Viral vaccines for human use, tests for extraneous agents in(2.6.16.) ............................................................................................ 176

Viscometer method, capillary (2.2.9.) ............................................ 27Viscometer method, falling ball (2.2.49.) ...................................... 83Viscose wadding, absorbent ........................................................3207Viscosity (2.2.8.) ................................................................................. 27Viscosity - rotating viscometer method (2.2.10.) ......................... 28Visible and ultraviolet absorption spectrophotometry(2.2.25.) .............................................................................................. 40

Visible particles, particulate contamination (2.9.20.) .............. 287Vitamin A .........................................................................................3208Vitamin A concentrate (oily form), synthetic ...........................3209Vitamin A concentrate (powder form), synthetic .................... 3211Vitamin A concentrate (solubilisate/emulsion), synthetic ...3212Volumetric analysis (4.2.) ............................................................... 494Volumetric solutions (4.2.2.).......................................................... 494Volumetric solutions, primary standards for (4.2.1.) ............... 494von Willebrand factor, human .................................................... 2189von Willebrand factor, human, assay of (2.7.21.) ...................... 226

WWarfarin sodium............................................................................. 3217Warfarin sodium clathrate ........................................................... 3218Washes, nasal.................................................................................... 721Water (15O) injection......................................................................1023Water, determination by distillation (2.2.13.) ...............................31Water for diluting concentrated haemodialysis solutions .... 2135Water for injections ....................................................................... 3219Water for pharmaceutical use, total organic carbon in(2.2.44.) .............................................................................................. 69

Water, highly purified ...................................................................3222Water in essential oils (2.8.5.) ....................................................... 239Water in gases (2.5.28.) .................................................................. 145Water : micro determination (2.5.32.) .......................................... 146Water, purified................................................................................3224

Water : semi-micro determination (2.5.12.)................................. 140Wettability of porous solids including powders (2.9.45.)........ 321Wheat-germ oil, refined ................................................................3226Wheat-germ oil, virgin...................................................................3227Wheat starch ...................................................................................3226White beeswax ................................................................................1453White horehound...........................................................................1265White soft paraffin.........................................................................2670Wild pansy (flowering aerial parts)............................................1266Wild thyme ......................................................................................1267Willow bark .....................................................................................1268Willow bark dry extract ................................................................1269Wool alcohols..................................................................................3227Wool fat ............................................................................................3228Wool fat, hydrogenated.................................................................3232Wool fat, hydrous...........................................................................3233Wormwood ......................................................................................1270

XXanthan gum ..................................................................................3237Xenon (133Xe) injection..................................................................1023X-ray fluorescence spectrometry (2.2.37.)..................................... 58X-ray powder diffraction (XRPD), characterisation of crystallineand partially crystalline solids by (2.9.33.) .............................. 301

Xylazine hydrochloride for veterinary use ...............................3238Xylitol ................................................................................................3239Xylometazoline hydrochloride ....................................................3241Xylose................................................................................................3242

YYarrow ..............................................................................................1271Yellow beeswax ...............................................................................1454Yellow fever vaccine (live) .............................................................. 840Yellow soft paraffin........................................................................2671Yohimbine hydrochloride .............................................................3247

ZZidovudine.......................................................................................3251Zinc acetate dihydrate...................................................................3252Zinc acexamate ...............................................................................3253Zinc chloride ...................................................................................3254Zinc gluconate ................................................................................3255Zinc oxide.........................................................................................3255Zinc stearate....................................................................................3256Zinc sulfate heptahydrate.............................................................3257Zinc sulfate hexahydrate ..............................................................3257Zinc sulfate monohydrate.............................................................3257Zinc undecylenate ..........................................................................3258Ziprasidone hydrochloride monohydrate .................................3258Zolpidem tartrate ...........................................................................3260Zopiclone .........................................................................................3261Zoster (shingles) vaccine (live), herpes ....................................... 828Zuclopenthixol decanoate ............................................................3263

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

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EUROPEAN PHARMACOPOEIA 7.0 Monographs deleted from the