EUROPEAN PHARMACOPOEIA 5.3 INDEX · 2.9.17. Test for extractable volume of parenteral preparations ... 2.9.28. Test for deliverable mass or volume of liquid and semi-solid preparations

EUROPEAN PHARMACOPOEIA 5.3

INDEX

To aid users the index includes a reference to the supplement where the latest version of a text can be found.

For example: Acetone...............................................5.1-2875

means the monograph Acetone can be found on page 2875 of Supplement 5.1.

Note that where no reference for a supplement is made, the text can be found in the principal volume.

General Notices (1) apply to all monographs and other texts 3649

EUROPEAN PHARMACOPOEIA 5.3

3650 See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 5.3 Index

Numerics1.1. General statements.................................................................51.2. Other provisions applying to general chapters andmonographs ...................................................................................5

1.3. General chapters .....................................................................61.4. Monographs .............................................................................71.5. Abbreviations and symbols ...................................................91.6. Units of the International System (SI) used in thePharmacopoeia and equivalence with other units..............10

1,8-Cineole in essential oils, assay of (2.8.11.) ......................2161. General notices ...........................................................................52.1.1. Droppers ..............................................................................172.1.2. Comparative table of porosity of sintered-glassfilters..............................................................................................17

2.1.3. Ultraviolet ray lamps for analytical purposes..............172.1.4. Sieves ...................................................................................182.1.5. Tubes for comparative tests ............................................192.1.6. Gas detector tubes.............................................................192.1. Apparatus ...............................................................................172.2.10. Viscosity - Rotating viscometer method .........5.3-33372.2.11. Distillation range ............................................................ 302.2.12. Boiling point ....................................................................312.2.13. Determination of water by distillation....................... 322.2.14. Melting point - capillary method................................. 322.2.15. Melting point - open capillary method ...................... 332.2.16. Melting point - instantaneous method ...................... 332.2.17. Drop point ........................................................................ 332.2.18. Freezing point................................................................. 342.2.19. Amperometric titration ................................................. 342.2.1. Clarity and degree of opalescence of liquids.............. 232.2.20. Potentiometric titration ................................................ 352.2.21. Fluorimetry...................................................................... 352.2.22. Atomic emission spectrometry .................................... 352.2.23. Atomic absorption spectrometry ................................ 362.2.24. Absorption spectrophotometry, infrared .................. 372.2.25. Absorption spectrophotometry, ultraviolet andvisible.................................................................................5.2-3089

2.2.26. Paper chromatography ................................................. 402.2.27. Thin-layer chromatography ...............................5.2-30902.2.28. Gas chromatography ..................................................... 422.2.29. Liquid chromatography ................................................ 432.2.2. Degree of coloration of liquids...................................... 242.2.30. Size-exclusion chromatography .................................. 452.2.31. Electrophoresis ............................................................... 452.2.32. Loss on drying ................................................................ 502.2.33. Nuclear magnetic resonance spectrometry ...............512.2.34. Thermal analysis............................................................. 522.2.35. Osmolality ........................................................................ 542.2.36. Potentiometric determination of ionicconcentration using ion-selective electrodes....................... 55

2.2.37. X-ray fluorescence spectrometry................................. 562.2.38. Conductivity .........................................................5.1-27832.2.39. Molecular mass distribution in dextrans .................. 572.2.3. Potentiometric determination of pH............................ 262.2.40. Near-infrared spectrophotometry ............................... 592.2.41. Circular dichroism.......................................................... 632.2.42. Density of solids ............................................................. 642.2.43. Mass spectrometry ......................................................... 652.2.44. Total organic carbon in water for pharmaceuticaluse................................................................................................. 68

2.2.45. Supercritical fluid chromatography........................... 682.2.46. Chromatographic separation techniques.................. 692.2.47. Capillary electrophoresis ...............................................742.2.48. Raman spectrometry ..................................................... 792.2.49. Falling ball viscometer method................................... 802.2.4. Relationship between reaction of solution,approximate pH and colour of certain indicators .............. 27

2.2.54. Isoelectric focusing.........................................................812.2.55. Peptide mapping............................................................. 82

2.2.56. Amino acid analysis ....................................................... 862.2.5. Relative density................................................................. 272.2.6. Refractive index ................................................................ 282.2.7. Optical rotation ................................................................. 282.2.8. Viscosity.............................................................................. 292.2.9. Capillary viscometer method ......................................... 292.2. Physical and physicochemical methods.......................... 232.3.1. Identification reactions of ions and functionalgroups .......................................................................................... 95

2.3.2. Identification of fatty oils by thin-layerchromatography......................................................................... 98

2.3.3. Identification of phenothiazines by thin-layerchromatography......................................................................... 99

2.3.4. Odour .................................................................................. 992.3. Identification......................................................................... 952.4.10. Lead in sugars............................................................... 1072.4.11. Phosphates..................................................................... 1082.4.12. Potassium....................................................................... 1082.4.13. Sulphates ....................................................................... 1082.4.14. Sulphated ash ......................................................5.3-33412.4.15. Nickel in polyols ........................................................... 1082.4.16. Total ash......................................................................... 1082.4.17. Aluminium...................................................................... 1082.4.18. Free formaldehyde ....................................................... 1092.4.19. Alkaline impurities in fatty oils ................................. 1092.4.1. Ammonium....................................................................... 1032.4.21. Foreign oils in fatty oils by thin-layerchromatography....................................................................... 109

2.4.22. Composition of fatty acids by gaschromatography........................................................................110

2.4.23. Sterols in fatty oils ..............................................5.1-27872.4.24. Identification and control of residual solvents...... 1132.4.25. Ethylene oxide and dioxan..........................................1182.4.26. N,N-Dimethylaniline .....................................................1192.4.27. Heavy metals in herbal drugs and fatty oils ............1192.4.28. 2-Ethylhexanoic acid ................................................... 1202.4.29. Composition of fatty acids in oils rich inomega-3-acids............................................................................ 121

2.4.2. Arsenic .............................................................................. 1032.4.30. Ethylene glycol and diethylene glycol in ethoxylatedsubstances ........................................................................5.2-3095

2.4.3. Calcium............................................................................. 1032.4.4. Chlorides .......................................................................... 1042.4.5. Fluorides .......................................................................... 1042.4.6. Magnesium....................................................................... 1042.4.7. Magnesium and alkaline-earth metals ....................... 1042.4.8. Heavy metals ................................................................... 1042.4.9. Iron .................................................................................... 1072.4. Limit tests ............................................................................ 1032.5.10. Oxygen-flask method................................................... 1302.5.11. Complexometric titrations.......................................... 1302.5.12. Water: semi-micro determination ............................. 1302.5.13. Aluminium in adsorbed vaccines...............................1312.5.14. Calcium in adsorbed vaccines ....................................1312.5.15. Phenol in immunosera and vaccines ........................1312.5.16. Protein in polysaccharide vaccines ...........................1312.5.17. Nucleic acids in polysaccharide vaccines ................ 1322.5.18. Phosphorus in polysaccharide vaccines.................. 1322.5.19. O-Acetyl in polysaccharide vaccines......................... 1322.5.1. Acid value................................................................5.2-30992.5.20. Hexosamines in polysaccharide vaccines................ 1322.5.21. Methylpentoses in polysaccharide vaccines ........... 1332.5.22. Uronic acids in polysaccharide vaccines ................. 1332.5.23. Sialic acid in polysaccharide vaccines ..................... 1332.5.24. Carbon dioxide in gases.............................................. 1342.5.25. Carbon monoxide in gases ......................................... 1342.5.26. Nitrogen monoxide and nitrogen dioxide ingases ........................................................................................... 135

2.5.27. Oxygen in gases ............................................................ 136


Index EUROPEAN PHARMACOPOEIA 5.3

2.5.28. Water in gases............................................................... 1362.5.29. Sulphur dioxide ............................................................ 1362.5.2. Ester value ....................................................................... 1272.5.30. Oxidising substances................................................... 1372.5.31. Ribose in polysaccharide vaccines............................ 1372.5.32. Water: micro determination ...................................... 1372.5.33. Total protein.................................................................. 1382.5.34. Acetic acid in synthetic peptides ...............................1412.5.35. Nitrous oxide in gases ..................................................1412.5.36. Anisidine value ............................................................. 1422.5.3. Hydroxyl value ................................................................ 1272.5.4. Iodine value ..................................................................... 1272.5.5. Peroxide value................................................................. 1282.5.6. Saponification value ...................................................... 1292.5.7. Unsaponifiable matter ................................................... 1292.5.8. Determination of primary aromaticamino-nitrogen ......................................................................... 129

2.5.9. Determination of nitrogen by sulphuric aciddigestion .................................................................................... 129

2.5. Assays ................................................................................... 1272.6.10. Histamine ....................................................................... 1532.6.11. Depressor substances.................................................. 1532.6.12. Microbiological examination of non-sterile products(total viable aerobic count).................................................... 154

2.6.13. Microbiological examination of non-sterile products(test for specified micro-organisms)..................................... 156

2.6.14. Bacterial endotoxins .....................................................1612.6.15. Prekallikrein activator................................................. 1682.6.16. Tests for extraneous agents in viral vaccines forhuman use................................................................................. 169

2.6.17. Test for anticomplementary activity ofimmunoglobulin....................................................................... 170

2.6.18. Test for neurovirulence of live virus vaccines........ 1722.6.19. Test for neurovirulence of poliomyelitis vaccine(oral) ........................................................................................... 172

2.6.1. Sterility ............................................................................. 1452.6.20. Anti-A and anti-B haemagglutinins(indirect method) ......................................................................174

2.6.21. Nucleic acid amplification techniques ......................1742.6.22. Activated coagulation factors .................................... 1772.6.24. Avian viral vaccines : tests for extraneous agents inseed lots ..................................................................................... 177

2.6.25. Avian live virus vaccines : tests for extraneous agentsin batches of finished product .....................................5.3-3345

2.6.26. Test for anti-D antibodies in human immunoglobulinfor intravenous administration ....................................5.3-3348

2.6.2. Mycobacteria ................................................................... 1492.6.7. Mycoplasmas.................................................................... 1492.6.8. Pyrogens........................................................................... 1522.6.9. Abnormal toxicity ........................................................... 1532.6. Biological tests ................................................................... 1452.7.10. Assay of human coagulation factor VII ................... 2032.7.11. Assay of human coagulation factor IX ..................... 2042.7.12. Assay of heparin in coagulation factors .................. 2042.7.13. Assay of human anti-D immunoglobulin................. 2052.7.14. Assay of hepatitis A vaccine ..............................5.1-27952.7.15. Assay of hepatitis B vaccine (rDNA)......................... 2072.7.16. Assay of pertussis vaccine (acellular)....................... 2082.7.17. Assay of human antithrombin III .............................. 2092.7.18. Assay of human coagulation factor II ...................... 2092.7.19. Assay of human coagulation factor X .......................2102.7.1. Immunochemical methods ........................................... 1872.7.20. In vivo assay of poliomyelitis vaccine(inactivated) ...............................................................................210

2.7.21. Assay of human von Willebrand factor.....................2112.7.22. Assay of human coagulation factor XI..................... 2122.7.2. Microbiological assay of antibiotics ............................ 1882.7.4. Assay of human coagulation factor VIII .................... 1942.7.5. Assay of heparin.............................................................. 195

2.7.6. Assay of diphtheria vaccine (adsorbed) ..................... 1962.7.7. Assay of pertussis vaccine............................................. 1972.7.8. Assay of tetanus vaccine (adsorbed)..................5.1-27912.7.9. Test for Fc function of immunoglobulin ................... 2022.7. Biological assays ................................................................ 1872.8.10. Solubility in alcohol of essential oils ........................2162.8.11. Assay of 1,8-cineole in essential oils .........................2162.8.12. Determination of essential oils in vegetabledrugs............................................................................................217

2.8.13. Pesticide residues..........................................................2182.8.14. Determination of tannins in herbal drugs .............. 2212.8.15. Bitterness value ............................................................ 2212.8.16. Dry residue of extracts................................................ 2222.8.17. Loss on drying of extracts .......................................... 2222.8.1. Ash insoluble in hydrochloric acid ............................. 2152.8.2. Foreign matter ................................................................ 2152.8.3. Stomata and stomatal index ........................................ 2152.8.4. Swelling index ................................................................. 2152.8.5. Water in essential oils.....................................................2162.8.6. Foreign esters in essential oils .....................................2162.8.7. Fatty oils and resinified essential oils in essentialoils................................................................................................216

2.8.8. Odour and taste of essential oils..................................2162.8.9. Residue on evaporation of essential oils ....................2162.8. Methods in pharmacognosy ............................................ 2152.9.10. Ethanol content and alcoholimetric tables ............ 2372.9.11. Test for methanol and 2-propanol ...................5.3-33622.9.12. Sieve test ........................................................................ 2392.9.13. Limit test of particle size by microscopy................. 2392.9.14. Specific surface area by air permeability ................ 2392.9.15. Apparent volume .......................................................... 2412.9.16. Flowability...................................................................... 2422.9.17. Test for extractable volume of parenteralpreparations .....................................................................5.3-3363

2.9.18. Preparations for inhalation : aerodynamic assessmentof fine particles ...............................................................5.2-3103

2.9.19. Particulate contamination : sub-visible particles... 2532.9.1. Disintegration of tablets and capsules..............5.3-33512.9.20. Particulate contamination : visible particles .......... 2552.9.22. Softening time determination of lipophilicsuppositories............................................................................. 256

2.9.23. Pycnometric density of solids.................................... 2572.9.24. Resistance to rupture of suppositories andpessaries .................................................................................... 258

2.9.25. Dissolution test for medicated chewinggums ..................................................................................5.2-3116

2.9.26. Specific surface area by gas adsorption.........5.1-28112.9.27. Uniformity of mass of delivered doses from multidosecontainers.................................................................................. 263

2.9.28. Test for deliverable mass or volume of liquid andsemi-solid preparations........................................................... 263

2.9.2. Disintegration of suppositories and pessaries ......... 2272.9.36. Powder flow..........................................................5.3-33632.9.37. Optical microscopy..............................................5.3-33662.9.38. Particle-size distribution estimation by analyticalsieving ...............................................................................5.3-3368

2.9.3. Dissolution test for solid dosage forms ............5.3-33532.9.40. Uniformity of dosage units................................5.3-33702.9.42. Dissolution test for lipophilic solid dosageforms..................................................................................5.3-3373

2.9.4. Dissolution test for transdermal patches .................. 2312.9.5. Uniformity of mass of single-dose preparations....... 2332.9.6. Uniformity of content of single-dose preparations.. 2342.9.7. Friability of uncoated tablets ..............................5.2-31032.9.8. Resistance to crushing of tablets................................ 2352.9.9. Measurement of consistency by penetrometry ........ 2352.9. Pharmaceutical technical procedures ........................... 2252-Ethylhexanoic acid (2.4.28.) ................................................. 1202-Propanol and methanol, test for (2.9.11.).................5.3-3362



3.1.10. Materials based on non-plasticised poly(vinyl chloride)for containers for non-injectable, aqueous solutions ...... 289

3.1.11. Materials based on non-plasticised poly(vinylchloride) for containers for dry dosage forms for oraladministration .......................................................................... 291

3.1.1.1. Materials based on plasticised poly(vinyl chloride) forcontainers for human blood and blood components....... 269

3.1.1.2. Materials based on plasticised poly(vinyl chloride)for tubing used in sets for the transfusion of blood andblood components ................................................................... 272

3.1.13. Plastic additives ............................................................ 2933.1.14. Materials based on plasticised poly(vinyl chloride)for containers for aqueous solutions for intravenousinfusion ...................................................................................... 296

3.1.15. Polyethylene terephthalate for containers forpreparations not for parenteral use..................................... 298

3.1.1. Materials for containers for human blood and bloodcomponents............................................................................... 269

3.1.3. Polyolefines...................................................................... 2743.1.4. Polyethylene without additives for containersfor parenteral preparations and for ophthalmicpreparations .............................................................................. 278

3.1.5. Polyethylene with additives for containersfor parenteral preparations and for ophthalmicpreparations .............................................................................. 279

3.1.6. Polypropylene for containers and closures forparenteral preparations and ophthalmic preparations ... 282

3.1.7. Poly(ethylene - vinyl acetate) for containers and tubingfor total parenteral nutrition preparations ........................ 285

3.1.8. Silicone oil used as a lubricant ................................... 2873.1.9. Silicone elastomer for closures and tubing .............. 2883.1. Materials used for the manufacture of containers ..... 2693.2.1. Glass containers for pharmaceutical use .................. 3033.2.2.1. Plastic containers for aqueous solutions forparenteral infusion .................................................................. 309

3.2.2. Plastic containers and closures for pharmaceuticaluse............................................................................................... 308

3.2.3. Sterile plastic containers for human blood and bloodcomponents............................................................................... 309

3.2.4. Empty sterile containers of plasticised poly(vinylchloride) for human blood and blood components...........311

3.2.5. Sterile containers of plasticised poly (vinyl chloride)for human blood containing anticoagulant solution....... 312

3.2.6. Sets for the transfusion of blood and bloodcomponents................................................................................313

3.2.8. Sterile single-use plastic syringes ................................3143.2.9. Rubber closures for containers for aqueous parenteralpreparations, for powders and for freeze-dried powders ..316

3.2. Containers ........................................................................... 3034.1.1. Reagents ........................................................................... 3214.1.1. Reagents ..................................................................5.1-28174.1.1. Reagents ..................................................................5.2-31234.1.1. Reagents ..................................................................5.3-33774.1.2. Standard solutions for limit tests................................ 4264.1.2. Standard solutions for limit tests.......................5.1-28184.1.3. Buffer solutions .............................................................. 4304.1.3. Buffer solutions .....................................................5.3-33784.1. Reagents, standard solutions, buffer solutions ........... 3214.2.1. Primary standards for volumetric solutions............. 4354.2.1. Primary standards for volumetric solutions....5.3-33784.2.2. Volumetric solutions...................................................... 4354.2.2. Volumetric solutions.............................................5.3-33784.2. Volumetric analysis............................................................ 4354-Aminobenzoic acid ................................................................. 9734. Reagents.................................................................................. 3215.10. Control of impurities in substances for pharmaceuticaluse............................................................................................... 559

5.11. Characters section in monographs .............................. 5655.1.1. Methods of preparation of sterile products .............. 445

5.1.2. Biological indicators of sterilisation........................... 4475.1.3. Efficacy of antimicrobial preservation ....................... 4475.1.4. Microbiological quality of pharmaceuticalpreparations .............................................................................. 449

5.1.5. Application of the F0 concept to steam sterilisation ofaqueous preparations ....................................................5.1-2821

5.1. General texts on sterility .................................................. 4455.2.1. Terminology used in monographs on vaccines ....... 4535.2.2. Chicken flocks free from specified pathogens for theproduction and quality control of vaccines...............5.1-2825

5.2.3. Cell substrates for the production of vaccines forhuman use................................................................................. 455

5.2.4. Cell cultures for the production of veterinaryvaccines...................................................................................... 458

5.2.5. Substances of animal origin for the production ofveterinary vaccines.................................................................. 460

5.2.6. Evaluation of safety of veterinary vaccines andimmunosera ....................................................................5.1-2827

5.2.7. Evaluation of efficacy of veterinary vaccines andimmunosera .....................................................................5.1-2829

5.2.8. Minimising the risk of transmitting animal spongiformencephalopathy agents via human and veterinary medicinalproducts ..................................................................................... 463

5.2.9. Evaluation of safety of each batch of veterinaryvaccines and immunosera.............................................5.1-2830

5.2. General texts on vaccines................................................. 4535.3. Statistical analysis of results of biological assays andtests............................................................................................. 475

5.4. Residual solvents ............................................................... 5075.5. Alcoholimetric tables .........................................................5195.6. Assay of interferons..................................................5.3-33815.7. Table of physical characteristics of radionuclidesmentioned in the European Pharmacopoeia..................... 539

5.8. Pharmacopoeial harmonisation ..................................... 5515.9. Polymorphism..................................................................... 555

AAbbreviations and symbols (1.5.).................................................9Abnormal toxicity (2.6.9.)......................................................... 153Absinthii herba ........................................................................ 2710Absorption spectrophotometry, infrared (2.2.24.) ................ 37Absorption spectrophotometry, ultraviolet and visible(2.2.25.) .............................................................................5.2-3089

Acacia............................................................................................ 905Acaciae gummi .......................................................................... 905Acaciae gummi dispersione desiccatum............................. 905Acacia, spray-dried ..................................................................... 905Acamprosate calcium ................................................................ 906Acamprosatum calcicum......................................................... 906Acarbose..............................................................................5.1-2873Acarbosum .........................................................................5.1-2873Acebutolol hydrochloride......................................................... 907Acebutololi hydrochloridum .................................................. 907Aceclofenac.................................................................................. 909Aceclofenacum........................................................................... 909Acesulfame potassium .....................................................5.3-3435Acesulfamum kalicum ....................................................5.3-3435Acetazolamide............................................................................. 912Acetazolamidum........................................................................ 912Acetic acid, glacial ......................................................................913Acetic acid in synthetic peptides (2.5.34.) .............................141Acetone................................................................................5.1-2875Acetonum ...........................................................................5.1-2875Acetylcholine chloride ...............................................................914Acetylcholini chloridum ...........................................................914Acetylcysteine ..............................................................................915Acetylcysteinum .........................................................................915Acetylsalicylic acid ......................................................................917Acetyltryptophan, N- ..................................................................918



Acetyltyrosine, N- ....................................................................... 920Aciclovir ..............................................................................5.3-3436Aciclovirum .......................................................................5.3-3436Acidum 4-aminobenzoicum ................................................... 973Acidum aceticum glaciale........................................................913Acidum acetylsalicylicum ........................................................917Acidum adipicum ...................................................................... 926Acidum alginicum..................................................................... 942Acidum amidotrizoicum dihydricum .................................. 967Acidum aminocaproicum ....................................................... 974Acidum ascorbicum ................................................................ 1025Acidum asparticum ................................................................ 1029Acidum benzoicum ................................................................. 1072Acidum boricum .......................................................................1117Acidum caprylicum ................................................................ 1172Acidum chenodeoxycholicum..............................................1247Acidum citricum anhydricum .............................................1306Acidum citricum monohydricum .......................................1307Acidum edeticum .................................................................... 1494Acidum etacrynicum ..............................................................1542Acidum folicum ....................................................................... 1630Acidum fusidicum ................................................................... 1645Acidum glutamicum ............................................................... 1670Acidum hydrochloridum concentratum............................ 1755Acidum hydrochloridum dilutum ....................................... 1756Acidum iopanoicum ...............................................................1824Acidum iotalamicum ..............................................................1825Acidum ioxaglicum.................................................................1826Acidum lacticum ..............................................................5.2-3227Acidum lactobionicum...........................................................1885Acidum maleicum ...................................................................1966Acidum malicum .....................................................................1966Acidum mefenamicum...........................................................1984Acidum methacrylicum et ethylis acrylas polymerisatum1:1 .............................................................................................2005

Acidum methacrylicum et ethylis acrylas polymerisatum1:1 dispersio 30 per centum ..............................................2005

Acidum methacrylicum et methylis methacrylaspolymerisatum 1:1................................................................2006

Acidum methacrylicum et methylis methacrylaspolymerisatum 1:2................................................................2007

Acidum nalidixicum ...............................................................2080Acidum nicotinicum...............................................................2097Acidum nitricum ..................................................................... 2105Acidum oleicum....................................................................... 2132Acidum oxolinicum ................................................................ 2165Acidum palmiticum ................................................................ 2179Acidum phosphoricum concentratum ...............................2237Acidum phosphoricum dilutum ..........................................2238Acidum pipemidicum trihydricum .....................................2249Acidum salicylicum .........................................................5.1-3007Acidum (S)-lacticum ........................................................5.2-3227Acidum sorbicum ....................................................................2467Acidum stearicum ...................................................................2490Acidum sulfuricum .................................................................2520Acidum tartaricum .................................................................2534Acidum tiaprofenicum ...........................................................2578Acidum tolfenamicum............................................................ 2601Acidum tranexamicum ..........................................................2609Acidum trichloraceticum ......................................................2620Acidum undecylenicum ........................................................2658Acidum ursodeoxycholicum.................................................2662Acidum valproicum ................................................................2669Acid value (2.5.1.)..............................................................5.2-3099Acitretin........................................................................................ 922Acitretinum ................................................................................. 922Acriflavinii monochloridum .................................................. 924Acriflavinium monochloride.................................................... 924Actinobacillosis vaccine (inactivated), porcine .................... 784

Activated charcoal....................................................................1246Activated coagulation factors (2.6.22.).................................. 177Additives, plastic (3.1.13.)......................................................... 293Adenine ........................................................................................ 924Adeninum.................................................................................... 924Adenosine .................................................................................... 925Adenosinum ............................................................................... 925Adeps lanae .......................................................................5.2-3285Adeps lanae cum aqua...........................................................2709Adeps lanae hydrogenatus ...................................................2708Adeps solidus............................................................................ 1711Adipic acid ................................................................................... 926Adrenaline tartrate .................................................................... 927Adrenalini tartras...................................................................... 927Aer medicinalis.......................................................................... 929Aer medicinalis artificiosus ................................................... 932Aerodynamic assessment of fine particles in preparations forinhalation (2.9.18.) .........................................................5.2-3103

Aether .........................................................................................1548Aether anaestheticus ..............................................................1549Agar............................................................................................... 928Agrimoniae herba ..................................................................... 929Agrimony ..................................................................................... 929Air, medicinal .............................................................................. 929Air, synthetic medicinal ............................................................ 932Alanine ......................................................................................... 933Alaninum..................................................................................... 933Albendazole................................................................................. 934Albendazolum ............................................................................ 934Albumini humani solutio ...............................................5.3-3511Albumin solution, human................................................5.3-3511Alchemilla .................................................................................... 935Alchemillae herba ..................................................................... 935Alcohol benzylicus ...........................................................5.1-2886Alcohol cetylicus...............................................................5.3-3475Alcohol cetylicus et stearylicus ....................................5.3-3474Alcohol cetylicus et stearylicus emulsificans A ..............1239Alcohol cetylicus et stearylicus emulsificans B .............. 1241Alcoholes adipis lanae ...........................................................2703Alcoholimetric tables (2.9.10.) ................................................ 237Alcoholimetric tables (5.5.) .......................................................519Alcohol isopropylicus............................................................. 1841Alcohol oleicus ......................................................................... 2134Alcohol stearylicus...........................................................5.3-3621Alcuronii chloridum ................................................................. 935Alcuronium chloride.................................................................. 935Alexandrian senna pods .........................................................2404Alfacalcidol .................................................................................. 937Alfacalcidolum ........................................................................... 937Alfadex.......................................................................................... 938Alfadexum ................................................................................... 938Alfentanil hydrochloride........................................................... 939Alfentanili hydrochloridum.................................................... 939Alfuzosin hydrochloride ........................................................... 941Alfuzosini hydrochloridum .................................................... 941Alginic acid .................................................................................. 942Alkaline-earth metals and magnesium (2.4.7.) .................... 104Alkaline impurities in fatty oils (2.4.19.) ............................... 109Allantoin....................................................................................... 942Allantoinum................................................................................ 942Allergen products....................................................................... 569Allii sativi bulbi pulvis ........................................................... 1651Allium sativum ad praeparationes homoeopathicas ....... 897Allopurinol................................................................................... 943Allopurinolum............................................................................ 943all-rac-α-Tocopherol..........................................................5.3-3631all-rac-α-Tocopheryl acetate ...........................................5.3-3632Almagate .............................................................................5.2-3169Almagatum.........................................................................5.2-3169



Almond oil, refined .................................................................... 946Almond oil, virgin .............................................................5.3-3437Aloe barbadensis ....................................................................... 947Aloe capensis.............................................................................. 948Aloes, barbados .......................................................................... 947Aloes, Cape .................................................................................. 948Aloes dry extract, standardised............................................... 949Aloes extractum siccum normatum...................................... 949Alphacyclodextrin ...................................................................... 938Alprazolam .................................................................................. 950Alprazolamum ........................................................................... 950Alprenolol hydrochloride ......................................................... 952Alprenololi hydrochloridum................................................... 952Alprostadil ................................................................................... 953Alprostadilum............................................................................. 953Alteplase for injection ............................................................... 956Alteplasum ad iniectabile........................................................ 956Althaeae folium........................................................................ 1974Althaeae radix ...................................................................5.2-3232Alum.............................................................................................. 959Alumen......................................................................................... 959Aluminii chloridum hexahydricum ..................................... 960Aluminii hydroxidum hydricum ad adsorptionem .......... 960Aluminii magnesii silicas ....................................................... 961Aluminii oxidum hydricum .................................................... 962Aluminii phosphas hydricus .................................................. 963Aluminii phosphatis liquamen .....................................5.3-3438Aluminii sulfas........................................................................... 964Aluminium (2.4.17.) ................................................................... 108Aluminium chloride hexahydrate ........................................... 960Aluminium hydroxide, hydrated, for adsorption................. 960Aluminium in adsorbed vaccines (2.5.13.).............................131Aluminium magnesium silicate............................................... 961Aluminium oxide, hydrated...................................................... 962Aluminium phosphate gel ...............................................5.3-3438Aluminium phosphate, hydrated ............................................ 963Aluminium sulphate .................................................................. 964Amantadine hydrochloride ...................................................... 964Amantadini hydrochloridum ................................................. 964Ambroxol hydrochloride........................................................... 965Ambroxoli hydrochloridum .................................................... 965Amfetamine sulphate ................................................................ 966Amfetamini sulfas ..................................................................... 966Amidotrizoic acid dihydrate..................................................... 967Amikacin ...................................................................................... 968Amikacini sulfas ........................................................................ 970Amikacin sulphate ..................................................................... 970Amikacinum ............................................................................... 968Amiloride hydrochloride..................................................5.3-3439Amiloridi hydrochloridum.............................................5.3-3439Amino acid analysis (2.2.56.) ..................................................... 86Aminocaproic acid ..................................................................... 974Aminoglutethimide.................................................................... 975Aminoglutethimidum ............................................................... 975Amiodarone hydrochloride ...................................................... 977Amiodaroni hydrochloridum ................................................. 977Amisulpride ................................................................................. 978Amisulpridum ............................................................................ 978Amitriptyline hydrochloride .................................................... 980Amitriptylini hydrochloridum ............................................... 980Amlodipine besilate ................................................................... 981Amlodipini besilas .................................................................... 981Ammonia (13N) injection ............................................................817Ammoniae (13N) solutio iniectabilis ......................................817Ammoniae solutio concentrata ............................................. 983Ammonia solution, concentrated ........................................... 983Ammonii bromidum ................................................................. 985Ammonii chloridum ................................................................. 986Ammonii glycyrrhizas ....................................................5.1-2876

Ammonii hydrogenocarbonas ............................................... 988Ammonio methacrylate copolymer (type A) ........................ 983Ammonio methacrylate copolymer (type B) ........................ 984Ammonio methacrylatis copolymerum A........................... 983Ammonio methacrylatis copolymerum B .......................... 984Ammonium (2.4.1.) .................................................................... 103Ammonium bromide.................................................................. 985Ammonium chloride.................................................................. 986Ammonium glycyrrhizate................................................5.1-2876Ammonium hydrogen carbonate ............................................ 988Amobarbital................................................................................. 988Amobarbital sodium .................................................................. 989Amobarbitalum .......................................................................... 988Amobarbitalum natricum ....................................................... 989Amoxicillin sodium .................................................................... 990Amoxicillin trihydrate ......................................................5.3-3440Amoxicillinum natricum ......................................................... 990Amoxicillinum trihydricum...........................................5.3-3440Amperometric titration (2.2.19.) ............................................... 34Amphotericin B .......................................................................... 995Amphotericinum B ................................................................... 995Ampicillin, anhydrous .............................................................. 996Ampicillin sodium ...................................................................... 998Ampicillin trihydrate ............................................................... 1001Ampicillinum anhydricum ..................................................... 996Ampicillinum natricum ........................................................... 998Ampicillinum trihydricum.................................................... 1001Amygdalae oleum raffinatum ................................................ 946Amygdalae oleum virginale ..........................................5.3-3437Amylum pregelificatum .........................................................2490Anaesthetic ether .....................................................................1549Analysis, thermal (2.2.34.).......................................................... 52Analytical sieving, particle-size distribution estimation by(2.9.38.) .............................................................................5.3-3368

Angelicae radix ........................................................................ 1003Angelica root ............................................................................. 1003Animal anti-T lymphocyte immunoglobulin for humanuse............................................................................................. 1010

Animal spongiform encephalopathies, products with risk oftransmitting agents of............................................................. 577

Animal spongiform encephalopathy agents, minimising therisk of transmitting via human and veterinary medicinalproducts (5.2.8.) ....................................................................... 463

Aniseed ....................................................................................... 1006Anise oil...................................................................................... 1004Anisi aetheroleum ................................................................... 1004Anisidine value (2.5.36.) ........................................................... 142Anisi fructus ............................................................................. 1006Anisi stellati aetheroleum .....................................................2488Anisi stellati fructus................................................................2487Antazoline hydrochloride....................................................... 1006Antazolini hydrochloridum .................................................. 1006Anthrax spore vaccine (live) for veterinary use................... 715Anti-A and anti-B haemagglutinins (indirect method)(2.6.20.) .......................................................................................174

Antibiotics, microbiological assay of (2.7.2.) ........................ 188Anticoagulant and preservative solutions for human blood................................................................................................... 1007

Anticomplementary activity of immunoglobulin (2.6.17.).. 170Anticorpora monoclonalia ad usum humanum ......5.2-3127Anti-D antibodies in human immunoglobulins for intravenousadministration, test for (2.6.26.) ..................................5.3-3348

Anti-D immunoglobulin, human ........................................... 1732Anti-D immunoglobulin, human, assay of (2.7.13.)............. 205Anti-D immunoglobulin, human, for intravenousadministration ........................................................................ 1733

Antimicrobial preservation, efficacy of (5.1.3.) .................... 447Antiserum, European viper venom ........................................ 806Antithrombin III concentrate, human ................................. 1733



Antithrombin III, human, assay of (2.7.17.) .......................... 209Antithrombinum III humanum densatum ....................... 1733Anti-T lymphocyte immunoglobulin for human use,animal....................................................................................... 1010

Apis mellifera ad praeparationes homoeopathicas.......... 898Apomorphine hydrochloride ..................................................1014Apomorphini hydrochloridum .............................................1014Apparatus (2.1.) .............................................................................17Apparent volume (2.9.15.)........................................................ 241Application of the F0 concept to steam sterilisation ofaqueous preparations (5.1.5.).......................................5.1-2821

Aprotinin .................................................................................... 1015Aprotinin concentrated solution........................................... 1016Aprotinini solutio concentrata ............................................ 1016Aprotininum ............................................................................. 1015Aqua ad dilutionem solutionium concentratarum adhaemodialysim ...................................................................... 1699

Aqua ad iniectabilia ...............................................................2692Aquae (15O) solutio iniectabilis .............................................. 868Aquae tritiatae (3H) solutio iniectabilis ............................... 867Aqua purificata ........................................................................2697Aqua valde purificata.............................................................2695Arachidis oleum hydrogenatum.......................................... 1018Arachidis oleum raffinatum ................................................. 1018Arachis oil, hydrogenated ...................................................... 1018Arachis oil, refined................................................................... 1018Argenti nitras ........................................................................... 2412Argentum colloidale ad usum externum ...................5.3-3613Arginine...................................................................................... 1019Arginine aspartate ................................................................... 1020Arginine hydrochloride........................................................... 1021Arginini aspartas .................................................................... 1020Arginini hydrochloridum...................................................... 1021Argininum................................................................................. 1019Arnicae flos............................................................................... 1022Arnicae tinctura ...............................................................5.1-2877Arnica flower............................................................................. 1022Arnica tincture...................................................................5.1-2877Arsenic (2.4.2.) ............................................................................ 103Arsenii trioxidum ad praeparationes homoeopathicas .. 895Arsenious trioxide for homoeopathic preparations............ 895Articaine hydrochloride.......................................................... 1023Articaini hydrochloridum ..................................................... 1023Ascorbic acid ............................................................................. 1025Ascorbylis palmitas................................................................. 1026Ascorbyl palmitate ................................................................... 1026Ash insoluble in hydrochloric acid (2.8.1.) ........................... 215Ash leaf....................................................................................... 1026Asparagine monohydrate .......................................................1027Asparaginum monohydricum.............................................. 1027Aspartame.................................................................................. 1028Aspartamum ............................................................................. 1028Aspartic acid.............................................................................. 1029Assay of 1,8-cineole in essential oils (2.8.11.) .......................216Assay of diphtheria vaccine (adsorbed) (2.7.6.) ................... 196Assay of heparin (2.7.5.) ........................................................... 195Assay of heparin in coagulation factors (2.7.12.) ................ 204Assay of hepatitis A vaccine (2.7.14.) ............................5.1-2795Assay of hepatitis B vaccine (rDNA) (2.7.15.) ...................... 207Assay of human anti-D immunoglobulin (2.7.13.)............... 205Assay of human antithrombin III (2.7.17.) ............................ 209Assay of human coagulation factor II (2.7.18.).................... 209Assay of human coagulation factor IX (2.7.11.)................... 204Assay of human coagulation factor VII (2.7.10.) ................. 203Assay of human coagulation factor VIII (2.7.4.).................. 194Assay of human coagulation factor X (2.7.19.) .....................210Assay of human coagulation factor XI (2.7.22.) .................. 212Assay of human von Willebrand factor (2.7.21.) ..................211Assay of interferons (5.6.)................................................5.3-3381

Assay of pertussis vaccine (2.7.7.)........................................... 197Assay of pertussis vaccine (acellular) (2.7.16.) .................... 208Assay of tetanus vaccine (adsorbed) (2.7.8.) ...............5.1-2791Assays (2.5.) ................................................................................. 127Astemizole ................................................................................. 1030Astemizolum ............................................................................. 1030Atenolol ......................................................................................1032Atenololum................................................................................ 1032Atomic absorption spectrometry (2.2.23.) .............................. 36Atomic emission spectrometry (2.2.22.).................................. 35Atracurii besilas................................................................5.2-3170Atracurium besilate ..........................................................5.2-3170Atropine ..................................................................................... 1033Atropine sulphate..................................................................... 1035Atropini sulfas.......................................................................... 1035Atropinum ................................................................................. 1033Aujeszky’s disease vaccine (inactivated) for pigs................ 715Aujeszky’s disease vaccine (live) for pigs for parenteraladministration, freeze-dried....................................................717

Aurantii amari epicarpii et mesocarpii tinctura ............ 1110Aurantii amari epicarpium et mesocarpium................... 1110Aurantii amari flos ..................................................................1111Aurantii dulcis aetheroleum.................................................2526Auricularia.........................................................................5.2-3137Avian infectious bronchitis vaccine (inactivated)................ 718Avian infectious bronchitis vaccine (live) ............................. 720Avian infectious bursal disease vaccine (inactivated) ....... 722Avian infectious bursal disease vaccine (live) ...................... 723Avian infectious encephalomyelitis vaccine (live) ............... 725Avian infectious laryngotracheitis vaccine (live)................. 727Avian live virus vaccines : tests for extraneous agents inbatches of finished product (2.6.25.)..........................5.3-3345

Avian paramyxovirus 3 vaccine (inactivated)....................... 728Avian viral tenosynovitis vaccine (live).................................. 729Avian viral vaccines : tests for extraneous agents in seed lots(2.6.24.) ...................................................................................... 177

Azaperone for veterinary use ................................................ 1036Azaperonum ad usum veterinarium..................................1036Azathioprine.............................................................................. 1037Azathioprinum......................................................................... 1037Azelastine hydrochloride........................................................ 1037Azelastini hydrochloridum ................................................... 1037Azithromycin......................................................................5.3-3442Azithromycinum...............................................................5.3-3442

BBacampicillin hydrochloride.................................................. 1043Bacampicillini hydrochloridum .......................................... 1043Bacitracin................................................................................... 1045Bacitracinum............................................................................ 1045Bacitracinum zincum ............................................................ 1047Bacitracin zinc .......................................................................... 1047Baclofen ..................................................................................... 1050Baclofenum............................................................................... 1050Bacterial endotoxins (2.6.14.)...................................................161Ballotae nigrae herba ............................................................ 1113Balsamum peruvianum......................................................... 2215Balsamum tolutanum ............................................................2603Bambuterol hydrochloride..................................................... 1051Bambuteroli hydrochloridum .............................................. 1051Barbados aloes ........................................................................... 947Barbital....................................................................................... 1052Barbitalum ................................................................................ 1052Barii chloridum dihydricum ad praeparationeshomoeopathicas .............................................................5.2-3161

Barii sulfas .........................................................................5.3-3447Barium chloride dihydrate for homoeopathicpreparations .....................................................................5.2-3161

Barium sulphate................................................................5.3-3447



Basic butylated methacrylate copolymer............................ 1053BCG ad immunocurationem .................................................. 635BCG for immunotherapy .......................................................... 635BCG vaccine, freeze-dried ........................................................ 636Bearberry leaf ...........................................................................1054Beclometasone dipropionate, anhydrous ....................5.1-2881Beclometasone dipropionate monohydrate ................5.1-2883Beclometasoni dipropionas anhydricus ....................5.1-2881Beclometasoni dipropionas monohydricus ..............5.1-2883Bee for homoeopathic preparations, honey......................... 898Beeswax, white ......................................................................... 1057Beeswax, yellow........................................................................ 1058Belladonnae folii extractum siccum normatum ............. 1060Belladonnae folii tinctura normata ................................... 1061Belladonnae folium ................................................................ 1058Belladonnae pulvis normatus.............................................. 1062Belladonna leaf......................................................................... 1058Belladonna leaf dry extract, standardised .......................... 1060Belladonna leaf tincture, standardised................................ 1061Belladonna, prepared .............................................................. 1062Bendroflumethiazide .......................................................5.1-2885Bendroflumethiazidum ..................................................5.1-2885Benfluorex hydrochloride ...................................................... 1064Benfluorexi hydrochloridum ............................................... 1064Benperidol ................................................................................. 1065Benperidolum .......................................................................... 1065Benserazide hydrochloride .................................................... 1067Benserazidi hydrochloridum ............................................... 1067Bentonite ................................................................................... 1068Bentonitum ............................................................................... 1068Benzalkonii chloridi solutio ................................................ 1069Benzalkonii chloridum.......................................................... 1068Benzalkonium chloride........................................................... 1068Benzalkonium chloride solution .......................................... 1069Benzathine benzylpenicillin ..................................................1077Benzbromarone........................................................................ 1070Benzbromaronum ................................................................... 1070Benzethonii chloridum ......................................................... 1071Benzethonium chloride .......................................................... 1071Benzocaine ................................................................................1072Benzocainum ........................................................................... 1072Benzoe tonkinensis .........................................................5.2-3175Benzoic acid .............................................................................. 1072Benzoin, Siam....................................................................5.2-3175Benzoylis peroxidum cum aqua ......................................... 1073Benzoyl peroxide, hydrous ....................................................1073Benzyl alcohol ...................................................................5.1-2886Benzyl benzoate ....................................................................... 1076Benzylis benzoas..................................................................... 1076Benzylpenicillin, benzathine ................................................. 1077Benzylpenicillin potassium.............................................5.2-3175Benzylpenicillin, procaine...................................................... 1080Benzylpenicillin sodium ..................................................5.2-3177Benzylpenicillinum benzathinum...................................... 1077Benzylpenicillinum kalicum.........................................5.2-3175Benzylpenicillinum natricum ......................................5.2-3177Benzylpenicillinum procainum .......................................... 1080Betacarotene ............................................................................. 1083Betacarotenum ........................................................................ 1083Betacyclodextrin ......................................................................1084Betadex ......................................................................................1084Betadexum ................................................................................ 1084Betahistine dihydrochloride ...........................................5.1-2887Betahistine mesilate ................................................................ 1086Betahistini dihydrochloridum ......................................5.1-2887Betahistini mesilas ................................................................. 1086Betamethasone......................................................................... 1087Betamethasone acetate .......................................................... 1089Betamethasone dipropionate .........................................5.3-3447

Betamethasone sodium phosphate...................................... 1092Betamethasone valerate ..................................................5.3-3449Betamethasoni acetas ............................................................ 1089Betamethasoni dipropionas ..........................................5.3-3447Betamethasoni natrii phosphas .......................................... 1092Betamethasoni valeras....................................................5.3-3449Betamethasonum .................................................................... 1087Betaxolol hydrochloride .........................................................1095Betaxololi hydrochloridum................................................... 1095Betulae folium.......................................................................... 1103Bezafibrate ................................................................................ 1096Bezafibratum ............................................................................ 1096Bifonazole.................................................................................. 1098Bifonazolum ............................................................................. 1098Bilberry fruit, dried ................................................................. 1099Bilberry fruit, fresh.................................................................. 1099Biological assays (2.7.) .............................................................. 187Biological assays and tests, statistical analysis of (5.3.) .... 475Biological indicators of sterilisation (5.1.2.) ........................ 447Biological tests (2.6.) ................................................................. 145Biotin .......................................................................................... 1100Biotinum ................................................................................... 1100Biperiden hydrochloride..........................................................1101Biperideni hydrochloridum ..................................................1101Biphasic insulin injection....................................................... 1802Biphasic isophane insulin injection ..................................... 1803Birch leaf.................................................................................... 1103Bisacodyl.................................................................................... 1104Bisacodylum ............................................................................. 1104Bismuthi subcarbonas ........................................................... 1105Bismuthi subgallas ................................................................. 1106Bismuthi subnitras ponderosum......................................... 1107Bismuthi subsalicylas ............................................................ 1107Bismuth subcarbonate............................................................ 1105Bismuth subgallate.................................................................. 1106Bismuth subnitrate, heavy ..................................................... 1107Bismuth subsalicylate ............................................................. 1107Bitter fennel ..............................................................................1580Bitter-fennel fruit oil................................................................ 1108Bitterness value (2.8.15.).......................................................... 221Bitter-orange epicarp and mesocarp.................................... 1110Bitter-orange-epicarp and mesocarp tincture .................... 1110Bitter-orange flower .................................................................1111Bitter-orange-flower oil ....................................................5.3-3562Black horehound ..................................................................... 1113Bleomycini sulfas .............................................................5.2-3179Bleomycin sulphate ..........................................................5.2-3179Blood and blood components, empty sterile containers ofplasticised poly(vinyl chloride) for (3.2.4.) ..........................311

Blood and blood components, materials for containers for(3.1.1.)......................................................................................... 269

Blood and blood components, sets for the transfusion of(3.2.6.) .........................................................................................313

Blood and blood components, sterile plastic containers for(3.2.3.) ........................................................................................ 309

Blood, anticoagulant and preservative solutions for .......1007Blood, sterile containers of plasticised poly (vinyl chloride)containing anticoagulant solution (3.2.5.) ......................... 312

Bogbean leaf ............................................................................. 1115Boiling point (2.2.12.) ..................................................................31Boldi folium .......................................................................5.3-3450Boldo leaf............................................................................5.3-3450Borage (starflower) oil, refined......................................5.1-2889Borago officinalis oleum raffinatum ..........................5.1-2889Borax .......................................................................................... 1116Boric acid....................................................................................1117Botulinum antitoxin .................................................................. 801Botulinum toxin type A for injection....................................1117



Bovine infectious rhinotracheitis vaccine (live),freeze-dried................................................................................ 768

Bovine insulin ........................................................................... 1797Bovine leptospirosis vaccine (inactivated)............................ 730Bovine parainfluenza virus vaccine (live), freeze-dried ..... 732Bovine respiratory syncytial virus vaccine (live),freeze-dried................................................................................ 733

Bovine viral diarrhoea vaccine (inactivated)........................ 734Bromazepam ............................................................................. 1119Bromazepamum ...................................................................... 1119Bromhexine hydrochloride .................................................... 1120Bromhexini hydrochloridum ............................................... 1120Bromocriptine mesilate .......................................................... 1121Bromocriptini mesilas ........................................................... 1121Bromperidol .............................................................................. 1124Bromperidol decanoate .......................................................... 1125Bromperidoli decanoas ......................................................... 1125Bromperidolum ....................................................................... 1124Brompheniramine maleate..................................................... 1127Brompheniramini maleas .................................................... 1127Brucellosis vaccine (live) (Brucella melitensis Rev. 1 strain),freeze-dried, for veterinary use ...................................5.1-2859

Buccal tablets and sublingual tablets.................................... 613Buckwheat herb ................................................................5.2-3180Budesonide................................................................................ 1128Budesonidum ........................................................................... 1128Bufexamac ................................................................................. 1130Bufexamacum .......................................................................... 1130Buffer solutions (4.1.3.) ............................................................ 430Buffer solutions (4.1.3.) ...................................................5.3-3378Buflomedil hydrochloride ...................................................... 1131Buflomedili hydrochloridum ............................................... 1131Bumetanide ............................................................................... 1132Bumetanidum .......................................................................... 1132Bupivacaine hydrochloride .................................................... 1133Bupivacaini hydrochloridum............................................... 1133Buprenorphine ......................................................................... 1135Buprenorphine hydrochloride .............................................. 1136Buprenorphini hydrochloridum ......................................... 1136Buprenorphinum ................................................................... 1135Buserelin.................................................................................... 1137Buserelinum ............................................................................. 1137Buspirone hydrochloride.................................................5.3-3452Buspironi hydrochloridum............................................5.3-3452Busulfan..................................................................................... 1138Busulfanum .............................................................................. 1138Butcher’s broom................................................................5.3-3454Butylhydroxyanisole.................................................................1141Butylhydroxyanisolum ...........................................................1141Butylhydroxytoluene................................................................1141Butylhydroxytoluenum...........................................................1141Butylis parahydroxybenzoas................................................ 1140Butyl parahydroxybenzoate................................................... 1140

CCabergoline ........................................................................5.3-3459Cabergolinum ...................................................................5.3-3459Cachets ................................................................................5.2-3136Cadmii sulfas hydricusad praeparationes homoeopathicas..........................5.3-3429

Cadmium sulphate hydrate for homoeopathic prepara-tions ...................................................................................5.3-3429

Caffeine ...................................................................................... 1145Caffeine monohydrate............................................................. 1146Calcifediol .................................................................................. 1147Calcifediolum ........................................................................... 1147Calcii acetas ......................................................................5.1-2893Calcii ascorbas ......................................................................... 1150Calcii carbonas .................................................................5.1-2894

Calcii chloridum dihydricum .............................................. 1152Calcii chloridum hexahydricum ......................................... 1153Calcii dobesilas monohydricum.......................................... 1153Calcii folinas ............................................................................ 1154Calcii glucoheptonas.............................................................. 1156Calcii gluconas ........................................................................ 1157Calcii gluconas ad iniectabile ............................................. 1158Calcii glycerophosphas.......................................................... 1159Calcii hydrogenophosphas anhydricus............................. 1160Calcii hydrogenophosphas dihydricus .............................. 1160Calcii hydroxidum .................................................................. 1161Calcii iodidum tetrahydricum ad praeparationeshomoeopathicas .............................................................5.2-3162

Calcii lactas anhydricus .................................................5.1-2894Calcii lactas monohydricus ...........................................5.1-2895Calcii lactas pentahydricus ...........................................5.1-2896Calcii lactas trihydricus .................................................5.1-2897Calcii laevulinas dihydricum............................................... 1165Calcii levofolinas pentahydricus ........................................ 1163Calcii pantothenas .................................................................. 1166Calcii stearas ............................................................................ 1167Calcii sulfas dihydricus ......................................................... 1169Calcipotriol, anhydrous ...................................................5.3-3460Calcipotriol monohydrate ...............................................5.3-3462Calcipotriolum anhydricum..........................................5.3-3460Calcipotriolum monohydricum....................................5.3-3462Calcitonin (salmon)...........................................................5.3-3465Calcitoninum salmonis ..................................................5.3-3465Calcitriol..................................................................................... 1149Calcitriolum.............................................................................. 1149Calcium (2.4.3.)........................................................................... 103Calcium acetate .................................................................5.1-2893Calcium ascorbate.................................................................... 1150Calcium carbonate ............................................................5.1-2894Calcium carboxymethylcellulose .......................................... 1188Calcium chloride dihydrate.................................................... 1152Calcium chloride hexahydrate .............................................. 1153Calcium dobesilate monohydrate ......................................... 1153Calcium folinate ....................................................................... 1154Calcium glucoheptonate......................................................... 1156Calcium gluconate ................................................................... 1157Calcium gluconate for injection............................................ 1158Calcium glycerophosphate..................................................... 1159Calcium hydrogen phosphate, anhydrous .......................... 1160Calcium hydrogen phosphate dihydrate ............................. 1160Calcium hydroxide ................................................................... 1161Calcium in adsorbed vaccines (2.5.14.) ..................................131Calcium iodide tetrahydrate for homoeopathicpreparations .....................................................................5.2-3162

Calcium lactate, anhydrous ............................................5.1-2894Calcium lactate monohydrate ........................................5.1-2895Calcium lactate pentahydrate ........................................5.1-2896Calcium lactate trihydrate...............................................5.1-2897Calcium levofolinate pentahydrate ...................................... 1163Calcium levulinate dihydrate................................................. 1165Calcium pantothenate............................................................. 1166Calcium phosphate .................................................................. 1167Calcium stearate....................................................................... 1167Calcium sulphate dihydrate ................................................... 1169Calendulae flos ........................................................................ 1169Calendula flower ...................................................................... 1169Calf coronavirus diarrhoea vaccine (inactivated)................ 736Calf rotavirus diarrhoea vaccine (inactivated)..................... 737Calicivirosis vaccine (inactivated), feline............................... 757Calicivirosis vaccine (live), feline, freeze-dried..................... 758Camphora racemica ............................................................... 1172Camphor, D- ............................................................................... 1170Camphor, racemic .................................................................... 1172Canine adenovirus vaccine (inactivated) .............................. 738



Canine adenovirus vaccine (live) ............................................ 738Canine distemper vaccine (live), freeze-dried....................... 740Canine leptospirosis vaccine (inactivated)............................ 740Canine parainfluenza virus vaccine (live)............................. 742Canine parvovirosis vaccine (inactivated)............................. 743Canine parvovirosis vaccine (live) .......................................... 744Cape aloes.................................................................................... 948Capillary electrophoresis (2.2.47.).............................................74Capillary viscometer method (2.2.9.)....................................... 29Caprylic acid.............................................................................. 1172Caprylocaproyl macrogolglycerides..................................... 1173Capsici fructus ..........................................................................1174Capsicum.....................................................................................1174Capsulae .............................................................................5.2-3135Capsules ..............................................................................5.2-3135Capsules and tablets, disintegration of (2.9.1.) ..........5.3-3351Capsules, gastro-resistant................................................5.2-3136Capsules, hard ...................................................................5.2-3135Capsules, intrauterine......................................................5.3-3397Capsules, modified-release ..............................................5.2-3136Capsules, oromucosal ............................................................... 613Capsules, rectal..................................................................5.2-3149Capsules, soft .....................................................................5.2-3135Capsules, vaginal...............................................................5.2-3153Captopril .............................................................................5.2-3185Captoprilum ......................................................................5.2-3185Caraway fruit............................................................................. 1177Caraway oil .........................................................................5.3-3467Carbachol................................................................................... 1177Carbacholum ............................................................................ 1177Carbamazepine ......................................................................... 1178Carbamazepinum ................................................................... 1178Carbasalate calcium................................................................. 1179Carbasalatum calcicum ......................................................... 1179Carbidopa .................................................................................. 1180Carbidopum .............................................................................. 1180Carbimazole .............................................................................. 1182Carbimazolum ......................................................................... 1182Carbo activatus ........................................................................1246Carbocisteine ............................................................................ 1182Carbocisteinum ....................................................................... 1182Carbomera ................................................................................ 1183Carbomers ................................................................................. 1183Carbon dioxide ......................................................................... 1185Carbon dioxide in gases (2.5.24.) ........................................... 134Carbonei dioxidum ................................................................. 1185Carbonei monoxidum (15O) .....................................................818Carbon monoxide (15O) ..............................................................818Carbon monoxide in gases (2.5.25.)....................................... 134Carboplatin................................................................................ 1186Carboplatinum ......................................................................... 1186Carboprost trometamol ...................................................5.3-3468Carboprostum trometamolum ......................................5.3-3468Carboxymethylamylum natricum A............................5.2-3272Carboxymethylamylum natricum B............................5.2-3273Carboxymethylamylum natricum C................................... 2451Carboxymethylcellulose calcium .......................................... 1188Carboxymethylcellulose sodium........................................... 1189Carboxymethylcellulose sodium, cross-linked ................... 1371Carboxymethylcellulose sodium, low-substituted............. 1190Carisoprodol.............................................................................. 1187Carisoprodolum....................................................................... 1187Carmellose calcium.................................................................. 1188Carmellose sodium .................................................................. 1189Carmellose sodium, low-substituted .................................... 1190Carmellosum calcicum .......................................................... 1188Carmellosum natricum ......................................................... 1189Carmellosum natricum conexum ....................................... 1371Carmellosum natricum, substitutum humile................... 1190

Carmustine ................................................................................ 1191Carmustinum ........................................................................... 1191Carnauba wax ........................................................................... 1191Carteolol hydrochloride.......................................................... 1192Carteololi hydrochloridum ................................................... 1192Carthami oleum raffinatum .................................................2389Carvedilol................................................................................... 1193Carvedilolum ............................................................................ 1193Carvi aetheroleum ...........................................................5.3-3467Carvi fructus............................................................................. 1177Caryophylli floris aetheroleum ...........................................1335Caryophylli flos .......................................................................1334Cascara ....................................................................................... 1194Cassia oil .................................................................................... 1196Castor oil, hydrogenated ........................................................ 1197Castor oil, polyoxyl ...........................................................5.3-3547Castor oil, polyoxyl hydrogenated.................................5.2-3231Castor oil, virgin....................................................................... 1197Catgut, sterile.............................................................................. 873Catgut, sterile, in distributor for veterinary use ................. 885Cefaclor ...............................................................................5.3-3470Cefaclorum ........................................................................5.3-3470Cefadroxil monohydrate ..................................................5.3-3471Cefadroxilum monohydricum ......................................5.3-3471Cefalexin monohydrate...........................................................1202Cefalexinum monohydricum ...............................................1202Cefalotin sodium ......................................................................1203Cefalotinum natricum ...........................................................1203Cefamandole nafate .................................................................1204Cefamandoli nafas ..................................................................1204Cefapirin sodium......................................................................1206Cefapirinum natricum...........................................................1206Cefatrizine propylene glycol..................................................1207Cefatrizinum propylen glycolum........................................1207Cefazolin sodium......................................................................1209Cefazolinum natricum...........................................................1209Cefixime ..................................................................................... 1211Cefiximum................................................................................. 1211Cefoperazone sodium ............................................................. 1212Cefoperazonum natricum..................................................... 1212Cefotaxime sodium .................................................................. 1214Cefotaximum natricum ......................................................... 1214Cefoxitin sodium ...................................................................... 1216Cefoxitinum natricum ........................................................... 1216Cefradine.................................................................................... 1217Cefradinum ............................................................................... 1217Ceftazidime................................................................................ 1218Ceftazidimum........................................................................... 1218Ceftriaxone sodium..................................................................1220Ceftriaxonum natricum.........................................................1220Cefuroxime axetil .....................................................................1222Cefuroxime sodium..................................................................1223Cefuroximum axetili...............................................................1222Cefuroximum natricum .........................................................1223Celiprolol hydrochloride..................................................5.3-3473Celiprololi hydrochloridum...........................................5.3-3473Cell cultures for the production of veterinary vaccines(5.2.4.) ........................................................................................ 458

Cell substrates for the production of vaccines for human use(5.2.3.) ........................................................................................ 455

Cellulose acetate ......................................................................1226Cellulose acetate butyrate......................................................1227Cellulose acetate phthalate....................................................1227Cellulose, microcrystalline.....................................................1228Cellulose, powdered ................................................................1232Cellulosi acetas ........................................................................1226Cellulosi acetas butyras .........................................................1227Cellulosi acetas phthalas.......................................................1227Cellulosi pulvis ........................................................................1232



Cellulosum microcristallinum .............................................1228Centaurii herba .......................................................................1235Centaury ....................................................................................1235Centella ......................................................................................1236Centellae asiaticae herba ......................................................1236Cera alba ................................................................................... 1057Cera carnauba ......................................................................... 1191Cera flava .................................................................................. 1058Cetirizine dihydrochloride .....................................................1237Cetirizini dihydrochloridum ................................................1237Cetobemidoni hydrochloridum ........................................... 1871Cetostearyl alcohol ...........................................................5.3-3474Cetostearyl alcohol (type A), emulsifying ...........................1239Cetostearyl alcohol (type B), emulsifying........................... 1241Cetostearylis isononanoas....................................................1242Cetostearyl isononanoate.......................................................1242Cetrimide ...................................................................................1243Cetrimidum...............................................................................1243Cetyl alcohol ......................................................................5.3-3475Cetylis palmitas .......................................................................1244Cetyl palmitate..........................................................................1244Cetylpyridinii chloridum ......................................................1244Cetylpyridinium chloride........................................................1244Ceylon cinnamon bark oil ......................................................1295Ceylon cinnamon leaf oil........................................................1296Chamomile flower, Roman.....................................................1245Chamomillae romanae flos ..................................................1245Characters section in monographs (5.11.)............................ 565Charcoal, activated ..................................................................1246Chelidonii herba...................................................................... 1690Chenodeoxycholic acid ..........................................................1247Chewing gum, medicated, dissolution test for(2.9.25.) .............................................................................5.2-3116

Chewing gums, medicated ..............................................5.2-3136Chicken flocks free from specified pathogens forthe production and quality control of vaccines(5.2.2.) ...............................................................................5.1-2825

Chicken infectious anaemia vaccine (live) ............................ 769Chinidini sulfas .......................................................................2347Chinini hydrochloridum .......................................................2348Chinini sulfas ...........................................................................2350Chitosan hydrochloride ..........................................................1248Chitosani hydrochloridum ...................................................1248Chloral hydrate.........................................................................1249Chlorali hydras ........................................................................1249Chlorambucil.............................................................................1250Chlorambucilum......................................................................1250Chloramine ................................................................................2605Chloramphenicol......................................................................1250Chloramphenicoli natrii succinas ......................................1252Chloramphenicoli palmitas .................................................. 1251Chloramphenicol palmitate ................................................... 1251Chloramphenicol sodium succinate.....................................1252Chloramphenicolum...............................................................1250Chlorcyclizine hydrochloride ................................................1253Chlorcyclizini hydrochloridum ...........................................1253Chlordiazepoxide ..............................................................5.2-3186Chlordiazepoxide hydrochloride ...................................5.2-3188Chlordiazepoxidi hydrochloridum ..............................5.2-3188Chlordiazepoxidum .........................................................5.2-3186Chlorhexidine diacetate..........................................................1256Chlorhexidine digluconate solution ....................................1258Chlorhexidine dihydrochloride .............................................1259Chlorhexidini diacetas...........................................................1256Chlorhexidini digluconatis solutio.....................................1258Chlorhexidini dihydrochloridum........................................1259Chlorides (2.4.4.) ........................................................................ 104Chlorobutanol, anhydrous ..................................................... 1261Chlorobutanol hemihydrate .................................................. 1261

Chlorobutanolum anhydricum............................................ 1261Chlorobutanolum hemihydricum ....................................... 1261Chlorocresol ..............................................................................1262Chlorocresolum .......................................................................1262Chloroquine phosphate ..........................................................1262Chloroquine sulphate..............................................................1263Chloroquini phosphas ...........................................................1262Chloroquini sulfas...................................................................1263Chlorothiazide ..........................................................................1264Chlorothiazidum .....................................................................1264Chlorphenamine maleate ................................................5.3-3476Chlorphenamini maleas.................................................5.3-3476Chlorpromazine hydrochloride......................................5.3-3477Chlorpromazini hydrochloridum ................................5.3-3477Chlorpropamide........................................................................1266Chlorpropamidum ..................................................................1266Chlorprothixene hydrochloride ............................................1267Chlorprothixeni hydrochloridum .......................................1267Chlortalidone .....................................................................5.3-3478Chlortalidonum ................................................................5.3-3478Chlortetracycline hydrochloride...........................................1270Chlortetracyclini hydrochloridum......................................1270Cholecalciferol ..........................................................................1272Cholecalciferol concentrate (oily form)...............................1273Cholecalciferol concentrate (powder form)........................1275Cholecalciferol concentrate (water-dispersible form).......1277Cholecalciferoli pulvis ...........................................................1275Cholecalciferolum ...................................................................1272Cholecalciferolum densatum oleosum ..............................1273Cholecalciferolum in aqua dispergibile ............................1277Cholera vaccine .......................................................................... 637Cholera vaccine, freeze-dried .................................................. 638Cholesterol ................................................................................1279Cholesterolum ..........................................................................1279Chorda resorbilis sterilis ......................................................... 873Chorda resorbilis sterilis in fuso ad usum veterinarium .. 885Chromatographic separation techniques (2.2.46.) ............... 69Chromatography, gas (2.2.28.).................................................. 42Chromatography, liquid (2.2.29.) ............................................. 43Chromatography, paper (2.2.26.).............................................. 40Chromatography, size-exclusion (2.2.30.)............................... 45Chromatography, supercritical fluid (2.2.45.) ....................... 68Chromatography, thin-layer (2.2.27.) ............................5.2-3090Chromii (51Cr) edetatis solutio iniectabilis ..........................819Chromium (51Cr) edetate injection ..........................................819Chymotrypsin............................................................................1280Chymotrypsinum ....................................................................1280Ciclopirox...................................................................................1282Ciclopirox olamine ...................................................................1283Ciclopirox olaminum .............................................................1283Ciclopiroxum............................................................................1282Ciclosporin ................................................................................1285Ciclosporinum .........................................................................1285Cilastatin sodium .....................................................................1286Cilastatinum natricum ..........................................................1286Cilazapril ....................................................................................1288Cilazaprilum ............................................................................1288Cimetidine..................................................................................1289Cimetidine hydrochloride.......................................................1290Cimetidini hydrochloridum .................................................1290Cimetidinum ............................................................................1289Cinchocaine hydrochloride.................................................... 1291Cinchocaini hydrochloridum .............................................. 1291Cinchona bark ..........................................................................1292Cinchonae cortex ....................................................................1292Cineole........................................................................................1294Cineole in essential oils, assay of, 1,8- (2.8.11.) ....................216Cineolum ...................................................................................1294Cinnamomi cassiae aetheroleum ....................................... 1196



Cinnamomi cortex ..................................................................1295Cinnamomi corticis tinctura................................................1297Cinnamomi zeylanici folii aetheroleum ...........................1296Cinnamomi zeylanicii corticis aetheroleum ...................1295Cinnamon ..................................................................................1295Cinnamon bark oil, Ceylon ....................................................1295Cinnamon leaf oil, Ceylon ......................................................1296Cinnamon tincture...................................................................1297Cinnarizine ................................................................................1297Cinnarizinum ..........................................................................1297Ciprofibrate ...............................................................................1299Ciprofibratum...........................................................................1299Ciprofloxacin.............................................................................1300Ciprofloxacin hydrochloride..................................................1302Ciprofloxacini hydrochloridum ..........................................1302Ciprofloxacinum .....................................................................1300Circular dichroism (2.2.41.) ....................................................... 63Cisapride monohydrate...........................................................1303Cisapride tartrate .....................................................................1304Cisapridi tartras ......................................................................1304Cisapridum monohydricum .................................................1303Cisplatin .....................................................................................1306Cisplatinum ..............................................................................1306Citric acid, anhydrous .............................................................1306Citric acid monohydrate .........................................................1307Citronellae aetheroleum........................................................1308Citronella oil..............................................................................1308Clarithromycin...................................................................5.1-2900Clarithromycinum ...........................................................5.1-2900Clarity and degree of opalescence of liquids (2.2.1.)............ 23Clary sage oil............................................................................. 1311Clazuril for veterinary use ..................................................... 1312Clazurilum ad usum veterinarium..................................... 1312Clebopride malate .................................................................... 1314Clebopridi malas ..................................................................... 1314Clemastine fumarate ............................................................... 1315Clemastini fumaras ................................................................ 1315Clenbuterol hydrochloride..............................................5.1-2902Clenbuteroli hydrochloridum .......................................5.1-2902Clindamycin hydrochloride.................................................... 1318Clindamycini hydrochloridum ............................................ 1318Clindamycini phosphas......................................................... 1319Clindamycin phosphate .......................................................... 1319Clioquinol .................................................................................. 1321Clioquinolum ........................................................................... 1321Clobazam ...................................................................................1322Clobazamum ............................................................................1322Clobetasone butyrate ..............................................................1323Clobetasoni butyras ................................................................1323Clofazimine................................................................................1324Clofaziminum ..........................................................................1324Clofibrate ...................................................................................1325Clofibratum ...............................................................................1325Clomifene citrate ......................................................................1326Clomifeni citras .......................................................................1326Clomipramine hydrochloride.................................................1328Clomipramini hydrochloridum ...........................................1328Clonazepam...............................................................................1330Clonazepamum .......................................................................1330Clonidine hydrochloride......................................................... 1331Clonidini hydrochloridum.................................................... 1331Closantel sodium dihydrate for veterinary use ..........5.1-2903Closantelum natricum dihydricumad usum veterinarium ..................................................5.1-2903

Clostridium botulinum vaccine for veterinary use ............. 745Clostridium chauvoei vaccine for veterinary use................ 745Clostridium novyi alpha antitoxin for veterinary use ........5.1-2865

Clostridium novyi (type B) vaccine for veterinary use....... 746

Clostridium perfringens beta antitoxin for veterinary use............................................................................................5.1-2866

Clostridium perfringens epsilon antitoxin for veterinary use............................................................................................5.1-2867

Clostridium perfringens vaccine for veterinary use ........... 747Clostridium septicum vaccine for veterinary use................ 749Closures and containers for parenteral preparations andophthalmic preparations, polypropylene for (3.1.6.)........ 282

Closures and containers for pharmaceutical use, plastic(3.2.2.) ........................................................................................ 308

Closures and tubing, silicone elastomer for (3.1.9.) ........... 288Closures for containers for aqueous parenteral preparations,for powders and for freeze-dried powders, rubber(3.2.9.) .........................................................................................316

Clotrimazole..............................................................................1333Clotrimazolum .........................................................................1333Clove ...........................................................................................1334Clove oil .....................................................................................1335Cloxacillin sodium....................................................................1335Cloxacillinum natricum ........................................................1335Clozapine ...................................................................................1337Clozapinum ..............................................................................1337Coagulation factor II, assay of (2.7.18.)................................. 209Coagulation factor IX, assay of (2.7.11.)................................ 204Coagulation factor IX, human............................................... 1738Coagulation factors, activated (2.6.22.)................................. 177Coagulation factors, assay of heparin (2.7.12.) ................... 204Coagulation factor VII, assay of (2.7.10.) .............................. 203Coagulation factor VII, human ............................................. 1734Coagulation factor VIII, assay of (2.7.4.)............................... 194Coagulation factor VIII, human.....................................5.3-3513Coagulation factor VIII (rDNA), human ............................. 1737Coagulation factor X, assay of (2.7.19.) ..................................210Coagulation factor XI, assay of (2.7.22.) ............................... 212Coagulation factor XI, human............................................... 1739Coated granules ................................................................ 5.2-3141Coated tablets ....................................................................5.2-3151Cocaine hydrochloride............................................................1338Cocaini hydrochloridum .......................................................1338Cocois oleum raffinatum.......................................................1339Coconut oil, refined.................................................................1339Cocoyl caprylocaprate......................................................5.2-3189Cocoylis caprylocapras...................................................5.2-3189Codeine ...............................................................................5.1-2905Codeine hydrochloride dihydrate..................................5.1-2906Codeine phosphate hemihydrate...................................5.1-2908Codeine phosphate sesquihydrate ................................5.1-2909Codeini hydrochloridum dihydricum.........................5.1-2906Codeini phosphas hemihydricus .................................5.1-2908Codeini phosphas sesquihydricus ...............................5.1-2909Codeinum ...........................................................................5.1-2905Codergocrine mesilate ............................................................1347Codergocrini mesilas .............................................................1347Cod-liver oil (type A)................................................................1348Cod-liver oil (type B)................................................................1352Coffeinum.................................................................................. 1145Coffeinum monohydricum ................................................... 1146Cola .............................................................................................1356Colae semen .............................................................................1356Colchicine ..................................................................................1357Colchicinum .............................................................................1357Colestyramine ...........................................................................1359Colestyraminum ......................................................................1359Colibacillosis vaccine (inactivated), neonatal piglet........... 776Colibacillosis vaccine (inactivated), neonatal ruminant .... 778Colistimethate sodium ............................................................1360Colistimethatum natricum ...................................................1360Colistini sulfas ..................................................................5.3-3480Colistin sulphate ...............................................................5.3-3480



Colloidal anhydrous silica ...................................................... 2410Colloidal hydrated silica ......................................................... 2411Colloidal silver, for external use ....................................5.3-3613Colophonium ...........................................................................1362Colophony .................................................................................1362Coloration of liquids (2.2.2.)...................................................... 24Common stinging nettle for homoeopathicpreparations .....................................................................5.3-3429

Comparative table of porosity of sintered-glass filters(2.1.2.)............................................................................................17

Complexometric titrations (2.5.11.)........................................ 130Composition of fatty acids by gas chromatography(2.4.22.) .......................................................................................110

Composition of fatty acids in oils rich in omega-3-acids(2.4.29.) ...................................................................................... 121

Compressed lozenges................................................................ 613Compressi...........................................................................5.2-3150Concentrated solutions for haemodialysis ......................... 1700Concentrates for injections or infusions......................5.2-3145Concentrates for intrauterine solutions.......................5.3-3397Conductivity (2.2.38.) .......................................................5.1-2783Coneflower root, narrow-leaved.....................................5.2-3246Coneflower root, pale.......................................................5.2-3257Conjugated estrogens .............................................................1539Containers (3.2.)......................................................................... 303Containers and closures for parenteral preparations andophthalmic preparations, polypropylene for (3.1.6.)........ 282

Containers and closures for pharmaceutical use, plastic(3.2.2.) ........................................................................................ 308

Containers and tubing for total parenteral nutritionpreparations, poly(ethylene - vinyl acetate) for (3.1.7.) ... 285

Containers for aqueous solutions for intravenous infusion,materials based on plasticised poly(vinyl chloride) for(3.1.14.) ...................................................................................... 296

Containers for aqueous solutions for parenteral infusion,plastic (3.2.2.1.) ........................................................................ 309

Containers for dry dosage forms for oral administration,materials based on non-plasticised poly(vinyl chloride) for(3.1.11.)....................................................................................... 291

Containers for human blood and blood components,materials based on plasticised poly(vinyl chloride) for(3.1.1.1.) ..................................................................................... 269

Containers for human blood and blood components,materials for (3.1.1.) ................................................................ 269

Containers for human blood and blood components, plastic,sterile (3.2.3.) ............................................................................ 309

Containers for non-injectable aqueous solutions, materialsbased on non-plasticised poly(vinyl chloride) for(3.1.10.) ...................................................................................... 289

Containers for parenteral preparations and for ophthalmicpreparations, polyethylene with additives for (3.1.5.) ..... 279

Containers for parenteral preparations and for ophthalmicpreparations, polyethylene without additives for(3.1.4.)......................................................................................... 278

Containers for pharmaceutical use, glass (3.2.1.)............... 303Containers for preparations not for parenteral use,polyethylene terephthalate for (3.1.15) .............................. 298

Containers of plasticised poly(vinyl chloride) for humanblood and blood components, empty sterile (3.2.4.) .........311

Containers of plasticised poly (vinyl chloride) for humanblood containing anticoagulant solution, sterile (3.2.5.).. 312

Contamination, microbial, test for specified micro-organisms(2.6.13.) ...................................................................................... 156

Contamination, microbial, total viable aerobic count(2.6.12.) ...................................................................................... 154

Content uniformity of single-dose preparations (2.9.6.).... 234Control of impurities in substances for pharmaceutical use(5.10.).......................................................................................... 559

Copolymerum methacrylatis butylati basicum ............... 1053

Copovidone................................................................................1363Copovidonum ...........................................................................1363Copper acetate monohydrate for homoeopathicpreparations .....................................................................5.2-3162

Copper for homoeopathic preparations................................ 896Copper sulphate, anhydrous..................................................1364Copper sulphate pentahydrate..............................................1365Coriander ...................................................................................1365Coriander oil .............................................................................1366Coriandri aetheroleum ..........................................................1366Coriandri fructus ....................................................................1365Corpora ad usum pharmaceuticum ..................................... 586Cortisone acetate .....................................................................1367Cortisoni acetas .......................................................................1367Cotton, absorbent ....................................................................1369Cottonseed oil, hydrogenated ..............................................1370Couch grass rhizome .............................................................. 1371Crataegi folii cum floreextractum fluidum quantificatum .............................5.3-3511

Crataegi folii cum flore extractum siccum ....................... 1714Crataegi folium cum flore..................................................... 1713Crataegi fructus ....................................................................... 1712Creams.......................................................................................... 625Cresol, crude ............................................................................. 1371Cresolum crudum ................................................................... 1371Croci stigma ad praeparationes homoeopathicas ............ 900Croscarmellose sodium........................................................... 1371Crospovidone ............................................................................1373Crospovidonum .......................................................................1373Crotamiton ................................................................................ 1374Crotamitonum.......................................................................... 1374Cupri acetas monohydricus ad praeparationeshomoeopathicas .............................................................5.2-3162

Cupri sulfas anhydricus ........................................................1364Cupri sulfas pentahydricus ..................................................1365Cuprum ad praeparationes homoeopathicas .................... 896Curcumae xanthorrhizae rhizoma.....................................2645Cutaneous application, liquid preparations for................... 607Cutaneous application, powders for .............................5.2-3147Cutaneous application, semi-solid preparations for ........... 624Cutaneous application, veterinary liquid preparationsfor ................................................................................................ 630

Cutaneous foams........................................................................ 608Cyamopsidis seminis pulvis ................................................. 1694Cyanocobalamin .......................................................................1375Cyanocobalamin (57Co) capsules .............................................819Cyanocobalamin (57Co) solution ............................................. 820Cyanocobalamin (58Co) capsules ............................................ 821Cyanocobalamin (58Co) solution ............................................. 822Cyanocobalamini (57Co) capsulae .........................................819Cyanocobalamini (57Co) solutio ............................................ 820Cyanocobalamini (58Co) capsulae ........................................ 821Cyanocobalamini (58Co) solutio ............................................ 822Cyanocobalaminum ...............................................................1375Cyclizine hydrochloride .......................................................... 1376Cyclizini hydrochloridum..................................................... 1376Cyclopentolate hydrochloride ...............................................1377Cyclopentolati hydrochloridum ..........................................1377Cyclophosphamide...................................................................1378Cyclophosphamidum .............................................................1378Cyproheptadine hydrochloride .............................................1379Cyproheptadini hydrochloridum ........................................1379Cyproterone acetate ................................................................1380Cyproteroni acetas..................................................................1380Cysteine hydrochloride monohydrate ................................. 1381Cysteini hydrochloridum monohydricum ........................ 1381Cystine........................................................................................1382Cystinum ...................................................................................1382Cytarabine .................................................................................1383



Cytarabinum.............................................................................1383

DDalteparin sodium ...................................................................1387Dalteparinum natricum ........................................................1387Dapsone .....................................................................................1388Dapsonum .................................................................................1388Daunorubicin hydrochloride .................................................1389Daunorubicini hydrochloridum..........................................1389D-Camphor ................................................................................. 1170D-Camphora .............................................................................. 1170Decylis oleas .............................................................................1390Decyl oleate ...............................................................................1390Deferoxamine mesilate............................................................1390Deferoxamini mesilas ............................................................1390Degree of coloration of liquids (2.2.2.).................................... 24Deliverable mass or volume of liquid and semi-solidpreparations, test for (2.9.28.)............................................... 263

Demeclocycline hydrochloride..............................................1392Demeclocyclini hydrochloridum ........................................1392Density of solids (2.2.42.) ........................................................... 64Density, relative (2.2.5.) .............................................................. 27Dental type silica...................................................................... 2411Depressor substances (2.6.11.)................................................ 153Deptropine citrate....................................................................1393Deptropini citras .....................................................................1393Dequalinii chloridum.............................................................1394Dequalinium chloride..............................................................1394Desipramine hydrochloride ...................................................1395Desipramini hydrochloridum ..............................................1395Deslanoside ...............................................................................1396Deslanosidum ..........................................................................1396Desmopressin............................................................................1397Desmopressinum.....................................................................1397Desoxycortone acetate............................................................1399Desoxycortoni acetas .............................................................1399Detector tubes, gas (2.1.6.) .........................................................19Determination of essential oils in vegetable drugs(2.8.12.) .......................................................................................217

Determination of nitrogen by sulphuric acid digestion(2.5.9.) ........................................................................................ 129

Determination of primary aromatic amino-nitrogen(2.5.8.) ........................................................................................ 129

Determination of tannins in herbal drugs (2.8.14.)............ 221Determination of water by distillation (2.2.13.) .................... 32Detomidine hydrochloride for veterinary use ................... 1400Detomidini hydrochloridum ad usum veterinarium ..... 1400Devil’s claw root ....................................................................... 1401Dexamethasone ........................................................................ 1402Dexamethasone acetate.......................................................... 1403Dexamethasone isonicotinate ........................................5.3-3485Dexamethasone sodium phosphate ..................................... 1404Dexamethasoni acetas ........................................................... 1403Dexamethasoni isonicotinas .........................................5.3-3485Dexamethasoni natrii phosphas ......................................... 1404Dexamethasonum ................................................................... 1402Dexchlorpheniramine maleate .............................................. 1406Dexchlorpheniramini maleas .............................................. 1406Dexpanthenol............................................................................ 1407Dexpanthenolum..................................................................... 1407Dextran 1 for injection............................................................ 1408Dextran 40 for injection ......................................................... 1409Dextran 60 for injection ......................................................... 1410Dextran 70 for injection ..........................................................1411Dextrans, molecular mass distribution in (2.2.39.) .............. 57Dextranum 1 ad iniectabile ................................................. 1408Dextranum 40 ad iniectabile ............................................... 1409Dextranum 60 ad iniectabile ............................................... 1410Dextranum 70 ad iniectabile ................................................1411

Dextrin........................................................................................ 1412Dextrinum ................................................................................. 1412Dextromethorphan hydrobromide ....................................... 1412Dextromethorphani hydrobromidum ................................ 1412Dextromoramide tartrate ........................................................1414Dextromoramidi tartras ..........................................................1414Dextropropoxyphene hydrochloride.....................................1414Dextropropoxypheni hydrochloridum................................1414Diazepam ................................................................................... 1415Diazepamum ............................................................................ 1415Diazoxide ................................................................................... 1416Diazoxidum .............................................................................. 1416Dibrompropamidine diisetionate ...................................5.3-3486Dibrompropamidini diisetionas ...................................5.3-3486Dibutylis phthalas ....................................................................1417Dibutyl phthalate ......................................................................1417Dichloromethane...................................................................... 2017Diclazuril for veterinary use.................................................. 1418Diclazurilum ad usum veterinarium ................................. 1418Diclofenac potassium .............................................................. 1419Diclofenac sodium ................................................................... 1420Diclofenacum kalicum........................................................... 1419Diclofenacum natricum ........................................................ 1420Dicloxacillin sodium ................................................................ 1422Dicloxacillinum natricum..................................................... 1422Dicycloverine hydrochloride.................................................. 1423Dicycloverini hydrochloridum ............................................ 1423Didanosine..........................................................................5.2-3193Didanosinum.....................................................................5.2-3193Dienestrol .................................................................................. 1424Dienestrolum ............................................................................ 1424Diethylcarbamazine citrate .................................................... 1426Diethylcarbamazini citras .................................................... 1426Diethylene glycol and ethylene glycol in ethoxylatedsubstances (2.4.30.)........................................................5.2-3095

Diethylene glycol monoethyl ether...................................... 1426Diethylene glycol palmitostearate .................................5.2-3194Diethylenglycoli monoethylicum aetherum .................... 1426Diethylenglycoli palmitostearas...................................5.2-3194Diethylis phthalas ................................................................... 1425Diethyl phthalate ..................................................................... 1425Diethylstilbestrol ...................................................................... 1429Diethylstilbestrolum ............................................................... 1429Diflunisal.................................................................................... 1429Diflunisalum ............................................................................ 1429Digitalis leaf .............................................................................. 1431Digitalis purpureae folium ................................................... 1431Digitoxin..................................................................................... 1432Digitoxinum.............................................................................. 1432Digoxin ....................................................................................... 1433Digoxinum ................................................................................ 1433Dihydralazine sulphate, hydrated ........................................ 1434Dihydralazini sulfas hydricus.............................................. 1434Dihydrocodeine hydrogen tartrate....................................... 1435Dihydrocodeini hydrogenotartras ...................................... 1435Dihydroergocristine mesilate ................................................ 1437Dihydroergocristini mesilas ................................................. 1437Dihydroergotamine mesilate ................................................. 1439Dihydroergotamine tartrate .................................................. 1440Dihydroergotamini mesilas .................................................. 1439Dihydroergotamini tartras.................................................... 1440Dihydrostreptomycini sulfas ad usum veterinarium..... 1441Dihydrostreptomycin sulphate for veterinary use ............ 1441Dihydrotachysterol ...........................................................5.3-3487Dihydrotachysterolum ....................................................5.3-3487Dikalii clorazepas ................................................................... 1457Dikalii phosphas...................................................................... 1458Diltiazem hydrochloride ......................................................... 1443Diltiazemi hydrochloridum .................................................. 1443



Dimenhydrinate........................................................................ 1444Dimenhydrinatum .................................................................. 1444Dimercaprol............................................................................... 1445Dimercaprolum........................................................................ 1445Dimethylacetamide ...........................................................5.1-2915Dimethylacetamidum......................................................5.1-2915Dimethylaniline, N,N- (2.4.26.) .................................................119Dimethylis sulfoxidum ........................................................... 1445Dimethyl sulfoxide ................................................................... 1445Dimeticone ................................................................................ 1447Dimeticonum............................................................................ 1447Dimetindene maleate .............................................................. 1448Dimetindeni maleas ............................................................... 1448Dinatrii edetas ......................................................................... 1462Dinatrii phosphas anhydricus............................................. 1463Dinatrii phosphas dihydricus .............................................. 1464Dinatrii phosphas dodecahydricus .............................5.1-2916Dinitrogenii oxidum........................................................5.1-2981Dinoprostone ............................................................................ 1450Dinoprostonum........................................................................ 1450Dinoprost trometamol............................................................. 1449Dinoprostum trometamolum ............................................... 1449Diosmin ...................................................................................... 1452Diosminum ............................................................................... 1452Dioxan and ethylene oxide (2.4.25.) .......................................118Dip concentrates ........................................................................ 630Diphenhydramine hydrochloride.......................................... 1454Diphenhydramini hydrochloridum.................................... 1454Diphenoxylate hydrochloride ................................................ 1455Diphenoxylati hydrochloridum ........................................... 1455Diphtheria and tetanus vaccine (adsorbed) ......................... 639Diphtheria and tetanus vaccine (adsorbed) for adults andadolescents................................................................................ 639

Diphtheria antitoxin .................................................................. 801Diphtheria, tetanus and hepatitis B (rDNA) vaccine(adsorbed).................................................................................. 641

Diphtheria, tetanus and pertussis (acellular, component)vaccine (adsorbed)................................................................... 642

Diphtheria, tetanus and pertussis vaccine (adsorbed) ..... 643Diphtheria, tetanus, pertussis (acellular, component) andhaemophilus type b conjugate vaccine (adsorbed) .......... 645

Diphtheria, tetanus, pertussis (acellular, component) andhepatitis B (rDNA) vaccine (adsorbed) ............................... 647

Diphtheria, tetanus, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed) .................. 648

Diphtheria, tetanus, pertussis (acellular, component),hepatitis B (rDNA), poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) .......... 650

Diphtheria, tetanus, pertussis (acellular, component),poliomyelitis (inactivated) and haemophilus type bconjugate vaccine (adsorbed)................................................ 653

Diphtheria, tetanus, pertussis and poliomyelitis (inactivated)vaccine (adsorbed)................................................................... 656

Diphtheria, tetanus, pertussis, poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) .......... 657

Diphtheria vaccine (adsorbed) ................................................ 660Diphtheria vaccine (adsorbed), assay of (2.7.6.) .................. 196Diphtheria vaccine (adsorbed) for adults andadolescents................................................................................ 661

Dipivefrine hydrochloride ...................................................... 1456Dipivefrini hydrochloridum ................................................. 1456Dipotassium clorazepate ........................................................ 1457Dipotassium phosphate .......................................................... 1458Diprophylline ............................................................................ 1459Diprophyllinum ....................................................................... 1459Dipyridamole............................................................................. 1460Dipyridamolum ....................................................................... 1460Dirithromycin............................................................................ 1461Dirithromycinum .................................................................... 1461

Disintegration of suppositories and pessaries (2.9.2.) ....... 227Disintegration of tablets and capsules (2.9.1.) ...........5.3-3351Disodium edetate ..................................................................... 1462Disodium phosphate, anhydrous.......................................... 1463Disodium phosphate dihydrate............................................. 1464Disodium phosphate dodecahydrate ............................5.1-2916Disopyramide ............................................................................ 1465Disopyramide phosphate........................................................ 1466Disopyramidi phosphas......................................................... 1466Disopyramidum ....................................................................... 1465Dispersible tablets ............................................................5.2-3151Dissolution test for lipophilic solid dosage forms(2.9.42.) .............................................................................5.3-3373

Dissolution test for medicated chewing gums (2.9.25.)............................................................................................5.2-3116

Dissolution test for solid dosage forms (2.9.3.) ..........5.3-3353Dissolution test for transdermal patches (2.9.4.)................ 231Distemper vaccine (live), canine, freeze-dried...................... 740Distemper vaccine (live) for mustelids, freeze-dried........... 751Distillation range (2.2.11.).......................................................... 30Distribution estimation by analytical sieving, particle-size(2.9.38.) .............................................................................5.3-3368

Disulfiram .................................................................................. 1467Disulfiramum ........................................................................... 1467Dithranol.................................................................................... 1468Dithranolum ............................................................................. 1468DL-Methionine ........................................................................... 2010DL-Methioninum ...................................................................... 2010DL-α-Tocopheryl hydrogen succinate...................................2597DL-α-Tocopherylis hydrogenosuccinas..............................2597Dobutamine hydrochloride.................................................... 1469Dobutamini hydrochloridum ............................................... 1469Docusate sodium...................................................................... 1471Dodecyl gallate ......................................................................... 1472Dodecylis gallas ....................................................................... 1472Dog rose ..................................................................................... 1472Domperidone ............................................................................ 1473Domperidone maleate ............................................................. 1475Domperidoni maleas .............................................................. 1475Domperidonum ....................................................................... 1473Dopamine hydrochloride........................................................ 1476Dopamini hydrochloridum................................................... 1476Dosage units, uniformity of (2.9.40.) ............................5.3-3370Dosulepin hydrochloride........................................................ 1477Dosulepini hydrochloridum ................................................. 1477Doxapram hydrochloride........................................................ 1479Doxaprami hydrochloridum ................................................ 1479Doxepin hydrochloride ........................................................... 1480Doxepini hydrochloridum .................................................... 1480Doxorubicin hydrochloride.................................................... 1481Doxorubicini hydrochloridum............................................. 1481Doxycycline hyclate ................................................................. 1482Doxycycline monohydrate...................................................... 1484Doxycyclini hyclas .................................................................. 1482Doxycyclinum monohydricum ............................................ 1484Doxylamine hydrogen succinate........................................... 1486Doxylamini hydrogenosuccinas ......................................... 1486Droperidol.................................................................................. 1487Droperidolum........................................................................... 1487Droppers (2.1.1.)............................................................................17Drop point (2.2.17.)...................................................................... 33Dry extracts ................................................................................. 572Dry residue of extracts (2.8.16.).............................................. 222Duck plague vaccine (live) ..............................................5.3-3419Duck viral hepatitis type I vaccine (live)............................... 751

EEar-drops and sprays ........................................................5.2-3137Ear powders .......................................................................5.2-3138



Ear preparations................................................................5.2-3137Ear preparations, semi-solid ...........................................5.2-3138Ear tampons.......................................................................5.2-3138Ear washes..........................................................................5.2-3138Ebastine ..................................................................................... 1491Ebastinum ................................................................................. 1491Echinaceae angustifoliae radix....................................5.2-3246Echinaceae pallidae radix .............................................5.2-3257Econazole .................................................................................. 1492Econazole nitrate ..................................................................... 1493Econazoli nitras ...................................................................... 1493Econazolum.............................................................................. 1492Edetic acid ................................................................................. 1494Edrophonii chloridum ........................................................... 1495Edrophonium chloride............................................................ 1495Effervescent granules....................................................... 5.2-3141Effervescent powders .......................................................5.2-3148Effervescent tablets ..........................................................5.2-3151Efficacy of antimicrobial preservation (5.1.3.) ..................... 447Egg drop syndrome ’76 vaccine (inactivated)...................... 753Elder flower............................................................................... 1496Electrophoresis (2.2.31.) ............................................................. 45Electrophoresis, capillary (2.2.47.) ............................................74Eleutherococci radix .......................................................5.3-3491Eleutherococcus................................................................5.3-3491Emetine hydrochloride heptahydrate.................................. 1499Emetine hydrochloride pentahydrate..................................1500Emetini hydrochloridum heptahydricum......................... 1499Emetini hydrochloridum pentahydricum ........................1500Emplastra transcutanea .................................................5.2-3146Empty sterile containers of plasticised poly(vinyl chloride)for human blood and blood components (3.2.4.) ..............311

Emulsifying cetostearyl alcohol (type A) ............................1239Emulsifying cetostearyl alcohol (type B)............................ 1241Enalaprili maleas.............................................................5.1-2919Enalapril maleate ..............................................................5.1-2919Encephalitis vaccine (inactivated), tick-borne ............5.3-3414Endotoxins, bacterial (2.6.14.)..................................................161Enilconazole for veterinary use............................................1503Enilconazolum ad usum veterinarium .............................1503Enoxaparin sodium...........................................................5.3-3493Enoxaparinum natricum ...............................................5.3-3493Enoxolone..................................................................................1505Enoxolonum .............................................................................1505Ephedrine, anhydrous.............................................................1506Ephedrine hemihydrate ..........................................................1507Ephedrine hydrochloride .......................................................1508Ephedrine hydrochloride, racemic.......................................1509Ephedrini hydrochloridum ..................................................1508Ephedrini racemici hydrochloridum .................................1509Ephedrinum anhydricum .....................................................1506Ephedrinum hemihydricum ................................................1507Epirubicin hydrochloride .......................................................1509Epirubicini hydrochloridum ................................................1509Equine herpesvirus vaccine (inactivated) ............................. 754Equine influenza vaccine (inactivated) ................................. 755Equiseti herba .......................................................................... 1511Equisetum stem........................................................................ 1511Ergocalciferol............................................................................ 1512Ergocalciferolum ..................................................................... 1512Ergometrine maleate............................................................... 1514Ergometrini maleas ................................................................ 1514Ergotamine tartrate................................................................. 1515Ergotamini tartras .................................................................. 1515Erysipelas vaccine (inactivated), swine ................................. 793Erythritol ................................................................................... 1516Erythritolum............................................................................. 1516Erythromycin ............................................................................ 1518Erythromycin estolate.............................................................1520

Erythromycin ethylsuccinate................................................. 1521Erythromycini estolas............................................................1520Erythromycini ethylsuccinas ............................................... 1521Erythromycini lactobionas ...................................................1523Erythromycini stearas ...........................................................1526Erythromycin lactobionate ....................................................1523Erythromycin stearate ............................................................1526Erythromycinum ..................................................................... 1518Erythropoietin concentrated solution..........................5.3-3494Erythropoietini solutio concentrata............................5.3-3494Eserine salicylate .....................................................................2239Eserine sulphate.......................................................................2240Eserini salicylas ......................................................................2239Eserini sulfas............................................................................2240Esketamine hydrochloride .....................................................1533Esketamini hydrochloridum ................................................1533Essential oils, assay of 1,8-cineole (2.8.11.) ...........................216Essential oils, fatty oils and resinified essential oils in(2.8.7.)..........................................................................................216

Essential oils, foreign esters in (2.8.6.) ..................................216Essential oils in vegetable drugs, determination of(2.8.12.) .......................................................................................217

Essential oils, odour and taste (2.8.8.) ...................................216Essential oils, residue on evaporation (2.8.9.) ......................216Essential oils, solubility in alcohol (2.8.10.)..........................216Essential oils, water in (2.8.5.) .................................................216Ester value (2.5.2.) ..................................................................... 127Estradiol benzoate...................................................................1534Estradiol hemihydrate.............................................................1535Estradioli benzoas...................................................................1534Estradioli valeras.....................................................................1536Estradiolum hemihydricum .................................................1535Estradiol valerate .....................................................................1536Estriol .........................................................................................1537Estriolum ...................................................................................1537Estrogeni coniuncti ................................................................1539Estrogens, conjugated ............................................................1539Etacrynic acid ...........................................................................1542Etamsylate .................................................................................1542Etamsylatum ............................................................................1542Ethacridine lactate monohydrate.........................................1543Ethacridini lactas monohydricus .......................................1543Ethambutol hydrochloride.....................................................1544Ethambutoli hydrochloridum ..............................................1544Ethanol (96 per cent) ..............................................................1545Ethanol, anhydrous .................................................................1547Ethanol content and alcoholimetric tables (2.9.10.) .......... 237Ethanolum (96 per centum) .................................................1545Ethanolum anhydricum ........................................................1547Ether ...........................................................................................1548Ether, anaesthetic ....................................................................1549Ethinylestradiol ........................................................................1550Ethinylestradiolum .................................................................1550Ethionamide.............................................................................. 1551Ethionamidum ......................................................................... 1551Ethosuximide .....................................................................5.3-3498Ethosuximidum ................................................................5.3-3498Ethoxylated substances, ethylene glycol and diethyleneglycol in (2.4.30.) ............................................................5.2-3095

Ethyl acetate .............................................................................1553Ethylcellulose ...........................................................................1555Ethylcellulosum .......................................................................1555Ethylendiaminum ...................................................................1556Ethylenediamine ......................................................................1556Ethylene glycol and diethylene glycol in ethoxylatedsubstances (2.4.30.)........................................................5.2-3095

Ethylene glycol monopalmitostearate.................................1556Ethylene glycol monostearate...............................................1556Ethylene oxide and dioxan (2.4.25.) .......................................118



Ethylenglycoli monopalmitostearas...................................1556Ethylhexanoic acid, 2- (2.4.28.) ............................................... 120Ethylis acetas ...........................................................................1553Ethylis oleas..............................................................................1553Ethylis parahydroxybenzoas................................................1554Ethylis parahydroxybenzoas natricum ......................5.1-2920Ethylmorphine hydrochloride...............................................1557Ethylmorphini hydrochloridum ..........................................1557Ethyl oleate ...............................................................................1553Ethyl parahydroxybenzoate...................................................1554Ethyl parahydroxybenzoate sodium .............................5.1-2920Etilefrine hydrochloride .........................................................1558Etilefrini hydrochloridum.....................................................1558Etodolac .....................................................................................1560Etodolacum...............................................................................1560Etofenamate .............................................................................. 1561Etofenamatum ......................................................................... 1561Etofylline....................................................................................1563Etofyllinum ...............................................................................1563Etomidate ..................................................................................1564Etomidatum ..............................................................................1564Etoposide ...................................................................................1565Etoposidum...............................................................................1565Eucalypti aetheroleum ...................................................5.2-3203Eucalypti folium ......................................................................1569Eucalyptus leaf .........................................................................1569Eucalyptus oil ....................................................................5.2-3203Eugenol ...................................................................................... 1571Eugenolum................................................................................ 1571European Goldenrod........................................................5.3-3507European viper venom antiserum.......................................... 806Evaluation of efficacy of veterinary vaccines and immunosera(5.2.7.)................................................................................5.1-2829

Evaluation of safety of each batch of veterinary vaccines andimmunosera (5.2.9.) .......................................................5.1-2830

Evaluation of safety of veterinary vaccines and immunosera(5.2.6.) ...............................................................................5.1-2827

Evening primrose oil, refined.........................................5.1-2921Extracta........................................................................................ 570Extractable volume of parenteral preparations, test for(2.9.17.)..............................................................................5.3-3363

Extracta fluida ........................................................................... 571Extracta sicca ............................................................................. 572Extracta spissa ........................................................................... 572Extracts ........................................................................................ 570Extracts, dry ................................................................................ 572Extracts, dry residue of (2.8.16.)............................................. 222Extracts, liquid............................................................................ 571Extracts, loss on drying of (2.8.17.)........................................ 222Extracts, soft ............................................................................... 572Extraneous agents in viral vaccines for human use, tests for(2.6.16.) ...................................................................................... 169

Extraneous agents : tests in batches of finished product ofavian live virus vaccines (2.6.25.)................................5.3-3345

Extraneous agents : tests in seed lots of avian viral vaccines(2.6.24.) ...................................................................................... 177

Eye drops ............................................................................5.3-3395Eye lotions ..........................................................................5.3-3395Eye preparations ...............................................................5.3-3395Eye preparations, semi-solid ...........................................5.3-3396

FF0 concept to steam sterilisation of aqueous preparations,application of (5.1.5.) .....................................................5.1-2821

Factor II, human coagulation, assay of (2.7.18.) ................. 209Factor IX coagulationis humanus ...................................... 1738Factor IX, human coagulation .............................................. 1738Factor IX, human coagulation, assay of (2.7.11.) ................ 204Factor VII coagulationis humanus .................................... 1734

Factor VII, human coagulation............................................. 1734Factor VII, human coagulation, assay of (2.7.10.) .............. 203Factor VIII coagulationis humanus ............................5.3-3513Factor VIII coagulationis humanus (ADNr) .................... 1737Factor VIII, human coagulation ....................................5.3-3513Factor VIII, human coagulation, assay of (2.7.4.) ............... 194Factor VIII (rDNA), human coagulation ............................. 1737Factor X, human coagulation, assay of (2.7.19.) ..................210Factor XI coagulationis humanus ...................................... 1739Factor XI, human coagulation .............................................. 1739Factor XI, human coagulation, assay of (2.7.22.)................ 212Fagopyri herba .................................................................5.2-3180Falling ball viscometer method (2.2.49.) ................................ 80Famotidine.................................................................................1575Famotidinum............................................................................1575Fatty acids, composition by gas chromatography(2.4.22.) .......................................................................................110

Fatty oils, alkaline impurities in (2.4.19.) ............................. 109Fatty oils and herbal drugs, heavy metals in (2.4.27.) ........119Fatty oils and resinified essential oils in essential oils(2.8.7.)..........................................................................................216

Fatty oils, foreign oils in, by thin-layer chromatography(2.4.21.) ...................................................................................... 109

Fatty oils, identification by thin-layer chromatography(2.3.2.) .......................................................................................... 98

Fatty oils, sterols in (2.4.23.) ..........................................5.1-2787Fc function of immunoglobulin, test for (2.7.9.) ................. 202Feline calicivirosis vaccine (inactivated) ............................... 757Feline calicivirosis vaccine (live), freeze-dried ..................... 758Feline infectious enteritis (feline panleucopenia) vaccine(inactivated) .............................................................................. 759

Feline infectious enteritis (feline panleucopenia) vaccine(live) ............................................................................................ 760

Feline leukaemia vaccine (inactivated)...................................761Feline panleucopenia vaccine (inactivated).......................... 759Feline panleucopenia vaccine (live) ....................................... 760Feline viral rhinotracheitis vaccine (inactivated) ................ 762Feline viral rhinotracheitis vaccine (live), freeze-dried ...... 763Felodipine .................................................................................. 1576Felodipinum ............................................................................. 1576Felypressin..........................................................................5.2-3207Felypressinum...................................................................5.2-3207Fenbendazole for veterinary use ..........................................1577Fenbendazolum ad usum veterinarium............................1577Fenbufen ....................................................................................1578Fenbufenum..............................................................................1578Fennel, bitter.............................................................................1580Fennel, sweet.............................................................................1580Fenofibrate ................................................................................ 1581Fenofibratum............................................................................ 1581Fenoterol hydrobromide.........................................................1583Fenoteroli hydrobromidum ..................................................1583Fentanyl .....................................................................................1584Fentanyl citrate.........................................................................1585Fentanyli citras ........................................................................1585Fentanylum...............................................................................1584Fenticonazole nitrate ..............................................................1586Fenticonazoli nitras ...............................................................1586Fenugreek..................................................................................1588Fermentation, products of ....................................................... 576Ferric chloride hexahydrate ..................................................1588Ferri chloridum hexahydricum...........................................1588Ferrosi fumaras .......................................................................1589Ferrosi gluconas ......................................................................1590Ferrosi sulfas heptahydricus ................................................ 1591Ferrous fumarate .....................................................................1589Ferrous gluconate....................................................................1590Ferrous sulphate heptahydrate............................................. 1591Ferrum ad praeparationes homoeopathicas ..................... 899



Feverfew .....................................................................................1592Fibrini glutinum......................................................................1593Fibrinogen, human .................................................................. 1740Fibrinogenum humanum ..................................................... 1740Fibrin sealant kit ......................................................................1593Fila non resorbilia sterilia .............................................5.3-3423Fila non resorbilia sterilia in fuso ad usumveterinarium ............................................................................ 888

Fila resorbilia synthetica monofilamenta sterilia ............ 880Fila resorbilia synthetica torta sterilia ................................ 878Filipendulae ulmariae herba ...............................................1980Filum bombycis tortum sterile in fuso ad usumveterinarium ............................................................................ 887

Filum ethyleni polyterephthalici sterile in fuso ad usumveterinarium ............................................................................ 887

Filum lini sterile in fuso ad usum veterinarium .............. 886Filum polyamidicum-6/6 sterile in fuso ad usumveterinarium ............................................................................ 887

Filum polyamidicum-6 sterile in fuso ad usumveterinarium ............................................................................ 886

Finasteride.................................................................................1594Finasteridum ............................................................................1594Fish oil, rich in omega-3-acids...............................................1595Flecainide acetate ....................................................................1598Flecainidi acetas .....................................................................1598Flowability (2.9.16.) ................................................................... 242Flubendazole ............................................................................1599Flubendazolum ........................................................................1599Flucloxacillin sodium .......................................................5.1-2925Flucloxacillinum natricum............................................5.1-2925Flucytosine ................................................................................ 1602Flucytosinum ........................................................................... 1602Fludarabine phosphate....................................................5.1-2926Fludarabini phosphas .....................................................5.1-2926Fludeoxyglucose (18F) injection .............................................. 822Fludeoxyglucosi (18F) solutio iniectabilis ........................... 822Fludrocortisone acetate.......................................................... 1603Fludrocortisoni acetas ........................................................... 1603Flumazenil ................................................................................. 1604Flumazenil (N-[11C]methyl) injection ..................................... 825Flumazenil (N-[11C]methyl) solutio iniectabilis................. 825Flumazenilum.......................................................................... 1604Flumequine ...............................................................................1605Flumequinum........................................................................... 1605Flumetasone pivalate ..............................................................1607Flumetasoni pivalas ............................................................... 1607Flunarizine dihydrochloride.................................................. 1608Flunarizini dihydrochloridum ............................................ 1608Flunitrazepam........................................................................... 1609Flunitrazepamum ................................................................... 1609Flunixini megluminum ad usum veterinarium.......5.1-2929Flunixin meglumine for veterinary use........................5.1-2929Fluocinolone acetonide .......................................................... 1610Fluocinoloni acetonidum ..................................................... 1610Fluocortolone pivalate............................................................ 1611Fluocortoloni pivalas ............................................................. 1611Fluorescein sodium ..........................................................5.2-3208Fluoresceinum natricum ...............................................5.2-3208Fluorides (2.4.5.) ........................................................................ 104Fluorimetry (2.2.21.) ................................................................... 35Fluorouracil............................................................................... 1614Fluorouracilum........................................................................ 1614Fluoxetine hydrochloride ................................................5.3-3503Fluoxetini hydrochloridum ...........................................5.3-3503Flupentixol dihydrochloride ...................................................1617Flupentixoli dihydrochloridum ............................................1617Fluphenazine decanoate ........................................................ 1619Fluphenazine enantate ........................................................... 1620Fluphenazine hydrochloride ................................................. 1621

Fluphenazini decanoas ......................................................... 1619Fluphenazini enantas............................................................ 1620Fluphenazini hydrochloridum ............................................ 1621Flurazepami monohydrochloridum................................... 1622Flurazepam monohydrochloride .......................................... 1622Flurbiprofen .............................................................................. 1623Flurbiprofenum ....................................................................... 1623Fluspirilene ............................................................................... 1625Fluspirilenum .......................................................................... 1625Flutamide................................................................................... 1626Flutamidum .............................................................................. 1626Fluticasone propionate ........................................................... 1627Fluticasoni propionas ............................................................ 1627Flutrimazole .............................................................................. 1629Flutrimazolum ......................................................................... 1629Foams, cutaneous ...................................................................... 608Foams, intrauterine ..........................................................5.3-3397Foams, medicated ...................................................................... 604Foams, rectal ......................................................................5.2-3150Foams, vaginal ...................................................................5.2-3154Foeniculi amari fructus.........................................................1580Foeniculi amari fructus aetheroleum................................ 1108Foeniculi dulcis fructus.........................................................1580Folic acid.................................................................................... 1630Foot-and-mouth disease (ruminants) vaccine(inactivated) .....................................................................5.1-2860

Foreign esters in essential oils (2.8.6.) ...................................216Foreign matter (2.8.2.) .............................................................. 215Foreign oils in fatty oils by thin-layer chromatography(2.4.21.) ...................................................................................... 109

Formaldehyde, free (2.4.18.) .................................................... 109Formaldehyde solution (35 per cent) .................................. 1632Formaldehydi solutio (35 per centum).............................. 1632Formoterol fumarate dihydrate ............................................ 1632Formoteroli fumaras dihydricus ......................................... 1632Foscarnet sodium hexahydrate............................................. 1634Foscarnetum natricum hexahydricum.............................. 1634Fosfomycin calcium ................................................................. 1636Fosfomycin sodium.................................................................. 1637Fosfomycin trometamol .......................................................... 1638Fosfomycinum calcicum ....................................................... 1636Fosfomycinum natricum....................................................... 1637Fosfomycinum trometamolum ............................................ 1638Fowl cholera vaccine (inactivated) ................................5.1-2861Fowl-pox vaccine (live) .............................................................. 766Framycetini sulfas .................................................................. 1639Framycetin sulphate................................................................ 1639Frangula bark ........................................................................... 1641Frangula bark dry extract, standardised ............................ 1642Frangulae cortex ..................................................................... 1641Frangulae corticis extractum siccum normatum ........... 1642Fraxini folium .......................................................................... 1026Free formaldehyde (2.4.18.) ..................................................... 109Freezing point (2.2.18.)............................................................... 34Friability of uncoated tablets (2.9.7.)............................5.2-3103Fructose .................................................................................... 1643Fructosum ................................................................................. 1643Fucus .......................................................................................... 1869Fucus vel Ascophyllum .......................................................... 1869Functional groups and ions, identification reactions(2.3.1.)........................................................................................... 95

Furosemide.........................................................................5.1-2930Furosemidum ....................................................................5.1-2930Furunculosis vaccine (inactivated, oil-adjuvanted, injectable)for salmonids ............................................................................ 767

Fusidic acid ............................................................................... 1645

GGalactose.................................................................................... 1649



Galactosum ............................................................................... 1649Gallamine triethiodide ............................................................1649Gallamini triethiodidum .......................................................1649Gallii (67Ga) citratis solutio iniectabilis ............................... 826Gallium (67Ga) citrate injection ............................................... 826Gargles.......................................................................................... 612Garlic for homoeopathic preparations .................................. 897Garlic powder............................................................................ 1651Gas chromatography (2.2.28.) ................................................... 42Gas detector tubes (2.1.6.) ..........................................................19Gases, carbon dioxide in (2.5.24.)........................................... 134Gases, carbon monoxide in (2.5.25.) ...................................... 134Gases, nitrogen monoxide and nitrogen dioxide in(2.5.26.) ...................................................................................... 135

Gases, nitrous oxide in (2.5.35.)...............................................141Gases, oxygen in (2.5.27.) ......................................................... 136Gases, water in (2.5.28.)............................................................ 136Gas-gangrene antitoxin, mixed ................................................ 802Gas-gangrene antitoxin (novyi) ............................................... 802Gas-gangrene antitoxin (perfringens) .................................... 803Gas-gangrene antitoxin (septicum)......................................... 804Gastro-resistant capsules .................................................5.2-3136Gastro-resistant granules................................................. 5.2-3141Gastro-resistant tablets ....................................................5.2-3152Gelatin ........................................................................................ 1651Gelatina ..................................................................................... 1651Gels................................................................................................ 625Gels for injections .............................................................5.2-3146General chapters (1.3.)...................................................................6General notices (1.).........................................................................5General statements (1.1.)...............................................................5General texts on sterility (5.1.) ................................................ 445General texts on vaccines (5.2.) .............................................. 453Gentamicini sulfas .................................................................. 1653Gentamicin sulphate................................................................ 1653Gentianae radix ....................................................................... 1654Gentianae tinctura.................................................................. 1655Gentian root ..............................................................................1654Gentian tincture ....................................................................... 1655Ginger ......................................................................................... 1656Gingival solutions ...................................................................... 612Ginkgo folium .......................................................................... 1657Ginkgo leaf ................................................................................ 1657Ginseng................................................................................5.1-2935Ginseng radix ....................................................................5.1-2935Glass containers for pharmaceutical use (3.2.1.) ................ 303Glibenclamide ........................................................................... 1659Glibenclamidum ...................................................................... 1659Gliclazide.................................................................................... 1660Gliclazidum............................................................................... 1660Glipizide ..................................................................................... 1662Glipizidum ................................................................................ 1662Glossary (dosage forms) ........................................................... 599Glucagon.................................................................................... 1663Glucagon, human..................................................................... 1665Glucagonum ............................................................................. 1663Glucagonum humanum ........................................................ 1665Glucose, anhydrous ................................................................. 1666Glucose, liquid .......................................................................... 1667Glucose, liquid, spray-dried.................................................... 1668Glucose monohydrate ............................................................. 1669Glucosum anhydricum .......................................................... 1666Glucosum liquidum ................................................................ 1667Glucosum liquidum dispersione desiccatum................... 1668Glucosum monohydricum .................................................... 1669Glutamic acid ............................................................................ 1670Glutathione.........................................................................5.1-2936Glutathionum ....................................................................5.1-2936Glycerol ...................................................................................... 1671

Glycerol (85 per cent).............................................................. 1672Glycerol dibehenate ..........................................................5.1-2938Glycerol distearate .................................................................. 1674Glyceroli dibehenas .........................................................5.1-2938Glyceroli distearas .................................................................. 1674Glyceroli monolinoleas ........................................................ 1675Glyceroli mono-oleates .......................................................... 1676Glyceroli monostearas 40-55................................................ 1677Glyceroli trinitratis solutio ................................................... 1678Glycerol monolinoleate ........................................................... 1675Glycerol mono-oleates ............................................................ 1676Glycerol monostearate 40-55................................................. 1677Glycerol triacetate.................................................................... 2612Glycerolum................................................................................ 1671Glycerolum (85 per centum) ................................................ 1672Glyceryl trinitrate solution..................................................... 1678Glycine ........................................................................................ 1680Glycinum ................................................................................... 1680Glycyrrhizate ammonium................................................5.1-2876Goldenrod ...........................................................................5.2-3213Goldenrod, European.......................................................5.3-3507Goldenseal rhizome................................................................. 1683Gonadorelin acetate ................................................................ 1684Gonadorelini acetas ............................................................... 1684Gonadotrophin, chorionic ......................................................1686Gonadotrophin, equine serum, for veterinary use............ 1686Gonadotropinum chorionicum ........................................... 1686Gonadotropinum sericum equinum ad usumveterinarium .......................................................................... 1686

Goserelin .................................................................................... 1687Goserelinum ............................................................................. 1687Gossypii oleum hydrogenatum............................................1370Gramicidin ................................................................................. 1689Gramicidinum .......................................................................... 1689Graminis rhizoma................................................................... 1371Granisetron hydrochloride..............................................5.1-2939Granisetroni hydrochloridum.......................................5.1-2939Granulata ...........................................................................5.2-3140Granules ..............................................................................5.2-3140Granules, coated................................................................ 5.2-3141Granules, effervescent...................................................... 5.2-3141Granules, gastro-resistant................................................ 5.2-3141Granules, modified-release.............................................. 5.2-3141Greater celandine ..................................................................... 1690Griseofulvin ............................................................................... 1691Griseofulvinum ........................................................................ 1691Guaifenesin................................................................................ 1692Guaifenesinum ........................................................................ 1692Guanethidine monosulphate ................................................. 1694Guanethidini monosulfas ..................................................... 1694Guar ............................................................................................ 1694Guar galactomannan ............................................................... 1695Guar galactomannanum ....................................................... 1695

HHaemodiafiltration and for haemofiltration, solutionsfor .............................................................................................. 1703

Haemodialysis, concentrated solutions for ........................ 1700Haemodialysis solutions, concentrated, water fordiluting..................................................................................... 1699

Haemodialysis, solutions for.................................................. 1700Haemofiltration and for haemodiafiltration, solutionsfor .............................................................................................. 1703

Haemophilus type b (conjugate), diphtheria, tetanus,pertussis (acellular, component) and poliomyelitis(inactivated) vaccine (adsorbed) ........................................... 653

Haemophilus type b (conjugate), diphtheria, tetanus,pertussis and poliomyelitis (inactivated) vaccine(adsorbed).................................................................................. 657



Haemophilus type b conjugate vaccine................................. 662Halofantrine hydrochloride ................................................... 1705Halofantrini hydrochloridum .............................................. 1705Haloperidol................................................................................ 1706Haloperidol decanoate............................................................ 1708Haloperidoli decanoas........................................................... 1708Haloperidolum ......................................................................... 1706Halothane .................................................................................. 1709Halothanum.............................................................................. 1709Hamamelidis folium ............................................................... 1711Hamamelis leaf ......................................................................... 1711Hard capsules.....................................................................5.2-3135Hard fat ...................................................................................... 1711Hard paraffin............................................................................. 2186Harpagophyti radix ................................................................ 1401Hawthorn berries ..................................................................... 1712Hawthorn leaf and flower ...................................................... 1713Hawthorn leaf and flower dry extract ................................. 1714Hawthorn leaf and flower liquid extract, quantified ..5.3-3511Heavy bismuth subnitrate ...................................................... 1107Heavy kaolin..............................................................................1869Heavy magnesium carbonate .........................................5.3-3547Heavy magnesium oxide.........................................................1958Heavy metals (2.4.8.) ................................................................. 104Heavy metals in herbal drugs and fatty oils (2.4.27.)..........119Hederae folium .................................................................5.1-2954Hedera helix ad praeparationes homoeopathicas...5.2-3163Hedera helix for homoeopathic preparations.............5.2-3163Helianthi annui oleum raffinatum.....................................2524Heparina massae molecularis minoris ..............................1717Heparin, assay of (2.7.5.) .......................................................... 195Heparin calcium ....................................................................... 1715Heparin in coagulation factors, assay of (2.7.12.) ............... 204Heparins, low-molecular-mass ................................................1717Heparin sodium........................................................................ 1716Heparinum calcicum ............................................................. 1715Heparinum natricum ............................................................. 1716Hepatitis A immunoglobulin, human ...................................1741Hepatitis A (inactivated) and hepatitis B (rDNA) vaccine(adsorbed).................................................................................. 664

Hepatitis A vaccine, assay of (2.7.14.) ...........................5.1-2795Hepatitis A vaccine (inactivated, adsorbed) ......................... 665Hepatitis A vaccine (inactivated, virosome) ......................... 667Hepatitis B immunoglobulin for intravenous administration,human .......................................................................................1741

Hepatitis B immunoglobulin, human ...................................1741Hepatitis B (rDNA), diphtheria and tetanus vaccine(adsorbed).................................................................................. 641

Hepatitis B (rDNA), diphtheria, tetanus and pertussis(acellular, component) vaccine (adsorbed) ........................ 647

Hepatitis B vaccine (rDNA)...................................................... 670Hepatitis B vaccine (rDNA), assay of (2.7.15.) ..................... 207Hepatitis C virus (HCV), validation of nucleic acidamplification techniques for the detection of HCV RNA inplasma pools : Guidelines........................................................176

Heptaminol hydrochloride ..................................................... 1719Heptaminoli hydrochloridum .............................................. 1719Herbal drug preparations......................................................... 572Herbal drugs ............................................................................... 572Herbal drugs and fatty oils, heavy metals in (2.4.27.).........119Herbal drugs, determination of tannins (2.8.14.) ............... 221Herbal drugs for homoeopathic preparations ............5.2-3161Herbal teas................................................................................... 573Hexamidine diisetionate ..................................................5.2-3217Hexamidini diisetionas ..................................................5.2-3217Hexetidine.................................................................................. 1721Hexetidinum ............................................................................. 1721Hexobarbital.............................................................................. 1722Hexobarbitalum ....................................................................... 1722

Hexosamines in polysaccharide vaccines (2.5.20.) ............. 132Hexylresorcinol......................................................................... 1723Hexylresorcinolum ................................................................. 1723Hibisci sabdariffae flos .......................................................... 2376Highly purified water ..............................................................2695Histamine (2.6.10.)..................................................................... 153Histamine dihydrochloride .................................................... 1724Histamine phosphate .............................................................. 1725Histamini dihydrochloridum ............................................... 1724Histamini phosphas................................................................ 1725Histidine..............................................................................5.1-2945Histidine hydrochloride monohydrate ................................ 1727Histidini hydrochloridum monohydricum....................... 1727Histidinum .........................................................................5.1-2945Homatropine hydrobromide .................................................. 1728Homatropine methylbromide ................................................ 1729Homatropini hydrobromidum ............................................. 1728Homatropini methylbromidum ........................................... 1729Homeopathic preparations, oriental cashew for ........5.3-3430Homoeopathic preparations .................................................... 893Homoeopathic preparations, arsenious trioxide for .......... 895Homoeopathic preparations, calcium iodide tetrahydratefor .......................................................................................5.2-3162

Homoeopathic preparations, common stinging nettlefor .......................................................................................5.3-3429

Homoeopathic preparations, copper acetate monohydratefor .......................................................................................5.2-3162

Homoeopathic preparations, copper for............................... 896Homoeopathic preparations, garlic for ................................. 897Homoeopathic preparations, hedera helix for............5.2-3163Homoeopathic preparations, herbal drugs for ...........5.2-3161Homoeopathic preparations, honey bee for......................... 898Homoeopathic preparations, hyoscyamus for ............5.2-3164Homoeopathic preparations, hypericum for ........................ 898Homoeopathic preparations, iron for .................................... 899Homoeopathic preparations, mother tinctures for............. 894Homoeopathic preparations, saffron for............................... 900Honey ..................................................................................5.1-2946Honey bee for homoeopathic preparations.......................... 898Hop strobile............................................................................... 1730Human albumin injection, iodinated (125I)............................ 827Human albumin solution ................................................5.3-3511Human anti-D immunoglobulin ............................................ 1732Human anti-D immunoglobulin, assay of (2.7.13.).............. 205Human anti-D immunoglobulin for intravenousadministration ........................................................................ 1733

Human antithrombin III, assay of (2.7.17.) ........................... 209Human antithrombin III concentrate .................................. 1733Human coagulation factor II, assay of (2.7.18.)................... 209Human coagulation factor IX................................................ 1738Human coagulation factor IX, assay of (2.7.11.).................. 204Human coagulation factor VII .............................................. 1734Human coagulation factor VII, assay of (2.7.10.) ................ 203Human coagulation factor VIII ......................................5.3-3513Human coagulation factor VIII, assay of (2.7.4.)................. 194Human coagulation factor VIII (rDNA)............................... 1737Human coagulation factor X, assay of (2.7.19.) ....................210Human coagulation factor XI ................................................ 1739Human coagulation factor XI, assay of (2.7.22.) ................. 212Human fibrinogen.................................................................... 1740Human hepatitis A immunoglobulin ....................................1741Human hepatitis B immunoglobulin ....................................1741Human hepatitis B immunoglobulin for intravenousadministration .........................................................................1741

Human insulin .......................................................................... 1800Human measles immunoglobulin......................................... 1742Human normal immunoglobulin...................................5.3-3514Human normal immunoglobulin for intravenousadministration .................................................................5.3-3516



Human plasma for fractionation....................................5.3-3518Human plasma (pooled and treated for virusinactivation) ............................................................................ 1747

Human prothrombin complex............................................... 1748Human rabies immunoglobulin............................................ 1750Human rubella immunoglobulin .......................................... 1751Human tetanus immunoglobulin ......................................... 1751Human varicella immunoglobulin........................................ 1752Human varicella immunoglobulin for intravenousadministration ........................................................................ 1753

Human von Willebrand factor, assay of (2.7.21.) .................211Hyaluronidase .......................................................................... 1753Hyaluronidasum ..................................................................... 1753Hydralazine hydrochloride .................................................... 1754Hydralazini hydrochloridum ............................................... 1754Hydrargyri dichloridum ........................................................1995Hydrastis rhizoma .................................................................. 1683Hydrochloric acid, concentrated........................................... 1755Hydrochloric acid, dilute ........................................................ 1756Hydrochlorothiazide................................................................ 1756Hydrochlorothiazidum .......................................................... 1756Hydrocortisone......................................................................... 1757Hydrocortisone acetate........................................................... 1759Hydrocortisone hydrogen succinate .....................................1761Hydrocortisoni acetas ............................................................ 1759Hydrocortisoni hydrogenosuccinas ....................................1761Hydrocortisonum .................................................................... 1757Hydrogenated arachis oil ....................................................... 1018Hydrogenated castor oil ......................................................... 1197Hydrogenated cottonseed oil ................................................1370Hydrogenated soya-bean oil...................................................2475Hydrogenated wool fat............................................................2708Hydrogenii peroxidum 30 per centum.............................. 1763Hydrogenii peroxidum 3 per centum ................................ 1762Hydrogen peroxide solution (30 per cent) ......................... 1763Hydrogen peroxide solution (3 per cent)............................ 1762Hydromorphone hydrochloride ............................................ 1763Hydromorphoni hydrochloridum ....................................... 1763Hydrous wool fat ......................................................................2709Hydroxocobalamin acetate..................................................... 1765Hydroxocobalamin chloride................................................... 1766Hydroxocobalamini acetas ................................................... 1765Hydroxocobalamini chloridum ........................................... 1766Hydroxocobalamini sulfas .................................................... 1767Hydroxocobalamin sulphate .................................................. 1767Hydroxycarbamide ................................................................... 1768Hydroxycarbamidum ............................................................. 1768Hydroxyethylcellulose......................................................5.1-2947Hydroxyethylcellulosum.................................................5.1-2947Hydroxyethylis salicylas........................................................ 1769Hydroxyethylmethylcellulose ................................................ 2018Hydroxyethyl salicylate........................................................... 1769Hydroxyl value (2.5.3.) .............................................................. 127Hydroxypropylbetadex............................................................ 1771Hydroxypropylbetadexum .................................................... 1771Hydroxypropylcellulose .......................................................... 1773Hydroxypropylcellulosum .................................................... 1773Hydroxypropylmethylcellulose.............................................. 1780Hydroxypropylmethylcellulose phthalate........................... 1781Hydroxyzine hydrochloride ................................................... 1774Hydroxyzini hydrochloridum .............................................. 1774Hymecromone........................................................................... 1775Hymecromonum...................................................................... 1775Hyoscine..............................................................................5.3-3519Hyoscine butylbromide ........................................................... 1776Hyoscine hydrobromide.......................................................... 1777Hyoscini butylbromidum ...................................................... 1776Hyoscini hydrobromidum..................................................... 1777Hyoscinum .........................................................................5.3-3519

Hyoscyamine sulphate .....................................................5.3-3520Hyoscyamini sulfas .........................................................5.3-3520Hyoscyamus for homoeopathic preparations .............5.2-3164Hyoscyamus niger ad praeparationes homoeopathicas ..5.2-3164

Hyperici herba .........................................................................2485Hypericum .................................................................................2485Hypericum for homoeopathic preparations ......................... 898Hypericum perforatumad praeparationes homoeopathicas................................... 898

Hypromellose ............................................................................ 1780Hypromellose phthalate ......................................................... 1781Hypromellosi phthalas........................................................... 1781Hypromellosum ....................................................................... 1780

IIbuprofen ................................................................................... 1785Ibuprofenum............................................................................. 1785Iceland moss.......................................................................5.3-3525ICH (5.8.)...................................................................................... 551Ichthammol ............................................................................... 1787Ichthammolum ........................................................................ 1787Identification (2.3.) ...................................................................... 95Identification and control of residual solvents (2.4.24.).... 113Identification of fatty oils by thin-layer chromatography(2.3.2.) .......................................................................................... 98

Identification of phenothiazines by thin-layerchromatography (2.3.3.) ........................................................... 99

Identification reactions of ions and functional groups(2.3.1.)........................................................................................... 95

Idoxuridine ................................................................................ 1788Idoxuridinum ........................................................................... 1788Iecoris aselli oleum A.............................................................1348Iecoris aselli oleum B ............................................................1352Ifosfamide .................................................................................. 1789Ifosfamidum ............................................................................. 1789Imipenem ................................................................................... 1791Imipenemum ............................................................................ 1791Imipramine hydrochloride ..................................................... 1792Imipramini hydrochloridum ................................................ 1792Immunochemical methods (2.7.1.) ......................................... 187Immunoglobulin, animal, anti-T lymphocyte, for humanuse............................................................................................. 1010

Immunoglobulin for intravenous administration, humanhepatitis B ................................................................................1741

Immunoglobulin for intravenous administration, humannormal ...............................................................................5.3-3516

Immunoglobulin for intravenous administration, humanvaricella.................................................................................... 1753

Immunoglobulin, human anti-D ........................................... 1732Immunoglobulin, human anti-D, assay of (2.7.13.) ............. 205Immunoglobulin, human anti-D, for intravenousadministration ........................................................................ 1733

Immunoglobulin, human hepatitis A....................................1741Immunoglobulin, human hepatitis B ...................................1741Immunoglobulin, human measles ........................................ 1742Immunoglobulin, human normal ..................................5.3-3514Immunoglobulin, human rabies ........................................... 1750Immunoglobulin, human rubella ......................................... 1751Immunoglobulin, human tetanus......................................... 1751Immunoglobulin, human varicella ....................................... 1752Immunoglobulin, test for anticomplementary activity of(2.6.17.)....................................................................................... 170

Immunoglobulin, test for Fc function of (2.7.9.)................. 202Immunoglobulinum anti-T lymphocytorum ex animale adusum humanum .................................................................... 1010

Immunoglobulinum humanum anti-D.............................. 1732Immunoglobulinum humanum anti-D ad usumintravenosum ......................................................................... 1733



Immunoglobulinum humanum hepatitidis A ..................1741Immunoglobulinum humanum hepatitidis B ..................1741Immunoglobulinum humanum hepatitidis B ad usumintravenosum ..........................................................................1741

Immunoglobulinum humanum morbillicum .................. 1742Immunoglobulinum humanum normale ..................5.3-3514Immunoglobulinum humanum normale ad usumintravenosum ..................................................................5.3-3516

Immunoglobulinum humanum rabicum.......................... 1750Immunoglobulinum humanum rubellae .......................... 1751Immunoglobulinum humanum tetanicum ...................... 1751Immunoglobulinum humanum varicellae ....................... 1752Immunoglobulinum humanum varicellae ad usumintravenosum ......................................................................... 1753

Immunosera ad usum veterinarium .................................... 575Immunosera and vaccines, phenol in (2.5.15.) .....................131Immunosera and vaccines, veterinary, evaluation of safety(5.2.6.) ...............................................................................5.1-2827

Immunosera and vaccines, veterinary, evaluation of theefficacy (5.2.7) .................................................................5.1-2829

Immunosera and vaccines, veterinary, evaluation of thesafety of each batch (5.2.9.) ..........................................5.1-2830

Immunosera ex animale ad usum humanum ................... 573Immunosera for human use, animal...................................... 573Immunosera for veterinary use ............................................. 575Immunoserum botulinicum ................................................... 801Immunoserum clostridii novyi alpha ad usumveterinarium ...................................................................5.1-2865

Immunoserum clostridii perfringentis beta ad usumveterinarium ...................................................................5.1-2866

Immunoserum clostridii perfringentis epsilon ad usumveterinarium ...................................................................5.1-2867

Immunoserum contra venena viperarumeuropaearum ........................................................................... 806

Immunoserum diphthericum ................................................ 801Immunoserum gangraenicum (Clostridium novyi) ........ 802Immunoserum gangraenicum(Clostridium perfringens)..................................................... 803

Immunoserum gangraenicum (Clostridium septicum) .. 804Immunoserum gangraenicum mixtum ............................... 802Immunoserum tetanicum ad usum humanum................. 805Immunoserum tetanicum ad usum veterinarium...5.1-2868Implants ..............................................................................5.2-3146Impurities in substances for pharmaceutical use, control of(5.10.).......................................................................................... 559

Indapamide.........................................................................5.3-3525Indapamidum ...................................................................5.3-3525Indicators, relationship between approximate pH and colour(2.2.4.) .......................................................................................... 27

Indii (111In) chloridi solutio .................................................... 828Indii (111In) oxini solutio ......................................................... 829Indii (111In) pentetatis solutio iniectabilis .......................... 830Indium (111In) chloride solution .............................................. 828Indium (111In) oxine solution ................................................... 829Indium (111In) pentetate injection........................................... 830Indometacin .............................................................................. 1794Indometacinum ....................................................................... 1794Infectious bovine rhinotracheitis vaccine (live),freeze-dried................................................................................ 768

Infectious bronchitis vaccine (inactivated), avian ............... 718Infectious bronchitis vaccine (live), avian............................. 720Infectious bursal disease vaccine (inactivated), avian........ 722Infectious bursal disease vaccine (live), avian ..................... 723Infectious chicken anaemia vaccine (live) ............................ 769Infectious encephalomyelitis vaccine (live), avian .............. 725Infectious laryngotracheitis vaccine (live), avian ................ 727Influenza vaccine (split virion, inactivated) ................5.3-3401Influenza vaccine (surface antigen, inactivated)........5.3-3402

Influenza vaccine (surface antigen, inactivated,virosome) ..........................................................................5.3-3404

Influenza vaccine (whole virion, inactivated) .............5.3-3406Infrared absorption spectrophotometry (2.2.24.) ................. 37Infusions .............................................................................5.2-3145Inhalanda...........................................................................5.1-2843Inhalation gas, krypton (81MKr) ............................................... 833Inhalation, preparations for............................................5.1-2843Inhalation, preparations for : aerodynamic assessment of fineparticles (2.9.18.) ............................................................5.2-3103

Injections ............................................................................5.2-3145Injections, gels for.............................................................5.2-3146Injections or infusions, concentrates for .....................5.2-3145Injections or infusions, powders for .............................5.2-3145Inositol, myo- .....................................................................5.3-3527Inserts, ophthalmic...........................................................5.3-3396Insulin aspart ............................................................................ 1795Insulin, bovine .......................................................................... 1797Insulin, human.......................................................................... 1800Insulini biphasici iniectabilium.......................................... 1802Insulini isophani biphasici iniectabilium ........................ 1803Insulini isophani iniectabilium .......................................... 1803Insulin injection, biphasic ...................................................... 1802Insulin injection, biphasic isophane .................................... 1803Insulin injection, isophane..................................................... 1803Insulin injection, soluble ........................................................1803Insulini solubilis iniectabilium ........................................... 1803Insulini zinci amorphi suspensio iniectabilis................. 1811Insulini zinci cristallini suspensio iniectabilis............... 1812Insulini zinci suspensio iniectabilis .................................. 1811Insulin lispro ............................................................................. 1804Insulin, porcine.........................................................................1806Insulin preparations, injectable ........................................... 1808Insulinum aspartum .............................................................. 1795Insulinum bovinum ................................................................ 1797Insulinum humanum............................................................. 1800Insulinum lisprum.................................................................. 1804Insulinum porcinum .............................................................. 1806Insulin zinc injectable suspension ....................................... 1811Insulin zinc injectable suspension (amorphous) .............. 1811Insulin zinc injectable suspension (crystalline) ................ 1812Interferon alfa-2 concentrated solution .............................. 1812Interferon gamma-1b concentrated solution ..................... 1815Interferoni alfa-2 solutio concentrata................................ 1812Interferoni gamma-1b solutio concentrata ...................... 1815Interferons, assay of (5.6.) ...............................................5.3-3381int-rac-α-Tocopherolum ..................................................5.3-3631int-rac-α-Tocopherylis acetas ........................................5.3-3632Intramammary preparations for veterinary use .................. 606Intraruminal devices ........................................................ 5.2-3141Intrauterine capsules .......................................................5.3-3397Intrauterine foams ............................................................5.3-3397Intrauterine preparations for veterinary use ..............5.3-3397Intrauterine solutions, suspensions..............................5.3-3397Intrauterine sticks.............................................................5.3-3397Intrauterine tablets...........................................................5.3-3397In vivo assay of poliomyelitis vaccine (inactivated)(2.7.20.) .......................................................................................210

Iobenguane (123I) injection....................................................... 831Iobenguane (131I) injection for diagnostic use ..................... 832Iobenguane (131I) injection for therapeutic use ................... 833Iobenguani (123I) solutio iniectabilis .................................... 831Iobenguani (131I) solutio iniectabilis ad usumdiagnosticum ........................................................................... 832

Iobenguani (131I) solutio iniectabilis ad usumtherapeuticum.......................................................................... 833

Iodinated (125I) human albumin injection ............................. 827Iodinated povidone.................................................................. 2291Iodinati (125I) humani albumini solutio iniectabilis ........ 827



Iodine.......................................................................................... 1819Iodine value (2.5.4.) ................................................................... 127Iodum ......................................................................................... 1819Iohexol........................................................................................ 1819Iohexolum ................................................................................. 1819Ionic concentration, potentiometric determination of usingion-selective electrodes (2.2.36.)............................................. 55

Ions and functional groups, identification reactions(2.3.1.)........................................................................................... 95

Ion-selective electrodes, potentiometric determination ofionic concentration (2.2.36.) ................................................... 55

Iopamidol ............................................................................5.2-3223Iopamidolum .....................................................................5.2-3223Iopanoic acid.............................................................................1824Iotalamic acid............................................................................1825Ioxaglic acid ..............................................................................1826Ipecacuanhae extractum fluidum normatum ..........5.1-2951Ipecacuanhae pulvis normatus ...........................................1829Ipecacuanhae radix ................................................................1829Ipecacuanhae tinctura normata ..................................5.1-2951Ipecacuanha liquid extract, standardised ....................5.1-2951Ipecacuanha, prepared............................................................1829Ipecacuanha root .....................................................................1829Ipecacuanha tincture, standardised..............................5.1-2951Ipratropii bromidum .............................................................. 1831Ipratropium bromide............................................................... 1831Iron (2.4.9.) .................................................................................. 107Iron for homoeopathic preparations ..................................... 899Irrigation, preparations for ...................................................... 622Isoconazole................................................................................1833Isoconazole nitrate ..................................................................1834Isoconazoli nitras ...................................................................1834Isoconazolum...........................................................................1833Isoelectric focusing (2.2.54.).......................................................81Isoflurane...................................................................................1835Isofluranum..............................................................................1835Isoleucine...................................................................................1836Isoleucinum ..............................................................................1836Isomalt........................................................................................1837Isomaltum .................................................................................1837Isoniazid.....................................................................................1839Isoniazidum .............................................................................1839Isophane insulin injection......................................................1803Isoprenaline hydrochloride....................................................1839Isoprenaline sulphate..............................................................1840Isoprenalini hydrochloridum ..............................................1839Isoprenalini sulfas ..................................................................1840Isopropyl alcohol...................................................................... 1841Isopropylis myristas ........................................................5.1-2952Isopropylis palmitas ........................................................5.1-2953Isopropyl myristate...........................................................5.1-2952Isopropyl palmitate...........................................................5.1-2953Isosorbide dinitrate, diluted .................................................1844Isosorbide mononitrate, diluted ..........................................1845Isosorbidi dinitras dilutus.....................................................1844Isosorbidi mononitras dilutus .............................................1845Isotretinoin ................................................................................1847Isotretinoinum .........................................................................1847Isoxsuprine hydrochloride .....................................................1848Isoxsuprini hydrochloridum ................................................1848Ispaghula husk .........................................................................1849Ispaghula seed ..........................................................................1850Isradipine ............................................................................5.3-3528Isradipinum .......................................................................5.3-3528Itraconazole ..............................................................................1852Itraconazolum..........................................................................1852Iuniperi aetheroleum .............................................................1863Iuniperi pseudo-fructus .........................................................1862Ivermectin..................................................................................1854

Ivermectinum ........................................................................... 1854Ivy leaf .................................................................................5.1-2954

JJavanese turmeric ....................................................................2645Java tea .......................................................................................1859Josamycin................................................................................... 1860Josamycini propionas ............................................................ 1861Josamycin propionate.............................................................. 1861Josamycinum ........................................................................... 1860Juniper........................................................................................ 1862Juniper oil .................................................................................. 1863

KKalii acetas ...............................................................................2273Kalii bromidum........................................................................2273Kalii carbonas .......................................................................... 2274Kalii chloridum.................................................................5.2-3261Kalii citras .................................................................................2275Kalii clavulanas ....................................................................... 2276Kalii clavulanas dilutus .........................................................2278Kalii dihydrogenophosphas .................................................2280Kalii hydrogenoaspartas hemihydricus ............................2280Kalii hydrogenocarbonas...................................................... 2281Kalii hydrogenotartras...........................................................2282Kalii hydroxidum ....................................................................2283Kalii iodidum ...........................................................................2283Kalii metabisulfis .............................................................5.3-3597Kalii natrii tartras tetrahydricus.........................................2286Kalii nitras ................................................................................2284Kalii perchloras .......................................................................2285Kalii permanganas .................................................................2286Kalii sorbas ...............................................................................2287Kalii sulfas ................................................................................2288Kanamycin acid sulphate ....................................................... 1867Kanamycini monosulfas ....................................................... 1868Kanamycini sulfas acidus ..................................................... 1867Kanamycin monosulphate...................................................... 1868Kaolin, heavy............................................................................. 1869Kaolinum ponderosum.......................................................... 1869Kelp ............................................................................................. 1869Ketamine hydrochloride ......................................................... 1870Ketamini hydrochloridum .................................................... 1870Ketobemidone hydrochloride................................................ 1871Ketoconazole ............................................................................ 1872Ketoconazolum ........................................................................ 1872Ketoprofen................................................................................. 1874Ketoprofenum .......................................................................... 1874Ketorolac trometamol ......................................................5.3-3533Ketorolacum trometamolum .........................................5.3-3533Ketotifen hydrogen fumarate ................................................ 1875Ketotifeni hydrogenofumaras .............................................. 1875Knotgrass................................................................................... 1877Krypton (81mKr) inhalation gas................................................ 833Kryptonum (81mKr) ad inhalationem .................................. 833

LLabetalol hydrochloride ......................................................... 1881Labetaloli hydrochloridum ................................................... 1881Lacca ..........................................................................................2409Lactic acid...........................................................................5.2-3227Lactic acid, (S)- ..................................................................5.2-3227Lactitol monohydrate.............................................................. 1883Lactitolum monohydricum................................................... 1883Lactobionic acid ....................................................................... 1885Lactose, anhydrous.................................................................. 1886Lactose monohydrate.............................................................. 1887Lactosum anhydricum........................................................... 1886



Lactosum monohydricum.....................................................1887Lactulose....................................................................................1888Lactulose, liquid .......................................................................1890Lactulosum ...............................................................................1888Lactulosum liquidum .............................................................1890Lamivudine.........................................................................5.3-3537Lamivudinum ...................................................................5.3-3537Lanugo cellulosi absorbens.................................................. 2681Lanugo gossypii absorbens ..................................................1369Lauroyl macrogolglycerides ..................................................1892Lavandulae aetheroleum ...............................................5.3-3539Lavandulae flos .......................................................................1893Lavender flower........................................................................1893Lavender oil........................................................................5.3-3539Lead in sugars (2.4.10.) ............................................................ 107Lemon oil ...................................................................................1895Leonuri cardiacae herba.......................................................2063Leptospirosis vaccine (inactivated), bovine.......................... 730Leptospirosis vaccine (inactivated), canine .......................... 740Leucine.......................................................................................1897Leucinum ..................................................................................1897Leuprorelin................................................................................1898Leuprorelinum.........................................................................1898Levamisole for veterinary use ...............................................1899Levamisole hydrochloride ......................................................1900Levamisoli hydrochloridum .................................................1900Levamisolum ad usum veterinarium ................................1899Levistici radix...........................................................................1932Levocabastine hydrochloride ................................................1902Levocabastini hydrochloridum ...........................................1902Levocarnitine .....................................................................5.1-2959Levocarnitinum ................................................................5.1-2959Levodopa....................................................................................1904Levodopum ...............................................................................1904Levodropropizine .....................................................................1905Levodropropizinum................................................................1905Levomenthol .............................................................................1907Levomentholum.......................................................................1907Levomepromazine hydrochloride.........................................1908Levomepromazine maleate ....................................................1908Levomepromazini hydrochloridum ...................................1908Levomepromazini maleas ....................................................1908Levomethadone hydrochloride .............................................1909Levomethadoni hydrochloridum ........................................1909Levonorgestrel .......................................................................... 1911Levonorgestrelum ................................................................... 1911Levothyroxine sodium .....................................................5.3-3540Levothyroxinum natricum ............................................5.3-3540Lichen islandicus .............................................................5.3-3525Lidocaine ................................................................................... 1913Lidocaine hydrochloride......................................................... 1914Lidocaini hydrochloridum ................................................... 1914Lidocainum .............................................................................. 1913Light liquid paraffin ................................................................ 2186Light magnesium carbonate...........................................5.3-3548Light magnesium oxide ..........................................................1958Lime flower ............................................................................... 1914Limit test of particle size by microscopy (2.9.13.) .............. 239Limit tests (2.4.).......................................................................... 103Limit tests, standard solutions for (4.1.2.)............................ 426Limit tests, standard solutions for (4.1.2.)...................5.1-2818Limonis aetheroleum .............................................................1895Lincomycin hydrochloride ..................................................... 1915Lincomycini hydrochloridum.............................................. 1915Lindane ...................................................................................... 1916Lindanum ................................................................................. 1916Linen thread, sterile, in distributor for veterinary use ..... 886Lini oleum virginale .............................................................. 1918Lini semen .........................................................................5.1-2960

Linoleoyl macrogolglycerides.................................................1917Linseed ................................................................................5.1-2960Linseed oil, virgin .................................................................... 1918Liothyronine sodium............................................................... 1919Liothyroninum natricum ..................................................... 1919Lipophilic solid dosage forms, dissolution test for(2.9.42.) .............................................................................5.3-3373

Liquid and semi-solid preparations, test for deliverable massor volume (2.9.28.) .................................................................. 263

Liquid chromatography (2.2.29.) .............................................. 43Liquid extracts ............................................................................ 571Liquid glucose .......................................................................... 1667Liquid glucose, spray-dried.................................................... 1668Liquid lactulose ........................................................................1890Liquid maltitol ..........................................................................1969Liquid paraffin .......................................................................... 2187Liquid preparations for cutaneous application ................... 607Liquid preparations for cutaneous application,veterinary .................................................................................. 630

Liquid preparations for inhalation ................................5.1-2843Liquid preparations for oral use....................................5.2-3142Liquid sorbitol (crystallising) ................................................2471Liquid sorbitol (non-crystallising) ........................................2472Liquid sorbitol, partially dehydrated ...................................2473Liquiritiae extractum fluidum ethanolicum normatum ..5.3-3541

Liquiritiae radix ...................................................................... 1921Liquorice ethanolic liquid extract, standardised .......5.3-3541Liquorice root ........................................................................... 1921Lisinopril dihydrate .................................................................1922Lisinoprilum dihydricum .....................................................1922Lithii carbonas.........................................................................1923Lithii citras ...............................................................................1924Lithium carbonate ...................................................................1923Lithium citrate..........................................................................1924L-Methionine ([11C]methyl) injection...................................... 834L-Methionini ([11C]methyl) solutio iniectabilis .................. 834Lobeline hydrochloride...........................................................1925Lobelini hydrochloridum ......................................................1925Lomustine..................................................................................1926Lomustinum .............................................................................1926Loosestrife .................................................................................1927Loperamide hydrochloride.....................................................1928Loperamide oxide monohydrate...........................................1930Loperamidi hydrochloridum................................................1928Loperamidi oxidum monohydricum..................................1930Lorazepam................................................................................. 1931Lorazepamum .......................................................................... 1931Loss on drying (2.2.32.).............................................................. 50Loss on drying of extracts (2.8.17.) ........................................ 222Lovage root................................................................................1932Lovastatin ..................................................................................1933Lovastatinum ...........................................................................1933Low-molecular-mass heparins ................................................1717Lozenges and pastilles .............................................................. 613Lozenges, compressed .............................................................. 613Lubricant, silicone oil (3.1.8.).................................................. 287Lupuli flos ................................................................................. 1730Lynestrenol................................................................................1935Lynestrenolum .........................................................................1935Lysine acetate ....................................................................5.3-3542Lysine hydrochloride...............................................................1936Lysini acetas......................................................................5.3-3542Lysini hydrochloridum..........................................................1936Lythri herba..............................................................................1927

MMacrogol 15 hydroxystearate ................................................ 1941Macrogol 20 glyceroli monostearas ...................................1942



Macrogol 20 glycerol monostearate ....................................1942Macrogol 6 glycerol caprylocaprate..................................... 1941Macrogol 6 glyceroli caprylocapras ................................... 1941Macrogola..................................................................................1950Macrogol cetostearyl ether ....................................................1943Macrogolglyceridorum caprylocaprates ........................... 1173Macrogolglyceridorum laurates ..........................................1892Macrogolglyceridorum linoleates ........................................1917Macrogolglyceridorum oleates ............................................ 2133Macrogolglyceridorum stearates..................................5.2-3274Macrogolglycerol cocoates.....................................................1947Macrogolglycerol hydroxystearate ................................5.2-3231Macrogolglyceroli cocoates ..................................................1947Macrogolglyceroli hydroxystearas...............................5.2-3231Macrogolglyceroli ricinoleas.........................................5.3-3547Macrogolglycerol ricinoleate ..........................................5.3-3547Macrogoli 15 hydroxystearas ............................................... 1941Macrogoli aether cetostearylicus ........................................1943Macrogoli aether laurilicum ................................................1944Macrogoli aether oleicum .....................................................1945Macrogoli aether stearylicus................................................1946Macrogoli oleas........................................................................1944Macrogoli stearas ....................................................................1946Macrogol lauryl ether .............................................................1944Macrogol oleate ........................................................................1944Macrogol oleyl ether ...............................................................1945Macrogols...................................................................................1950Macrogol stearate.....................................................................1946Macrogol stearyl ether............................................................1946Magaldrate................................................................................. 1951Magaldratum ............................................................................ 1951Magnesii acetas tetrahydricus .............................................1952Magnesii aspartas dihydricus ..............................................1953Magnesii chloridum 4.5-hydricum .....................................1955Magnesii chloridum hexahydricum ...................................1956Magnesii glycerophosphas ...................................................1957Magnesii hydroxidum ............................................................1957Magnesii lactas dihydricus ............................................5.3-3549Magnesii oxidum leve ............................................................1958Magnesii oxidum ponderosum ............................................1958Magnesii peroxidum...............................................................1959Magnesii pidolas .....................................................................1960Magnesii stearas ...................................................................... 1961Magnesii subcarbonas levis...........................................5.3-3548Magnesii subcarbonas ponderosus .............................5.3-3547Magnesii sulfas heptahydricus ............................................1962Magnesii trisilicas ...................................................................1963Magnesium (2.4.6.) .................................................................... 104Magnesium acetate tetrahydrate ..........................................1952Magnesium and alkaline-earth metals (2.4.7.) ..................... 104Magnesium aspartate dihydrate ...........................................1953Magnesium carbonate, heavy .........................................5.3-3547Magnesium carbonate, light ...........................................5.3-3548Magnesium chloride 4.5-hydrate ..........................................1955Magnesium chloride hexahydrate ........................................1956Magnesium glycerophosphate .............................................1957Magnesium hydroxide .............................................................1957Magnesium lactate dihydrate .........................................5.3-3549Magnesium oxide, heavy.........................................................1958Magnesium oxide, light...........................................................1958Magnesium peroxide ...............................................................1959Magnesium pidolate ................................................................1960Magnesium stearate................................................................. 1961Magnesium sulphate heptahydrate......................................1962Magnesium trisilicate ..............................................................1963Maize oil, refined......................................................................1964Maize starch .......................................................................5.1-2965Malathion...................................................................................1965Malathionum ............................................................................1965

Maleic acid .................................................................................1966Malic acid ...................................................................................1966Mallow flower............................................................................1967Maltitol .......................................................................................1968Maltitol, liquid...........................................................................1969Maltitolum .................................................................................1968Maltitolum liquidum...............................................................1969Maltodextrin ..............................................................................1970Maltodextrinum .......................................................................1970Malvae sylvestris flos .............................................................1967Manganese sulphate monohydrate ...................................... 1971Mangani sulfas monohydricus ............................................ 1971Mannheimia vaccine (inactivated) for cattle ........................ 771Mannheimia vaccine (inactivated) for sheep........................ 772Mannitol ..............................................................................5.3-3549Mannitolum .......................................................................5.3-3549Maprotiline hydrochloride .....................................................1973Maprotilini hydrochloridum ................................................1973Marek’s disease vaccine (live).................................................. 774Marrubii herba..................................................................5.1-3039Marshmallow leaf ..................................................................... 1974Marshmallow root .............................................................5.2-3232Mass spectrometry (2.2.43.)....................................................... 65Mass uniformity of delivered doses from multidose containers(2.9.27.) ...................................................................................... 263

Mass uniformity of single-dose preparations (2.9.5.) ......... 233Mastic..........................................................................................1975Masticabilia gummis medicata.....................................5.2-3136Mastix .........................................................................................1975Materials based on non-plasticised poly(vinyl chloride) forcontainers for dry dosage forms for oral administration(3.1.11.)....................................................................................... 291

Materials based on non-plasticised poly(vinyl chloride)for containers for non-injectable, aqueous solutions(3.1.10.) ...................................................................................... 289

Materials based on plasticised poly(vinyl chloride) forcontainers for aqueous solutions for intravenous infusion(3.1.14.) ...................................................................................... 296

Materials based on plasticised poly(vinyl chloride) forcontainers for human blood and blood components(3.1.1.1.) ..................................................................................... 269

Materials based on plasticised poly(vinyl chloride) fortubing used in sets for the transfusion of blood and bloodcomponents (3.1.1.2.).............................................................. 272

Materials for containers for human blood and bloodcomponents (3.1.1.) ................................................................. 269

Materials used for the manufacture of containers (3.1.) ... 269Matricariae aetheroleum................................................5.1-2967Matricariae extractum fluidum ....................................5.1-2966Matricariae flos ................................................................5.1-2965Matricaria flower ...............................................................5.1-2965Matricaria liquid extract ..................................................5.1-2966Matricaria oil ......................................................................5.1-2967Maydis amylum ................................................................5.1-2965Maydis oleum raffinatum......................................................1964Meadowsweet ............................................................................1980Measles immunoglobulin, human ........................................ 1742Measles, mumps and rubella vaccine (live) .......................... 678Measles vaccine (live) ................................................................ 679Measurement of consistency by penetrometry (2.9.9.) ...... 235Mebendazole ............................................................................. 1981Mebendazolum......................................................................... 1981Meclozine hydrochloride ........................................................1982Meclozini hydrochloridum ...................................................1982Medicated chewing gum, dissolution test for(2.9.25.) .............................................................................5.2-3116

Medicated chewing gums ................................................5.2-3136Medicated feeding stuffs for veterinary use, premixes for ..617Medicated foams......................................................................... 604



Medicated plasters ..................................................................... 626Medicated tampons.................................................................... 628Medicated vaginal tampons ............................................5.2-3154Medicinal air................................................................................ 929Medicinal air, synthetic............................................................. 932Medium-chain triglycerides....................................................2623Medroxyprogesterone acetate ........................................5.3-3551Medroxyprogesteroni acetas .........................................5.3-3551Mefenamic acid .........................................................................1984Mefloquine hydrochloride......................................................1986Mefloquini hydrochloridum .................................................1986Megestrol acetate .....................................................................1987Megestroli acetas .....................................................................1987Meglumine.................................................................................1988Megluminum ............................................................................1988Mel........................................................................................5.1-2946Melaleucae aetheroleum .......................................................2534Melilot..................................................................................5.3-3552Meliloti herba ....................................................................5.3-3552Melissae folium ........................................................................1989Melissa leaf ................................................................................1989Melting point - capillary method (2.2.14.)............................... 32Melting point - instantaneous method (2.2.16.) .................... 33Melting point - open capillary method (2.2.15.) .................... 33Menadione .................................................................................1990Menadionum ............................................................................1990Meningococcal group C conjugate vaccine.......................... 680Meningococcal polysaccharide vaccine................................. 682Menthae arvensis aetheroleum partim mentholumdepletum...........................................................................5.2-3235

Menthae piperitae aetheroleum ..........................................2206Menthae piperitae folium .....................................................2205Menthol, racemic...................................................................... 1991Mentholum racemicum ......................................................... 1991Menyanthidis trifoliatae folium .......................................... 1115Mepivacaine hydrochloride....................................................1992Mepivacaini hydrochloridum ..............................................1992Meprobamate ............................................................................1993Meprobamatum........................................................................1993Mepyramine maleate ...............................................................1994Mepyramini maleas ................................................................1994Mercaptopurine ........................................................................1995Mercaptopurinum ...................................................................1995Mercuric chloride.....................................................................1995Mesalazine .................................................................................1996Mesalazinum ............................................................................1996Mesna...................................................................................5.1-2971Mesnum ..............................................................................5.1-2971Mesterolone...............................................................................1999Mesterolonum ..........................................................................1999Mestranol ...................................................................................2000Mestranolum.............................................................................2000Metacresol ..........................................................................5.2-3232Metacresolum ....................................................................5.2-3232Metamizole sodium .................................................................2002Metamizolum natricum .........................................................2002Metformin hydrochloride .......................................................2003Metformini hydrochloridum ................................................2003Methacrylic acid - ethyl acrylate copolymer (1:1) .............2005Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion30 per cent ..............................................................................2005

Methacrylic acid - methyl methacrylate copolymer (1:1) ..2006Methacrylic acid - methyl methacrylate copolymer (1:2) ..2007Methadone hydrochloride...............................................5.2-3233Methadoni hydrochloridum ..........................................5.2-3233Methanol .............................................................................5.2-3234Methanol and 2-propanol, test for (2.9.11.) .................5.3-3362Methanolum.......................................................................5.2-3234Methaqualone ...........................................................................2008

Methaqualonum ......................................................................2008Methenamine ............................................................................2009Methenaminum .......................................................................2009Methionine ................................................................................ 2010Methionine ([11C]methyl) injection, L-.................................... 834Methionine, DL- ......................................................................... 2010Methioninum............................................................................ 2010Methods in pharmacognosy (2.8.) .......................................... 215Methods of preparation of sterile products (5.1.1.) ............ 445Methotrexate ............................................................................. 2011Methotrexatum ......................................................................... 2011Methylatropine bromide ......................................................... 2014Methylatropine nitrate ............................................................ 2015Methylatropini bromidum..................................................... 2014Methylatropini nitras ............................................................. 2015Methylcellulose......................................................................... 2016Methylcellulosum .................................................................... 2016Methyldopa................................................................................ 2016Methyldopum ........................................................................... 2016Methylene blue .........................................................................2028Methylene chloride .................................................................. 2017Methyleni chloridum .............................................................. 2017Methylhydroxyethylcellulose ................................................. 2018Methylhydroxyethylcellulosum............................................ 2018Methylis nicotinas ............................................................5.1-2972Methylis parahydroxybenzoas ............................................. 2013Methylis parahydroxybenzoas natricum .......................... 2441Methylis salicylas .................................................................... 2014Methyl nicotinate ..............................................................5.1-2972Methyl parahydroxybenzoate ................................................ 2013Methylpentoses in polysaccharide vaccines (2.5.21.) ......... 133Methylphenobarbital ............................................................... 2019Methylphenobarbitalum ........................................................ 2019Methylprednisolone.................................................................2020Methylprednisolone acetate...................................................2022Methylprednisolone hydrogen succinate ............................2024Methylprednisoloni acetas....................................................2022Methylprednisoloni hydrogenosuccinas ...........................2024Methylprednisolonum ............................................................2020Methylpyrrolidone, N- .............................................................2026Methylrosanilinii chloridum .........................................5.1-2973Methylrosanilinium chloride ..........................................5.1-2973Methyl salicylate....................................................................... 2014Methyltestosterone ..................................................................2027Methyltestosteronum ..............................................................2027Methylthioninii chloridum ...................................................2028Methylthioninium chloride ....................................................2028Metixene hydrochloride ..........................................................2029Metixeni hydrochloridum .....................................................2029Metoclopramide........................................................................2030Metoclopramide hydrochloride............................................. 2031Metoclopramidi hydrochloridum ........................................ 2031Metoclopramidum ...................................................................2030Metoprololi succinas ..............................................................2032Metoprololi tartras ..................................................................2034Metoprolol succinate...............................................................2032Metoprolol tartrate ..................................................................2034Metrifonate ................................................................................2035Metrifonatum............................................................................2035Metronidazole ...........................................................................2037Metronidazole benzoate .........................................................2038Metronidazoli benzoas ..........................................................2038Metronidazolum ......................................................................2037Mexiletine hydrochloride........................................................2039Mexiletini hydrochloridum...................................................2039Mianserin hydrochloride ........................................................ 2041Mianserini hydrochloridum ................................................. 2041Miconazole ................................................................................2042Miconazole nitrate ...................................................................2043



Miconazoli nitras ....................................................................2043Miconazolum............................................................................2042Microbiological assay of antibiotics (2.7.2.).......................... 188Microbiological examination of non-sterile products (test forspecified micro-organisms) (2.6.13.) .................................... 156

Microbiological examination of non-sterile products (totalviable aerobic count) (2.6.12.)............................................... 154

Microbiological quality of pharmaceutical preparations(5.1.4.)......................................................................................... 449

Microcrystalline cellulose.......................................................1228Micro determination of water (2.5.32.).................................. 137Microscopy, limit test of particle size (2.9.13.) .................... 239Microscopy, optical (2.9.37.) ...........................................5.3-3366Midazolam .................................................................................2045Midazolamum ..........................................................................2045Milk-thistle fruit........................................................................2046Millefolii herba.........................................................................2723Minimising the risk of transmitting animal spongiformencephalopathy agents via human and veterinary medicinalproducts (5.2.8.) ....................................................................... 463

Minocycline hydrochloride.....................................................2047Minocyclini hydrochloridum ...............................................2047Minoxidil .............................................................................5.1-2974Minoxidilum ......................................................................5.1-2974Mint oil, partly dementholised .......................................5.2-3235Misoprostol.........................................................................5.3-3553Misoprostolum ..................................................................5.3-3553Mitomycin .................................................................................. 2051Mitomycinum ........................................................................... 2051Mitoxantrone hydrochloride..................................................2053Mitoxantroni hydrochloridum .............................................2053Modified-release capsules................................................5.2-3136Modified-release granules ............................................... 5.2-3141Modified-release tablets ...................................................5.2-3151Molecular mass distribution in dextrans (2.2.39.) ................ 57Molgramostim concentrated solution .................................2054Molgramostimi solutio concentrata ...................................2054Mometasone furoate.........................................................5.3-3555Mometasoni furoas ..........................................................5.3-3555Monoclonal antibodies for human use.........................5.2-3127Monographs (1.4.) ...........................................................................7Morantel hydrogen tartrate for veterinary use .................2059Moranteli hydrogenotartras ad usum veterinarium ......2059Morphine hydrochloride..................................................5.2-3237Morphine sulphate............................................................5.2-3238Morphini hydrochloridum .............................................5.2-3237Morphini sulfas.................................................................5.2-3238Moss, Iceland .....................................................................5.3-3525Mother tinctures for homoeopathic preparations .............. 894Motherwort ...............................................................................2063Mouthwashes .............................................................................. 612Moxonidine ................................................................................2064Moxonidinum ...........................................................................2064Mucoadhesive preparations ..................................................... 613Mullein flower...........................................................................2065Multidose containers, uniformity of mass of delivered doses(2.9.27.) ...................................................................................... 263

Mumps vaccine (live) ................................................................. 684Mupirocin...................................................................................2065Mupirocin calcium ...................................................................2067Mupirocinum............................................................................2065Mupirocinum calcicum .........................................................2067Musci medicati........................................................................... 604Mycobacteria (2.6.2.) ................................................................. 149Mycophenolas mofetil .....................................................5.2-3239Mycophenolate mofetil.....................................................5.2-3239Mycoplasmas (2.6.7.).................................................................. 149myo-Inositol .......................................................................5.3-3527myo-Inositolum.................................................................5.3-3527

Myristicae fragrantis aetheroleum ..................................... 2123Myrrh ..........................................................................................2069Myrrha .......................................................................................2069Myrrhae tinctura .....................................................................2069Myrrh tincture ..........................................................................2069Myrtilli fructus recens............................................................ 1099Myrtilli fructus siccus............................................................. 1099Myxomatosis vaccine (live) for rabbits .................................. 775

NNabumetone ..............................................................................2073Nabumetonum .........................................................................2073N-Acetyltryptophan.....................................................................918N-Acetyltryptophanum..............................................................918N-Acetyltyrosine ......................................................................... 920N-Acetyltyrosinum .................................................................... 920Nadolol ....................................................................................... 2074Nadololum................................................................................. 2074Nadroparin calcium .................................................................2075Nadroparinum calcicum .......................................................2075Naftidrofuryl hydrogen oxalate.............................................2078Naftidrofuryli hydrogenooxalas ..........................................2078Nalidixic acid.............................................................................2080Naloxone hydrochloride dihydrate.......................................2080Naloxoni hydrochloridum dihydricum .............................2080Naltrexone hydrochloride................................................5.1-2979Naltrexoni hydrochloridum ...........................................5.1-2979Naphazoline hydrochloride....................................................2082Naphazoline nitrate ..........................................................5.3-3561Naphazolini hydrochloridum ..............................................2082Naphazolini nitras ...........................................................5.3-3561Naproxen.............................................................................5.2-3245Naproxenum ......................................................................5.2-3245Narrow-leaved coneflower root ......................................5.2-3246Nasal drops and liquid nasal sprays........................................610Nasalia ..........................................................................................610Nasal powders..............................................................................611Nasal preparations ......................................................................610Nasal preparations, semi-solid..................................................611Nasal sticks...................................................................................611Nasal washes ................................................................................611Natrii acetas trihydricus ....................................................... 2415Natrii acetatis ([1-11C]) solutio iniectabilis ......................... 839Natrii alendronas .................................................................... 2416Natrii alginas ........................................................................... 2417Natrii amidotrizoas ................................................................ 2418Natrii aminosalicylas dihydricus........................................ 2419Natrii ascorbas .........................................................................2420Natrii aurothiomalas .......................................................5.3-3613Natrii benzoas .......................................................................... 2421Natrii bromidum......................................................................2422Natrii calcii edetas ..................................................................2422Natrii caprylas .........................................................................2423Natrii carbonas anhydricus...........................................5.1-3008Natrii carbonas decahydricus.......................................5.1-3008Natrii carbonas monohydricus.....................................5.1-3009Natrii cetylo- et stearylosulfas. ............................................2426Natrii chloridum......................................................................2428Natrii chromatis (51Cr) solutio sterilis ................................. 840Natrii citras ...............................................................................2429Natrii cromoglicas ..................................................................2429Natrii cyclamas ........................................................................2430Natrii dihydrogenophosphas dihydricus .......................... 2431Natrii docusas .......................................................................... 1471Natrii fluoridi (18F) solutio iniectabilis................................ 841Natrii fluoridum ......................................................................2432Natrii fusidas ............................................................................2433Natrii glycerophosphas hydricus ........................................2434Natrii hyaluronas ....................................................................2434



Natrii hydrogenocarbonas....................................................2437Natrii hydroxidum ..................................................................2437Natrii iodidi (123I) solutio iniectabilis .................................. 842Natrii iodidi (131I) capsulae ad usum diagnosticum......... 843Natrii iodidi (131I) capsulae ad usum therapeuticum.......5.2-3157

Natrii iodidi (131I) solutio......................................................... 844Natrii iodidi (131I) solutio ad radio-signandum ................. 845Natrii iodidum .........................................................................2438Natrii iodohippurati (123I) solutio iniectabilis ................... 845Natrii iodohippurati (131I) solutio iniectabilis.................... 846Natrii lactatis solutio ..............................................................2438Natrii laurilsulfas ....................................................................2440Natrii metabisulfis .................................................................. 2441Natrii molybdas dihydricus ..................................................2442Natrii nitris ...............................................................................2443Natrii nitroprussias ................................................................2443Natrii perboras hydricus .......................................................2444Natrii pertechnetatis (99mTc) fissione formati solutioiniectabilis ................................................................................ 847

Natrii pertechnetatis (99mTc) sine fissione formati solutioiniectabilis ................................................................................ 848

Natrii phosphatis (32P) solutio iniectabilis ......................... 849Natrii picosulfas ......................................................................2445Natrii polystyrenesulfonas....................................................2446Natrii propionas ......................................................................2447Natrii salicylas .........................................................................2449Natrii selenis pentahydricus ................................................2449Natrii (S)-lactatis solutio .......................................................2439Natrii stearas ............................................................................2452Natrii stearylis fumaras.........................................................2453Natrii sulfas anhydricus ........................................................2454Natrii sulfas decahydricus ....................................................2455Natrii sulfis anhydricus.........................................................2455Natrii sulfis heptahydricus ...................................................2456Natrii thiosulfas ................................................................5.1-3009Natrii valproas .........................................................................2457Near-infrared spectrophotometry (2.2.40.) ............................. 59Neohesperidin-dihydrochalcone ...........................................2085Neohesperidin-dihydrochalconum .....................................2085Neomycini sulfas .....................................................................2086Neomycin sulphate ..................................................................2086Neonatal piglet colibacillosis vaccine (inactivated) ............ 776Neonatal ruminant colibacillosis vaccine (inactivated) ..... 778Neostigmine bromide ..............................................................2088Neostigmine metilsulfate........................................................2089Neostigmini bromidum..........................................................2088Neostigmini metilsulfas .........................................................2089Neroli aetheroleum ..........................................................5.3-3562Neroli oil .............................................................................5.3-3562Netilmicini sulfas ....................................................................2089Netilmicin sulphate..................................................................2089Nettle leaf............................................................................5.3-3563Neurovirulence test for poliomyelitis vaccine (oral)(2.6.19.) ...................................................................................... 172

Neurovirulence test of live viral vaccines (2.6.18.) ............. 172Newcastle disease vaccine (inactivated) ................................ 779Newcastle disease vaccine (live).............................................. 781Nicergoline ................................................................................ 2091Nicergolinum ........................................................................... 2091Nicethamidum ......................................................................... 2100Nickel in polyols (2.4.15.) ......................................................... 108Niclosamide, anhydrous .........................................................2092Niclosamide monohydrate .....................................................2093Niclosamidum anhydricum..................................................2092Niclosamidum monohydricum............................................2093Nicotinamide .............................................................................2094Nicotinamidum........................................................................2094Nicotine ......................................................................................2095

Nicotine resinate ......................................................................2096Nicotinic acid ............................................................................2097Nicotini resinas .......................................................................2096Nicotinum .................................................................................2095Nifedipine...................................................................................2098Nifedipinum..............................................................................2098Nifuroxazide ..............................................................................2099Nifuroxazidum .........................................................................2099Nikethamide .............................................................................. 2100Nimesulide................................................................................. 2101Nimesulidum ............................................................................ 2101Nimodipine ................................................................................ 2102Nimodipinum ........................................................................... 2102Nitrazepam ................................................................................ 2103Nitrazepamum ......................................................................... 2103Nitrendipine .............................................................................. 2104Nitrendipinum ......................................................................... 2104Nitric acid .................................................................................. 2105Nitric oxide ................................................................................ 2105Nitrofural ................................................................................... 2106Nitrofuralum............................................................................. 2106Nitrofurantoin........................................................................... 2107Nitrofurantoinum.................................................................... 2107Nitrogen ..................................................................................... 2108Nitrogen determination by sulphuric acid digestion(2.5.9.) ........................................................................................ 129

Nitrogen determination, primary aromatic amino(2.5.8.) ........................................................................................ 129

Nitrogenii oxidum................................................................... 2105Nitrogenium ............................................................................. 2108Nitrogenium oxygenio depletum ........................................ 2109Nitrogen, low-oxygen............................................................... 2109Nitrogen monoxide and nitrogen dioxide in gases(2.5.26.) ...................................................................................... 135

Nitrous oxide......................................................................5.1-2981Nitrous oxide in gases (2.5.35.)................................................141Nizatidine....................................................................................2111Nizatidinum...............................................................................2111N-Methylpyrrolidone................................................................2026N-Methylpyrrolidonum ..........................................................2026N,N-Dimethylaniline (2.4.26.) ...................................................119Nomegestrol acetate................................................................ 2113Nomegestroli acetas................................................................ 2113Nonoxinol 9................................................................................2114Nonoxinolum 9 .........................................................................2114Non-sterile products, microbiological examination of (test forspecified micro-organisms) (2.6.13.) .................................... 156

Non-sterile products, microbiological examination of (totalviable aerobic count) (2.6.12.)............................................... 154

Noradrenaline hydrochloride .................................................2114Noradrenaline tartrate ............................................................ 2115Noradrenalini hydrochloridum ............................................2114Noradrenalini tartras ............................................................. 2115Norcholesteroli iodinati (131I) solutio iniectabilis ............. 836Norcholesterol injection, iodinated (131I) .............................. 836Norethisterone.......................................................................... 2116Norethisterone acetate ............................................................2117Norethisteroni acetas ..............................................................2117Norethisteronum ..................................................................... 2116Norfloxacin................................................................................ 2118Norfloxacinum......................................................................... 2118Norgestrel .................................................................................. 2119Norgestrelum ............................................................................ 2119Normal immunoglobulin for intravenous administration,human ...............................................................................5.3-3516

Normal immunoglobulin, human ..................................5.3-3514Nortriptyline hydrochloride............................................5.3-3565Nortriptylini hydrochloridum.......................................5.3-3565Noscapine .................................................................................. 2121



Noscapine hydrochloride........................................................ 2122Noscapini hydrochloridum................................................... 2122Noscapinum.............................................................................. 2121Nuclear magnetic resonance spectrometry (2.2.33.).............51Nucleic acid amplification techniques (2.6.21.) ....................174Nucleic acids in polysaccharide vaccines (2.5.17.) .............. 132Nutmeg oil ................................................................................. 2123Nystatin ...................................................................................... 2124Nystatinum ............................................................................... 2124

OO-Acetyl in polysaccharide vaccines (2.5.19.) ...................... 132Oak bark .................................................................................... 2129Octoxinol 10 .......................................................................5.2-3251Octoxinolum 10 ................................................................5.2-3251Octyldodecanol ..................................................................5.3-3569Octyldodecanolum ...........................................................5.3-3569Octyl gallate .............................................................................. 2129Octylis gallas ............................................................................ 2129Odour (2.3.4.)................................................................................ 99Odour and taste of essential oils (2.8.8.) ...............................216Oenotherae oleum raffinatum ......................................5.1-2921Ofloxacin.................................................................................... 2131Ofloxacinum............................................................................. 2131Oils rich in omega-3- acids, composition of fatty acids(2.4.29.) ...................................................................................... 121

Ointments .................................................................................... 625Oleae folium ............................................................................. 2134Olea herbaria ............................................................................ 595Oleic acid ................................................................................... 2132Oleoyl macrogolglycerides..................................................... 2133Oleyl alcohol ............................................................................. 2134Olivae oleum raffinatum ....................................................... 2135Olivae oleum virginale .......................................................... 2136Olive leaf .................................................................................... 2134Olive oil, refined ....................................................................... 2135Olive oil, virgin ......................................................................... 2136Olsalazine sodium.................................................................... 2137Olsalazinum natricum........................................................... 2137Omega-3-acid ethyl esters 60..........................................5.3-3569Omega-3-acid ethyl esters 90..........................................5.3-3571Omega-3 acidorum esteri ethylici 60..........................5.3-3569Omega-3 acidorum esteri ethylici 90..........................5.3-3571Omega-3 acidorum triglycerida .......................................... 2144Omega-3-acids, composition of fatty acids in oils rich in(2.4.29.) ...................................................................................... 121

Omega-3-acids, fish oil rich in ...............................................1595Omega-3-acid triglycerides ..................................................... 2144Omeprazole ........................................................................5.2-3251Omeprazole sodium................................................................. 2148Omeprazolum....................................................................5.2-3251Omeprazolum natricum ........................................................ 2148Ondansetron hydrochloride dihydrate ................................ 2149Ondansetroni hydrochloridum dihydricum .................... 2149Ononidis radix ......................................................................... 2361Opalescence of liquids, clarity and degree (2.2.1.) ............... 23Ophthalmica ......................................................................5.3-3395Ophthalmic inserts ...........................................................5.3-3396Opii pulvis normatus ......................................................5.3-3573Opium crudum .................................................................5.3-3575Opium, prepared................................................................5.3-3573Opium, raw .........................................................................5.3-3575Optical microscopy (2.9.37.) ...........................................5.3-3366Optical rotation (2.2.7.)............................................................... 28Oral drops ...........................................................................5.2-3143Oral powders......................................................................5.2-3147Oral solutions, emulsions and suspensions ................5.2-3143Oral use, liquid preparations for....................................5.2-3142Orciprenaline sulphate.....................................................5.3-3576

Orciprenalini sulfas .........................................................5.3-3576Oregano...................................................................................... 2155Organ preservation, solutions for.........................................2458Oriental cashew for homoeopathic preparations.......5.3-3430Origani herba ........................................................................... 2155Orodispensible tablets......................................................5.2-3151Oromucosal capsules ................................................................ 613Oromucosal drops, oromucosal sprays and sublingualsprays.......................................................................................... 612

Oromucosal preparations..........................................................611Oromucosal preparations, semi-solid..................................... 612Oromucosal solutions and oromucosal suspensions ......... 612Orphenadrine citrate............................................................... 2156Orphenadrine hydrochloride................................................. 2157Orphenadrini citras ................................................................ 2156Orphenadrini hydrochloridum............................................ 2157Orthosiphonis folium ............................................................. 1859Oryzae amylum .......................................................................2369Osmolality (2.2.35.)...................................................................... 54Other provisions applying to general chapters andmonographs (1.2.).........................................................................5

Ouabain...................................................................................... 2158Ouabainum ............................................................................... 2158Oxaliplatin ................................................................................. 2159Oxaliplatinum .......................................................................... 2159Oxazepam .................................................................................. 2162Oxazepamum ........................................................................... 2162Oxeladin hydrogen citrate...................................................... 2163Oxeladini hydrogenocitras ................................................... 2163Oxfendazole for veterinary use ............................................. 2164Oxfendazolum ad usum veterinarium .............................. 2164Oxidising substances (2.5.30.)................................................. 137Oxolinic acid.............................................................................. 2165Oxprenolol hydrochloride ...................................................... 2166Oxprenololi hydrochloridum .............................................. 2166Oxybuprocaine hydrochloride............................................... 2167Oxybuprocaini hydrochloridum ......................................... 2167Oxybutynin hydrochloride ..............................................5.3-3577Oxybutynini hydrochloridum .......................................5.3-3577Oxycodone hydrochloride ...............................................5.1-2987Oxycodoni hydrochloridum ..........................................5.1-2987Oxygen........................................................................................ 2169Oxygen (15O) ................................................................................ 837Oxygen-flask method (2.5.10.)................................................. 130Oxygen in gases (2.5.27.).......................................................... 136Oxygenium................................................................................ 2169Oxygenium (15O) ........................................................................ 837Oxymetazoline hydrochloride ............................................... 2170Oxymetazolini hydrochloridum .......................................... 2170Oxytetracycline dihydrate ...................................................... 2171Oxytetracycline hydrochloride .............................................. 2172Oxytetracyclini hydrochloridum ......................................... 2172Oxytetracyclinum dihydricum............................................. 2171Oxytocin ......................................................................................2174Oxytocin bulk solution ........................................................... 2175Oxytocini solutio ..................................................................... 2175Oxytocinum ...............................................................................2174

PPale coneflower root ........................................................5.2-3257Palmitic acid.............................................................................. 2179Pancreas powder ...............................................................5.3-3583Pancreatis pulvis ..............................................................5.3-3583Pancuronii bromidum ........................................................... 2182Pancuronium bromide ............................................................ 2182Pansy, wild (flowering aerial parts) .....................................2700Papaverine hydrochloride ...................................................... 2183Papaverini hydrochloridum ................................................. 2183Papaveris rhoeados flos ........................................................2359



Paper chromatography (2.2.26.) ............................................... 40Paracetamol .............................................................................. 2184Paracetamolum........................................................................ 2184Paraffin, hard ............................................................................ 2186Paraffin, light liquid ................................................................ 2186Paraffin, liquid .......................................................................... 2187Paraffinum liquidum.............................................................. 2187Paraffinum perliquidum ....................................................... 2186Paraffinum solidum................................................................ 2186Paraffin, white soft .................................................................. 2187Paraffin, yellow soft................................................................. 2188Parainfluenza virus vaccine (live), bovine, freeze-dried .... 732Parainfluenza virus vaccine (live), canine ............................ 742Paraldehyde............................................................................... 2189Paraldehydum .......................................................................... 2189Parenteralia .......................................................................5.2-3144Parenteral preparations...................................................5.2-3144Parenteral preparations, test for extractable volume of(2.9.17.)..............................................................................5.3-3363

Parnaparin sodium .................................................................. 2189Parnaparinum natricum....................................................... 2189Paroxetine hydrochloride hemihydrate............................... 2190Paroxetini hydrochloridum hemihydricum ..................... 2190Particles, fine, aerodynamic assessment of in preparationsfor inhalation (2.9.18.) ...................................................5.2-3103

Particle size by microscopy, limit test of (2.9.13.) .............. 239Particle-size distribution estimation by analytical sieving(2.9.38.) .............................................................................5.3-3368

Particulate contamination : sub-visible particles(2.9.19.) ...................................................................................... 253

Particulate contamination : visible particles (2.9.20.)........ 255Parvovirosis vaccine (inactivated), canine ............................ 743Parvovirosis vaccine (inactivated), porcine .......................... 787Parvovirosis vaccine (live), canine.......................................... 744Passiflorae herba..................................................................... 2192Passiflorae herbae extractum siccum .........................5.3-3585Passion flower .......................................................................... 2192Passion flower dry extract ..............................................5.3-3585Pastes............................................................................................ 625Pasteurella vaccine (inactivated) for sheep .......................... 783Pastilles and lozenges ............................................................... 613Patches, transdermal........................................................5.2-3146Patches, transdermal, dissolution test for (2.9.4.) .............. 231Pefloxacini mesilas dihydricus ........................................... 2193Pefloxacin mesilate dihydrate ............................................... 2193Penbutololi sulfas .................................................................... 2195Penbutolol sulphate ................................................................ 2195Penetrometry, measurement of consistency (2.9.9.) .......... 235Penicillamine......................................................................5.3-3586Penicillaminum ................................................................5.3-3586Pentaerythrityli tetranitras dilutus..................................... 2198Pentaerythrityl tetranitrate, diluted .................................... 2198Pentamidine diisetionate.................................................5.3-3588Pentamidini diisetionas .................................................5.3-3588Pentazocine........................................................................5.1-2991Pentazocine hydrochloride .............................................5.1-2991Pentazocine lactate ..........................................................5.1-2992Pentazocini hydrochloridum ........................................5.1-2991Pentazocini lactas ............................................................5.1-2992Pentazocinum ...................................................................5.1-2991Pentobarbital ............................................................................ 2201Pentobarbital sodium..............................................................2202Pentobarbitalum ...................................................................... 2201Pentobarbitalum natricum ...................................................2202Pentoxifylline .....................................................................5.2-3258Pentoxifyllinum ................................................................5.2-3258Pentoxyverine hydrogen citrate ............................................2204Pentoxyverini hydrogenocitras ...........................................2204Peppermint leaf ........................................................................2205

Peppermint oil ..........................................................................2206Pepsini pulvis ...........................................................................2207Pepsin powder ..........................................................................2207Peptide mapping (2.2.55.) .......................................................... 82Peptides, synthetic, acetic acid in (2.5.34.)............................141Pergolide mesilate....................................................................2209Pergolidi mesilas .....................................................................2209Perindopril tert-butylamine.............................................5.3-3589Peritoneal dialysis, solutions for........................................... 2212Peroxide value (2.5.5.)............................................................... 128Perphenazine ............................................................................ 2214Perphenazinum ....................................................................... 2214Pertussis (acellular, component), diphtheria, tetanus,poliomyelitis (inactivated) and haemophilus type bconjugate vaccine (adsorbed)................................................ 653

Pertussis, diphtheria, tetanus and poliomyelitis (inactivated)vaccine (adsorbed)................................................................... 656

Pertussis, diphtheria, tetanus, poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) .......... 657

Pertussis vaccine........................................................................ 685Pertussis vaccine (acellular), assay of (2.7.16.) .................... 208Pertussis vaccine (acellular, component, adsorbed) ..5.3-3407Pertussis vaccine (acellular, co-purified, adsorbed) ........... 688Pertussis vaccine (adsorbed) ................................................... 690Pertussis vaccine, assay of (2.7.7.) .......................................... 197Peru balsam............................................................................... 2215Pessaries..............................................................................5.2-3152Pessaries and suppositories, disintegration of (2.9.2.) ...... 227Pessaries and suppositories, resistance to rupture(2.9.24.) ...................................................................................... 258

Pesticide residues (2.8.13.)........................................................218Pethidine hydrochloride ......................................................... 2216Pethidini hydrochloridum .................................................... 2216Pharmaceutical technical procedures (2.9.)......................... 225Pharmacognosy, methods in (2.8.)......................................... 215Pharmacopoeial harmonisation (5.8.) ................................... 551Phenazone................................................................................. 2217Phenazonum ............................................................................ 2217Pheniramine maleate .............................................................. 2218Pheniramini maleas ............................................................... 2218Phenobarbital ........................................................................... 2219Phenobarbital sodium.............................................................2220Phenobarbitalum..................................................................... 2219Phenobarbitalum natricum ..................................................2220Phenol ........................................................................................ 2221Phenol in immunosera and vaccines (2.5.15.) ......................131Phenolphthalein.......................................................................2222Phenolphthaleinum................................................................2222Phenolsulfonphthalein ...........................................................2222Phenolsulfonphthaleinum ....................................................2222Phenolum .................................................................................. 2221Phenothiazines, identification by thin-layer chromatography(2.3.3.) .......................................................................................... 99

Phenoxyethanol........................................................................2223Phenoxyethanolum ................................................................2223Phenoxymethylpenicillin .................................................5.1-2992Phenoxymethylpenicillin potassium.............................5.3-3591Phenoxymethylpenicillinum.........................................5.1-2992Phenoxymethylpenicillinum kalicum ........................5.3-3591Phentolamine mesilate ...........................................................2227Phentolamini mesilas ............................................................2227Phenylalanine ...........................................................................2228Phenylalaninum......................................................................2228Phenylbutazone .......................................................................2229Phenylbutazonum...................................................................2229Phenylephrine........................................................................... 2231Phenylephrine hydrochloride................................................2232Phenylephrini hydrochloridum ..........................................2232Phenylephrinum ..................................................................... 2231



Phenylhydrargyri acetas .......................................................2232Phenylhydrargyri boras.........................................................2233Phenylhydrargyri nitras ........................................................2234Phenylmercuric acetate ..........................................................2232Phenylmercuric borate ...........................................................2233Phenylmercuric nitrate ...........................................................2234Phenylpropanolamine hydrochloride ..................................2234Phenylpropanolamini hydrochloridum ............................2234Phenytoin...................................................................................2235Phenytoin sodium....................................................................2236Phenytoinum............................................................................2235Phenytoinum natricum .........................................................2236Phloroglucinol, anhydrous .............................................5.3-3593Phloroglucinol dihydrate ................................................5.3-3594Phloroglucinolum anhydricum....................................5.3-3593Phloroglucinolum dihydricum .....................................5.3-3594Pholcodine.................................................................................2237Pholcodinum ............................................................................2237Phosphates (2.4.11.) .................................................................. 108Phosphoric acid, concentrated .............................................2237Phosphoric acid, dilute ...........................................................2238Phosphorus in polysaccharide vaccines (2.5.18.) ............... 132pH, potentiometric determination of (2.2.3.) ......................... 26Phthalylsulfathiazole ..............................................................2238Phthalylsulfathiazolum .........................................................2238Physical and physicochemical methods (2.2.) ....................... 23Physostigmine salicylate.........................................................2239Physostigmine sulphate..........................................................2240Physostigmini salicylas .........................................................2239Physostigmini sulfas ..............................................................2240Phytomenadione ...................................................................... 2241Phytomenadionum ................................................................. 2241Phytosterol ................................................................................2242Phytosterolum ..........................................................................2242Picotamide monohydrate .......................................................2243Picotamidum monohydricum..............................................2243Pilocarpine hydrochloride......................................................2244Pilocarpine nitrate ...................................................................2246Pilocarpini hydrochloridum ................................................2244Pilocarpini nitras ....................................................................2246Pimobendan .......................................................................5.3-3594Pimobendanum ................................................................5.3-3594Pimozide ....................................................................................2247Pimozidum ...............................................................................2247Pindolol ......................................................................................2248Pindololum ...............................................................................2248Pipemidic acid trihydrate .......................................................2249Piperacillin ................................................................................2250Piperacillin sodium..................................................................2252Piperacillinum ........................................................................2250Piperacillinum natricum ......................................................2252Piperazine adipate ...................................................................2253Piperazine citrate.....................................................................2254Piperazine hydrate...................................................................2255Piperazini adipas ....................................................................2253Piperazini citras ......................................................................2254Piperazinum hydricum .........................................................2255Piracetam...................................................................................2256Piracetamum ............................................................................2256Pirenzepine dihydrochloride monohydrate .......................2257Pirenzepini dihydrochloridum monohydricum .............2257Piretanide ..................................................................................2258Piretanidum..............................................................................2258Piroxicam ...................................................................................2259Piroxicamum ............................................................................2259Piscis oleum omega-3 acidis abundans ............................1595Pivampicillin.............................................................................. 2261Pivampicillinum ...................................................................... 2261Pivmecillinam hydrochloride.................................................2262

Pivmecillinami hydrochloridum ........................................2262Plantae ad ptisanam ................................................................ 573Plantae medicinales ................................................................. 572Plantae medicinales ad praeparationeshomoeopathicas .............................................................5.2-3161

Plantae medicinales praeparatore ....................................... 572Plantaginis lanceolatae folium ...........................................2368Plantaginis ovatae semen ..................................................... 1850Plantaginis ovatae seminis tegumentum ......................... 1849Plasma for fractionation, human...................................5.3-3518Plasma, human (pooled and treated for virusinactivation) ............................................................................ 1747

Plasma humanum ad separationem ...........................5.3-3518Plasma humanum collectum deinde conditum ad virosexstinguendos ........................................................................ 1747

Plastic additives (3.1.13.).......................................................... 293Plastic containers and closures for pharmaceutical use(3.2.2.) ........................................................................................ 308

Plastic containers for aqueous solutions for parenteralinfusion (3.2.2.1.) ..................................................................... 309

Plastic containers for human blood and blood components,sterile (3.2.3.) ............................................................................ 309

Plastic syringes, single-use, sterile (3.2.8.) ............................314Pneumococcal polysaccharide conjugate vaccine(adsorbed).........................................................................5.1-2851

Pneumococcal polysaccharide vaccine ................................. 691Poliomyelitis (inactivated), diphtheria, tetanus and pertussis(acellular, component) vaccine (adsorbed) ........................ 648

Poliomyelitis (inactivated), diphtheria, tetanus and pertussisvaccine (adsorbed)................................................................... 656

Poliomyelitis (inactivated), diphtheria, tetanus, pertussis(acellular, component) and haemophilus type b conjugatevaccine (adsorbed)................................................................... 653

Poliomyelitis (inactivated), diphtheria, tetanus, pertussis andhaemophilus type b conjugate vaccine (adsorbed) .......... 657

Poliomyelitis vaccine (inactivated) ......................................... 692Poliomyelitis vaccine (inactivated), in vivo assay of(2.7.20.) .......................................................................................210

Poliomyelitis vaccine (oral) .............................................5.3-3410Poliomyelitis vaccine (oral), test for neurovirulence(2.6.19.) ...................................................................................... 172

Poloxamera ...............................................................................2264Poloxamers ................................................................................2264Polyacrylate dispersion 30 per cent.....................................2265Polyacrylatis dispersio 30 per centum ..............................2265Poly(alcohol vinylicus) ..........................................................2272Polyamide 6/6 suture, sterile, in distributor for veterinaryuse .............................................................................................. 887

Polyamide 6 suture, sterile, in distributor for veterinary use..................................................................................................... 886

Polyethyleneglycols .................................................................1950Polyethylene terephthalate for containers for preparationsnot for parenteral use (3.1.15.) ............................................. 298

Poly(ethylene terephthalate) suture, sterile, in distributor forveterinary use .......................................................................... 887

Poly(ethylene - vinyl acetate) for containers and tubing fortotal parenteral nutrition preparations (3.1.7.) ................. 285

Polyethylene with additives for containers for parenteralpreparations and for ophthalmic preparations (3.1.5.) ... 279

Polyethylene without additives for containers for parenteralpreparations and for ophthalmic preparations (3.1.4.) ... 278

Polygalae radix ........................................................................ 2401Polygoni avicularis herba ..................................................... 1877Polymorphism (5.9.) .................................................................. 555Polymyxin B sulphate ......................................................5.3-3595Polymyxini B sulfas.........................................................5.3-3595Polyolefines (3.1.3.) ................................................................... 274Polyoxyl castor oil.............................................................5.3-3547Polyoxyl hydrogenated castor oil ..................................5.2-3231



Polypropylene for containers and closures for parenteralpreparations and ophthalmic preparations (3.1.6.).......... 282

Polysaccharide vaccines, hexosamines in (2.5.20.)............. 132Polysaccharide vaccines, methylpentoses in (2.5.21.)........ 133Polysaccharide vaccines, nucleic acids in (2.5.17.) ............. 132Polysaccharide vaccines, O-acetyl in (2.5.19.)...................... 132Polysaccharide vaccines, phosphorus in (2.5.18.)............... 132Polysaccharide vaccines, protein in (2.5.16.) ........................131Polysaccharide vaccines, ribose in (2.5.31.) ......................... 137Polysaccharide vaccines, sialic acid in (2.5.23.) .................. 133Polysaccharide vaccines, uronic acids in (2.5.22.) .............. 133Polysorbate 20 ..........................................................................2267Polysorbate 40 ..........................................................................2268Polysorbate 60 ..........................................................................2269Polysorbate 80 ..........................................................................2270Polysorbatum 20 .....................................................................2267Polysorbatum 40 .....................................................................2268Polysorbatum 60 .....................................................................2269Polysorbatum 80 .....................................................................2270Poly(vinyl acetate)....................................................................2271Poly(vinyl alcohol) ...................................................................2272Poly(vinyl chloride), non-plasticised, materials based on forcontainers for dry dosage forms for oral administration(3.1.11.)....................................................................................... 291

Poly(vinyl chloride), non-plasticised, materials based onfor containers for non-injectable aqueous solutions(3.1.10.) ...................................................................................... 289

Poly(vinyl chloride), plasticised, empty sterile containers offor human blood and blood components (3.2.4.) ..............311

Poly(vinyl chloride), plasticised, materials based on forcontainers for aqueous solutions for intravenous infusion(3.1.14.) ...................................................................................... 296

Poly(vinyl chloride), plasticised, materials based on forcontainers for human blood and blood components(3.1.1.1.) ..................................................................................... 269

Poly(vinyl chloride), plasticised, materials based on fortubing used in sets for the transfusion of blood and bloodcomponents (3.1.1.2.).............................................................. 272

Poly (vinyl chloride), plasticised, sterile containers offor human blood containing anticoagulant solution(3.2.5.) ........................................................................................ 312

Poly(vinylis acetas) .................................................................2271Poppy petals, red......................................................................2359Porcine actinobacillosis vaccine (inactivated) ..................... 784Porcine influenza vaccine (inactivated) ................................ 785Porcine insulin..........................................................................1806Porcine parvovirosis vaccine (inactivated) ........................... 787Porcine progressive atrophic rhinitis vaccine(inactivated) .............................................................................. 788

Porosity of sintered-glass filters (2.1.2.) ...................................17Potassium (2.4.12.) .................................................................... 108Potassium acetate ....................................................................2273Potassium bromide ..................................................................2273Potassium carbonate............................................................... 2274Potassium chloride ...........................................................5.2-3261Potassium citrate .....................................................................2275Potassium clavulanate ............................................................ 2276Potassium clavulanate, diluted .............................................2278Potassium dihydrogen phosphate ........................................2280Potassium hydrogen aspartate hemihydrate .....................2280Potassium hydrogen carbonate ............................................ 2281Potassium hydrogen tartrate.................................................2282Potassium hydroxide ...............................................................2283Potassium iodide......................................................................2283Potassium metabisulphite...............................................5.3-3597Potassium nitrate .....................................................................2284Potassium perchlorate ............................................................2285Potassium permanganate.......................................................2286Potassium sodium tartrate tetrahydrate.............................2286

Potassium sorbate....................................................................2287Potassium sulphate .................................................................2288Potato starch.............................................................................2288Potentiometric determination of ionic concentration usingion-selective electrodes (2.2.36.)............................................. 55

Potentiometric determination of pH (2.2.3.).......................... 26Potentiometric titration (2.2.20.).............................................. 35Poultices....................................................................................... 625Pour-on preparations ................................................................ 631Povidone .............................................................................5.2-3262Povidone, iodinated ................................................................. 2291Povidonum.........................................................................5.2-3262Povidonum iodinatum ........................................................... 2291Powdered cellulose ..................................................................1232Powder flow (2.9.36.) .......................................................5.3-3363Powders and granules for oral solutions andsuspensions......................................................................5.2-3143

Powders and granules for syrups ..................................5.2-3143Powders and tablets for rectal solutions andsuspensions......................................................................5.2-3149

Powders, ear.......................................................................5.2-3138Powders, effervescent.......................................................5.2-3148Powders for cutaneous application...............................5.2-3147Powders for eye drops and powders for eye lotions ..5.3-3396Powders for inhalation.....................................................5.1-2845Powders for injections or infusions ..............................5.2-3145Powders for oral drops.....................................................5.2-3143Powders, nasal .............................................................................611Powders, oral .....................................................................5.2-3147Praeadmixta ad alimenta medicataad usum veterinarium ............................................................617

Praeparationes ad irrigationem............................................ 622Praeparationes buccales ..........................................................611Praeparationes homoeopathicas .......................................... 893Praeparationes insulini iniectabiles .................................. 1808Praeparationes intramammariaead usum veterinarium ........................................................... 606

Praeparationes intraruminales .................................... 5.2-3141Praeparationes intra-uterinae ad usum veterinarium ....5.3-3397

Praeparationes liquidae ad usum dermicum .................... 607Praeparationes liquidae peroraliae.............................5.2-3142Praeparationes liquidae veterinariae ad usum dermicum..................................................................................................... 630

Praeparationes molles ad usum dermicum ....................... 624Praeparationes pharmaceuticae in vasis cum pressu..... 622Pravastatin sodium..................................................................2292Pravastatinum natricum .......................................................2292Prazepam ...................................................................................2293Prazepamum ............................................................................2293Praziquantel ..............................................................................2294Praziquantelum .......................................................................2294Prazosin hydrochloride ..........................................................2295Prazosini hydrochloridum ...................................................2295Prednicarbate............................................................................2297Prednicarbatum.......................................................................2297Prednisolone .............................................................................2298Prednisolone acetate...............................................................2299Prednisolone pivalate.............................................................. 2301Prednisolone sodium phosphate ..........................................2302Prednisoloni acetas ................................................................2299Prednisoloni natrii phosphas ..............................................2302Prednisoloni pivalas............................................................... 2301Prednisolonum ........................................................................2298Prednisone.................................................................................2303Prednisonum ............................................................................2303Prekallikrein activator (2.6.15.) .............................................. 168Premixes for medicated feeding stuffs for veterinary use ..617Preparations for inhalation.............................................5.1-2843



Preparations for inhalation : aerodynamic assessment of fineparticles (2.9.18.) ............................................................5.2-3103

Preparations for irrigation....................................................... 622Pressurised pharmaceutical preparations ............................ 622Prilocaine...................................................................................2305Prilocaine hydrochloride........................................................2307Prilocaini hydrochloridum...................................................2307Prilocainum..............................................................................2305Primaquine diphosphate ........................................................2308Primaquini diphosphas .........................................................2308Primary aromatic amino-nitrogen, determination of(2.5.8.) ........................................................................................ 129

Primary standards for volumetric solutions (4.2.1.)........... 435Primary standards for volumetric solutions (4.2.1.) ..5.3-3378Primidone ..................................................................................2309Primidonum .............................................................................2309Primulae radix ......................................................................... 2310Primula root .............................................................................. 2310Probenecid................................................................................. 2311Probenecidum .......................................................................... 2311Procainamide hydrochloride ................................................. 2312Procainamidi hydrochloridum............................................ 2312Procaine benzylpenicillin ....................................................... 1080Procaine hydrochloride .......................................................... 2312Procaini hydrochloridum ..................................................... 2312Prochlorperazine maleate ...................................................... 2313Prochlorperazini maleas....................................................... 2313Producta ab ADN recombinante ........................................... 584Producta ab fermentatione ..................................................... 576Producta allergenica ................................................................ 569Producta cum possibili transmissione vectoriumenkephalopathiarum spongiformium animalium ......... 577

Products of fermentation ......................................................... 576Products of recombinant DNA technology .......................... 584Products with risk of transmitting agents of animalspongiform encephalopathies............................................... 577

Progesterone ............................................................................. 2314Progesteronum ........................................................................ 2314Proguanil hydrochloride ........................................................ 2315Proguanili hydrochloridum ................................................. 2315Proline ........................................................................................ 2316Prolinum ................................................................................... 2316Promazine hydrochloride....................................................... 2317Promazini hydrochloridum.................................................. 2317Promethazine hydrochloride................................................. 2318Promethazini hydrochloridum............................................ 2318Propacetamol hydrochloride ................................................. 2319Propacetamoli hydrochloridum .......................................... 2319Propafenone hydrochloride ............................................5.1-2996Propafenoni hydrochloridum .......................................5.1-2996Propanol.....................................................................................2320Propanolum..............................................................................2320Propantheline bromide........................................................... 2321Propanthelini bromidum ...................................................... 2321Propofol......................................................................................2322Propofolum ...............................................................................2322Propranolol hydrochloride.....................................................2324Propranololi hydrochloridum..............................................2324Propylene glycol.......................................................................2327Propylene glycol dicaprylocaprate.......................................2327Propylene glycol dilaurate .....................................................2328Propylene glycol monolaurate ..............................................2329Propylene glycol monopalmitostearate...............................2330Propylene glycol monostearate.............................................2330Propylenglycoli dicaprylocapras ........................................2327Propylenglycoli dilauras .......................................................2328Propylenglycoli monolauras ................................................2329Propylenglycoli monopalmitostearas ................................2330Propylenglycolum ...................................................................2327

Propyl gallate ............................................................................2325Propylis gallas..........................................................................2325Propylis parahydroxybenzoas .............................................2326Propylis parahydroxybenzoas natricum ..........................2448Propyl parahydroxybenzoate.................................................2326Propylthiouracil ....................................................................... 2331Propylthiouracilum ................................................................ 2331Propyphenazone ......................................................................2332Propyphenazonum .................................................................2332Protamine hydrochloride .......................................................2332Protamine sulphate .................................................................2334Protamini hydrochloridum ..................................................2332Protamini sulfas ......................................................................2334Protein in polysaccharide vaccines (2.5.16.) .........................131Protein, total (2.5.33.) ............................................................... 138Prothrombin complex, human .............................................. 1748Prothrombinum multiplex humanum ............................... 1748Protirelin ....................................................................................2335Protirelinum .............................................................................2335Proxyphylline ............................................................................2336Proxyphyllinum.......................................................................2336Pruni africanae cortex ..........................................................2339Pseudoephedrine hydrochloride ..........................................2337Pseudoephedrini hydrochloridum .....................................2337Psyllii semen ............................................................................2338Psyllium seed ............................................................................2338Pulveres ad usum dermicum ........................................5.2-3147Pulveres perorales............................................................5.2-3147Purified water ...........................................................................2697Purified water, highly .............................................................2695Pycnometric density of solids (2.9.23.) ................................. 257Pygeum africanum bark .........................................................2339Pyrantel embonate...................................................................2339Pyranteli embonas ..................................................................2339Pyrazinamide ............................................................................2340Pyrazinamidum.......................................................................2340Pyridostigmine bromide ......................................................... 2341Pyridostigmini bromidum .................................................... 2341Pyridoxine hydrochloride.......................................................2342Pyridoxini hydrochloridum .................................................2342Pyrimethamine .........................................................................2343Pyrimethaminum ....................................................................2343Pyrogens (2.6.8.)......................................................................... 152

QQuantified hawthorn leaf and flower liquid extract ..5.3-3511Quercus cortex ......................................................................... 2129Quinidine sulphate ..................................................................2347Quinine hydrochloride............................................................2348Quinine sulphate......................................................................2350

RRabies immunoglobulin, human .......................................... 1750Rabies vaccine for human use prepared in cell cultures... 699Rabies vaccine (inactivated) for veterinary use................... 790Rabies vaccine (live, oral) for foxes ........................................ 792Racemic camphor..................................................................... 1172Racemic ephedrine hydrochloride .......................................1509Racemic menthol ..................................................................... 1991Raclopride ([11C]methoxy) injection....................................... 838Raclopridi ([11C]methoxy) solutio iniectabilis ................... 838Radionuclides, table of physical characteristics (5.7.) ....... 539Radiopharmaceutica ................................................................ 578Radiopharmaceutical preparations ........................................ 578Raman spectrometry (2.2.48.) ................................................... 79Ramipril......................................................................................2355Ramiprilum ..............................................................................2355Ranitidine hydrochloride.................................................5.3-3601



Ranitidini hydrochloridum ...........................................5.3-3601Rapae oleum raffinatum .......................................................2359Rapeseed oil, refined...............................................................2359Ratanhiae radix .......................................................................2362Ratanhiae tinctura ..................................................................2362Reagents (4.) ............................................................................... 321Reagents (4.1.1.) ......................................................................... 321Reagents (4.1.1.) ................................................................5.1-2817Reagents (4.1.1.) ................................................................5.2-3123Reagents (4.1.1.) ................................................................5.3-3377Reagents, standard solutions, buffer solutions (4.1.)......... 321Recombinant DNA technology, products of......................... 584Rectal capsules ..................................................................5.2-3149Rectal foams.......................................................................5.2-3150Rectalia ...............................................................................5.2-3148Rectal preparations...........................................................5.2-3148Rectal preparations, semi-solid ......................................5.2-3149Rectal solutions, emulsions and suspensions.............5.2-3149Rectal tampons..................................................................5.2-3150Red poppy petals......................................................................2359Refractive index (2.2.6.) .............................................................. 28Relationship between reaction of solution, approximate pHand colour of certain indicators (2.2.4.) ............................... 27

Relative density (2.2.5.)............................................................... 27Repaglinide.........................................................................5.2-3267Repaglinidum....................................................................5.2-3267Reserpine ...................................................................................2360Reserpinum ..............................................................................2360Residual solvents (5.4.) ............................................................. 507Residual solvents, identification and control (2.4.24.) ...... 113Residue on evaporation of essential oils (2.8.9.)..................216Resistance to crushing of tablets (2.9.8.) ............................. 235Resistance to rupture of suppositories and pessaries(2.9.24.) ...................................................................................... 258

Resorcinol ..................................................................................2360Resorcinolum ...........................................................................2360Restharrow root ....................................................................... 2361Rhamni purshianae cortex................................................... 1194Rhatany root .............................................................................2362Rhatany tincture ......................................................................2362Rhei radix..................................................................................2363Rhenii sulfidi colloidalis et technetii (99mTc) solutioiniectabilis ................................................................................ 851

Rhubarb .....................................................................................2363Ribavirin..............................................................................5.1-3002Ribavirinum ......................................................................5.1-3002Riboflavin...................................................................................2365Riboflavini natrii phosphas .................................................2366Riboflavin sodium phosphate................................................2366Riboflavinum............................................................................2365Ribose in polysaccharide vaccines (2.5.31.) ......................... 137Ribwort plantain ......................................................................2368Rice starch.................................................................................2369Ricini oleum hydrogenatum ................................................ 1197Ricini oleum virginale ........................................................... 1197Rifabutin ....................................................................................2369Rifabutinum..............................................................................2369Rifampicin..................................................................................2371Rifampicinum ..........................................................................2371Rifamycin sodium.....................................................................2372Rifamycinum natricum .........................................................2372Rilmenidine dihydrogen phosphate .....................................2373Rilmenidini dihydrogenophosphas....................................2373Risperidone ........................................................................5.3-3602Risperidonum ...................................................................5.3-3602Roman chamomile flower ......................................................1245Rosae pseudo-fructus ............................................................. 1472Roselle ........................................................................................ 2376Rosemary leaf ...........................................................................2377

Rosemary oil .............................................................................2378Rosmarini aetheroleum.........................................................2378Rosmarini folium ....................................................................2377Rotating viscometer method - viscosity (2.2.10.) .......5.3-3337Roxithromycin...........................................................................2379Roxithromycinum ...................................................................2379RRR-α-Tocopherol ................................................................... 2591RRR-α-Tocopherolum ............................................................ 2591RRR-α-Tocopheryl acetate .....................................................2595RRR-α-Tocopheryl hydrogen succinate .......................5.1-3026RRR-α-Tocopherylis acetas ..................................................2595RRR-α-Tocopherylis hydrogenosuccinas...................5.1-3026Rubber closures for containers for aqueous parenteralpreparations, for powders and for freeze-dried powders(3.2.9.) .........................................................................................316

Rubella immunoglobulin, human......................................... 1751Rubella vaccine (live) ................................................................ 701Rusci rhizoma...................................................................5.3-3454Rutoside trihydrate.................................................................. 2381Rutosidum trihydricum ......................................................... 2381

SSabalis serrulatae fructus .....................................................2398Saccharin ............................................................................5.3-3607Saccharin sodium .............................................................5.3-3608Saccharinum .....................................................................5.3-3607Saccharinum natricum ..................................................5.3-3608Sacchari spheri........................................................................2503Saccharum ................................................................................2499Safflower oil, refined ...............................................................2389Saffron for homoeopathic preparations................................ 900Sage leaf (salvia officinalis)....................................................2389Sage leaf, three-lobed..............................................................2390Sage tincture............................................................................. 2391Salbutamol .........................................................................5.3-3609Salbutamoli sulfas ..........................................................5.3-3611Salbutamol sulphate ........................................................5.3-3611Salbutamolum ...................................................................5.3-3609Salicis cortex ............................................................................2702Salicylic acid.......................................................................5.1-3007Salmeteroli xinafoas .......................................................5.2-3271Salmeterol xinafoate.........................................................5.2-3271Salmonis domestici oleum ...................................................2396Salmon oil, farmed...................................................................2396Salviae officinalis folium ......................................................2389Salviae sclareae aetheroleum .............................................. 1311Salviae tinctura ....................................................................... 2391Salviae trilobae folium ..........................................................2390Sambuci flos ............................................................................. 1496Saponification value (2.5.6.) .................................................... 129Saw palmetto fruit ...................................................................2398Scopolamine.......................................................................5.3-3519Scopolamine butylbromide .................................................... 1776Scopolamine hydrobromide................................................... 1777Scopolamini butylbromidum ............................................... 1776Scopolamini hydrobromidum.............................................. 1777Scopolaminum..................................................................5.3-3519Selegiline hydrochloride ........................................................2400Selegilini hydrochloridum....................................................2400Selenii disulfidum................................................................... 2401Selenium disulphide................................................................ 2401Semecarpus anacardiumad praeparationes homoeopathicas..........................5.3-3430

Semi-micro determination of water (2.5.12.) ....................... 130Semi-solid and liquid preparations, test for deliverable massor volume (2.9.28.) .................................................................. 263

Semi-solid ear preparations ............................................5.2-3138Semi-solid eye preparations ............................................5.3-3396Semi-solid intrauterine preparations ............................5.3-3397



Semi-solid nasal preparations...................................................611Semi-solid oromucosal preparations...................................... 612Semi-solid preparations for cutaneous application ............ 624Semi-solid rectal preparations........................................5.2-3149Semi-solid vaginal preparations.....................................5.2-3153Senega root ............................................................................... 2401Sennae folii extractum siccum normatum.......................2403Sennae folium..........................................................................2402Sennae fructus acutifoliae....................................................2404Sennae fructus angustifoliae ...............................................2405Senna leaf ..................................................................................2402Senna leaf dry extract, standardised ...................................2403Senna pods, Alexandrian........................................................2404Senna pods, Tinnevelly ...........................................................2405Separation techniques, chromatographic (2.2.46.) .............. 69Serine..........................................................................................2406Serinum .....................................................................................2406Serpylli herba........................................................................... 2701Sertaconazole nitrate..............................................................2407Sertaconazoli nitras ...............................................................2407Sesame oil, refined ..................................................................2408Sesami oleum raffinatum .....................................................2408Sets for the transfusion of blood and blood components(3.2.6.) .........................................................................................313

Shampoos .................................................................................... 608Shellac .......................................................................................2409Sialic acid in polysaccharide vaccines (2.5.23.)................... 133Sieves (2.1.4.) .................................................................................18Sieve test (2.9.12.)...................................................................... 239Sieving, analytical, particle-size distribution estimation by(2.9.38.) .............................................................................5.3-3368

Silica ad usum dentalem....................................................... 2411Silica, colloidal anhydrous ..................................................... 2410Silica, colloidal hydrated ........................................................ 2411Silica colloidalis anhydrica.................................................. 2410Silica colloidalis hydrica....................................................... 2411Silica, dental type..................................................................... 2411Silicone elastomer for closures and tubing (3.1.9.) ............ 288Silicone oil used as a lubricant (3.1.8.) ................................. 287Silk suture, sterile, braided, in distributor for veterinary use..................................................................................................... 887

Silver, colloidal, for external use ...................................5.3-3613Silver nitrate ............................................................................. 2412Silybi mariani fructus............................................................2046Simeticone................................................................................. 2412Simeticonum ............................................................................ 2412Simvastatin................................................................................ 2413Simvastatinum ......................................................................... 2413Single-dose preparations, uniformity of content (2.9.6.)... 234Single-dose preparations, uniformity of mass (2.9.5.)........ 233Sintered-glass filters (2.1.2.) .......................................................17Size-exclusion chromatography (2.2.30.)................................ 45(S)-Lactic acid.....................................................................5.2-3227Sodium acetate ([1-11C]) injection........................................... 839Sodium acetate trihydrate ..................................................... 2415Sodium alendronate ................................................................ 2416Sodium alginate ....................................................................... 2417Sodium amidotrizoate............................................................. 2418Sodium aminosalicylate dihydrate ....................................... 2419Sodium ascorbate ....................................................................2420Sodium aurothiomalate ...................................................5.3-3613Sodium benzoate ..................................................................... 2421Sodium bromide.......................................................................2422Sodium calcium edetate .........................................................2422Sodium caprylate .....................................................................2423Sodium carbonate, anhydrous .......................................5.1-3008Sodium carbonate decahydrate .....................................5.1-3008Sodium carbonate monohydrate ...................................5.1-3009Sodium carboxymethylcellulose ........................................... 1189

Sodium carboxymethylcellulose, cross-linked ................... 1371Sodium carboxymethylcellulose, low-substituted............. 1190Sodium cetostearyl sulphate .................................................2426Sodium chloride .......................................................................2428Sodium chromate (51Cr) sterile solution ............................... 840Sodium citrate ..........................................................................2429Sodium cromoglicate ..............................................................2429Sodium cyclamate....................................................................2430Sodium dihydrogen phosphate dihydrate .......................... 2431Sodium fluoride .......................................................................2432Sodium fluoride (18F) injection ............................................... 841Sodium fusidate .......................................................................2433Sodium glycerophosphate, hydrated ...................................2434Sodium hyaluronate ................................................................2434Sodium hydrogen carbonate .................................................2437Sodium hydroxide....................................................................2437Sodium iodide...........................................................................2438Sodium iodide (123I) injection .................................................. 842Sodium iodide (131I) capsules for diagnostic use................. 843Sodium iodide (131I) capsules for therapeutic use .....5.2-3157Sodium iodide (131I) solution ................................................... 844Sodium iodide (131I) solution for radiolabelling .................. 845Sodium iodohippurate (123I) injection ................................... 845Sodium iodohippurate (131I) injection ................................... 846Sodium lactate solution..........................................................2438Sodium laurilsulfate ................................................................2440Sodium metabisulphite........................................................... 2441Sodium methyl parahydroxybenzoate................................. 2441Sodium molybdate dihydrate ................................................2442Sodium nitrite...........................................................................2443Sodium nitroprusside .............................................................2443Sodium perborate, hydrated..................................................2444Sodium pertechnetate (99mTc) injection (fission) ................ 847Sodium pertechnetate (99mTc) injection (non-fission) ........ 848Sodium phosphate (32P) injection .......................................... 849Sodium picosulfate .................................................................2445Sodium polystyrene sulphonate ...........................................2446Sodium propionate ..................................................................2447Sodium propyl parahydroxybenzoate..................................2448Sodium salicylate .....................................................................2449Sodium selenite pentahydrate ..............................................2449Sodium (S)-lactate solution ...................................................2439Sodium starch glycolate (type A) ..................................5.2-3272Sodium starch glycolate (type B) ..................................5.2-3273Sodium starch glycolate (type C) ......................................... 2451Sodium stearate .......................................................................2452Sodium stearyl fumarate ........................................................2453Sodium sulphate, anhydrous.................................................2454Sodium sulphate decahydrate...............................................2455Sodium sulphite, anhydrous..................................................2455Sodium sulphite heptahydrate..............................................2456Sodium thiosulphate........................................................5.1-3009Sodium valproate .....................................................................2457Soft capsules ......................................................................5.2-3135Softening time determination of lipophilic suppositories(2.9.22.) ...................................................................................... 256

Soft extracts ................................................................................ 572Soiae oleum hydrogenatum .................................................2475Soiae oleum raffinatum ........................................................ 2476Solani amylum ........................................................................2288Solidaginis herba .............................................................5.2-3213Solidaginis virgaureae herba........................................5.3-3507Solid dosage forms, dissolution test for (2.9.3.) .........5.3-3353Solids, density of (2.2.42.) .......................................................... 64Solids, pycnometric density of (2.9.23.) ................................ 257Solubility in alcohol of essential oils (2.8.10.) ......................216Soluble tablets ...................................................................5.2-3151Solutiones ad conservationem partium corporis ...........2458



Solutiones ad haemocolaturamhaemodiacolaturamque ...................................................... 1703

Solutiones ad haemodialysim ............................................. 1700Solutiones ad peritonealem dialysim ................................ 2212Solutiones anticoagulantes et sanguinem humanumconservantes .......................................................................... 1007

Solutions for haemodialysis................................................... 1700Solutions for haemodialysis, concentrated, water fordiluting..................................................................................... 1699

Solutions for haemofiltration and for haemodiafiltra-tion............................................................................................ 1703

Solutions for organ preservation..........................................2458Solutions for peritoneal dialysis ........................................... 2212Solutions, suspensions, intrauterine ............................5.3-3397Solvents, residual (5.4.) ............................................................ 507Solvents, residual, identification and control (2.4.24.) ...... 113Somatostatin .............................................................................2459Somatostatinum ......................................................................2459Somatropin.........................................................................5.3-3614Somatropin bulk solution ...............................................5.3-3616Somatropin for injection .................................................5.3-3619Somatropini solutio ad praeparationem ...................5.3-3616Somatropinum ..................................................................5.3-3614Somatropinum ad iniectabilium..................................5.3-3619Sorbic acid.................................................................................2467Sorbitani lauras .......................................................................2467Sorbitani oleas .........................................................................2468Sorbitani palmitas ..................................................................2468Sorbitani sesquioleas .............................................................2468Sorbitani stearas .....................................................................2469Sorbitani trioleas ....................................................................2469Sorbitan laurate .......................................................................2467Sorbitan oleate .........................................................................2468Sorbitan palmitate ...................................................................2468Sorbitan sesquioleate..............................................................2468Sorbitan stearate......................................................................2469Sorbitan trioleate .....................................................................2469Sorbitol.......................................................................................2470Sorbitol, liquid (crystallising)................................................2471Sorbitol, liquid (non-crystallising)........................................2472Sorbitol, liquid, partially dehydrated...................................2473Sorbitolum ................................................................................2470Sorbitolum liquidum cristallisabile....................................2471Sorbitolum liquidum non cristallisabile ...........................2472Sorbitolum liquidum partim deshydricum ......................2473Sotalol hydrochloride ............................................................. 2474Sotaloli hydrochloridum ....................................................... 2474Soya-bean oil, hydrogenated..................................................2475Soya-bean oil, refined.............................................................. 2476Specific surface area by air permeability (2.9.14.).............. 239Specific surface area by gas adsorption (2.9.26.) ......5.1-2811Spectinomycin hydrochloride................................................ 2476Spectinomycini hydrochloridum ........................................ 2476Spectrometry, atomic absorption (2.2.23.) ............................. 36Spectrometry, atomic emission (2.2.22.)................................. 35Spectrometry, mass (2.2.43.) ..................................................... 65Spectrometry, nuclear magnetic resonance (2.2.33.) ...........51Spectrometry, Raman (2.2.48.) ................................................. 79Spectrometry, X-ray fluorescence (2.2.37.)............................. 56Spectrophotometry, infrared absorption (2.2.24.)................ 37Spectrophotometry, near-infrared (2.2.40.)............................ 59Spectrophotometry, ultraviolet and visible absorption(2.2.25.) .............................................................................5.2-3089

SPF chicken flocks for the production and quality control ofvaccines (5.2.2.) ...............................................................5.1-2825

Spiramycin..........................................................................5.1-3010Spiramycinum ..................................................................5.1-3010Spirapril hydrochloride monohydrate.................................2480Spiraprili hydrochloridum monohydricum .....................2480

Spironolactone .........................................................................2482Spironolactonum ....................................................................2482Spot-on preparations................................................................. 631Sprays ........................................................................................... 631Squalane ....................................................................................2483Squalanum................................................................................2483Standard solutions for limit tests (4.1.2.) ............................. 426Standard solutions for limit tests (4.1.2.) ....................5.1-2818Stanni colloidalis et technetii (99mTc)solutio iniectabilis .................................................................. 853

Stanni pyrophosphatis et technetii (99mTc) solutioiniectabilis ................................................................................ 865

Stannosi chloridum dihydricum.........................................2486Stannous chloride dihydrate .................................................2486Stanozolol..................................................................................2486Stanozololum ...........................................................................2486Star anise ...................................................................................2487Star anise oil .............................................................................2488Starch glycolate (type A), sodium .................................5.2-3272Starch glycolate (type B), sodium .................................5.2-3273Starch glycolate (type C), sodium ........................................ 2451Starch, maize .....................................................................5.1-2965Starch, potato ...........................................................................2288Starch, pregelatinised .............................................................2490Starch, rice ................................................................................2369Starch, wheat ............................................................................2698Statistical analysis of results of biological assays and tests(5.3.) ............................................................................................ 475

Stavudine............................................................................5.1-3012Stavudinum .......................................................................5.1-3012Steam sterilisation of aqueous preparations, application ofthe F0 concept (5.1.5.)....................................................5.1-2821

Stearic acid................................................................................2490Stearoyl macrogolglycerides ..........................................5.2-3274Stearyl alcohol...................................................................5.3-3621Sterile braided silk suture in distributor for veterinaryuse............................................................................................... 887

Sterile catgut............................................................................... 873Sterile catgut in distributor for veterinary use ................... 885Sterile containers of plasticised poly (vinyl chloride)for human blood containing anticoagulant solution(3.2.5.) ........................................................................................ 312

Sterile linen thread in distributor for veterinary use......... 886Sterile non-absorbable strands in distributor for veterinaryuse............................................................................................... 888

Sterile non-absorbable sutures ......................................5.3-3423Sterile plastic containers for human blood and bloodcomponents (3.2.3.) ................................................................. 309

Sterile polyamide 6/6 suture in distributor for veterinaryuse............................................................................................... 887

Sterile polyamide 6 suture in distributor for veterinaryuse............................................................................................... 886

Sterile poly(ethylene terephthalate) suture in distributor forveterinary use ........................................................................... 887

Sterile products, methods of preparation (5.1.1.) ............... 445Sterile single-use plastic syringes (3.2.8.) ..............................314Sterile synthetic absorbable braided sutures ...................... 878Sterile synthetic absorbable monofilament sutures........... 880Sterilisation procedures, biological indicators (5.1.2.) ...... 447Sterility (2.6.1.) ........................................................................... 145Sterols in fatty oils (2.4.23.)............................................5.1-2787Sticks ............................................................................................ 626Sticks, intrauterine ...........................................................5.3-3397Sticks, nasal..................................................................................611St. John’s wort..........................................................................2485Stomata and stomatal index (2.8.3.) ...................................... 215Stramonii folium .....................................................................2492Stramonii pulvis normatus...................................................2494Stramonium leaf.......................................................................2492



Stramonium, prepared ............................................................2494Strands, sterile non-absorbable, in distributor for veterinaryuse .............................................................................................. 888

Streptokinase bulk solution ...........................................5.3-3622Streptokinasi solutio ad praeparationem ..................5.3-3622Streptomycini sulfas...............................................................2496Streptomycin sulphate ............................................................2496Strontii (89Sr) chloridi solutio iniectabilis .......................... 850Strontium (89Sr) chloride injection ........................................ 850Styli ............................................................................................... 626Subdivision of tablets.......................................................5.2-3150Sublingual tablets and buccal tablets ................................... 613Substances for pharmaceutical use ....................................... 586Substances for pharmaceutical use, control of impurities(5.10.).......................................................................................... 559

Substances of animal origin for the production of veterinaryvaccines (5.2.5.) ........................................................................ 460

Sub-visible particles, particulate contamination (2.9.19.) .. 253Succinylsulfathiazole ..............................................................2498Succinylsulfathiazolum .........................................................2498Sucrose.......................................................................................2499Sufentanil .................................................................................. 2501Sufentanil citrate .....................................................................2502Sufentanili citras .....................................................................2502Sufentanilum............................................................................ 2501Sugars, lead in (2.4.10.) ............................................................ 107Sugar spheres ...........................................................................2503Sulfacetamide sodium.............................................................2504Sulfacetamidum natricum ....................................................2504Sulfadiazine...............................................................................2505Sulfadiazinum .........................................................................2505Sulfadimidine............................................................................2506Sulfadimidinum.......................................................................2506Sulfadoxine................................................................................2507Sulfadoxinum...........................................................................2507Sulfafurazole.............................................................................2508Sulfafurazolum ........................................................................2508Sulfaguanidine..........................................................................2508Sulfaguanidinum ....................................................................2508Sulfamerazine...........................................................................2509Sulfamerazinum......................................................................2509Sulfamethizole.......................................................................... 2510Sulfamethizolum ..................................................................... 2510Sulfamethoxazole .............................................................5.3-3623Sulfamethoxazolum.........................................................5.3-3623Sulfamethoxypyridazine for veterinary use ....................... 2512Sulfamethoxypyridazinum ad usum veterinarium ....... 2512Sulfanilamide ............................................................................ 2513Sulfanilamidum....................................................................... 2513Sulfasalazine ............................................................................. 2514Sulfasalazinum ........................................................................ 2514Sulfathiazole ............................................................................. 2516Sulfathiazolum ........................................................................ 2516Sulfinpyrazone ......................................................................... 2517Sulfinpyrazonum .................................................................... 2517Sulfisomidine ............................................................................ 2518Sulfisomidinum ....................................................................... 2518Sulfur ad usum externum .....................................................2520Sulfuris colloidalis et technetii (99mTc) solutioiniectabilis ................................................................................ 852

Sulindac ..................................................................................... 2518Sulindacum .............................................................................. 2518Sulphated ash (2.4.14.) ....................................................5.3-3341Sulphates (2.4.13.) ..................................................................... 108Sulphur dioxide (2.5.29.).......................................................... 136Sulphur for external use ........................................................2520Sulphuric acid...........................................................................2520Sulpiride..................................................................................... 2521Sulpiridum ................................................................................ 2521

Sumatriptani succinas...........................................................2522Sumatriptan succinate............................................................2522Sunflower oil, refined .............................................................2524Supercritical fluid chromatography (2.2.45.) ........................ 68Suppositories .....................................................................5.2-3149Suppositories and pessaries, disintegration of (2.9.2.)...... 227Suppositories and pessaries, resistance to rupture(2.9.24.) ...................................................................................... 258

Suppositories, lipophilic, softening time determination(2.9.22.) ...................................................................................... 256

Suspensions, solutions, intrauterine ............................5.3-3397Sutures, sterile non-absorbable .....................................5.3-3423Sutures, sterile synthetic absorbable braided .................... 878Sutures, sterile synthetic absorbable monofilament ........ 880Suxamethonii chloridum ......................................................2525Suxamethonium chloride.......................................................2525Suxibuzone................................................................................2525Suxibuzonum ...........................................................................2525Sweet fennel ..............................................................................1580Sweet orange oil.......................................................................2526Swelling index (2.8.4.)............................................................... 215Swine erysipelas vaccine (inactivated) .................................. 793Swine-fever vaccine (live), classical, freeze-dried ................ 793Symbols and abbreviations (1.5.).................................................9Synthetic absorbable braided sutures, sterile ..................... 878Synthetic absorbable monofilament sutures, sterile.......... 880Syringes, plastic, sterile single-use (3.2.8.) ............................314Syrups..................................................................................5.2-3143

TTable of physical characteristics of radionuclides mentionedin the European Pharmacopoeia (5.7.) ............................... 539

Tablets .................................................................................5.2-3150Tablets and capsules, disintegration of (2.9.1.) ..........5.3-3351Tablets, buccal ............................................................................ 613Tablets, coated...................................................................5.2-3151Tablets, dispersible ...........................................................5.2-3151Tablets, effervescent .........................................................5.2-3151Tablets for intrauterine solutions and suspensions ..5.3-3397Tablets for use in the mouth ..........................................5.2-3152Tablets for vaginal solutions and suspensions ...........5.2-3153Tablets, gastro-resistant...................................................5.2-3152Tablets, intrauterine .........................................................5.3-3397Tablets, modified-release .................................................5.2-3151Tablets, orodispersible .....................................................5.2-3151Tablets, resistance to crushing (2.9.8.) ................................. 235Tablets, soluble..................................................................5.2-3151Tablets, sublingual..................................................................... 613Tablets, uncoated ..............................................................5.2-3150Tablets, uncoated, friability of (2.9.7.) ..........................5.2-3103Tablets, vaginal..................................................................5.2-3153Talc.......................................................................................5.1-3017Talcum ................................................................................5.1-3017Tamoxifen citrate ..............................................................5.1-3018Tamoxifeni citras..............................................................5.1-3018Tamponae medicatae ............................................................... 628Tampons, ear......................................................................5.2-3138Tampons, medicated ................................................................. 628Tampons, rectal .................................................................5.2-3150Tampons, vaginal, medicated .........................................5.2-3154Tanaceti parthenii herba ......................................................1592Tannic acid ................................................................................2534Tannins in herbal drugs, determination of (2.8.14.) .......... 221Tanninum .................................................................................2534Tartaric acid ..............................................................................2534Teat dips....................................................................................... 631Tea tree oil .................................................................................2534Teat sprays................................................................................... 631Technetii (99mTc) et etifenini solutio iniectabilis ............... 853



Technetii (99mTc) exametazimi solutio iniectabilis ........... 854Technetii (99mTc) gluconatis solutio iniectabilis................ 856Technetii (99mTc) humani albumini solutio iniectabilis .. 856Technetii (99mTc) macrosalbi suspensio iniectabilis......... 858Technetii (99mTc) medronati solutio iniectabilis................ 859Technetii (99mTc) mertiatidi solutio iniectabilis................. 860Technetii (99mTc) microsphaerarum suspensioiniectabilis ................................................................................ 861

Technetii (99mTc) pentetatis solutio iniectabilis ................. 862Technetii (99mTc) sestamibi solutio iniectabilis.................. 863Technetii (99mTc) succimeri solutio iniectabilis ................. 865Technetium (99mTc) colloidal rhenium sulphide injection..................................................................................................... 851

Technetium (99mTc) colloidal sulphur injection ................... 852Technetium (99mTc) colloidal tin injection ............................ 853Technetium (99mTc) etifenin injection .................................... 853Technetium (99mTc) exametazime injection .......................... 854Technetium (99mTc) gluconate injection ................................ 856Technetium (99mTc) human albumin injection ..................... 856Technetium (99mTc) macrosalb injection................................ 858Technetium (99mTc) medronate injection............................... 859Technetium (99mTc) mertiatide injection ............................... 860Technetium (99mTc) microspheres injection.......................... 861Technetium (99mTc) pentetate injection................................. 862Technetium (99mTc) sestamibi injection ................................. 863Technetium (99mTc) succimer injection.................................. 865Technetium (99mTc) tin pyrophosphate injection................. 865Temazepam................................................................................2535Temazepamum ........................................................................2535Tenosynovitis avian viral vaccine (live) ................................. 729Tenoxicam..................................................................................2537Tenoxicamum ..........................................................................2537Terbinafine hydrochloride...............................................5.3-3627Terbinafini hydrochloridum .........................................5.3-3627Terbutaline sulphate ...............................................................2538Terbutalini sulfas ....................................................................2538Terconazole ...............................................................................2539Terconazolum ..........................................................................2539Terebinthini aetheroleum ab pinum pinastrum .............2645Terfenadine................................................................................2540Terfenadinum...........................................................................2540Terminology used in monographs on vaccines (5.2.1.) ..... 453tert-Butylamini perindoprilum.....................................5.3-3589Test for anticomplementary activity of immunoglobulin(2.6.17.)....................................................................................... 170

Test for anti-D antibodies in human immunoglobulin forintravenous administration (2.6.26.) ..........................5.3-3348

Test for deliverable mass or volume of liquid and semi-solidpreparations (2.9.28.).............................................................. 263

Test for extractable volume of parenteral preparations(2.9.17.)..............................................................................5.3-3363

Test for Fc function of immunoglobulin (2.7.9.) ................. 202Test for methanol and 2-propanol (2.9.11.) .................5.3-3362Test for neurovirulence of live virus vaccines (2.6.18.) ..... 172Test for neurovirulence of poliomyelitis vaccine (oral)(2.6.19.) ...................................................................................... 172

Testosterone..............................................................................2542Testosterone enantate.............................................................2544Testosterone propionate.........................................................2545Testosteroni enantas ..............................................................2544Testosteroni propionas ..........................................................2545Testosteronum..........................................................................2542Tests for extraneous agents in viral vaccines for human use(2.6.16.) ...................................................................................... 169

Tetanus antitoxin for human use ........................................... 805Tetanus antitoxin for veterinary use.............................5.1-2868Tetanus, diphtheria and hepatitis B (rDNA) vaccine(adsorbed).................................................................................. 641

Tetanus, diphtheria, pertussis (acellular, component),poliomyelitis (inactivated) and haemophilus type bconjugate vaccine (adsorbed)................................................ 653

Tetanus, diphtheria, pertussis and poliomyelitis (inactivated)vaccine (adsorbed)................................................................... 656

Tetanus, diphtheria, pertussis, poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) .......... 657

Tetanus immunoglobulin, human ........................................ 1751Tetanus vaccine (adsorbed) ..................................................... 702Tetanus vaccine (adsorbed), assay of (2.7.8.) ..............5.1-2791Tetanus vaccine for veterinary use ........................................ 795Tetracaine hydrochloride .......................................................2546Tetracaini hydrochloridum ..................................................2546Tetracosactide ...........................................................................2547Tetracosactidum ......................................................................2547Tetracycline ...............................................................................2549Tetracycline hydrochloride .................................................... 2551Tetracyclini hydrochloridum ............................................... 2551Tetracyclinum ..........................................................................2549Tetrazepam................................................................................2552Tetrazepamum .........................................................................2552Tetryzoline hydrochloride...............................................5.1-3020Tetryzolini hydrochloridum ..........................................5.1-3020Thallosi (201Tl) chloridi solutio iniectabilis......................... 867Thallous (201Tl) chloride injection........................................... 867Theobromine.............................................................................2554Theobrominum ........................................................................2554Theophylline .............................................................................2554Theophylline-ethylenediamine ..............................................2557Theophylline-ethylenediamine hydrate ...............................2557Theophylline monohydrate....................................................2555Theophyllinum.........................................................................2554Theophyllinum et ethylenediaminum ...............................2557Theophyllinum et ethylenediaminum hydricum............2557Theophyllinum monohydricum ..........................................2555Thermal analysis (2.2.34.). ......................................................... 52Thermogravimetry (2.2.34.). ...................................................... 52Thiamazole ................................................................................2558Thiamazolum ...........................................................................2558Thiamine hydrochloride .........................................................2559Thiamine nitrate....................................................................... 2561Thiamini hydrochloridum ....................................................2559Thiamini nitras ........................................................................ 2561Thiamphenicol ..........................................................................2562Thiamphenicolum...................................................................2562Thin-layer chromatography (2.2.27.).............................5.2-3090Thiomersal ..........................................................................5.1-3021Thiomersalum ...................................................................5.1-3021Thiopental sodium and sodium carbonate.........................2564Thiopentalum natricum et natrii carbonas .....................2564Thioridazine ..............................................................................2565Thioridazine hydrochloride ...................................................2566Thioridazini hydrochloridum ..............................................2566Thioridazinum .........................................................................2565Three-lobed sage leaf...............................................................2390Threonine...................................................................................2566Threoninum..............................................................................2566Thyme .........................................................................................2567Thyme oil ..................................................................................2569Thyme, wild ............................................................................... 2701Thymi aetheroleum ................................................................2569Thymi herba .............................................................................2567Thymol........................................................................................2570Thymolum .................................................................................2570Tiabendazole .............................................................................2570Tiabendazolum ........................................................................2570Tiamulin for veterinary use ...................................................2571Tiamulin hydrogen fumarate for veterinary use ...............2573Tiamulini hydrogenofumaras ad usum veterinarium ..2573



Tiamulinum ad usum veterinarium ..................................2571Tianeptine sodium ...................................................................2575Tianeptinum natricum ..........................................................2575Tiapride hydrochloride ...........................................................2577Tiapridi hydrochloridum ......................................................2577Tiaprofenic acid ........................................................................2578Ticarcillin sodium..............................................................5.3-3628Ticarcillinum natricum ..................................................5.3-3628Tick-borne encephalitis vaccine (inactivated) .............5.3-3414Ticlopidine hydrochloride ...................................................... 2581Ticlopidini hydrochloridum ................................................. 2581Tiliae flos................................................................................... 1914Tilidine hydrochloride hemihydrate ....................................2582Tilidini hydrochloridum hemihydricum...........................2582Timololi maleas .......................................................................2584Timolol maleate ........................................................................2584Tincturae ..................................................................................... 571Tincturae maternaead praeparationes homoeopathicas................................... 894

Tinctures ...................................................................................... 571Tinidazole ..................................................................................2585Tinidazolum .............................................................................2585Tinnevelly senna pods.............................................................2405Tinzaparin sodium...................................................................2586Tinzaparinum natricum .......................................................2586Tioconazole ...............................................................................2586Tioconazolum ..........................................................................2586Titanii dioxidum......................................................................2587Titanium dioxide ......................................................................2587Titration, amperometric (2.2.19.).............................................. 34Titration, potentiometric (2.2.20.) ............................................ 35Titrations, complexometric (2.5.11.) ...................................... 130Tobramycin .........................................................................5.3-3629Tobramycinum..................................................................5.3-3629α-Tocopherol acetate concentrate (powder form) ............2592Tocopherol, all-rac-α- .......................................................5.3-3631α-Tocopheroli acetatis pulvis ...............................................2592Tocopherol, RRR-α- ................................................................. 2591Tocopheryl acetate, all-rac-α- .........................................5.3-3632Tocopheryl acetate, RRR-α-...................................................2595Tocopheryl hydrogen succinate, DL-α- ................................2597Tocopheryl hydrogen succinate, RRR-α- .....................5.1-3026Tolbutamide ..............................................................................2600Tolbutamidum ..........................................................................2600Tolfenamic acid......................................................................... 2601Tolnaftate ..................................................................................2602Tolnaftatum ..............................................................................2602Tolu balsam ...............................................................................2603Torasemide, anhydrous....................................................5.2-3279Torasemidum anhydricum ............................................5.2-3279Tormentil ...................................................................................2604Tormentillae rhizoma ............................................................2604Tormentillae tinctura .............................................................2605Tormentil tincture....................................................................2605Tosylchloramide sodium.........................................................2605Tosylchloramidum natricum ...............................................2605Total ash (2.4.16.)....................................................................... 108Total organic carbon in water for pharmaceutical use(2.2.44.) ........................................................................................ 68

Total protein (2.5.33.) ............................................................... 138Toxicity, abnormal (2.6.9.)........................................................ 153Toxin, botulinum type A for injection...................................1117Toxinum botulinicum typum A ad iniectabile .................1117Tragacanth ................................................................................2606Tragacantha..............................................................................2606Tramadol hydrochloride .........................................................2607Tramadoli hydrochloridum ..................................................2607Tramazoline hydrochloride monohydrate ...................5.3-3633Tramazolini hydrochloridum monohydricum .........5.3-3633

Tranexamic acid .......................................................................2609Transdermal patches ........................................................5.2-3146Transdermal patches, dissolution test for (2.9.4.) .............. 231Trapidil ....................................................................................... 2610Trapidilum ................................................................................ 2610Tretinoin .................................................................................... 2611Tretinoinum.............................................................................. 2611Triacetin ..................................................................................... 2612Triacetinum .............................................................................. 2612Triamcinolone........................................................................... 2613Triamcinolone acetonide........................................................ 2614Triamcinolone hexacetonide ................................................. 2616Triamcinoloni acetonidum................................................... 2614Triamcinoloni hexacetonidum ............................................ 2616Triamcinolonum ..................................................................... 2613Triamterene ............................................................................... 2617Triamterenum .......................................................................... 2617Tribenoside................................................................................ 2617Tribenosidum ........................................................................... 2617Tributyl acetylcitrate ............................................................... 2619Tributylis acetylcitras............................................................. 2619Tricalcii phosphas................................................................... 1167Trichloroacetic acid .................................................................2620Triethanolamine .......................................................................2632Triethyl citrate ..........................................................................2620Triethylis citras ........................................................................2620Trifluoperazine hydrochloride .............................................. 2621Trifluoperazini hydrochloridum......................................... 2621Triflusal ......................................................................................2622Triflusalum ...............................................................................2622Triglycerida saturata media .................................................2623Triglycerides, medium-chain..................................................2623Triglycerides, omega-3-acid.................................................... 2144Trigonellae foenugraeci semen ...........................................1588Trihexyphenidyl hydrochloride.............................................2625Trihexyphenidyli hydrochloridum .....................................2625Trimetazidine dihydrochloride..............................................2626Trimetazidini dihydrochloridum ........................................2626Trimethadione ..........................................................................2627Trimethadionum .....................................................................2627Trimethoprim............................................................................2628Trimethoprimum.....................................................................2628Trimipramine maleate .............................................................2630Trimipramini maleas .............................................................2630Tri-n-butylis phosphas............................................................ 2631Tri-n-butyl phosphate .............................................................. 2631Tritiated (3H) water injection................................................... 867Tritici aestivi oleum raffinatum ..........................................2699Tritici aestivi oleum virginale..............................................2699Tritici amylum .........................................................................2698Trolamine...................................................................................2632Trolaminum..............................................................................2632Trometamol ...............................................................................2633Trometamolum ........................................................................2633Tropicamide...............................................................................2634Tropicamidum .........................................................................2634Trospii chloridum ............................................................5.2-3281Trospium chloride.............................................................5.2-3281Troxerutin...........................................................................5.3-3634Troxerutinum ....................................................................5.3-3634Trypsin .......................................................................................2635Trypsinum.................................................................................2635Tryptophan................................................................................2636Tryptophanum .........................................................................2636TSE, animal, minimising the risk of transmitting via humanand veterinary medicinal products (5.2.8.) ........................ 463

TSE, animal, products with risk of transmitting agentsof.................................................................................................. 577

Tuberculin for human use, old..............................................2638



Tuberculini aviarii derivatum proteinosumpurificatum.............................................................................2640

Tuberculini bovini derivatum proteinosumpurificatum............................................................................. 2641

Tuberculini derivatum proteinosum purificatum ad usumhumanum ...............................................................................2642

Tuberculin purified protein derivative, avian ....................2640Tuberculin purified protein derivative, bovine.................. 2641Tuberculin purified protein derivative for human use ....2642Tuberculinum pristinum ad usum humanum ................2638Tubes for comparative tests (2.1.5.) ..........................................19Tubing and closures, silicone elastomer for (3.1.9.)........... 288Tubing and containers for total parenteral nutritionpreparations, poly(ethylene - vinyl acetate) for (3.1.7.) ... 285

Tubing used in sets for the transfusion of blood and bloodcomponents, materials based on plasticised poly(vinylchloride) for (3.1.1.2.) ............................................................. 272

Tubocurarine chloride ............................................................2644Tubocurarini chloridum........................................................2644Turmeric, javanese...................................................................2645Turpentine oil, Pinus pinaster type .....................................2645Tylosin for veterinary use ......................................................2647Tylosini phosphatis solutio ad usum veterinarium .......2648Tylosini tartras ad usum veterinarium .............................2650Tylosin phosphate bulk solution for veterinary use ........2648Tylosin tartrate for veterinary use .......................................2650Tylosinum ad usum veterinarium ......................................2647Typhoid polysaccharide vaccine ............................................. 705Typhoid vaccine.......................................................................... 707Typhoid vaccine, freeze-dried.................................................. 707Typhoid vaccine (live, oral, strain Ty 21a)............................ 708Tyrosine...................................................................................... 2651Tyrosinum................................................................................. 2651Tyrothricin..........................................................................5.1-3028Tyrothricinum...................................................................5.1-3028

UUbidecarenone..........................................................................2657Ubidecarenonum .....................................................................2657Udder-washes .............................................................................. 631Ultraviolet absorption spectrophotometry (2.2.25.) ..5.2-3089Ultraviolet ray lamps for analytical purposes (2.1.3.)............17Uncoated tablets................................................................5.2-3150Undecylenic acid ......................................................................2658Uniformity of content of single-dose preparations(2.9.6.) ........................................................................................ 234

Uniformity of dosage units (2.9.40.) .............................5.3-3370Uniformity of mass of delivered doses from multidosecontainers (2.9.27.) .................................................................. 263

Uniformity of mass of single-dose preparations (2.9.5.) .... 233Units of the International System (SI) used in thePharmacopoeia and equivalence with other units (1.6.) ...10

Unsaponifiable matter (2.5.7.) ................................................. 129Urea.............................................................................................2658Ureum.........................................................................................2658Urofollitropin ............................................................................2659Urofollitropinum .....................................................................2659Urokinase................................................................................... 2661Urokinasum .............................................................................. 2661Uronic acids in polysaccharide vaccines (2.5.22.)............... 133Ursodeoxycholic acid .............................................................2662Urtica dioica ad praeparationes homoeopathicas ..5.3-3429Urticae folium ...................................................................5.3-3563Uvae ursi folium ...................................................................... 1054

VVaccina ad usum humanum .........................................5.2-3129Vaccina ad usum veterinarium ....................................5.3-3387

Vaccines, adsorbed, aluminium in (2.5.13.)...........................131Vaccines, adsorbed, calcium in (2.5.14.).................................131Vaccines and immunosera, phenol in (2.5.15.) .....................131Vaccines and immunosera, veterinary, evaluation of efficacy(5.2.7.)................................................................................5.1-2829

Vaccines and immunosera, veterinary, evaluation of safety(5.2.6.) ...............................................................................5.1-2827

Vaccines and immunosera, veterinary, evaluation of thesafety of each batch (5.2.9.) ..........................................5.1-2830

Vaccines for human use...................................................5.2-3129Vaccines for human use, cell substrates for the production of(5.2.3.) ........................................................................................ 455

Vaccines for human use, viral, extraneous agents in(2.6.16.) ...................................................................................... 169

Vaccines for veterinary use.............................................5.3-3387Vaccines, polysaccharide, hexosamines in (2.5.20.)............ 132Vaccines, polysaccharide, methylpentoses in (2.5.21.)....... 133Vaccines, polysaccharide, nucleic acids in (2.5.17.) ............ 132Vaccines, polysaccharide, O-acetyl in (2.5.19.)..................... 132Vaccines, polysaccharide, phosphorus in (2.5.18.) ............. 132Vaccines, polysaccharide, protein in (2.5.16.) .......................131Vaccines, polysaccharide, ribose in (2.5.31.) ........................ 137Vaccines, polysaccharide, sialic acid in (2.5.23.) ................. 133Vaccines, polysaccharide, uronic acids in (2.5.22.)............. 133Vaccines, SPF chicken flocks for the production and qualitycontrol of (5.2.2.) ...........................................................5.1-2825

Vaccines, terminology (5.2.1.) ................................................. 453Vaccines, veterinary, cell cultures for the production of(5.2.4.) ........................................................................................ 458

Vaccines, veterinary, substances of animal origin for theproduction of (5.2.5.) .............................................................. 460

Vaccines, viral live, test for neurovirulence (2.6.18.).......... 172Vaccinum actinobacillosis inactivatum ad suem ............. 784Vaccinum adenovirosidis caninae vivum........................... 738Vaccinum adenovirosis caninae inactivatum ................... 738Vaccinum anaemiae infectivae pulli vivum....................... 769Vaccinum anthracis vivum ad usum veterinarium.......... 715Vaccinum aphtharum epizooticarum inactivatum adruminantes ......................................................................5.1-2860

Vaccinum bronchitidis infectivae aviariae inactivatum.. 718Vaccinum bronchitidis infectivae aviariae vivum ............ 720Vaccinum brucellosis (Brucella melitensis stirpe Rev. 1)vivum cryodesiccatum ad usum veterinarium ......5.1-2859

Vaccinum bursitidis infectivae aviariae inactivatum ...... 722Vaccinum bursitidis infectivae aviariae vivum ................. 723Vaccinum calicivirosis felinae inactivatum ....................... 757Vaccinum calicivirosis felinae vivum cryodesiccatum ... 758Vaccinum cholerae ................................................................... 637Vaccinum cholerae aviariae inactivatum ..................5.1-2861Vaccinum cholerae cryodesiccatum..................................... 638Vaccinum clostridii botulini ad usum veterinarium ....... 745Vaccinum clostridii chauvoei ad usum veterinarium ..... 745Vaccinum clostridii novyi B ad usum veterinarium ....... 746Vaccinum clostridii perfringentisad usum veterinarium ........................................................... 747

Vaccinum clostridii septici ad usum veterinarium .......... 749Vaccinum colibacillosis fetus a partu recentis inactivatumad ruminantes ......................................................................... 778

Vaccinum colibacillosis fetus a partu recentis inactivatumad suem ..................................................................................... 776

Vaccinum diarrhoeae viralis bovinae inactivatum .......... 734Vaccinum diphtheriae adsorbatum ...................................... 660Vaccinum diphtheriae adulti et adulescentisadsorbatum............................................................................... 661

Vaccinum diphtheriae et tetani adsorbatum ..................... 639Vaccinum diphtheriae et tetani adulti et adulescentisadsorbatum............................................................................... 639

Vaccinum diphtheriae, tetani et hepatitidis B (ADNr)adsorbatum............................................................................... 641



Vaccinum diphtheriae, tetani et pertussis adsorbatum .. 643Vaccinum diphtheriae, tetani et pertussis sine cellulis exelementis praeparatum adsorbatum.................................. 642

Vaccinum diphtheriae, tetani, pertussis et poliomyelitidisinactivatum adsorbatum ....................................................... 656

Vaccinum diphtheriae, tetani, pertussis, poliomyelitidisinactivatum et haemophili stirpe b coniugatumadsorbatum............................................................................... 657

Vaccinum diphtheriae, tetani, pertussis sine cellulis exelementis praeparatum et haemophili stirpe b coniugatumadsorbatum............................................................................... 645

Vaccinum diphtheriae, tetani, pertussis sine cellulisex elementis praeparatum et hepatitidis B (ADNr)adsorbatum............................................................................... 647

Vaccinum diphtheriae, tetani, pertussis sine cellulis exelementis praeparatum et poliomyelitidis inactivatumadsorbatum............................................................................... 648

Vaccinum diphtheriae, tetani, pertussis sine cellulisex elementis praeparatum, hepatitidis B (ADNr),poliomyelitidis inactivatum et haemophili stirpe bconiugatum adsorbatum ....................................................... 650

Vaccinum diphtheriae, tetani, pertussis sine cellulis exelementis praeparatum poliomyelitidis inactivatum ethaemophili stirpe b coniugatum adsorbatum ................. 653

Vaccinum encephalitidis ixodibus advectaeinactivatum .....................................................................5.3-3414

Vaccinum encephalomyelitidis infectivae aviariaevivum.......................................................................................... 725

Vaccinum erysipelatis suillae inactivatum ........................ 793Vaccinum febris flavae vivum.......................................5.1-2852Vaccinum febris typhoidi ........................................................ 707Vaccinum febris typhoidi cryodesiccatum ......................... 707Vaccinum febris typhoidis polysaccharidicum ................. 705Vaccinum febris typhoidis vivum perorale (stirpeTy 21a) ....................................................................................... 708

Vaccinum furunculosidis ad salmonidas inactivatum cumadiuvatione oleosa ad iniectionem .................................... 767

Vaccinum haemophili stirpe b coniugatum....................... 662Vaccinum hepatitidis A inactivatum adsorbatum ............ 665Vaccinum hepatitidis A inactivatum et hepatitidis B (ADNr)adsorbatum............................................................................... 664

Vaccinum hepatitidis A inactivatum virosomale .............. 667Vaccinum hepatitidis B (ADNr)............................................. 670Vaccinum hepatitidis viralis anatis stirpe I vivum .......... 751Vaccinum herpesviris equini inactivatum ......................... 754Vaccinum inactivatum diarrhoeae vituli coronaviroillatae ......................................................................................... 736

Vaccinum inactivatum diarrhoeae vituli rotaviroillatae ......................................................................................... 737

Vaccinum influenzae equi inactivatum .............................. 755Vaccinum influenzae inactivatum ad suem ...................... 785Vaccinum influenzae inactivatum ex corticis antigeniispraeparatum....................................................................5.3-3402

Vaccinum influenzae inactivatum ex corticis antigeniispraeparatum virosomale ..............................................5.3-3404

Vaccinum influenzae inactivatum ex viris integrispraeparatum....................................................................5.3-3406

Vaccinum influenzae inactivatum ex virorum fragmentispraeparatum....................................................................5.3-3401

Vaccinum laryngotracheitidis infectivae aviariaevivum.......................................................................................... 727

Vaccinum leptospirosis bovinae inactivatum .................... 730Vaccinum leptospirosis caninae inactivatum ................... 740Vaccinum leucosis felinae inactivatum................................761Vaccinum mannheimiae inactivatum ad bovidas ............ 771Vaccinum mannheimiae inactivatum ad ovem ................ 772Vaccinum meningococcale classis C coniugatum ........... 680Vaccinum meningococcale polysaccharidicum................ 682Vaccinum morbi Aujeszkyi ad suem inactivatum ............ 715

Vaccinum morbi Aujeszkyi ad suem vivum cryodesiccatumad usum parenterale ...............................................................717

Vaccinum morbi Carrei vivum cryodesiccatum ad canem..................................................................................................... 740

Vaccinum morbi Carrei vivum cryodesiccatum admustelidas ................................................................................. 751

Vaccinum morbillorum, parotitidis et rubellae vivum .... 678Vaccinum morbillorum vivum............................................... 679Vaccinum morbi Marek vivum .............................................. 774Vaccinum morbi partus diminutionis MCMLXXVIinactivatum ad pullum .......................................................... 753

Vaccinum myxomatosidis vivum ad cuniculum ............... 775Vaccinum panleucopeniae felinae infectivaeinactivatum .............................................................................. 759

Vaccinum panleucopeniae felinae infectivae vivum ....... 760Vaccinum parainfluenzae viri bovini vivumcryodesiccatum ....................................................................... 732

Vaccinum parainfluenzae viri canini vivum..................... 742Vaccinum paramyxoviris 3 aviarii inactivatum ............... 728Vaccinum parotitidis vivum ................................................... 684Vaccinum parvovirosis caninae inactivatum .................... 743Vaccinum parvovirosis caninae vivum ............................... 744Vaccinum parvovirosis inactivatum ad suem ................... 787Vaccinum pasteurellae inactivatum ad ovem.................... 783Vaccinum pertussis................................................................... 685Vaccinum pertussis adsorbatum ........................................... 690Vaccinum pertussis sine cellulis copurificatumadsorbatum............................................................................... 688

Vaccinum pertussis sine cellulis ex elementis praeparatumadsorbatum......................................................................5.3-3407

Vaccinum pestis anatis vivum ......................................5.3-3419Vaccinum pestis classicae suillae vivumcryodesiccatum ....................................................................... 793

Vaccinum pneumococcale polysaccharidicum ................. 691Vaccinum pneumococcale polysaccharidicum coniugatumadsorbatum......................................................................5.1-2851

Vaccinum poliomyelitidis inactivatum ............................... 692Vaccinum poliomyelitidis perorale .............................5.3-3410Vaccinum pseudopestis aviariae inactivatum ................... 779Vaccinum pseudopestis aviariae vivum .............................. 781Vaccinum rabiei ex cellulis ad usum humanum .............. 699Vaccinum rabiei inactivatum ad usum veterinarium ..... 790Vaccinum rabiei perorale vivum ad vulpem ...................... 792Vaccinum rhinitidis atrophicantis ingravescentis suillaeinactivatum .............................................................................. 788

Vaccinum rhinotracheitidis infectivae bovinae vivumcryodesiccatum ....................................................................... 768

Vaccinum rhinotracheitidis viralis felinae inactivatum.. 762Vaccinum rhinotracheitidis viralis felinae vivumcryodesiccatum ....................................................................... 763

Vaccinum rubellae vivum ....................................................... 701Vaccinum tenosynovitidis viralis aviariae vivum ............ 729Vaccinum tetani adsorbatum ................................................. 702Vaccinum tetani ad usum veterinarium ............................. 795Vaccinum tuberculosis (BCG) cryodesiccatum ................. 636Vaccinum varicellae vivum .................................................... 709Vaccinum variolae gallinaceae vivum ............................... 766Vaccinum vibriosidis ad salmonidas inactivatum ........... 797Vaccinum vibriosidis aquae frigidae inactivatum adsalmonidas................................................................................ 796

Vaccinum viri syncytialis meatus spiritus bovini vivumcryodesiccatum ....................................................................... 733

Vaginal capsules ................................................................5.2-3153Vaginal foams.....................................................................5.2-3154Vaginalia ............................................................................5.2-3152Vaginal preparations ........................................................5.2-3152Vaginal preparations, semi-solid ....................................5.2-3153Vaginal solutions and suspensions, tablets for...........5.2-3153Vaginal solutions, emulsions and suspensions...........5.2-3153



Vaginal tablets ...................................................................5.2-3153Vaginal tampons, medicated...........................................5.2-3154Valerianae radix ......................................................................2667Valerian root..............................................................................2667Validation of nucleic acid amplification techniques for thedetection of hepatitis C virus (HCV) RNA in plasma pools :Guidelines...................................................................................176

Valine ..........................................................................................2668Valinum .....................................................................................2668Valproic acid..............................................................................2669Vancomycin hydrochloride ....................................................2670Vancomycini hydrochloridum .............................................2670Vanillin .......................................................................................2672Vanillinum ................................................................................2672Varicella immunoglobulin for intravenous administration,human ...................................................................................... 1753

Varicella immunoglobulin, human....................................... 1752Varicella vaccine (live)............................................................... 709Vaselinum album..................................................................... 2187Vaselinum flavum ................................................................... 2188Vegetable drugs, determination of essential oils in vegetabledrugs (2.8.12.) ...........................................................................217

Vegetable fatty oils..................................................................... 595Verapamil hydrochloride ........................................................2673Verapamili hydrochloridum .................................................2673Verbasci flos..............................................................................2065Veterinary liquid preparations for cutaneous application.. 630Vibriosis (cold-water) vaccine (inactivated) for salmonids.. 796Vibriosis vaccine (inactivated) for salmonids....................... 797VICH (5.8.) ................................................................................... 551Vinblastine sulphate ................................................................2675Vinblastini sulfas .....................................................................2675Vincristine sulphate.................................................................2675Vincristini sulfas .....................................................................2675Vindesine sulphate ..................................................................2677Vindesini sulfas .......................................................................2677Vinorelbine tartrate ..........................................................5.1-3033Vinorelbini tartras............................................................5.1-3033Violae herba cum flore ..........................................................2700Viper venom antiserum, European ........................................ 806Viscometer method, capillary (2.2.9.) ...................................... 29Viscometer method, falling ball (2.2.49.) ................................ 80Viscose wadding, absorbent .................................................. 2681Viscosity (2.2.8.) ........................................................................... 29Viscosity - rotating viscometer method (2.2.10.) ........5.3-3337Visible absorption spectrophotometry (2.2.25.) .........5.2-3089Visible particles, particulate contamination (2.9.20.) ........ 255Vitamin A ............................................................................5.3-3639Vitamin A concentrate (oily form), synthetic ..............5.3-3640Vitamin A concentrate (powder form), synthetic .......5.3-3641Vitamin A concentrate (solubilisate/emulsion),synthetic ...........................................................................5.3-3642

Vitaminum A .....................................................................5.3-3639Vitaminum A densatum oleosum ................................5.3-3640Vitaminum A in aqua dispergibile ..............................5.3-3642Vitaminum A pulvis .........................................................5.3-3641Volumetric analysis (4.2.) ......................................................... 435Volumetric solutions (4.2.2.).................................................... 435Volumetric solutions (4.2.2.)...........................................5.3-3378Volumetric solutions, primary standards for (4.2.1.) ......... 435Volumetric solutions, primary standards for (4.2.1.) ..5.3-3378Von Willebrand factor, human, assay of (2.7.21.).................211

WWarfarin sodium....................................................................... 2691Warfarin sodium clathrate ..................................................... 2691Warfarinum natricum............................................................ 2691Warfarinum natricum clathratum ...................................... 2691Water (15O) injection.................................................................. 868

Water, determination by distillation (2.2.13.) ........................ 32Water for diluting concentrated haemodialysissolutions .................................................................................. 1699

Water for injections .................................................................2692Water for pharmaceutical use, total organic carbon in(2.2.44.) ........................................................................................ 68

Water, highly purified .............................................................2695Water in essential oils (2.8.5.) ..................................................216Water in gases (2.5.28.) ............................................................ 136Water: micro determination (2.5.32.) .................................... 137Water, purified..........................................................................2697Water: semi-micro determination (2.5.12.) ........................... 130Wheat-germ oil, refined ..........................................................2699Wheat-germ oil, virgin.............................................................2699Wheat starch .............................................................................2698White beeswax .......................................................................... 1057White horehound..............................................................5.1-3039White soft paraffin................................................................... 2187Wild pansy (flowering aerial parts)......................................2700Wild thyme ................................................................................ 2701Willow bark ...............................................................................2702Wool alcohols............................................................................2703Wool fat ...............................................................................5.2-3285Wool fat, hydrogenated...........................................................2708Wool fat, hydrous.....................................................................2709Wormwood ................................................................................ 2710

XXanthan gum ............................................................................ 2715Xanthani gummi ..................................................................... 2715Xenon (133Xe) injection.............................................................. 869Xenoni (133Xe) solutio iniectabilis ......................................... 869X-ray fluorescence spectrometry (2.2.37.)............................... 56Xylazine hydrochloride for veterinary use ......................... 2716Xylazini hydrochloridum ad usum veterinarium .......... 2716Xylitol ...................................................................................5.3-3647Xylitolum ............................................................................5.3-3647Xylometazoline hydrochloride .............................................. 2719Xylometazolini hydrochloridum ......................................... 2719Xylose..........................................................................................2720Xylosum .....................................................................................2720

YYarrow ........................................................................................2723Yellow beeswax ......................................................................... 1058Yellow fever vaccine (live) ...............................................5.1-2852Yellow soft paraffin.................................................................. 2188

ZZidovudine..........................................................................5.1-3043Zidovudinum .....................................................................5.1-3043Zinc acetate dihydrate.............................................................2728Zinc acexamate .........................................................................2729Zinc chloride .............................................................................2730Zinci acetas dihydricus .........................................................2728Zinci acexamas ........................................................................2729Zinci chloridum .......................................................................2730Zinci oxidum ............................................................................ 2731Zinci stearas .............................................................................2732Zinci sulfas heptahydricus....................................................2732Zinci sulfas hexahydricus .....................................................2733Zinci undecylenas...................................................................2733Zinc oxide................................................................................... 2731Zinc stearate..............................................................................2732Zinc sulphate heptahydrate ...................................................2732Zinc sulphate hexahydrate.....................................................2733Zinc undecylenate ....................................................................2733Zingiberis rhizoma ................................................................. 1656



Zolpidemi tartras.....................................................................2734Zolpidem tartrate .....................................................................2734Zopiclone ...................................................................................2735

Zopiclonum...............................................................................2735Zuclopenthixol decanoate ......................................................2736Zuclopenthixoli decanoas .....................................................2736


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EUROPEAN PHARMACOPOEIA 5.3 INDEX · 2.9.17. Test for extractable volume of parenteral preparations ... 2.9.28. Test for deliverable mass or volume of liquid and semi-solid preparations