EUROPEAN PHARMACOPOEIA 9.2 Index
Numerics1. General notices ............................................................ 9.2-42752.1.1. Droppers ........................................................................... 152.1.2. Comparative table of porosity of sintered-glass filters.. 152.1.3. Ultraviolet ray lamps for analytical purposes............... 152.1.4. Sieves ................................................................................. 162.1.5. Tubes for comparative tests ............................................ 172.1.6. Gas detector tubes............................................................ 172.1. Apparatus ............................................................................. 152.2.10. Viscosity - Rotating viscometer method ..................... 282.2.11. Distillation range ........................................................... 302.2.12. Boiling point................................................................... 312.2.13. Determination of water by distillation ........................ 312.2.14. Melting point - capillary method...................... 9.1-40372.2.15. Melting point - open capillary method ....................... 322.2.16. Melting point - instantaneous method........................ 332.2.17. Drop point ...................................................................... 332.2.18. Freezing point................................................................. 342.2.19. Amperometric titration................................................. 352.2.1. Clarity and degree of opalescence of liquids .....9.2-42852.2.20. Potentiometric titration ................................................ 352.2.21. Fluorimetry..................................................................... 362.2.22. Atomic emission spectrometry .................................... 362.2.23. Atomic absorption spectrometry ................................. 372.2.24. Absorption spectrophotometry, infrared.................... 392.2.25. Absorption spectrophotometry, ultraviolet andvisible ......................................................................................... 41
2.2.26. Paper chromatography .................................................. 422.2.27. Thin-layer chromatography.......................................... 432.2.28. Gas chromatography...................................................... 442.2.29. Liquid chromatography................................................. 462.2.2. Degree of coloration of liquids....................................... 222.2.30. Size-exclusion chromatography ................................... 472.2.31. Electrophoresis ............................................................... 482.2.32. Loss on drying................................................................ 532.2.33. Nuclear magnetic resonance spectrometry ................ 542.2.34. Thermal analysis ............................................................ 572.2.35. Osmolality....................................................................... 592.2.36. Potentiometric determination of ionicconcentration using ion-selective electrodes ........................ 60
2.2.37. X-ray fluorescence spectrometry ................................. 612.2.38. Conductivity ................................................................... 622.2.39. Molecular mass distribution in dextrans .................... 622.2.3. Potentiometric determination of pH............................. 242.2.40. Near-infrared spectroscopy .......................................... 642.2.41. Circular dichroism......................................................... 692.2.42. Density of solids............................................................. 702.2.43. Mass spectrometry......................................................... 712.2.44. Total organic carbon in water for pharmaceuticaluse............................................................................................... 73
2.2.45. Supercritical fluid chromatography ............................. 742.2.46. Chromatographic separation techniques ......... 9.2-42862.2.47. Capillary electrophoresis............................................... 812.2.48. Raman spectroscopy...................................................... 862.2.49. Falling ball viscometer method.................................... 882.2.4. Approximate pH of solutions ......................................... 252.2.54. Isoelectric focusing ........................................................ 892.2.55. Peptide mapping ............................................................ 902.2.56. Amino acid analysis....................................................... 932.2.57. Inductively coupled plasma-atomic emissionspectrometry ........................................................................... 100
2.2.58. Inductively coupled plasma-mass spectrometry...... 1012.2.59. Glycan analysis of glycoproteins ................................ 1032.2.5. Relative density................................................................. 252.2.61. Characterisation of crystalline solids bymicrocalorimetry and solution calorimetry........................ 109
2.2.64. Peptide identification by nuclear magnetic resonancespectrometry ........................................................................... 112
2.2.65. Voltametric titration .................................................... 1122.2.66. Detection and measurement of radioactivity ........... 1132.2.6. Refractive index................................................................ 262.2.7. Optical rotation ................................................................ 26
2.2.8. Viscosity ............................................................................ 272.2.9. Capillary viscometer method ......................................... 272.2. Physical and physicochemical methods ........................... 212.3.1. Identification reactions of ions and functionalgroups ...................................................................................... 123
2.3.2. Identification of fatty oils by thin-layerchromatography...................................................................... 126
2.3.3. Identification of phenothiazines by thin-layerchromatography...................................................................... 127
2.3.4. Odour .............................................................................. 1272.3. Identification...................................................................... 1232.4.10. Lead in sugars............................................................... 1362.4.11. Phosphates .................................................................... 1362.4.12. Potassium...................................................................... 1362.4.13. Sulfates........................................................................... 1362.4.14. Sulfated ash ................................................................... 1362.4.15. Nickel in polyols........................................................... 1372.4.16. Total ash ........................................................................ 1372.4.17. Aluminium ................................................................... 1372.4.18. Free formaldehyde ....................................................... 1372.4.19. Alkaline impurities in fatty oils.................................. 1382.4.1. Ammonium .................................................................... 1312.4.20. Determination of metal catalyst or metal reagentresidues .................................................................................... 138
2.4.21. Foreign oils in fatty oils by thin-layerchromatography...................................................................... 141
2.4.22. Composition of fatty acids by gas chromatography.. 1412.4.23. Sterols in fatty oils........................................................ 1442.4.24. Identification and control of residual solvents ......... 1462.4.25. Ethylene oxide and dioxan.......................................... 1512.4.26. N,N-Dimethylaniline ................................................... 1522.4.27. Heavy metals in herbal drugs and herbal drugpreparations ............................................................................ 152
2.4.28. 2-Ethylhexanoic acid ................................................... 1542.4.29. Composition of fatty acids in oils rich in omega-3acids.......................................................................................... 155
2.4.2. Arsenic............................................................................. 1312.4.30. Ethylene glycol and diethylene glycol in ethoxylatedsubstances ................................................................................ 157
2.4.31. Nickel in hydrogenated vegetable oils ....................... 1572.4.32. Total cholesterol in oils rich in omega-3 acids ......... 1572.4.3. Calcium ........................................................................... 1322.4.4. Chlorides ......................................................................... 1322.4.5. Fluorides.......................................................................... 1322.4.6. Magnesium ..................................................................... 1322.4.7. Magnesium and alkaline-earth metals ........................ 1332.4.8. Heavy metals................................................................... 1332.4.9. Iron .................................................................................. 1362,4-Dichlorobenzyl alcohol ................................................... 22422.4. Limit tests........................................................................... 1312.5.10. Oxygen-flask method .................................................. 1642.5.11. Complexometric titrations.......................................... 1642.5.12. Water : semi-micro determination ............................. 1652.5.13. Aluminium in adsorbed vaccines .............................. 1652.5.14. Calcium in adsorbed vaccines .................................... 1662.5.15. Phenol in immunosera and vaccines......................... 1662.5.16. Protein in polysaccharide vaccines ............................ 1662.5.17. Nucleic acids in polysaccharide vaccines .................. 1662.5.18. Phosphorus in polysaccharide vaccines .................... 1662.5.19. O-Acetyl in polysaccharide vaccines ......................... 1672.5.1. Acid value........................................................................ 1612.5.20. Hexosamines in polysaccharide vaccines.................. 1672.5.21. Methylpentoses in polysaccharide vaccines.............. 1672.5.22. Uronic acids in polysaccharide vaccines ................... 1682.5.23. Sialic acid in polysaccharide vaccines ....................... 1682.5.24. Carbon dioxide in gases .............................................. 1682.5.25. Carbon monoxide in gases ......................................... 1692.5.26. Nitrogen monoxide and nitrogen dioxide in gases.. 1702.5.27. Oxygen in gases............................................................ 1702.5.28. Water in gases............................................................... 1702.5.29. Sulfur dioxide ............................................................... 1712.5.2. Ester value....................................................................... 1612.5.30. Oxidising substances ................................................... 171
General Notices (1) apply to all monographs and other texts 4631
Index EUROPEAN PHARMACOPOEIA 9.2
2.5.31. Ribose in polysaccharide vaccines ............................. 1712.5.32. Water : micro determination....................................... 1722.5.33. Total protein ................................................................. 1722.5.34. Acetic acid in synthetic peptides................................ 1752.5.35. Nitrous oxide in gases ................................................. 1762.5.36. Anisidine value............................................................. 1762.5.37. Methyl, ethyl and isopropyl methanesulfonate inmethanesulfonic acid ............................................................. 176
2.5.38. Methyl, ethyl and isopropyl methanesulfonate in activesubstances ................................................................................ 177
2.5.39. Methanesulfonyl chloride in methanesulfonicacid ........................................................................................... 178
2.5.3. Hydroxyl value ............................................................... 1612.5.40. Methyl, ethyl and isopropyl toluenesulfonate in activesubstances ................................................................................ 179
2.5.41. Methyl, ethyl and isopropyl benzenesulfonate in activesubstances ................................................................................ 180
2.5.4. Iodine value .................................................................... 1612.5.5. Peroxide value................................................................. 1622.5.6. Saponification value....................................................... 1632.5.7. Unsaponifiable matter ................................................... 1632.5.8. Determination of primary aromatic amino-nitrogen.................................................................................... 163
2.5.9. Determination of nitrogen by sulfuric aciddigestion .................................................................................. 164
2.5. Assays ................................................................................. 1612.6.10. Histamine...................................................................... 1942.6.11. Depressor substances................................................... 1952.6.12. Microbiological examination of non-sterile products :microbial enumeration tests.................................................. 195
2.6.13. Microbiological examination of non-sterile products :test for specified micro-organisms ....................................... 199
2.6.14. Bacterial endotoxins .................................................... 2042.6.15. Prekallikrein activator ................................................. 2082.6.16. Tests for extraneous agents in viral vaccines for humanuse ............................................................................................ 208
2.6.17. Test for anticomplementary activity ofimmunoglobulin..................................................................... 210
2.6.18. Test for neurovirulence of live virus vaccines .......... 2122.6.1. Sterility ............................................................................ 1852.6.20. Anti-A and anti-B haemagglutinins .......................... 2132.6.21. Nucleic acid amplification techniques....................... 2142.6.22. Activated coagulation factors ..................................... 2192.6.24. Avian viral vaccines : tests for extraneous agents inseed lots ................................................................................... 219
2.6.25. Avian live virus vaccines : tests for extraneous agents inbatches of finished product ................................................... 222
2.6.26. Test for anti-D antibodies in human immunoglobu-lin.............................................................................................. 225
2.6.27. Microbiological examination of cell-basedpreparations ................................................................... 9.2-4297
2.6.2. Mycobacteria .................................................................. 1882.6.30. Monocyte-activation test.................................... 9.2-42992.6.31. Microbiological examination of herbal medicinalproducts for oral use and extracts used in theirpreparation .............................................................................. 232
2.6.33. Residual pertussis toxin and irreversibility of pertussistoxoid ....................................................................................... 235
2.6.34. Host-cell protein assays...................................... 9.1-40412.6.7. Mycoplasmas .................................................................. 1882.6.8. Pyrogens.......................................................................... 1932.6.9. Abnormal toxicity .......................................................... 1942.6. Biological tests ................................................................... 1852.7.10. Assay of human coagulation factor VII .................... 2582.7.11. Assay of human coagulation factor IX ...................... 2592.7.12. Assay of heparin in coagulation factors .................... 2592.7.13. Assay of human anti-D immunoglobulin ................. 2602.7.14. Assay of hepatitis A vaccine ....................................... 2622.7.15. Assay of hepatitis B vaccine (rDNA) ......................... 2632.7.16. Assay of pertussis vaccine (acellular) ........................ 2632.7.17. Assay of human antithrombin III .............................. 2652.7.18. Assay of human coagulation factor II ....................... 2662.7.19. Assay of human coagulation factor X........................ 266
2.7.1. Immunochemical methods........................................... 2392.7.20. In vivo assay of poliomyelitis vaccine (inactivated).. 2672.7.21. Assay of human von Willebrand factor..................... 2682.7.22. Assay of human coagulation factor XI ...................... 2692.7.23. Numeration of CD34/CD45+ cells inhaematopoietic products ....................................................... 269
2.7.24. Flow cytometry ............................................................ 2712.7.25. Assay of human plasmin inhibitor............................. 2722.7.27. Flocculation value (Lf) of diphtheria and tetanus toxinsand toxoids (Ramon assay) ................................................... 273
2.7.28. Colony-forming cell assay for humanhaematopoietic progenitor cells............................................ 274
2.7.29. Nucleated cell count and viability.............................. 2752.7.2. Microbiological assay of antibiotics............................. 2402.7.30. Assay of human protein C .......................................... 2762.7.31. Assay of human protein S ........................................... 2772.7.32. Assay of human α-1-proteinase inhibitor ................. 2782.7.34. Assay of human C1-esterase inhibitor ...................... 2782.7.35. Immunonephelometry for vaccine componentassay ......................................................................................... 279
2.7.4. Assay of human coagulation factor VIII ..................... 2462.7.5. Assay of heparin.................................................... 9.1-40492.7.6. Assay of diphtheria vaccine (adsorbed) ...................... 2472.7.7. Assay of pertussis vaccine (whole cell)........................ 2522.7.8. Assay of tetanus vaccine (adsorbed)............................ 2532.7.9. Test for Fc function of immunoglobulin..................... 2572.7. Biological assays ................................................................ 2392.8.10. Solubility in alcohol of essential oils.......................... 2842.8.11. Assay of 1,8-cineole in essential oils.......................... 2852.8.12. Essential oils in herbal drugs...................................... 2852.8.13. Pesticide residues ......................................................... 2862.8.14. Tannins in herbal drugs .............................................. 2882.8.15. Bitterness value............................................................. 2882.8.16. Dry residue of extracts ................................................ 2892.8.17. Loss on drying of extracts........................................... 2892.8.18. Determination of aflatoxin B1 in herbal drugs ......... 2892.8.1. Ash insoluble in hydrochloric acid .............................. 2832.8.20. Herbal drugs : sampling and sample preparation .... 2912.8.21. Test for aristolochic acids in herbal drugs ................ 2922.8.22. Determination of ochratoxin A in herbal drugs ...... 2942.8.23. Microscopic examination of herbal drugs ................ 2952.8.25. High-performance thin-layer chromatography ofherbal drugs and herbal drug preparations ........................ 295
2.8.2. Foreign matter ................................................................ 2832.8.3. Stomata and stomatal index.......................................... 2832.8.4. Swelling index................................................................. 2842.8.5. Water in essential oils .................................................... 2842.8.6. Foreign esters in essential oils ...................................... 2842.8.7. Fatty oils and resinified essential oils in essentialoils ............................................................................................ 284
2.8.8. Odour and taste of essential oils .................................. 2842.8.9. Residue on evaporation of essential oils ..................... 2842.8. Methods in pharmacognosy ............................................ 2832.9.10. Ethanol content ............................................................ 3152.9.11. Test for methanol and 2-propanol ............................. 3182.9.12. Sieve test........................................................................ 3192.9.14. Specific surface area by air permeability.......... 9.1-40532.9.16. Flowability..................................................................... 3212.9.17. Test for extractable volume of parenteralpreparations ............................................................................ 322
2.9.18. Preparations for inhalation : aerodynamic assessmentof fine particles........................................................................ 323
2.9.19. Particulate contamination : sub-visible particles...... 3352.9.1. Disintegration of tablets and capsules ......................... 2992.9.20. Particulate contamination : visible particles ............. 3372.9.22. Softening time determination of lipophilicsuppositories ........................................................................... 338
2.9.23. Gas pycnometric density of solids ............................. 3392.9.25. Dissolution test for medicated chewing gums ......... 3402.9.26. Specific surface area by gas adsorption ..................... 3442.9.27. Uniformity of mass of delivered doses from multidosecontainers ................................................................................ 347
2.9.29. Intrinsic dissolution..................................................... 347
4632 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 9.2 Index
2.9.2. Disintegration of suppositories and pessaries ............ 3012.9.31. Particle size analysis by laser light diffraction.......... 3492.9.32. Porosity and pore-size distribution of solids bymercury porosimetry ............................................................. 352
2.9.33. Characterisation of crystalline and partially crystallinesolids by X-ray powder diffraction (XRPD) ....................... 354
2.9.34. Bulk density and tapped density of powders............ 3592.9.35. Powder fineness............................................................ 3622.9.36. Powder flow .................................................................. 3622.9.37. Optical microscopy...................................................... 3652.9.38. Particle-size distribution estimation by analyticalsieving ...................................................................................... 367
2.9.39. Water-solid interactions : determination ofsorption-desorption isotherms and of water activity......... 369
2.9.3. Dissolution test for solid dosage forms ....................... 3022.9.40. Uniformity of dosage units ................................ 9.1-40552.9.41. Friability of granules and spheroids .......................... 3752.9.42. Dissolution test for lipophilic solid dosage forms ... 3772.9.43. Apparent dissolution ................................................... 3772.9.44. Preparations for nebulisation : characterisation....... 3782.9.45. Wettability of porous solids including powders....... 3812.9.47. Demonstration of uniformity of dosage units usinglarge sample sizes.................................................................... 384
2.9.4. Dissolution test for transdermal patches .................... 3092.9.5. Uniformity of mass of single-dose preparations ........ 3112.9.6. Uniformity of content of single-dose preparations.... 3122.9.7. Friability of uncoated tablets ........................................ 3122.9.8. Resistance to crushing of tablets .................................. 3132.9.9. Measurement of consistency by penetrometry .......... 3132.9. Pharmaceutical technical procedures ............................. 2993.1.10. Materials based on non-plasticised poly(vinyl chloride)for containers for non-injectable, aqueous solutions......... 410
3.1.11. Materials based on non-plasticised poly(vinylchloride) for containers for solid dosage forms for oraladministration......................................................................... 412
3.1.1.1. Materials based on plasticised poly(vinyl chloride) forcontainers for human blood and blood components......... 391
3.1.1.2. Materials based on plasticised poly(vinyl chloride) fortubing used in sets for the transfusion of blood and bloodcomponents ............................................................................. 393
3.1.13. Plastic additives ............................................................ 4143.1.14. Materials based on plasticised poly(vinyl chloride)for containers for aqueous solutions for intravenousinfusion .................................................................................... 416
3.1.15. Polyethylene terephthalate for containers forpreparations not for parenteral use ...................................... 419
3.1.1. Materials for containers for human blood and bloodcomponents ............................................................................. 391
3.1.3. Polyolefins .............................................................. 9.2-43073.1.4. Polyethylene without additives for containersfor parenteral preparations and for ophthalmicpreparations ................................................................... 9.2-4310
3.1.5. Polyethylene with additives for containers for parenteralpreparations and for ophthalmic preparations .......... 9.2-4311
3.1.6. Polypropylene for containers and closures for parenteralpreparations and ophthalmic preparations ................ 9.2-4314
3.1.7. Poly(ethylene - vinyl acetate) for containers and tubingfor total parenteral nutrition preparations ................. 9.2-4318
3.1.8. Silicone oil used as a lubricant ..................................... 4083.1.9. Silicone elastomer for closures and tubing ................. 4093.1. Materials used for the manufacture of containers ........ 3913.2.1. Glass containers for pharmaceutical use..................... 4233.2.2.1. Plastic containers for aqueous solutions forinfusion .................................................................................... 429
3.2.2. Plastic containers and closures for pharmaceuticaluse............................................................................................. 428
3.2.3. Sterile plastic containers for human blood andblood components .................................................................. 430
3.2.4. Empty sterile containers of plasticised poly(vinylchloride) for human blood and blood components........... 432
3.2.5. Sterile containers of plasticised poly(vinyl chloride) forhuman blood containing anticoagulant solution ............... 432
3.2.6. Sets for the transfusion of blood and bloodcomponents ............................................................................. 433
3.2.8. Sterile single-use plastic syringes ................................. 4343.2.9. Rubber closures for containers for aqueousparenteral preparations, for powders and forfreeze-dried powders.............................................................. 435
3.2. Containers.......................................................................... 4233-O-Desacyl-4-monophosphoryl lipid A............................ 22074.1.1. Reagents .......................................................................... 4414.1.1. Reagents .................................................................9.1-40614.1.1. Reagents ................................................................. 9.2-43234.1.2. Standard solutions for limit tests ................................. 5554.1.2. Standard solutions for limit tests ........................ 9.2-43244.1.3. Buffer solutions .............................................................. 5604.1.3. Buffer solutions ..................................................... 9.1-40614.1.3. Buffer solutions ..................................................... 9.2-43244.1. Reagents, standard solutions, buffer solutions .............. 4414.2.1. Primary standards for volumetric solutions ...... 9.2-43244.2.2. Volumetric solutions............................................. 9.2-43254.2. Volumetric analysis........................................................... 5654-Aminobenzoic acid ............................................................. 17024. Reagents................................................................................. 4415.10. Control of impurities in substances for pharmaceuticaluse............................................................................................. 723
5.1.10. Guidelines for using the test for bacterialendotoxins ............................................................................... 593
5.1.11. Determination of bactericidal, fungicidal or yeasticidalactivity of antiseptic medicinal products.................... 9.2-4348
5.11. Characters section in monographs ............................... 7295.1.1. Methods of preparation of sterile products ....... 9.2-43335.1.2. Biological indicators and related microbial preparationsused in the manufacture of sterile products............... 9.2-4336
5.12. Reference standards ........................................................ 7335.1.3. Efficacy of antimicrobial preservation ........................ 5775.14. Gene transfer medicinal products for human use ...... 7395.1.4. Microbiological quality of non-sterile pharmaceuticalpreparations and substances for pharmaceutical use......... 579
5.1.5. Application of the F0 concept to steam sterilisation ofaqueous preparations ............................................................. 580
5.15. Functionality-related characteristics ofexcipients ........................................................................ 9.2-4411
5.1.6. Alternative methods for control of microbiologicalquality ............................................................................. 9.2-4339
5.16. Crystallinity ..................................................................... 7575.17.1. Recommendations on dissolution testing................. 7615.17. Recommendations on methods for dosage formstesting....................................................................................... 761
5.1.7. Viral safety ...................................................................... 5915.1.8. Microbiological quality of herbal medicinal products fororal use and extracts used in their preparation .................. 591
5.19. Extemporaneous preparation of radiopharmaceuti-cals ............................................................................................ 767
5.1.9. Guidelines for using the test for sterility..................... 5925.1. General texts on microbiology ........................................ 5755.20. Metal catalyst or metal reagent residues ...................... 7755.2.11. Carrier proteins for the production of conjugatedpolysaccharide vaccines for human use............................... 626
5.2.12. Raw materials of biological origin for the productionof cell-based and gene therapy medicinal products ........... 627
5.2.13. Healthy chicken flocks for the production of inactivatedvaccines for veterinary use .................................................... 630
5.21. Chemometric methods applied to analytical data ...... 7835.2.1. Terminology used in monographs on biologicalproducts ................................................................................... 599
5.2.2. Chicken flocks free from specified pathogens for theproduction and quality control of vaccines......................... 599
5.22. Names of herbal drugs used in traditional Chinesemedicine ......................................................................... 9.2-4415
5.2.3. Cell substrates for the production of vaccines for humanuse............................................................................................. 602
5.23. Monographs on herbal drug extracts (informationchapter) .................................................................................... 807
General Notices (1) apply to all monographs and other texts 4633
Index EUROPEAN PHARMACOPOEIA 9.2
5.2.4. Cell cultures for the production of veterinaryvaccines .................................................................................... 606
5.2.5. Substances of animal origin for the production ofimmunological veterinary medicinal products .................. 608
5.2.6. Evaluation of safety of veterinary vaccines andimmunosera ........................................................................... 610
5.2.7. Evaluation of efficacy of veterinary vaccines andimmunosera ............................................................................ 612
5.2.8. Minimising the risk of transmitting animal spongiformencephalopathy agents via human and veterinary medicinalproducts ................................................................................... 613
5.2.9. Evaluation of safety of each batch of immunosera forveterinary use.......................................................................... 625
5.2. General texts on biological products .............................. 5995.3. Statistical analysis of results of biological assays andtests.................................................................................. 9.2-4353
5.4. Residual solvents ............................................................... 6655.5. Alcoholimetric tables........................................................ 6755.6. Assay of interferons .......................................................... 6895.7. Table of physical characteristics of radionuclidesmentioned in the European Pharmacopoeia ............. 9.2-4385
5.8. Pharmacopoeial harmonisation ............................. 9.2-43955.9. Polymorphism ................................................................... 719
AAbacavir sulfate....................................................................... 1619Abbreviations and symbols (1.) ..................................... 9.2-4275Abnormal toxicity (2.6.9.)........................................................ 194Absorption spectrophotometry, infrared (2.2.24.) ................. 39Absorption spectrophotometry, ultraviolet and visible(2.2.25.) ...................................................................................... 41
Acacia ....................................................................................... 1229Acacia, spray-dried ................................................................. 1620Acamprosate calcium ............................................................. 1621Acanthopanax bark ......................................................... 9.2-4447Acarbose .................................................................................. 1622Acebutolol hydrochloride ...................................................... 1624Aceclofenac.............................................................................. 1626Acemetacin .............................................................................. 1628Acesulfame potassium............................................................ 1629Acetate trihydrate, sodium .................................................... 3558Acetazolamide......................................................................... 1630Acetic acid, glacial .................................................................. 1632Acetic acid in synthetic peptides (2.5.34.) ............................. 175Acetone .................................................................................... 1632Acetylcholine chloride ........................................................... 1633Acetylcysteine.......................................................................... 1634β-Acetyldigoxin....................................................................... 1635Acetylsalicylic acid ................................................................. 1638Acetyltryptophan, N- ............................................................. 1639Acetyltyrosine, N- ................................................................... 1641Aciclovir................................................................................... 1642Acidum picrinicum for homoeopathic preparations ......... 1587Acid value (2.5.1.) ..................................................................... 161Acitretin ................................................................................... 1644Actinobacillosis vaccine (inactivated), porcine .................. 1085Activated charcoal .................................................................. 2025Activated coagulation factors (2.6.22.)................................... 219Adapalene ................................................................................ 1646Additives, plastic (3.1.13.) ....................................................... 414Adenine.................................................................................... 1647Adeno-associated-virus vectors for human use .................... 748Adenosine ................................................................................ 1648Adenovirus vaccine (inactivated), canine............................ 1027Adenovirus vaccine (live), canine......................................... 1028Adipic acid............................................................................... 1649Adrenaline ............................................................................... 1650Adrenaline tartrate ................................................................. 1652Adsorption, gas, specific surface area by (2.9.26.)................ 344Aerodynamic assessment of fine particles in preparations forinhalation (2.9.18.) ................................................................. 323
Aflatoxin B1 in herbal drugs, determination of (2.8.18.) ..... 289
Agar .......................................................................................... 1230Agaricus phalloides for homoeopathic preparations ......... 1588Agnus castus fruit ................................................................... 1231Agnus castus fruit dry extract ............................................... 1232Agrimony................................................................................. 1233Air, medicinal ......................................................................... 1653Air, synthetic medicinal......................................................... 1655Akebia stem ............................................................................. 1234Alanine..................................................................................... 1656Albendazole............................................................................. 1657Albumin solution, human ..................................................... 2660Alchemilla................................................................................ 1235Alcoholimetric tables (5.5.) ..................................................... 675Alcuronium chloride.............................................................. 1658Alendronate trihydrate, sodium ........................................... 3559Alexandrian senna pods ........................................................ 1518Alfacalcidol.............................................................................. 1660Alfadex ..................................................................................... 1661Alfentanil hydrochloride ....................................................... 1662Alfuzosin hydrochloride ................................................. 9.1-4123Alginate, sodium..................................................................... 3560Alginic acid.............................................................................. 1665Alimemazine hemitartrate..................................................... 1666Alkaline-earth metals and magnesium (2.4.7.)..................... 133Alkaline impurities in fatty oils (2.4.19.) ............................... 138Allantoin .................................................................................. 1667Allergen products ..................................................................... 811Allergen products, animal epithelia and outgrowths for... 1736Allergen products, Hymenoptera venoms for..................... 2732Allergen products, mites for.................................................. 3077Allergen products, moulds for .............................................. 3094Allergen products, pollens for............................................... 3362Allium sativum for homoeopathic preparations ................ 1590Allopurinol .............................................................................. 1668all-rac-α-Tocopherol............................................................... 3800all-rac-α-Tocopheryl acetate.................................................. 3802Almagate .................................................................................. 1670Almond oil, refined ................................................................ 1671Almond oil, virgin .................................................................. 1671Aloes, Barbados ...................................................................... 1236Aloes, Cape.............................................................................. 1237Aloes dry extract, standardised............................................. 1238Alovudine (18F) injection ....................................................... 1127Alphacyclodextrin .................................................................. 1661Alprazolam .............................................................................. 1672Alprenolol hydrochloride ...................................................... 1674Alprostadil ............................................................................... 1675Alteplase for injection ............................................................ 1677Alternative methods for control of microbiological quality(5.1.6.) ............................................................................. 9.2-4339
Altizide..................................................................................... 1681Alum......................................................................................... 1682Aluminium (2.4.17.)................................................................. 137Aluminium chloride hexahydrate......................................... 1682Aluminium hydroxide, hydrated, for adsorption ............... 1682Aluminium in adsorbed vaccines (2.5.13.)............................ 165Aluminium magnesium silicate ............................................ 1683Aluminium oxide, hydrated .................................................. 1684Aluminium phosphate gel ..................................................... 1685Aluminium phosphate, hydrated.......................................... 1686Aluminium sodium silicate ................................................... 1686Aluminium stearate................................................................ 1687Aluminium sulfate.................................................................. 1689Alverine citrate........................................................................ 1690Amantadine hydrochloride ................................................... 1691Ambroxol hydrochloride ................................................ 9.2-4499Amfetamine sulfate ................................................................ 1694Amidotrizoate, sodium .......................................................... 3561Amidotrizoic acid dihydrate ................................................. 1694Amikacin ................................................................................. 1696Amikacin sulfate ..................................................................... 1698Amiloride hydrochloride dihydrate .............................. 9.2-4500Amino acid analysis (2.2.56.) .................................................... 93
4634 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 9.2 Index
Aminobenzoic acid, 4- ........................................................... 1702Aminocaproic acid ................................................................. 1703Aminoglutethimide ................................................................ 1704Aminophylline ........................................................................ 3752Aminophylline hydrate .......................................................... 3754Aminosalicylate dihydrate, sodium...................................... 3562Amiodarone hydrochloride................................................... 1706Amisulpride............................................................................. 1707Amitriptyline hydrochloride ................................................. 1709Amlodipine besilate................................................................ 1710Ammonia (13N) injection....................................................... 1129Ammonia solution, concentrated ......................................... 1712Ammonio methacrylate copolymer (type A)...................... 1712Ammonio methacrylate copolymer (type B) ...................... 1713Ammonium (2.4.1.).................................................................. 131Ammonium bromide ............................................................. 1714Ammonium chloride.............................................................. 1715Ammonium glycyrrhizate ..................................................... 1716Ammonium hydrogen carbonate ......................................... 1717Amobarbital ............................................................................ 1717Amobarbital sodium .............................................................. 1718Amomum fruit........................................................................ 1239Amomum fruit, round ........................................................... 1502Amorolfine hydrochloride..................................................... 1719Amoxicillin sodium................................................................ 1720Amoxicillin trihydrate............................................................ 1723Amperometric titration (2.2.19.) .............................................. 35Amphotericin B ...................................................................... 1725Ampicillin ................................................................................ 1727Ampicillin sodium.................................................................. 1729Ampicillin trihydrate.............................................................. 1731Amylmetacresol ...................................................................... 1733Anacardium for homoeopathic preparations...................... 1591Anaemia vaccine (live), chicken, infectious ........................ 1069Anaesthetic ether .................................................................... 2422Analysis, thermal (2.2.34.)......................................................... 57Analytical sieving, particle-size distribution estimation by(2.9.38.) .................................................................................... 367
Anamirta cocculus for homoeopathic preparations .......... 1597Anastrozole.............................................................................. 1735Andrographis herb .......................................................... 9.1-4099Anemarrhena asphodeloides rhizome ................................. 1241Angelica archangelica root .................................................... 1242Angelica dahurica root........................................................... 1243Angelica pubescens root ........................................................ 1245Angelica sinensis root ..................................................... 9.1-4100Animal anti-T lymphocyte immunoglobulin for humanuse........................................................................................... 1741
Animal epithelia and outgrowths for allergen products.... 1736Animal immunosera for human use ...................................... 821Animal spongiform encephalopathies, products with risk oftransmitting agents of ............................................................ 832
Animal spongiform encephalopathy agents, minimising therisk of transmitting via human and veterinary medicinalproducts (5.2.8.)...................................................................... 613
Aniseed ............................................................................. 9.2-4448Anise oil ................................................................................... 1248Anisidine value (2.5.36.) .......................................................... 176Antazoline hydrochloride...................................................... 1737Anthrax spore vaccine (live) for veterinary use.................. 1003Anthrax vaccine for human use (adsorbed, prepared fromculture filtrates)....................................................................... 893
Anti-A and anti-B haemagglutinins (2.6.20.)........................ 213Antibiotics, microbiological assay of (2.7.2.) ........................ 240Antibodies (anti-D) in human immunoglobulin, test for(2.6.26.) .................................................................................... 225
Antibodies for human use, monoclonal ................................ 826Anticoagulant and preservative solutions for human blood................................................................................................ 1738
Anticomplementary activity of immunoglobulin (2.6.17.).. 210Anti-D antibodies in human immunoglobulin, test for(2.6.26.) .................................................................................... 225
Anti-D immunoglobulin for intravenous administration,human .................................................................................... 2663
Anti-D immunoglobulin, human ......................................... 2662Anti-D immunoglobulin, human, assay of (2.7.13.) ............ 260Antimicrobial preservation, efficacy of (5.1.3.) .................... 577Antiseptic medicinal products, determination of bactericidal,fungicidal or yeasticidal activity of (5.1.11.) .............. 9.2-4348
Antiserum, European viper venom ...................................... 1119Antithrombin III concentrate, human................................. 2664Antithrombin III, human, assay of (2.7.17.) ......................... 265Anti-T lymphocyte immunoglobulin for human use,animal .................................................................................... 1741
Apis for homoeopathic preparations.................................... 1592Apomorphine hydrochloride hemihydrate ......................... 1744Apparatus (2.1.) .......................................................................... 15Apparent dissolution (2.9.43.)................................................. 377Application of the F0 concept to steam sterilisation of aqueouspreparations (5.1.5.) ............................................................... 580
Approximate pH of solutions (2.2.4.)....................................... 25Aprepitant................................................................................ 1746Aprotinin ................................................................................. 1747Aprotinin concentrated solution .......................................... 1749Arachis oil, hydrogenated...................................................... 1752Arachis oil, refined ................................................................. 1752Arginine ................................................................................... 1753Arginine aspartate .................................................................. 1754Arginine hydrochloride ......................................................... 1755Argon ....................................................................................... 1756Aripiprazole............................................................................. 1757Aristolochic acids in herbal drugs, test for (2.8.21) ............. 292Arnica flower........................................................................... 1251Arnica tincture........................................................................ 1253Arsenic (2.4.2.) .......................................................................... 131Arsenicum album for homoeopathic preparations ............ 1593Arsenious trioxide for homoeopathic preparations ........... 1593Articaine hydrochloride......................................................... 1758Artichoke leaf .......................................................................... 1254Artichoke leaf dry extract ...................................................... 1256Ascorbate, calcium ................................................................. 1911Ascorbate, sodium.................................................................. 3563Ascorbic acid ........................................................................... 1760Ascorbyl palmitate.................................................................. 1762Ash insoluble in hydrochloric acid (2.8.1.) ........................... 283Ash leaf .................................................................................... 1257Ash, sulfated (2.4.14.)............................................................... 136Ash, total (2.4.16.) .................................................................... 137Asparagine monohydrate....................................................... 1762Aspartame................................................................................ 1763Aspartic acid............................................................................ 1764Assay of 1,8-cineole in essential oils (2.8.11.) ....................... 285Assay of diphtheria vaccine (adsorbed) (2.7.6.).................... 247Assay of heparin (2.7.5.) ................................................. 9.1-4049Assay of heparin in coagulation factors (2.7.12.) ................. 259Assay of hepatitis A vaccine (2.7.14.)..................................... 262Assay of hepatitis B vaccine (rDNA) (2.7.15.) ...................... 263Assay of human α-1-proteinase inhibitor (2.7.32.) .............. 278Assay of human anti-D immunoglobulin (2.7.13.) .............. 260Assay of human antithrombin III (2.7.17.)............................ 265Assay of human C1-esterase inhibitor (2.7.34.).................... 278Assay of human coagulation factor II (2.7.18.)..................... 266Assay of human coagulation factor IX (2.7.11.) ................... 259Assay of human coagulation factor VII (2.7.10.).................. 258Assay of human coagulation factor VIII (2.7.4.) .................. 246Assay of human coagulation factor X (2.7.19.) ..................... 266Assay of human coagulation factor XI (2.7.22.) ................... 269Assay of human plasmin inhibitor (2.7.25.) .......................... 272Assay of human protein C (2.7.30.)........................................ 276Assay of human protein S (2.7.31.) ........................................ 277Assay of human von Willebrand factor (2.7.21.) .................. 268Assay of interferons (5.6.)........................................................ 689Assay of pertussis vaccine (acellular) (2.7.16.)...................... 263Assay of pertussis vaccine (whole cell) (2.7.7.) ..................... 252
General Notices (1) apply to all monographs and other texts 4635
Index EUROPEAN PHARMACOPOEIA 9.2
Assay of poliomyelitis vaccine (inactivated), in vivo(2.7.20.) .................................................................................... 267
Assay of tetanus vaccine (adsorbed) (2.7.8.) ......................... 253Assays (2.5.)............................................................................... 161Astragalus mongholicus root ......................................... 9.2-4449Atenolol............................................................................. 9.1-4124Atomic absorption spectrometry (2.2.23.) .............................. 37Atomic emission spectrometry (2.2.22.).................................. 36Atomic emission spectrometry, inductively coupled plasma-(2.2.57.) .................................................................................... 100
Atomoxetine hydrochloride .................................................. 1767Atorvastatin calcium trihydrate ............................................ 1769Atovaquone.............................................................................. 1771Atractylodes lancea rhizome ................................................. 1259Atractylodes rhizome, largehead .......................................... 1260Atracurium besilate ................................................................ 1772Atropine ................................................................................... 1775Atropine sulfate....................................................................... 1776Aucklandia root ............................................................... 9.2-4450Aujeszky’s disease vaccine (inactivated) for pigs ................ 1003Aujeszky’s disease vaccine (live) for pigs for parenteraladministration....................................................................... 1005
Aurothiomalate, sodium........................................................ 3565Aurum chloratum natronatum for homoeopathicpreparations .......................................................................... 1593
Avian infectious bronchitis vaccine (inactivated)............... 1007Avian infectious bronchitis vaccine (live)............................ 1008Avian infectious bursal disease vaccine (inactivated) ........ 1010Avian infectious bursal disease vaccine (live) ..................... 1011Avian infectious encephalomyelitis vaccine (live) .............. 1013Avian infectious laryngotracheitis vaccine (live)................ 1014Avian live virus vaccines : tests for extraneous agents in batchesof finished product (2.6.25.).................................................. 222
Avian paramyxovirus 1 (Newcastle disease) vaccine(inactivated) .......................................................................... 1080
Avian paramyxovirus 1 (Newcastle disease) vaccine(live) ....................................................................................... 1082
Avian paramyxovirus 3 vaccine (inactivated) for turkeys.. 1016Avian tuberculin purified protein derivative....................... 3862Avian viral tenosynovitis vaccine (live) ............................... 1017Avian viral vaccines : tests for extraneous agents in seed lots(2.6.24.) .................................................................................... 219
Azaperone for veterinary use ................................................ 1778Azathioprine............................................................................ 1779Azelastine hydrochloride ....................................................... 1780Azithromycin .......................................................................... 1782
BB19 virus (B19V), validation of nucleic acid amplificationtechniques for the quantification of B19V DNA in plasmapools : guidelines..................................................................... 214
Bacampicillin hydrochloride ................................................. 1787Bacitracin.......................................................................... 9.1-4129Bacitracin zinc.................................................................. 9.1-4133Baclofen ................................................................................... 1794Bacterial endotoxins (2.6.14.).................................................. 204Bacterial endotoxins, guidelines for using the test for(5.1.10.) .................................................................................... 593
Bactericidal, fungicidal or yeasticidal activity of antisepticmedicinal products, determination of (5.1.11.) ......... 9.2-4348
Baical skullcap root ................................................................ 1262Bambuterol hydrochloride .................................................... 1795Barbados aloes ........................................................................ 1236Barbary wolfberry fruit.......................................................... 1263Barbital..................................................................................... 1797Barium chloratum for homoeopathic preparations ........... 1594Barium chloride dihydrate for homoeopathicpreparations .......................................................................... 1594
Barium sulfate ......................................................................... 1797Basic butylated methacrylate copolymer ............................. 1798BCG for immunotherapy......................................................... 894BCG vaccine, freeze-dried....................................................... 895
Bearberry leaf .......................................................................... 1264Beclometasone dipropionate ................................................. 1799Beclometasone dipropionate monohydrate......................... 1802Beeswax, white ........................................................................ 1804Beeswax, yellow....................................................................... 1805Belamcanda chinensis rhizome............................................. 1266Belladonna for homoeopathic preparations................. 9.2-4492Belladonna leaf................................................................. 9.2-4452Belladonna leaf dry extract, standardised .................... 9.2-4453Belladonna leaf tincture, standardised.......................... 9.2-4454Belladonna, prepared ...................................................... 9.2-4456Benazepril hydrochloride ...................................................... 1806Bendroflumethiazide.............................................................. 1807Benperidol ............................................................................... 1808Benserazide hydrochloride .................................................... 1810Bentonite.................................................................................. 1811Benzalkonium chloride.......................................................... 1811Benzalkonium chloride solution........................................... 1813Benzathine benzylpenicillin .................................................. 1822Benzbromarone....................................................................... 1815Benzenesulfonate (methyl, ethyl and isopropyl) in activesubstances (2.5.41).................................................................. 180
Benzethonium chloride ......................................................... 1816Benzocaine............................................................................... 1817Benzoic acid ............................................................................ 1818Benzoin, Siam ......................................................................... 1272Benzoin, Sumatra.................................................................... 1273Benzoin tincture, Siam........................................................... 1274Benzoin tincture, Sumatra..................................................... 1274Benzoyl peroxide, hydrous .................................................... 1819Benzyl alcohol ......................................................................... 1820Benzyl benzoate ...................................................................... 1822Benzylpenicillin, benzathine ................................................. 1822Benzylpenicillin potassium ............................................ 9.2-4505Benzylpenicillin, procaine .............................................. 9.2-4506Benzylpenicillin sodium ................................................. 9.2-4508Betacarotene ............................................................................ 1829Betacyclodextrin ..................................................................... 1829Betacyclodextrin, poly(hydroxypropyl) ether ..................... 2725Betadex..................................................................................... 1829Betahistine dihydrochloride.................................................. 1831Betahistine mesilate................................................................ 1832Betamethasone........................................................................ 1833Betamethasone acetate ........................................................... 1835Betamethasone dipropionate................................................. 1837Betamethasone sodium phosphate....................................... 1839Betamethasone valerate ......................................................... 1840Betaxolol hydrochloride......................................................... 1842Bezafibrate ............................................................................... 1843Bicalutamide............................................................................ 1845Bifonazole ................................................................................ 1846Bilberry fruit, dried ................................................................ 1275Bilberry fruit dry extract, fresh, refined and standardised.. 1361Bilberry fruit, fresh................................................................. 1276Biological assays (2.7.) ............................................................. 239Biological assays and tests, statistical analysis of results of(5.3.) ................................................................................ 9.2-4353
Biological indicators and related microbial preparations usedin the manufacture of sterile products (5.1.2.) .......... 9.2-4336
Biological products, general texts on (5.2.) ........................... 599Biological products, terminology used in monographs on(5.2.1.) ...................................................................................... 599
Biological tests (2.6.) ................................................................ 185Biotin........................................................................................ 1847Biperiden hydrochloride........................................................ 1848Biphasic insulin injection ...................................................... 2770Biphasic isophane insulin injection...................................... 2770Birch leaf .................................................................................. 1276Bisacodyl .................................................................................. 1850Bismuth subcarbonate............................................................ 1851Bismuth subgallate.................................................................. 1852Bismuth subnitrate, heavy ..................................................... 1853Bismuth subsalicylate ............................................................. 1854
4636 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 9.2 Index
Bisoprolol fumarate ................................................................ 1855Bistort rhizome ....................................................................... 1278Bitter fennel ............................................................................. 1352Bitter-fennel fruit oil .............................................................. 1279Bitter-fennel herb oil .............................................................. 1280Bitterness value (2.8.15.) .......................................................... 288Bitter-orange epicarp and mesocarp .................................... 1283Bitter-orange-epicarp and mesocarp tincture..................... 1284Bitter-orange flower................................................................ 1284Bitter-orange-flower oil.......................................................... 1449Black cohosh............................................................................ 1285Blackcurrant leaf ..................................................................... 1290Black horehound..................................................................... 1289Bleomycin sulfate.................................................................... 1857Blood and blood components, empty sterile containers ofplasticised poly(vinyl chloride) for (3.2.4.) ......................... 432
Blood and blood components, human, materials for containersfor (3.1.1.) ................................................................................ 391
Blood and blood components, sets for the transfusion of(3.2.6.) ...................................................................................... 433
Blood and blood components, sterile plastic containers for(3.2.3.) ...................................................................................... 430
Blood, anticoagulant and preservative solutions for .......... 1738Blood, sterile containers of plasticised poly(vinyl chloride)containing anticoagulant solution (3.2.5.)........................... 432
Bogbean leaf ............................................................................ 1291Boiling point (2.2.12.) ................................................................ 31Boldo leaf ................................................................................. 1292Boldo leaf dry extract............................................................. 1293Borage (starflower) oil, refined ............................................. 1858Borax ........................................................................................ 1859Bordetella bronchiseptica vaccine (live) for dogs............... 1018Boric acid................................................................................. 1859Botulinum antitoxin ............................................................... 1115Botulinum toxin type A for injection .................................. 1860Botulinum toxin type B for injection................................... 1861Bovine insulin ......................................................................... 2763Bovine leptospirosis vaccine (inactivated) .......................... 1019Bovine parainfluenza virus vaccine (live)............................ 1021Bovine respiratory syncytial virus vaccine (live) ................ 1022Bovine rhinotracheitis vaccine (inactivated), infectious ... 1067Bovine rhinotracheitis vaccine (live), infectious ................ 1068Bovine serum .......................................................................... 1863Bovine tuberculin purified protein derivative..................... 3863Bovine viral diarrhoea vaccine (inactivated) ...................... 1023Brimonidine tartrate .............................................................. 1864Bromazepam ........................................................................... 1865Bromhexine hydrochloride............................................. 9.1-4137Bromocriptine mesilate.......................................................... 1868Bromperidol ............................................................................ 1870Bromperidol decanoate.......................................................... 1872Brompheniramine maleate .................................................... 1873Bronchitis vaccine (inactivated), infectious, avian ............. 1007Bronchitis vaccine (live), infectious, avian .......................... 1008Brotizolam ............................................................................... 1875Brucellosis vaccine (live) (Brucella melitensis Rev. 1 strain) forveterinary use........................................................................ 1024
Buccal tablets and sublingual tablets...................................... 870Buckwheat herb ...................................................................... 1294Budesonide .............................................................................. 1876Bufexamac ............................................................................... 1878Buffer solutions (4.1.3.)............................................................ 560Buffer solutions (4.1.3.)................................................... 9.1-4061Buffer solutions (4.1.3.)................................................... 9.2-4324Buflomedil hydrochloride...................................................... 1879Bulk density and tapped density of powders (2.9.34.) ......... 359Bumetanide ............................................................................. 1881Bupivacaine hydrochloride.................................................... 1882Buprenorphine ........................................................................ 1884Buprenorphine hydrochloride .............................................. 1886Bursal disease vaccine (inactivated), infectious, avian....... 1010Bursal disease vaccine (live), infectious, avian.................... 1011Buserelin .................................................................................. 1887
Buspirone hydrochloride ....................................................... 1889Busulfan ................................................................................... 1891Butcher’s broom...................................................................... 1296Butylated methacrylate copolymer, basic ............................ 1798Butylhydroxyanisole ............................................................... 1893Butylhydroxytoluene .............................................................. 1894Butyl parahydroxybenzoate................................................... 1892
CCabergoline ............................................................................. 1897Cachets....................................................................................... 855Cadmium sulfate hydrate for homoeopathic prepara-tions........................................................................................ 1596
Cadmium sulfuricum for homoeopathic preparations...... 1596Caffeine .................................................................................... 1898Caffeine monohydrate............................................................ 1899Calcifediol................................................................................ 1901Calcipotriol.............................................................................. 1902Calcipotriol monohydrate ..................................................... 1904Calcitonin (salmon)................................................................ 1906Calcitriol .................................................................................. 1909Calcium (2.4.3.)......................................................................... 132Calcium acetate....................................................................... 1910Calcium ascorbate .................................................................. 1911Calcium carbonate.................................................................. 1912Calcium carboxymethylcellulose .......................................... 1957Calcium chloride dihydrate................................................... 1912Calcium chloride hexahydrate .............................................. 1913Calcium dobesilate monohydrate ......................................... 1914Calcium edetate, sodium ....................................................... 3568Calcium folinate...................................................................... 1914Calcium glucoheptonate ........................................................ 1917Calcium gluconate .................................................................. 1917Calcium gluconate, anhydrous.............................................. 1918Calcium gluconate for injection ........................................... 1919Calcium glycerophosphate .................................................... 1920Calcium hydrogen phosphate ............................................... 1921Calcium hydrogen phosphate dihydrate.............................. 1922Calcium hydroxide ................................................................. 1923Calcium in adsorbed vaccines (2.5.14.) ................................. 166Calcium iodatum for homoeopathic preparations ............. 1596Calcium iodide tetrahydrate for homoeopathicpreparations .......................................................................... 1596
Calcium lactate........................................................................ 1923Calcium lactate monohydrate ............................................... 1924Calcium lactate pentahydrate................................................ 1924Calcium lactate trihydrate ..................................................... 1925Calcium levofolinate pentahydrate....................................... 1926Calcium levulinate dihydrate ................................................ 1928Calcium pantothenate ............................................................ 1929Calcium pentetate (sodium) for radiopharmaceuticalpreparations .......................................................................... 1164
Calcium phosphate ................................................................. 1929Calcium stearate ..................................................................... 1930Calcium sulfate dihydrate...................................................... 1932Calendula flower..................................................................... 1297Calf coronavirus diarrhoea vaccine (inactivated)............... 1025Calf rotavirus diarrhoea vaccine (inactivated).................... 1026Calicivirosis vaccine (inactivated), feline ............................ 1053Calicivirosis vaccine (live), feline ......................................... 1054Camphor, D-............................................................................ 1932Camphor, racemic .................................................................. 1934Candesartan cilexetil .............................................................. 1935Canine adenovirus vaccine (inactivated)............................. 1027Canine adenovirus vaccine (live).......................................... 1028Canine distemper vaccine (live) ........................................... 1029Canine leptospirosis vaccine (inactivated) .......................... 1030Canine parainfluenza virus vaccine (live) ........................... 1032Canine parvovirosis vaccine (inactivated)........................... 1033Canine parvovirosis vaccine (live)........................................ 1034Cape aloes................................................................................ 1237Capecitabine............................................................................ 1937
General Notices (1) apply to all monographs and other texts 4637
Index EUROPEAN PHARMACOPOEIA 9.2
Cape jasmine fruit .................................................................. 1299Capillary electrophoresis (2.2.47.) ............................................ 81Capillary viscometer method (2.2.9.)....................................... 27Caprylate, sodium................................................................... 3569Caprylic acid ........................................................................... 1938Caprylocaproyl macrogolglycerides .............................. 9.1-4141Capsicum ................................................................................. 1300Capsicum oleoresin, refined and standardised ................... 1302Capsicum soft extract, standardised .................................... 1303Capsicum tincture, standardised .......................................... 1304Capsules ..................................................................................... 853Capsules and tablets, disintegration of (2.9.1.) ..................... 299Capsules, gastro-resistant ........................................................ 854Capsules, hard ........................................................................... 854Capsules, intrauterine .............................................................. 862Capsules, modified-release ...................................................... 854Capsules, oromucosal............................................................... 870Capsules, rectal ......................................................................... 882Capsules, soft............................................................................. 854Capsules, vaginal....................................................................... 888Captopril .................................................................................. 1940Caraway fruit........................................................................... 1305Caraway oil .............................................................................. 1306Carbachol................................................................................. 1942Carbamazepine ....................................................................... 1943Carbasalate calcium................................................................ 1945Carbidopa ................................................................................ 1946Carbimazole ............................................................................ 1948Carbocisteine........................................................................... 1949Carbomers ............................................................................... 1950Carbon dioxide ....................................................................... 1951Carbon dioxide in gases (2.5.24.) ........................................... 168Carbon monoxide................................................................... 1953Carbon monoxide (15O) ......................................................... 1130Carbon monoxide in gases (2.5.25.)....................................... 169Carboplatin.............................................................................. 1954Carboprost trometamol ......................................................... 1955Carboxymethylcellulose......................................................... 1957Carboxymethylcellulose calcium .......................................... 1957Carboxymethylcellulose sodium........................................... 1958Carboxymethylcellulose sodium, cross-linked ................... 2174Carboxymethylcellulose sodium, low-substituted.............. 1958Carisoprodol............................................................................ 1956Carmellose............................................................................... 1957Carmellose calcium ................................................................ 1957Carmellose sodium................................................................. 1958Carmellose sodium and microcrystalline cellulose............ 3068Carmellose sodium, low-substituted.................................... 1958Carmustine .............................................................................. 1960Carnauba wax.......................................................................... 1960Carprofen for veterinary use ................................................. 1961Carrageenan ............................................................................ 1962Carrier proteins for the production of conjugatedpolysaccharide vaccines for human use (5.2.11.) ............... 626
Carteolol hydrochloride......................................................... 1963Carvedilol ................................................................................ 1965Cascara..................................................................................... 1307Cascara dry extract, standardised......................................... 1308Cassia oil .................................................................................. 1310Castor oil, hydrogenated........................................................ 1966Castor oil, polyoxyl................................................................. 2950Castor oil, polyoxyl hydrogenated........................................ 2949Castor oil, refined ................................................................... 1967Castor oil, virgin ..................................................................... 1968Catgut, sterile .......................................................................... 1207Catgut, sterile, in distributor for veterinary use ................. 1219CD34/CD45+ cells in haematopoietic products, numerationof (2.7.23.)................................................................................ 269
Cefaclor.................................................................................... 1969Cefadroxil monohydrate........................................................ 1970Cefalexin monohydrate.......................................................... 1972Cefalotin sodium .................................................................... 1973Cefamandole nafate................................................................ 1974
Cefapirin sodium.................................................................... 1976Cefatrizine propylene glycol.................................................. 1977Cefazolin sodium.................................................................... 1978Cefepime dihydrochloride monohydrate ..................... 9.2-4513Cefixime................................................................................... 1983Cefoperazone sodium ............................................................ 1984Cefotaxime sodium ................................................................ 1985Cefoxitin sodium .................................................................... 1987Cefpodoxime proxetil ............................................................ 1989Cefprozil monohydrate .......................................................... 1992Cefradine ................................................................................. 1994Ceftazidime pentahydrate...................................................... 1996Ceftazidime pentahydrate with sodium carbonate forinjection ................................................................................. 1998
Ceftriaxone sodium................................................................ 2000Cefuroxime axetil ............................................................ 9.2-4515Cefuroxime sodium................................................................ 2003Celandine, greater................................................................... 1380Celecoxib ................................................................................. 2004Celiprolol hydrochloride ....................................................... 2005Cell-based and gene therapy medicinal products, raw materialsof biological origin for the production of (5.2.12.) ............ 627
Cell-based preparations, microbiological examination of(2.6.27.) ........................................................................... 9.2-4297
Cell count and viability, nucleated (2.7.29.).......................... 275Cell cultures for the production of veterinary vaccines(5.2.4.) ...................................................................................... 606
Cell substrates for the production of vaccines for human use(5.2.3.) ...................................................................................... 602
Cellulose acetate .............................................................. 9.2-4516Cellulose acetate butyrate ...................................................... 2008Cellulose acetate phthalate .................................................... 2009Cellulose, microcrystalline .................................................... 2010Cellulose (microcrystalline) and carmellose sodium......... 3068Cellulose, powdered ............................................................... 2013Centaury .................................................................................. 1310Centella .................................................................................... 1311Cetirizine dihydrochloride .................................................... 2017Cetostearyl alcohol ................................................................. 2019Cetostearyl alcohol (type A), emulsifying ........................... 2019Cetostearyl alcohol (type B), emulsifying ........................... 2021Cetostearyl isononanoate ...................................................... 2022Cetostearyl sulfate, sodium ................................................... 3571Cetrimide................................................................................. 2022Cetyl alcohol............................................................................ 2023Cetyl palmitate ........................................................................ 2024Cetylpyridinium chloride ...................................................... 2025Ceylon cinnamon bark oil ..................................................... 1318Ceylon cinnamon leaf oil....................................................... 1318CFC assay for human haematopoietic progenitor cells(2.7.28.) .................................................................................... 274
Chamomile flower, Roman ................................................... 1313Characterisation of crystalline and partially crystalline solidsby X-ray powder diffraction (XRPD) (2.9.33.) ................... 354
Characterisation of crystalline solids by microcalorimetry andsolution calorimetry (2.2.61.)................................................ 109
Characterisation of preparations for nebulisation (2.9.44.).. 378Characters section in monographs (5.11.) ............................ 729Charcoal, activated ................................................................. 2025Chemical precursors for radiopharmaceuticalpreparations ............................................................................ 813
Chemometric methods applied to analytical data (5.21.) ... 783Chenodeoxycholic acid ......................................................... 2026Chewable tablets ....................................................................... 887Chewing gums, medicated ...................................................... 855Chewing gums, medicated, dissolution test for (2.9.25.)..... 340Chicken anaemia vaccine (live), infectious ......................... 1069Chicken flocks free from specified pathogens for theproduction and quality control of vaccines (5.2.2.) ........... 599
Chinese goldthread rhizome .......................................... 9.1-4102Chitosan hydrochloride ......................................................... 2028Chlamydiosis vaccine (inactivated), feline ......................... 1055Chloral hydrate ....................................................................... 2029
4638 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 9.2 Index
Chlorambucil .......................................................................... 2029Chloramine.............................................................................. 3816Chloramphenicol ............................................................. 9.1-4142Chloramphenicol palmitate................................................... 2032Chloramphenicol sodium succinate..................................... 2033Chlorcyclizine hydrochloride................................................ 2034Chlordiazepoxide.................................................................... 2035Chlordiazepoxide hydrochloride .......................................... 2036Chlorhexidine diacetate ......................................................... 2037Chlorhexidine digluconate solution ..................................... 2039Chlorhexidine dihydrochloride ............................................ 2041Chlorides (2.4.4.) ...................................................................... 132Chlormadinone acetate.......................................................... 2043Chlorobutanol ......................................................................... 2045Chlorobutanol hemihydrate .................................................. 2046Chlorocresol ............................................................................ 2046Chloroquine phosphate ......................................................... 2047Chloroquine sulfate ................................................................ 2048Chlorphenamine maleate ...................................................... 2048Chlorpromazine hydrochloride ............................................ 2050Chlorpropamide ..................................................................... 2051Chlorprothixene hydrochloride............................................ 2052Chlortalidone .......................................................................... 2054Chlortetracycline hydrochloride........................................... 2055Cholecalciferol ........................................................................ 2058Cholecalciferol concentrate (oily form)............................... 2059Cholecalciferol concentrate (powder form) ........................ 2061Cholecalciferol concentrate (water-dispersible form)........ 2062Cholera vaccine......................................................................... 897Cholera vaccine, freeze-dried.................................................. 897Cholera vaccine (inactivated), fowl ...................................... 1063Cholera vaccine (inactivated, oral)......................................... 898Cholesterol............................................................................... 2064Cholesterol for parenteral use ........................................ 9.2-4517Cholesterol in oils rich in omega-3 acids, total (2.4.32.) ..... 157Chondroitin sulfate sodium .................................................. 2067Chromatographic separation techniques (2.2.46.) ......9.2-4286Chromatography, gas (2.2.28.).................................................. 44Chromatography, liquid (2.2.29.) ............................................. 46Chromatography, paper (2.2.26.) ............................................. 42Chromatography, size-exclusion (2.2.30.) ............................... 47Chromatography, supercritical fluid (2.2.45.)......................... 74Chromatography, thin-layer (2.2.27.) ...................................... 43Chromium (51Cr) edetate injection ...................................... 1131Chymotrypsin ......................................................................... 2069Ciclesonide .............................................................................. 2070Ciclopirox ................................................................................ 2071Ciclopirox olamine ................................................................. 2072Ciclosporin .............................................................................. 2074Cilastatin sodium.................................................................... 2075Cilazapril.................................................................................. 2077Cimetidine ............................................................................... 2078Cimetidine hydrochloride ..................................................... 2080Cinchocaine hydrochloride ................................................... 2082Cinchona bark......................................................................... 1314Cinchona liquid extract, standardised ................................. 1316Cineole ..................................................................................... 2083Cineole in essential oils, 1,8-, assay of (2.8.11.) .................... 285Cineole type niaouli oil.......................................................... 1453Cinnamon................................................................................ 1317Cinnamon bark oil, Ceylon................................................... 1318Cinnamon leaf oil, Ceylon..................................................... 1318Cinnarizine.............................................................................. 2084Ciprofibrate ............................................................................. 2085Ciprofloxacin........................................................................... 2086Ciprofloxacin hydrochloride ................................................. 2088Circular dichroism (2.2.41.) ...................................................... 69Cisatracurium besilate ........................................................... 2089Cisplatin................................................................................... 2094Citalopram hydrobromide..................................................... 2095Citalopram hydrochloride ..................................................... 2097Citric acid ................................................................................ 2098Citric acid monohydrate ........................................................ 2099
Citronella oil............................................................................ 1319Cladribine ................................................................................ 2100Clarithromycin........................................................................ 2101Clarity and degree of opalescence of liquids (2.2.1.)... 9.2-4285Clary sage oil ........................................................................... 1320Classical swine-fever vaccine (live, prepared in cellcultures) ................................................................................. 1104
Clazuril for veterinary use..................................................... 2104Clebopride malate .................................................................. 2106Clemastine fumarate .............................................................. 2107Clematis armandii stem......................................................... 1321Clenbuterol hydrochloride .................................................... 2109Clindamycin hydrochloride .................................................. 2110Clindamycin phosphate ......................................................... 2111Clioquinol................................................................................ 2114Clobazam................................................................................. 2115Clobetasol propionate ............................................................ 2116Clobetasone butyrate.............................................................. 2118Clodronate disodium tetrahydrate ....................................... 2119Clofazimine ............................................................................. 2120Clofibrate ................................................................................. 2122Clomifene citrate .................................................................... 2122Clomipramine hydrochloride ............................................... 2124Clonazepam............................................................................. 2126Clonidine hydrochloride........................................................ 2127Clopamide ............................................................................... 2128Clopidogrel besilate ................................................................ 2129Clopidogrel hydrochloride .................................................... 2131Clopidogrel hydrogen sulfate ................................................ 2133Clorazepate, dipotassium....................................................... 2291Closantel sodium dihydrate for veterinary use................... 2134Clostridium botulinum vaccine for veterinary use ............ 1035Clostridium chauvoei vaccine for veterinary use ............... 1036Clostridium novyi (type B) vaccine for veterinary use...... 1036Clostridium perfringens vaccine for veterinary use........... 1038Clostridium septicum vaccine for veterinary use............... 1040Closures and containers for parenteral preparationsand ophthalmic preparations, polypropylene for(3.1.6.) ............................................................................. 9.2-4314
Closures and containers for pharmaceutical use, plastic(3.2.2.) ...................................................................................... 428
Closures and tubing, silicone elastomer for (3.1.9.) ............. 409Closures for containers for aqueous parenteral preparations,for powders and for freeze-dried powders, rubber(3.2.9.) ...................................................................................... 435
Clotrimazole............................................................................ 2136Clove......................................................................................... 1322Clove oil ................................................................................... 1323Cloxacillin sodium ................................................................. 2137Clozapine ................................................................................. 2139Coagulation factor II, human, assay of (2.7.18.)................... 266Coagulation factor IX, human .............................................. 2674Coagulation factor IX, human, assay of (2.7.11.) ................. 259Coagulation factor IX (rDNA) concentrated solution,human .................................................................................... 2676
Coagulation factors, activated (2.6.22.) ................................. 219Coagulation factors, assay of heparin (2.7.12.) ..................... 259Coagulation factor VIIa (rDNA) concentrated solution,human .................................................................................... 2668
Coagulation factor VII, human ............................................ 2666Coagulation factor VII, human, assay of (2.7.10.)................ 258Coagulation factor VIII, human........................................... 2672Coagulation factor VIII, human, assay of (2.7.4.) ................ 246Coagulation factor VIII (rDNA), human ............................ 2673Coagulation factor X, assay of (2.7.19.) ................................. 266Coagulation factor XI, human .............................................. 2681Coagulation factor XI, human, assay of (2.7.22.) ................. 269Coated granules ........................................................................ 860Coated tablets............................................................................ 886Cocaine hydrochloride........................................................... 2140Coccidiosis vaccine (live) for chickens ................................ 1042Cocculus for homoeopathic preparations ........................... 1597Coconut oil, refined................................................................ 2141
General Notices (1) apply to all monographs and other texts 4639
Index EUROPEAN PHARMACOPOEIA 9.2
Cocoyl caprylocaprate............................................................ 2142Codeine.................................................................................... 2143Codeine hydrochloride dihydrate......................................... 2144Codeine phosphate hemihydrate .......................................... 2146Codeine phosphate sesquihydrate ........................................ 2148Codergocrine mesilate ........................................................... 2149Cod-liver oil, farmed.............................................................. 2151Cod-liver oil (type A)............................................................. 2155Cod-liver oil (type B) ............................................................. 2159Codonopsis root ..................................................................... 1324Coix seed........................................................................... 9.2-4457Cola .......................................................................................... 1326Colchicine................................................................................ 2162Cold-water vibriosis vaccine (inactivated) forsalmonids........................................................................ 9.2-4428
Colestyramine ......................................................................... 2164Colibacillosis vaccine (inactivated), neonatal piglet .......... 1077Colibacillosis vaccine (inactivated), neonatal ruminant.... 1079Colistimethate sodium.................................................... 9.2-4519Colistin sulfate ........................................................................ 2166Colloidal anhydrous silica ..................................................... 3549Colloidal hydrated silica ........................................................ 3550Colloidal silica, hydrophobic ................................................ 3551Colloidal silver, for external use ........................................... 3552Colony-forming cell assay for human haematopoieticprogenitor cells (2.7.28.) ........................................................ 274
Colophony ............................................................................... 1327Coloration of liquids (2.2.2.) ..................................................... 22Common selfheal fruit-spike ................................................ 1327Common stinging nettle for homoeopathic preparations.. 1614Comparative table of porosity of sintered-glass filters(2.1.2.) ........................................................................................ 15
Complexometric titrations (2.5.11.) ....................................... 164Composition of fatty acids by gas chromatography(2.4.22.) .................................................................................... 141
Composition of fatty acids in oils rich in omega-3 acids(2.4.29.) .................................................................................... 155
Compressed lozenges ............................................................... 870Concentrated solutions for haemodialysis .......................... 2628Concentrates for injections or infusions................................ 872Concentrates for intrauterine solutions ................................. 862Conductivity (2.2.38.) ................................................................ 62Coneflower herb, purple ........................................................ 1486Coneflower root, narrow-leaved ........................................... 1447Coneflower root, pale............................................................. 1467Coneflower root, purple......................................................... 1488Conjugated estrogens ............................................................. 2410Conjugated polysaccharide vaccines for human use, carrierproteins for the production of (5.2.11.) ............................... 626
Consistency by penetrometry, measurement of (2.9.9.) ...... 313Containers (3.2.) ....................................................................... 423Containers and closures for parenteral preparationsand ophthalmic preparations, polypropylene for(3.1.6.) ............................................................................. 9.2-4314
Containers and closures for pharmaceutical use, plastic(3.2.2.) ...................................................................................... 428
Containers and tubing for total parenteral nutritionpreparations, poly(ethylene - vinyl acetate) for(3.1.7.) ............................................................................. 9.2-4318
Containers for aqueous solutions for infusion, plastic(3.2.2.1.) ................................................................................... 429
Containers for aqueous solutions for intravenous infusion,materials based on plasticised poly(vinyl chloride) for(3.1.14.) .................................................................................... 416
Containers for human blood and blood components, materialsbased on plasticised poly(vinyl chloride) for (3.1.1.1.)...... 391
Containers for human blood and blood components, materialsfor (3.1.1.) ................................................................................ 391
Containers for human blood and blood components, plastic,sterile (3.2.3.)........................................................................... 430
Containers for non-injectable aqueous solutions, materialsbased on non-plasticised poly(vinyl chloride) for(3.1.10.) .................................................................................... 410
Containers for parenteral preparations and forophthalmic preparations, polyethylene with additives for(3.1.5.) ............................................................................. 9.2-4311
Containers for parenteral preparations and for ophthalmicpreparations, polyethylene without additives for(3.1.4.) ............................................................................. 9.2-4310
Containers for pharmaceutical use, glass (3.2.1.) ................. 423Containers for preparations not for parenteral use,polyethylene terephthalate for (3.1.15) ................................ 419
Containers for solid dosage forms for oral administration,materials based on non-plasticised poly(vinyl chloride) for(3.1.11.) .................................................................................... 412
Containers, materials used for the manufacture of (3.1.).... 391Containers of plasticised poly(vinyl chloride) for human bloodand blood components, empty sterile (3.2.4.)..................... 432
Containers of plasticised poly(vinyl chloride) for human bloodcontaining anticoagulant solution, sterile (3.2.5.) .............. 432
Contamination, microbial : microbial enumeration tests(2.6.12.) .................................................................................... 195
Contamination, microbial : test for specified micro-organisms(2.6.13.) .................................................................................... 199
Content uniformity of single-dose preparations (2.9.6.) ..... 312Control of impurities in substances for pharmaceutical use(5.10.) ....................................................................................... 723
Control of microbiological quality, alternative methods for(5.1.6.) ............................................................................. 9.2-4339
Copolymer, basic butylated methacrylate ........................... 1798Copolymer, grafted, macrogol poly(vinyl alcohol) ............ 2945Copolymer, methacrylic acid - ethyl acrylate (1:1) ............ 3015Copolymer, methacrylic acid - ethyl acrylate (1:1) dispersion30 per cent ............................................................................. 3017
Copolymer, methacrylic acid – methyl methacrylate(1:1) ........................................................................................ 3018
Copolymer, methacrylic acid - methyl methacrylate(1:2) ........................................................................................ 3019
Copolymer (type A), ammonio methacrylate..................... 1712Copolymer (type B), ammonio methacrylate ..................... 1713Copovidone ............................................................................. 2167Copper acetate monohydrate for homoeopathicpreparations .......................................................................... 1599
Copper for homoeopathic preparations .............................. 1600Copper sulfate ......................................................................... 2169Copper sulfate pentahydrate ................................................. 2170Copper tetramibi tetrafluoroborate for radiopharmaceuticalpreparations ................................................................... 9.2-4435
Coriander................................................................................. 1329Coriander oil ........................................................................... 1330Coronavirus diarrhoea vaccine (inactivated), calf ............. 1025Cortisone acetate .................................................................... 2170Cotton, absorbent ................................................................... 2172Cottonseed oil, hydrogenated .............................................. 2173Couch grass rhizome.............................................................. 1331Creams ....................................................................................... 883Cresol, crude ........................................................................... 2173Crocus for homoeopathic preparations ............................... 1599Cromoglicate, sodium............................................................ 3574Croscarmellose sodium ......................................................... 2174Crospovidone .......................................................................... 2175Crotamiton .............................................................................. 2177Crystalline and partially crystalline solids, characterisationby X-ray powder diffraction (XRPD) of (2.9.33.)............... 354
Crystalline solids, characterisation by microcalorimetry andsolution calorimetry (2.2.61.)................................................ 109
Crystallinity (5.16.)................................................................... 757Cuprum aceticum for homoeopathic preparations............ 1599Cuprum metallicum for homoeopathic preparations........ 1600Cutaneous application, liquid preparations for .................... 864Cutaneous application, powders for....................................... 874Cutaneous application, semi-solid preparations for ............ 882Cutaneous application, veterinary liquid preparations for.. 889Cutaneous foams ...................................................................... 864Cutaneous patches .................................................................... 882Cyanocobalamin ..................................................................... 2178
4640 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 9.2 Index
Cyanocobalamin (57Co) capsules .......................................... 1132Cyanocobalamin (57Co) solution .......................................... 1133Cyanocobalamin (58Co) capsules .......................................... 1134Cyanocobalamin (58Co) solution .......................................... 1134Cyclamate, sodium ................................................................. 3576Cyclizine hydrochloride......................................................... 2179Cyclopentolate hydrochloride ............................................... 2180Cyclophosphamide ................................................................. 2181Cyproheptadine hydrochloride............................................. 2182Cyproterone acetate................................................................ 2183Cysteine hydrochloride monohydrate.................................. 2185Cystine ..................................................................................... 2187Cytarabine ............................................................................... 2188
DDacarbazine............................................................................. 2193Dalteparin sodium.................................................................. 2194Danaparoid sodium................................................................ 2196Dandelion herb with root ...................................................... 1332Dandelion root........................................................................ 1333Dapsone ................................................................................... 2198Daunorubicin hydrochloride ................................................ 2199D-Camphor.............................................................................. 1932Decyl oleate ............................................................................. 2200Deferoxamine mesilate.................................................... 9.2-4525Degree of coloration of liquids (2.2.2.) .................................... 22Dembrexine hydrochloride monohydrate for veterinaryuse.................................................................................... 9.2-4526
Demeclocycline hydrochloride ............................................. 2203Demonstration of uniformity of dosage units using largesample sizes (2.9.47.).............................................................. 384
Density of powders, bulk density and tapped (2.9.34.)........ 359Density of solids (2.2.42.) .......................................................... 70Density of solids, gas pycnometric (2.9.23.).......................... 339Density, relative (2.2.5.) ............................................................. 25Dental type silica .................................................................... 3550Depressor substances (2.6.11.) ................................................ 195Deptropine citrate................................................................... 2205Dequalinium chloride ............................................................ 2206Desacyl-4-monophosphoryl lipid A, 3-O- ......................... 2207Desflurane................................................................................ 2209Desipramine hydrochloride................................................... 2210Deslanoside ............................................................................. 2211Desloratadine .......................................................................... 2212Desmopressin .......................................................................... 2213Desogestrel .............................................................................. 2215Desoxycortone acetate ........................................................... 2216Detection and measurement of radioactivity (2.2.66.) ........ 113Detector tubes, gas (2.1.6.) ........................................................ 17Determination of aflatoxin B1 in herbal drugs (2.8.18.) ...... 289Determination of bactericidal, fungicidal or yeasticidal activityof antiseptic medicinal products (5.1.11.) .................. 9.2-4348
Determination of metal catalyst or metal reagent residues(2.4.20.) .................................................................................... 138
Determination of nitrogen by sulfuric acid digestion(2.5.9.) ...................................................................................... 164
Determination of primary aromatic amino-nitrogen(2.5.8.) ...................................................................................... 163
Determination of water by distillation (2.2.13.) ..................... 31Detomidine hydrochloride for veterinary use .................... 2217Devil’s claw dry extract .......................................................... 1334Devil’s claw root ...................................................................... 1335Dexamethasone....................................................................... 2218Dexamethasone acetate.......................................................... 2220Dexamethasone isonicotinate ............................................... 2222Dexamethasone sodium phosphate...................................... 2223Dexchlorpheniramine maleate.............................................. 2226Dexpanthenol.......................................................................... 2227Dextran 1 for injection........................................................... 2228Dextran 40 for injection ........................................................ 2229Dextran 60 for injection ........................................................ 2230Dextran 70 for injection ........................................................ 2231
Dextranomer ........................................................................... 2231Dextrans, molecular mass distribution in (2.2.39.)................ 62Dextrin ..............................................................................9.2-4527Dextromethorphan hydrobromide....................................... 2233Dextromoramide tartrate ...................................................... 2234Dextropropoxyphene hydrochloride.................................... 2235Dextrose............................................................................ 9.1-4167Dextrose monohydrate.................................................... 9.1-4168Diacerein.................................................................................. 2236Diazepam................................................................................. 2238Diazoxide ................................................................................. 2240Dibrompropamidine diisetionate ......................................... 2240Dibutyl phthalate .................................................................... 2241Dichlorobenzyl alcohol, 2,4- ................................................. 2242Dichloromethane .................................................................... 3034Diclazuril for veterinary use.................................................. 2243Diclofenac potassium ............................................................. 2245Diclofenac sodium.................................................................. 2246Dicloxacillin sodium .............................................................. 2248Dicycloverine hydrochloride.......................................... 9.1-4147Didanosine .............................................................................. 2250Dienogest ................................................................................. 2252Diethylcarbamazine citrate.................................................... 2254Diethylene glycol and ethylene glycol in ethoxylatedsubstances (2.4.30.)................................................................. 157
Diethylene glycol monoethyl ether ...................................... 2256Diethylene glycol palmitostearate......................................... 2257Diethyl phthalate .................................................................... 2253Diethylstilbestrol..................................................................... 2258Diffraction, laser light, particle size analysis by (2.9.31.) ... 349Difloxacin hydrochloride trihydrate for veterinary use..... 2259Digitalis leaf............................................................................. 1336Digitoxin .................................................................................. 2260Digoxin .................................................................................... 2261Dihydralazine sulfate, hydrated ..................................... 9.2-4528Dihydrocodeine hydrogen tartrate ....................................... 2266Dihydroergocristine mesilate ................................................ 2267Dihydroergotamine mesilate................................................. 2269Dihydroergotamine tartrate .................................................. 2271Dihydrostreptomycin sulfate for veterinary use ................. 2272Dihydrotachysterol ................................................................. 2274Diltiazem hydrochloride........................................................ 2276Dimenhydrinate...................................................................... 2277Dimercaprol ............................................................................ 2279Dimethylacetamide ................................................................ 2280Dimethylaniline, N,N- (2.4.26.) .............................................. 152Dimethyl sulfoxide ................................................................. 2279Dimeticone .............................................................................. 2281Dimetindene maleate ............................................................. 2282Dinoprostone ................................................................... 9.2-4529Dinoprost trometamol ........................................................... 2283Dioscorea nipponica rhizome ........................................ 9.2-4458Dioscorea oppositifolia rhizome........................................... 1337Diosmin ................................................................................... 2286Dioxan and ethylene oxide (2.4.25.)....................................... 151Dip concentrates ....................................................................... 889Diphenhydramine hydrochloride ......................................... 2288Diphenoxylate hydrochloride................................................ 2289Diphtheria and tetanus toxins and toxoids, flocculation value(Lf) of, (Ramon assay) (2.7.27.)............................................ 273
Diphtheria and tetanus vaccine (adsorbed) .......................... 899Diphtheria and tetanus vaccine (adsorbed, reduced antigen(s)content).................................................................................... 900
Diphtheria antitoxin............................................................... 1115Diphtheria, tetanus and hepatitis B (rDNA) vaccine(adsorbed) ............................................................................... 901
Diphtheria, tetanus and pertussis (acellular, component)vaccine (adsorbed) ................................................................. 902
Diphtheria, tetanus and pertussis (acellular, component)vaccine (adsorbed, reduced antigen(s) content)................. 903
Diphtheria, tetanus and pertussis (whole cell) vaccine(adsorbed) ............................................................................... 905
General Notices (1) apply to all monographs and other texts 4641
Index EUROPEAN PHARMACOPOEIA 9.2
Diphtheria, tetanus and poliomyelitis (inactivated) vaccine(adsorbed, reduced antigen(s) content)............................... 906
Diphtheria, tetanus, pertussis (acellular, component) andhaemophilus type b conjugate vaccine (adsorbed) ............ 908
Diphtheria, tetanus, pertussis (acellular, component) andhepatitis B (rDNA) vaccine (adsorbed) ............................... 910
Diphtheria, tetanus, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed)................... 911
Diphtheria, tetanus, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed, reducedantigen(s) content) ................................................................. 913
Diphtheria, tetanus, pertussis (acellular, component),hepatitis B (rDNA), poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) ............ 915
Diphtheria, tetanus, pertussis (acellular, component),poliomyelitis (inactivated) and haemophilus type b conjugatevaccine (adsorbed) ................................................................. 917
Diphtheria, tetanus, pertussis (whole cell) and poliomyelitis(inactivated) vaccine (adsorbed) .......................................... 920
Diphtheria, tetanus, pertussis (whole cell), poliomyelitis(inactivated) and haemophilus type b conjugate vaccine(adsorbed) ............................................................................... 922
Diphtheria vaccine (adsorbed)................................................ 924Diphtheria vaccine (adsorbed), assay of (2.7.6.)................... 247Diphtheria vaccine (adsorbed, reduced antigen content) ... 925Dipivefrine hydrochloride ..................................................... 2290Dipotassium clorazepate........................................................ 2291Dipotassium phosphate ......................................................... 2292Diprophylline .......................................................................... 2293Dipyridamole .......................................................................... 2294Dirithromycin ......................................................................... 2296Disintegration of suppositories and pessaries (2.9.2.) ......... 301Disintegration of tablets and capsules (2.9.1.) ...................... 299Disodium clodronate tetrahydrate ....................................... 2119Disodium edetate.................................................................... 2297Disodium etidronate .............................................................. 2433Disodium pamidronate pentahydrate .................................. 3259Disodium phosphate .............................................................. 2298Disodium phosphate dihydrate............................................. 2299Disodium phosphate dodecahydrate.................................... 2299Disopyramide.......................................................................... 2300Disopyramide phosphate ....................................................... 2301Dispersible tablets..................................................................... 886Dissolution, apparent (2.9.43.)................................................ 377Dissolution, intrinsic (2.9.29.) ................................................ 347Dissolution test for lipophilic solid dosage forms (2.9.42.).. 377Dissolution test for solid dosage forms (2.9.3.) .................... 302Dissolution test for transdermal patches (2.9.4.).................. 309Dissolution testing, recommendations on (5.17.1.) ............. 761Distemper vaccine (live), canine........................................... 1029Distemper vaccine (live) for mustelids ................................ 1045Distillation range (2.2.11.)......................................................... 30Distribution estimation by analytical sieving, particle-size(2.9.38.) .................................................................................... 367
Disulfiram................................................................................ 2302Dithranol ................................................................................. 2303DL-Methionine ........................................................................ 3025DL-α-Tocopheryl hydrogen succinate................................... 3806Dobesilate monohydrate, calcium ........................................ 1914Dobutamine hydrochloride ................................................... 2304Docetaxel ................................................................................. 2305Docetaxel trihydrate ............................................................... 2307Docusate sodium .................................................................... 2309Dodecyl gallate........................................................................ 2309Dog rose................................................................................... 1338Domperidone .......................................................................... 2310Domperidone maleate............................................................ 2312Dopamine hydrochloride ...................................................... 2313Dopexamine dihydrochloride ............................................... 2315Dorzolamide hydrochloride .................................................. 2316Dosage forms (glossary) ................................................. 9.2-4423Dosage units, demonstration of uniformity using large samplesizes (2.9.47.) ........................................................................... 384
Dosage units, uniformity of (2.9.40.) ............................ 9.1-4055Dosulepin hydrochloride....................................................... 2318DOTATOC (gallium (68Ga)) injection ................................. 1150Doxapram hydrochloride ...................................................... 2319Doxazosin mesilate................................................................. 2320Doxepin hydrochloride .......................................................... 2322Doxorubicin hydrochloride................................................... 2323Doxycycline hyclate ................................................................ 2324Doxycycline monohydrate..................................................... 2326Doxylamine hydrogen succinate........................................... 2328Droperidol ............................................................................... 2329Droppers (2.1.1.)......................................................................... 15Drop point (2.2.17.).................................................................... 33Drops (nasal) and sprays (liquid nasal) ................................. 867Drops, oral ................................................................................. 865Drospirenone .......................................................................... 2331Dry extracts ............................................................................... 818Drynaria rhizome ............................................................9.2-4459Dry residue of extracts (2.8.16.).............................................. 289Duck plague vaccine (live)..................................................... 1046Duck viral hepatitis type I vaccine (live) ............................. 1047Duloxetine hydrochloride...................................................... 2332Dutasteride .............................................................................. 2334Dwarf pine oil ......................................................................... 1340Dydrogesterone....................................................................... 2336
EEar drops and ear sprays.......................................................... 856Ear powders............................................................................... 856Ear preparations........................................................................ 855Ear preparations, semi-solid ................................................... 856Ear sprays and ear drops.......................................................... 856Ear tampons .............................................................................. 856Ear washes ................................................................................. 856Ebastine.................................................................................... 2341Eclipta herb ...................................................................... 9.2-4461Econazole................................................................................. 2342Econazole nitrate .................................................................... 2343Edetate (chromium (51Cr)) injection.................................... 1131Edetate, disodium................................................................... 2297Edetate, sodium calcium........................................................ 3568Edetic acid ............................................................................... 2344Edotreotide (gallium (68Ga)) injection................................. 1150Edrophonium chloride........................................................... 2345Effervescent granules ............................................................... 860Effervescent powders ............................................................... 875Effervescent tablets................................................................... 886Efficacy of antimicrobial preservation (5.1.3.)...................... 577Efficacy of veterinary vaccines and immunosera, evaluation of(5.2.7.) ...................................................................................... 612
Egg drop syndrome 76 vaccine (inactivated) ..................... 1048Egg phospholipids for injection..................................... 9.2-4533Elder flower ............................................................................. 1342Electrophoresis (2.2.31.) ............................................................ 48Electrophoresis, capillary (2.2.47.) ........................................... 81Eleutherococcus ...................................................................... 1344Emedastine difumarate .......................................................... 2346Emetine hydrochloride pentahydrate .................................. 2347Empty sterile containers of plasticised poly(vinyl chloride) forhuman blood and blood components (3.2.4.)..................... 432
Emulsifying cetostearyl alcohol (type A)............................. 2019Emulsifying cetostearyl alcohol (type B) ............................. 2021Emulsions, solutions and suspensions, oral .......................... 865Enalaprilat dihydrate.............................................................. 2349Enalapril maleate .................................................................... 2348Encephalitis vaccine (inactivated), tick-borne...................... 988Encephalomyelitis vaccine (live), infectious, avian ............ 1013Endotoxins, bacterial (2.6.14.) ................................................ 204Endotoxins, bacterial, guidelines for using the test for(5.1.10.) .................................................................................... 593
Enilconazole for veterinary use ............................................ 2351Enoxaparin sodium ................................................................ 2352
4642 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 9.2 Index
Enoxolone ................................................................................ 2354Enrofloxacin for veterinary use...................................... 9.2-4535Entacapone .............................................................................. 2357Entecavir monohydrate.......................................................... 2359Enzootic pneumonia vaccine (inactivated), porcine.......... 1086Ephedra herb ........................................................................... 1346Ephedrine ................................................................................ 2360Ephedrine hemihydrate ......................................................... 2361Ephedrine hydrochloride....................................................... 2362Ephedrine hydrochloride, racemic ....................................... 2363Epinastine hydrochloride....................................................... 2364Epinephrine ............................................................................. 1650Epinephrine tartrate ............................................................... 1652Epirubicin hydrochloride ...................................................... 2365Eplerenone............................................................................... 2367Eptacog alfa (activated) concentrated solution................... 2668Equine herpesvirus vaccine (inactivated)............................ 1050Equine influenza vaccine (inactivated) ................................ 1051Equisetum stem ...................................................................... 1347Ergocalciferol .......................................................................... 2368Ergoloid mesilates................................................................... 2149Ergometrine maleate .............................................................. 2370Ergotamine tartrate ................................................................ 2371Erysipelas vaccine (inactivated), swine................................ 1104Erythritol ................................................................................. 2373Erythromycin .......................................................................... 2374Erythromycin estolate ............................................................ 2378Erythromycin ethylsuccinate................................................. 2381Erythromycin lactobionate ............................................. 9.2-4536Erythromycin stearate ............................................................ 2388Erythropoietin concentrated solution.................................. 2391Escitalopram............................................................................ 2395Escitalopram oxalate .............................................................. 2397Eserine salicylate..................................................................... 3335Esketamine hydrochloride..................................................... 2399Esomeprazole magnesium dihydrate ................................... 2401Esomeprazole magnesium trihydrate................................... 2402Essential oils .............................................................................. 814Essential oils, assay of 1,8-cineole in (2.8.11.)....................... 285Essential oils, fatty oils and resinified essential oils in(2.8.7.) ...................................................................................... 284
Essential oils, foreign esters in (2.8.6.) ................................... 284Essential oils in herbal drugs (2.8.12.) ................................... 285Essential oils, odour and taste (2.8.8.) ................................... 284Essential oils, residue on evaporation (2.8.9.)....................... 284Essential oils, solubility in alcohol (2.8.10.) .......................... 284Essential oils, water in (2.8.5.)................................................. 284Ester value (2.5.2.) .................................................................... 161Estradiol benzoate .................................................................. 2404Estradiol hemihydrate..................................................... 9.1-4151Estradiol valerate .................................................................... 2407Estriol ....................................................................................... 2409Estrogens, conjugated............................................................. 2410Etacrynic acid.......................................................................... 2413Etamsylate................................................................................ 2414Ethacridine lactate monohydrate.......................................... 2415Ethambutol hydrochloride .................................................... 2416Ethanol (96 per cent).............................................................. 2417Ethanol, anhydrous................................................................. 2419Ethanol content (2.9.10.) ......................................................... 315Ether ......................................................................................... 2421Ether, anaesthetic.................................................................... 2422Ethinylestradiol ....................................................................... 2422Ethionamide ............................................................................ 2424Ethosuximide .......................................................................... 2425Ethoxylated substances, ethylene glycol and diethylene glycolin (2.4.30.) ............................................................................... 157
Ethyl acetate ............................................................................ 2427Ethyl acrylate - methacrylic acid copolymer (1:1).............. 3015Ethyl acrylate - methacrylic acid copolymer (1:1) dispersion30 per cent ............................................................................. 3017
Ethylcellulose.................................................................... 9.2-4539Ethylenediamine ..................................................................... 2431
Ethylene glycol and diethylene glycol in ethoxylated substances(2.4.30.) .................................................................................... 157
Ethylene glycol monopalmitostearate .................................. 2430Ethylene glycol monostearate................................................ 2430Ethylene oxide and dioxan (2.4.25.) ....................................... 151Ethylhexanoic acid, 2- (2.4.28.)............................................... 154Ethylmorphine hydrochloride............................................... 2431Ethyl oleate .............................................................................. 2428Ethyl parahydroxybenzoate ................................................... 2428Ethyl parahydroxybenzoate sodium..................................... 3577Etidronate disodium............................................................... 2433Etilefrine hydrochloride......................................................... 2433Etodolac ................................................................................... 2435Etofenamate............................................................................. 2437Etomidate................................................................................. 2439Etoposide ..........................................................................9.1-4152Eucalyptus leaf ........................................................................ 1349Eucalyptus oil .......................................................................... 1349Eucommia bark................................................................ 9.2-4462Eugenol .................................................................................... 2443European goldenrod............................................................... 1376European viper venom antiserum ........................................ 1119Evaluation of efficacy of veterinary vaccines and immunosera(5.2.7.) ...................................................................................... 612
Evaluation of safety of each batch of immunosera forveterinary use (5.2.9.)............................................................. 625
Evaluation of safety of veterinary vaccines and immunosera(5.2.6.) ...................................................................................... 610
Evening primrose oil, refined................................................ 2444Evodia fruit....................................................................... 9.2-4464Excipients, functionality-related characteristics of(5.15.) .............................................................................. 9.2-4411
Exemestane.............................................................................. 2445Extemporaneous preparation of radiopharmaceuticals(5.19.) ....................................................................................... 767
Extractable volume of parenteral preparations, test for(2.9.17.) .................................................................................... 322
Extracts, dry .............................................................................. 818Extracts, dry residue of (2.8.16.)............................................. 289Extracts, herbal drug ................................................................ 815Extracts, herbal drug, monographs on (information chapter)(5.23.) ....................................................................................... 807
Extracts, liquid (fluid) .............................................................. 817Extracts, loss on drying of (2.8.17.)........................................ 289Extracts, soft .............................................................................. 817Extracts used in the preparation of herbal medicinal productsfor oral use, microbiological examination (2.6.31.) ........... 232
Extracts used in the preparation of herbal medicinal productsfor oral use, microbiological quality (5.1.8.) ....................... 591
Extracts, water for preparation of......................................... 3932Extraneous agents in viral vaccines for human use, tests for(2.6.16.) .................................................................................... 208
Extraneous agents : tests in batches of finished product ofavian live virus vaccines (2.6.25.) ......................................... 222
Extraneous agents : tests in seed lots of avian viral vaccines(2.6.24.) .................................................................................... 219
Eye drops ................................................................................... 857Eye lotions ................................................................................. 857Eye preparations ....................................................................... 857Eye preparations, semi-solid ................................................... 858
FF0 concept to steam sterilisation of aqueous preparations,application of (5.1.5.) ............................................................. 580
Factor II, human coagulation, assay of (2.7.18.)................... 266Factor IX, human coagulation .............................................. 2674Factor IX, human coagulation, assay of (2.7.11.) ................. 259Factor IX (rDNA) concentrated solution, humancoagulation ............................................................................ 2676
Factor VIIa (rDNA) concentrated solution, human coagulation................................................................................................ 2668
Factor VII, human coagulation............................................. 2666
General Notices (1) apply to all monographs and other texts 4643
Index EUROPEAN PHARMACOPOEIA 9.2
Factor VII, human coagulation, assay of (2.7.10.)................ 258Factor VIII, human coagulation ........................................... 2672Factor VIII, human coagulation, assay of (2.7.4.) ................ 246Factor VIII (rDNA), human coagulation ............................ 2673Factor X, human coagulation, assay of (2.7.19.) ................... 266Factor XI, human coagulation .............................................. 2681Factor XI, human coagulation, assay of (2.7.22.) ................. 269Falling ball viscometer method (2.2.49.) ................................. 88Famotidine............................................................................... 2449Fat, hard ................................................................................... 2639Fat, hard with additives.......................................................... 2640Fatty acids, composition by gas chromatography (2.4.22.).. 141Fatty acids in oils rich in omega-3 acids, composition of(2.4.29.) .................................................................................... 155
Fatty oils, alkaline impurities in (2.4.19.) .............................. 138Fatty oils and resinified essential oils in essential oils(2.8.7.) ...................................................................................... 284
Fatty oils, foreign oils in, by thin-layer chromatography(2.4.21.) .................................................................................... 141
Fatty oils, identification by thin-layer chromatography(2.3.2.) ...................................................................................... 126
Fatty oils, sterols in (2.4.23.).................................................... 144Fatty oils, vegetable................................................................... 848Fc function of immunoglobulin, test for (2.7.9.) .................. 257Febantel for veterinary use .................................................... 2450Feeding stuffs for veterinary use, medicated, premixes for.. 875Felbinac .................................................................................... 2451Feline calicivirosis vaccine (inactivated).............................. 1053Feline calicivirosis vaccine (live)........................................... 1054Feline chlamydiosis vaccine (inactivated) ........................... 1055Feline infectious enteritis (feline panleucopenia) vaccine(inactivated) .......................................................................... 1056
Feline infectious enteritis (feline panleucopenia) vaccine(live) ....................................................................................... 1057
Feline leukaemia vaccine (inactivated) ................................ 1058Feline panleucopenia vaccine (inactivated)......................... 1056Feline panleucopenia vaccine (live) ..................................... 1057Feline viral rhinotracheitis vaccine (inactivated) ............... 1059Feline viral rhinotracheitis vaccine (live) ............................ 1060Felodipine ................................................................................ 2452Felypressin ............................................................................... 2454Fenbendazole for veterinary use........................................... 2455Fenbufen .................................................................................. 2456Fennel, bitter ........................................................................... 1352Fennel, sweet ........................................................................... 1353Fenofibrate............................................................................... 2457Fenoterol hydrobromide ........................................................ 2458Fentanyl.................................................................................... 2459Fentanyl citrate........................................................................ 2461Fenticonazole nitrate .............................................................. 2462Fenugreek ................................................................................ 1354Fermentation, products of ....................................................... 830Ferric chloride hexahydrate................................................... 2463Ferrous fumarate..................................................................... 2464Ferrous gluconate ................................................................... 2465Ferrous sulfate, dried.............................................................. 2466Ferrous sulfate heptahydrate ................................................. 2467Ferrum metallicum for homoeopathic preparations ......... 1601FET (18F) injection.................................................................. 1143Feverfew................................................................................... 1355Fexofenadine hydrochloride.................................................. 2468Fibrinogen, human ................................................................. 2682Fibrin sealant kit ..................................................................... 2469Filgrastim concentrated solution................................... 9.1-4159Films, orodispersible ................................................................ 870Finasteride ............................................................................... 2473Fineness, powder (2.9.35.) ....................................................... 362Fish oil, rich in omega-3 acids .............................................. 2474Flavoxate hydrochloride......................................................... 2476Flecainide acetate.................................................................... 2478Fleeceflower root..................................................................... 1356Flocculation value (Lf) of diphtheria and tetanus toxins andtoxoids (Ramon assay) (2.7.27.)............................................ 273
Flowability (2.9.16.) .................................................................. 321Flow cytometry (2.7.24.).......................................................... 271FLT (18F) injection .................................................................. 1127Flubendazole ........................................................................... 2479Flucloxacillin magnesium octahydrate ................................ 2480Flucloxacillin sodium............................................................. 2482Fluconazole.............................................................................. 2484Flucytosine............................................................................... 2485Fludarabine phosphate........................................................... 2487Fludeoxyglucose (18F) injection ............................................ 1135Fludrocortisone acetate.......................................................... 2489Flumazenil ............................................................................... 2490Flumazenil (N-[11C]methyl) injection.................................. 1137Flumequine.............................................................................. 2492Flumetasone pivalate.............................................................. 2493Flunarizine dihydrochloride.................................................. 2494Flunitrazepam ......................................................................... 2495Flunixin meglumine for veterinary use ............................... 2496Fluocinolone acetonide.......................................................... 2497Fluocortolone pivalate............................................................ 2500Fluorescein .............................................................................. 2501Fluorescein sodium ................................................................ 2502Fluoride (18F) solution for radiolabelling............................. 1139Fluorides (2.4.5.) ....................................................................... 132Fluorimetry (2.2.21.) .................................................................. 36Fluorocholine (18F) injection................................................. 1139Fluorodeoxythymidine (18F) injection ................................. 1127Fluorodopa (18F) (prepared by electrophilic substitution)injection ................................................................................. 1141
Fluoroethyl-L-tyrosine (18F) injection .................................. 1143Fluoromisonidazole (18F) injection....................................... 1146Fluorouracil ...................................................................... 9.2-4545Fluoxetine hydrochloride....................................................... 2505Flupentixol dihydrochloride.................................................. 2507Fluphenazine decanoate......................................................... 2509Fluphenazine dihydrochloride .............................................. 2510Fluphenazine enantate ........................................................... 2512Flurazepam monohydrochloride .......................................... 2513Flurbiprofen............................................................................. 2514Fluspirilene .............................................................................. 2516Flutamide................................................................................. 2517Fluticasone propionate........................................................... 2518Flutrimazole ............................................................................ 2520Fluvastatin sodium ................................................................. 2521Fluvoxamine maleate.............................................................. 2523FMISO (18F) injection ............................................................ 1146Foams, cutaneous ..................................................................... 864Foams, intrauterine .................................................................. 862Foams, medicated ..................................................................... 859Foams, rectal ............................................................................. 882Foams, vaginal........................................................................... 889Folic acid.................................................................................. 2524Folinate, calcium..................................................................... 1914Follitropin................................................................................ 2526Follitropin concentrated solution ......................................... 2531Foot-and-mouth disease (ruminants) vaccine(inactivated) .......................................................................... 1062
Foreign esters in essential oils (2.8.6.).................................... 284Foreign matter (2.8.2.) ............................................................. 283Foreign oils in fatty oils by thin-layer chromatography(2.4.21.) .................................................................................... 141
Formaldehyde, free (2.4.18.).................................................... 137Formaldehyde solution (35 per cent) ................................... 2537Formoterol fumarate dihydrate............................................. 2537Foscarnet sodium hexahydrate ...................................... 9.2-4546Fosfomycin calcium................................................................ 2541Fosfomycin sodium ................................................................ 2542Fosfomycin trometamol......................................................... 2543Fosinopril sodium .................................................................. 2544Fourstamen stephania root.................................................... 1357Fowl cholera vaccine (inactivated) ....................................... 1063Fowl-pox vaccine (live) .......................................................... 1064Framycetin sulfate .................................................................. 2547
4644 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 9.2 Index
Frangula bark .......................................................................... 1358Frangula bark dry extract, standardised.............................. 1359Frankincense, Indian.............................................................. 1392Fraxinus rhynchophylla bark ................................................ 1360Free formaldehyde (2.4.18.)..................................................... 137Freezing point (2.2.18.) .............................................................. 34Fresh bilberry fruit dry extract, refined and standardised.. 1361Friability of granules and spheroids (2.9.41.)........................ 375Friability of uncoated tablets (2.9.7.) ..................................... 312Fructose.................................................................................... 2548Fucus ........................................................................................ 1405Fulvestrant ............................................................................... 2549Fumitory ........................................................................... 9.2-4465Functional groups and ions, identification reactions of(2.3.1.) ...................................................................................... 123
Functionality-related characteristics of excipients(5.15.) .............................................................................. 9.2-4411
Fungicidal, bactericidal or yeasticidal activity of antisepticmedicinal products, determination of (5.1.11.) ......... 9.2-4348
Furosemide .............................................................................. 2551Furunculosis vaccine (inactivated, oil-adjuvanted, injectable)for salmonids.................................................................. 9.2-4427
Fusidate, sodium..................................................................... 3579Fusidic acid.............................................................................. 2552
GGabapentin .............................................................................. 2559Gadobutrol monohydrate ...................................................... 2560Gadodiamide hydrate...................................................... 9.1-4165Galactose.................................................................................. 2562Galantamine hydrobromide .................................................. 2563Gallium (67Ga) citrate injection ............................................ 1148Gallium (68Ga) chloride solution for radiolabelling ........... 1148Gallium (68Ga) DOTATOC injection ................................... 1150Gallium (68Ga) edotreotide injection ................................... 1150Ganciclovir .............................................................................. 2566Gargles ....................................................................................... 869Garlic for homoeopathic preparations................................. 1590Garlic powder.......................................................................... 1364Gas adsorption, specific surface area by (2.9.26.)................. 344Gas chromatography (2.2.28.) ................................................... 44Gas detector tubes (2.1.6.) ......................................................... 17Gases, carbon dioxide in (2.5.24.) .......................................... 168Gases, carbon monoxide in (2.5.25.)...................................... 169Gases, nitrogen monoxide and nitrogen dioxide in(2.5.26.) .................................................................................... 170
Gases, nitrous oxide in (2.5.35.) ............................................. 176Gases, oxygen in (2.5.27.) ........................................................ 170Gases, water in (2.5.28.) ........................................................... 170Gas-gangrene antitoxin, mixed............................................. 1116Gas-gangrene antitoxin (novyi) ............................................ 1116Gas-gangrene antitoxin (perfringens).................................. 1117Gas-gangrene antitoxin (septicum)...................................... 1118Gas pycnometric density of solids (2.9.23.)........................... 339Gastro-resistant capsules ......................................................... 854Gastro-resistant granules ......................................................... 860Gastro-resistant tablets ............................................................ 886Gefitinib ................................................................................... 2567Gelatin...................................................................................... 2568Gels ............................................................................................. 884Gels for injections..................................................................... 873Gemcitabine hydrochloride................................................... 2570Gemfibrozil.............................................................................. 2571General notices (1.) ......................................................... 9.2-4275General texts on biological products (5.2.) ........................... 599General texts on microbiology (5.1.) ..................................... 575Gene transfer medicinal products for human use (5.14.).... 739Gentamicin sulfate.................................................................. 2573Gentian root ............................................................................ 1365Gentian tincture...................................................................... 1366Gestodene ................................................................................ 2575Ginger ...................................................................................... 1367
Gingival solutions ..................................................................... 869Ginkgo dry extract, refined and quantified......................... 1368Ginkgo leaf .............................................................................. 1370Ginseng .................................................................................... 1372Ginseng dry extract ................................................................ 1374Glass containers for pharmaceutical use (3.2.1.) .................. 423Glibenclamide ......................................................................... 2577Gliclazide ................................................................................. 2578Glimepiride ............................................................................. 2580Glipizide................................................................................... 2582Glossary (dosage forms) ................................................. 9.2-4423Glucagon, human ................................................................... 2584Glucoheptonate, calcium ....................................................... 1917Glucosamine hydrochloride .................................................. 2585Glucosamine sulfate potassium chloride ............................. 2586Glucosamine sulfate sodium chloride.................................. 2587Glucose.............................................................................. 9.1-4167Glucose, liquid ........................................................................ 2590Glucose, liquid, spray-dried .................................................. 2591Glucose monohydrate ..................................................... 9.1-4168Glutamic acid .......................................................................... 2593Glutathione.............................................................................. 2594Glycan analysis of glycoproteins (2.2.59.) ............................. 103Glycerol .................................................................................... 2595Glycerol (85 per cent) ............................................................ 2597Glycerol dibehenate................................................................ 2598Glycerol distearate .................................................................. 2599Glycerol formal ....................................................................... 2600Glycerol monocaprylate......................................................... 2601Glycerol monocaprylocaprate ............................................... 2602Glycerol monolinoleate.......................................................... 2603Glycerol mono-oleate ............................................................. 2604Glycerol monostearate 40-55 ......................................... 9.2-4551Glycerol triacetate................................................................... 3825Glyceryl trinitrate solution .................................................... 2606Glycine ..................................................................................... 2608Glycoproteins, glycan analysis of (2.2.59.) ............................ 103Glycopyrronium bromide...................................................... 2609Glycyrrhizate ammonium...................................................... 1716Goldenrod................................................................................ 1375Goldenrod, European............................................................. 1376Goldenseal rhizome................................................................ 1378Gonadorelin acetate................................................................ 2611Gonadotrophin, chorionic..................................................... 2613Gonadotrophin, equine serum, for veterinary use............. 2613Goserelin.................................................................................. 2614Grafted copolymer, macrogol poly(vinyl alcohol) ............. 2945Gramicidin .............................................................................. 2616Granisetron hydrochloride.................................................... 2617Granules..................................................................................... 860Granules and powders for oral solutions and suspensions.. 865Granules and powders for syrups ........................................... 866Granules and spheroids, friability of (2.9.41.)....................... 375Granules, coated ....................................................................... 860Granules, effervescent .............................................................. 860Granules, gastro-resistant ........................................................ 860Granules, modified-release...................................................... 860Greater celandine.................................................................... 1380Griseofulvin............................................................................. 2619Guaiacol ................................................................................... 2620Guaifenesin.............................................................................. 2622Guanethidine monosulfate .................................................... 2623Guar.......................................................................................... 1381Guar galactomannan .............................................................. 2623Guidelines for using the test for bacterial endotoxins(5.1.10.) .................................................................................... 593
Guidelines for using the test for sterility (5.1.9.) .................. 592
HHaemagglutinins, anti-A and anti-B (2.6.20.)....................... 213Haematopoietic products, numeration of CD34/CD45+ cellsin (2.7.23.) ............................................................................... 269
General Notices (1) apply to all monographs and other texts 4645
Index EUROPEAN PHARMACOPOEIA 9.2
Haematopoietic progenitor cells, human, colony-forming cellassay for (2.7.28.) .................................................................... 274
Haematopoietic stem cells, human....................................... 2682Haemodiafiltration and haemofiltration, solutions for...... 2631Haemodialysis, concentrated solutions for ......................... 2628Haemodialysis solutions, concentrated, water fordiluting................................................................................... 2627
Haemodialysis, solutions for ................................................. 2628Haemofiltration and haemodiafiltration, solutions for...... 2631Haemophilus type b and meningococcal group C conjugatevaccine ..................................................................................... 926
Haemophilus type b (conjugate), diphtheria, tetanus andpertussis (acellular, component) vaccine (adsorbed)......... 908
Haemophilus type b (conjugate), diphtheria, tetanus, pertussis(acellular, component) and poliomyelitis (inactivated)vaccine (adsorbed) ................................................................. 917
Haemophilus type b (conjugate), diphtheria, tetanus, pertussis(acellular, component), hepatitis B (rDNA) and poliomyelitis(inactivated) vaccine (adsorbed) .......................................... 915
Haemophilus type b (conjugate), diphtheria, tetanus,pertussis (whole cell) and poliomyelitis (inactivated) vaccine(adsorbed) ............................................................................... 922
Haemophilus type b conjugate vaccine.................................. 927Haemorrhagic disease vaccine (inactivated), rabbit........... 1092Halofantrine hydrochloride................................................... 2633Haloperidol.............................................................................. 2634Haloperidol decanoate ........................................................... 2636Halothane ................................................................................ 2637Hamamelis bark...................................................................... 1382Hamamelis leaf........................................................................ 1383Hard capsules ............................................................................ 854Hard fat .................................................................................... 2639Hard fat with additives........................................................... 2640Hard paraffin........................................................................... 3268Harmonisation, pharmacopoeial (5.8.)......................... 9.2-4395Hawthorn berries.................................................................... 1384Hawthorn leaf and flower ...................................................... 1385Hawthorn leaf and flower dry extract .................................. 1386Hawthorn leaf and flower liquid extract, quantified .......... 1387HCP assays (2.6.34.) ........................................................9.1-4041Healthy chicken flocks for the production of inactivatedvaccines for veterinary use (5.2.13.)..................................... 630
Heavy bismuth subnitrate...................................................... 1853Heavy kaolin............................................................................ 2847Heavy magnesium carbonate ................................................ 2955Heavy magnesium oxide........................................................ 2962Heavy metals (2.4.8.) ................................................................ 133Heavy metals in herbal drugs and herbal drug preparations(2.4.27.) .................................................................................... 152
Hedera helix for homoeopathic preparations ..................... 1602Helium ..................................................................................... 2642Heparin, assay of (2.7.5.) ................................................ 9.1-4049Heparin calcium ..................................................................... 2642Heparin in coagulation factors, assay of (2.7.12.)................. 259Heparins, low-molecular-mass ............................................. 2646Heparin sodium...................................................................... 2644Hepatitis A immunoglobulin, human.................................. 2683Hepatitis A (inactivated, adsorbed) and typhoid polysaccharidevaccine ..................................................................................... 929
Hepatitis A (inactivated) and hepatitis B (rDNA) vaccine(adsorbed) ............................................................................... 930
Hepatitis A vaccine, assay of (2.7.14.) .................................... 262Hepatitis A vaccine (inactivated, adsorbed).......................... 931Hepatitis A vaccine (inactivated, virosome) ......................... 932Hepatitis B immunoglobulin for intravenous administration,human .................................................................................... 2684
Hepatitis B immunoglobulin, human .................................. 2684Hepatitis B (rDNA), diphtheria and tetanus vaccine(adsorbed) ............................................................................... 901
Hepatitis B (rDNA), diphtheria, tetanus and pertussis(acellular, component) vaccine (adsorbed) ......................... 910
Hepatitis B (rDNA), diphtheria, tetanus, pertussis (acellular,component), poliomyelitis (inactivated) and haemophilustype b conjugate vaccine (adsorbed) .................................... 915
Hepatitis B vaccine (rDNA) .................................................... 935Hepatitis B vaccine (rDNA), assay of (2.7.15.)...................... 263Hepatitis C virus (HCV), validation of nucleic acidamplification techniques for the detection of HCV RNA inplasma pools : guidelines ....................................................... 214
Hepatitis type I vaccine (live), viral, duck ........................... 1047Heptaminol hydrochloride .................................................... 2649Herbal drug extracts................................................................. 815Herbal drug extracts, monographs on (information chapter)(5.23.) ....................................................................................... 807
Herbal drug preparations ........................................................ 819Herbal drugs..................................................................... 9.2-4419Herbal drugs and herbal drug preparations, heavy metals in(2.4.27.) .................................................................................... 152
Herbal drugs and herbal drug preparations, high-performancethin-layer chromatography of (2.8.25.)................................ 295
Herbal drugs, determination of aflatoxin B1 in (2.8.18.) ..... 289Herbal drugs, essential oils in (2.8.12.).................................. 285Herbal drugs for homoeopathic preparations..................... 1570Herbal drugs, microscopic examination of (2.8.23)............. 295Herbal drugs : sampling and sample preparation (2.8.20.).. 291Herbal drugs, tannins in (2.8.14.)........................................... 288Herbal drugs, test for aristolochic acids in (2.8.21) ............. 292Herbal medicinal products for oral use and extracts used intheir preparation, microbiological examination (2.6.31.).. 232
Herbal medicinal products for oral use and extracts used intheir preparation, microbiological quality (5.1.8.) ............. 591
Herbal preparations.................................................................. 819Herbal substances ............................................................ 9.2-4419Herbal teas................................................................................. 820Herbal teas, instant................................................................... 820Herpesvirus vaccine (inactivated), equine........................... 1050Herpes zoster (shingles) vaccine (live)................................... 982Hexamidine diisetionate ........................................................ 2650Hexetidine ............................................................................... 2651Hexosamines in polysaccharide vaccines (2.5.20.) ............... 167Hexylresorcinol ....................................................................... 2652Highly purified water ............................................................. 3933High-molecular-mass macrogols.......................................... 2952High-performance thin-layer chromatography of herbal drugsand herbal drug preparations (2.8.25.) ................................ 295
Histamine (2.6.10.) ................................................................... 194Histamine dihydrochloride ................................................... 2653Histamine for homoeopathic preparations .................. 9.1-4118Histaminum for homoeopathic preparations .............. 9.1-4118Histidine .................................................................................. 2654Histidine hydrochloride monohydrate ................................ 2655Homatropine hydrobromide ................................................. 2657Homatropine methylbromide ............................................... 2658Homoeopathic pillules, coated.............................................. 1587Homoeopathic pillules, impregnated ............................ 9.1-4118Homoeopathic preparations........................................... 9.1-4117Homoeopathic preparations, Agaricus phalloides for ....... 1588Homoeopathic preparations, Allium sativum for .............. 1590Homoeopathic preparations, Anacardium for.................... 1591Homoeopathic preparations, Apis for.................................. 1592Homoeopathic preparations, arsenicum album for ........... 1593Homoeopathic preparations, aurum chloratum natronatumfor ........................................................................................... 1593
Homoeopathic preparations, barium chloratum for.......... 1594Homoeopathic preparations, Belladonna for............... 9.2-4492Homoeopathic preparations, cadmium sulfuricum for..... 1596Homoeopathic preparations, calcium iodatum for ............ 1596Homoeopathic preparations, Cocculus for ......................... 1597Homoeopathic preparations, Crocus for ............................. 1599Homoeopathic preparations, cuprum aceticum for........... 1599Homoeopathic preparations, cuprum metallicum for....... 1600Homoeopathic preparations, ferrum metallicum for ........ 1601Homoeopathic preparations, hedera helix for .................... 1602Homoeopathic preparations, herbal drugs for.................... 1570
4646 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 9.2 Index
Homoeopathic preparations, hydrastis canadensis for ...... 1603Homoeopathic preparations, hyoscyamus for .................... 1604Homoeopathic preparations, hypericum for....................... 1605Homoeopathic preparations, kalium bichromicum for..... 1608Homoeopathic preparations, magnesium fluoratum for ... 1609Homoeopathic preparations, magnesium phosphoricumfor ........................................................................................... 1609
Homoeopathic preparations, mother tinctures for ............ 1571Homoeopathic preparations, Nux-vomica for .................... 1610Homoeopathic preparations, petroleum rectificatum for.. 1612Homoeopathic preparations, pillules for ............................. 1586Homoeopathic preparations, selenium for................... 9.2-4494Homoeopathic preparations, Staphysagria for.................... 1612Homoeopathic preparations, sulfur for ............................... 1614Homoeopathic preparations, Urtica dioica for ................... 1614Homoeopathic stocks (methods of preparation of) andpotentisation .................................................................. 9.2-4479
Homoepathic preparations, Ignatia for................................ 1606Honey ....................................................................................... 2659Honey bee for homoeopathic preparations......................... 1592Hop strobile............................................................................. 1388Horse-chestnut ........................................................................ 1389Horse-chestnut dry extract, standardised............................ 1390Host-cell protein assays (2.6.34.) ................................... 9.1-4041Human α-1-proteinase inhibitor .......................................... 2694Human α-1-proteinase inhibitor, assay of (2.7.32.).............. 278Human albumin injection, iodinated (125I) ......................... 1152Human albumin solution ...................................................... 2660Human anti-D immunoglobulin .......................................... 2662Human anti-D immunoglobulin, assay of (2.7.13.) ............. 260Human anti-D immunoglobulin for intravenousadministration....................................................................... 2663
Human antithrombin III, assay of (2.7.17.)........................... 265Human antithrombin III concentrate .................................. 2664Human C1-esterase inhibitor................................................ 2665Human C1-esterase inhibitor, assay of (2.7.34.) ................... 278Human coagulation factor II, assay of (2.7.18.).................... 266Human coagulation factor IX ............................................... 2674Human coagulation factor IX, assay of (2.7.11.) .................. 259Human coagulation factor IX (rDNA) concentratedsolution .................................................................................. 2676
Human coagulation factor VII.............................................. 2666Human coagulation factor VIIa (rDNA) concentratedsolution .................................................................................. 2668
Human coagulation factor VII, assay of (2.7.10.)................. 258Human coagulation factor VIII ............................................ 2672Human coagulation factor VIII, assay of (2.7.4.) ................. 246Human coagulation factor VIII (rDNA) ............................. 2673Human coagulation factor X, assay of (2.7.19.) .................... 266Human coagulation factor XI ............................................... 2681Human coagulation factor XI, assay of (2.7.22.) .................. 269Human fibrinogen .................................................................. 2682Human glucagon..................................................................... 2584Human haematopoietic progenitor cells, colony-forming cellassay for (2.7.28.) .................................................................... 274
Human haematopoietic stem cells........................................ 2682Human hepatitis A immunoglobulin................................... 2683Human hepatitis B immunoglobulin ................................... 2684Human hepatitis B immunoglobulin for intravenousadministration....................................................................... 2684
Human insulin ........................................................................ 2768Human measles immunoglobulin ........................................ 2685Human normal immunoglobulin for intramuscularadministration....................................................................... 2685
Human normal immunoglobulin for intravenousadministration....................................................................... 2687
Human normal immunoglobulin for subcutaneousadministration....................................................................... 2689
Human papillomavirus vaccine (rDNA) ............................... 936Human plasma for fractionation .......................................... 2691Human plasma (pooled and treated for virusinactivation) ................................................................... 9.2-4555
Human plasmin inhibitor, assay of (2.7.25.) ......................... 272
Human protein C, assay of (2.7.30.)....................................... 276Human protein S, assay of (2.7.31.)........................................ 277Human prothrombin complex .............................................. 2695Human rabies immunoglobulin ........................................... 2696Human rubella immunoglobulin ......................................... 2698Human tetanus immunoglobulin ......................................... 2698Human varicella immunoglobulin ....................................... 2700Human varicella immunoglobulin for intravenousadministration....................................................................... 2700
Human von Willebrand factor .............................................. 2701Human von Willebrand factor, assay of (2.7.21.) ................. 268Hyaluronate, sodium.............................................................. 3583Hyaluronidase ........................................................................ 2702Hydralazine hydrochloride............................................. 9.2-4557Hydrastis canadensis for homoeopathic preparations ....... 1603Hydrochloric acid, concentrated .......................................... 2704Hydrochloric acid, dilute ....................................................... 2704Hydrochlorothiazide .............................................................. 2705Hydrocodone hydrogen tartrate 2.5-hydrate ...................... 2706Hydrocortisone ....................................................................... 2708Hydrocortisone acetate .......................................................... 2711Hydrocortisone hydrogen succinate..................................... 2713Hydrogenated arachis oil ....................................................... 1752Hydrogenated castor oil ......................................................... 1966Hydrogenated cottonseed oil................................................. 2173Hydrogenated soya-bean oil.................................................. 3630Hydrogenated vegetable oils, nickel in (2.4.31.) ................... 157Hydrogenated wool fat........................................................... 3943Hydrogen peroxide solution (30 per cent) .......................... 2715Hydrogen peroxide solution (3 per cent) ............................ 2715Hydromorphone hydrochloride............................................ 2716Hydrophobic colloidal silica.................................................. 3551Hydrous wool fat .................................................................... 3944Hydroxocobalamin acetate .................................................... 2717Hydroxocobalamin chloride.................................................. 2718Hydroxocobalamin sulfate..................................................... 2719Hydroxycarbamide ................................................................. 2720Hydroxychloroquine sulfate .................................................. 2721Hydroxyethylcellulose ............................................................ 2724Hydroxyethylmethylcellulose ................................................ 3037Hydroxyethyl salicylate .......................................................... 2723Hydroxyethyl starches ............................................................ 3649Hydroxyl value (2.5.3.)............................................................. 161Hydroxypropylbetadex........................................................... 2725Hydroxypropylcellulose ......................................................... 2727Hydroxypropylcellulose, low-substituted ............................ 2729Hydroxypropylmethylcellulose ............................................. 2738Hydroxypropylmethylcellulose phthalate ............................ 2740Hydroxypropyl starch............................................................. 3645Hydroxypropyl starch, pregelatinised .................................. 3647Hydroxyzine hydrochloride................................................... 2730Hymecromone......................................................................... 2731Hymenoptera venoms for allergen products....................... 2732Hyoscine .................................................................................. 2733Hyoscine butylbromide.......................................................... 2734Hyoscine hydrobromide ........................................................ 2735Hyoscyamine sulfate............................................................... 2737Hyoscyamus for homoeopathic preparations ..................... 1604Hypericum............................................................................... 1526Hypericum for homoeopathic preparations........................ 1605Hypromellose .......................................................................... 2738Hypromellose phthalate ......................................................... 2740
IIbuprofen ................................................................................. 2745Iceland moss............................................................................ 1392ICH (5.8.).......................................................................... 9.2-4395Ichthammol ............................................................................. 2747Identification (2.3.) ................................................................... 123Identification and control of residual solvents (2.4.24.) ...... 146Identification of fatty oils by thin-layer chromatography(2.3.2.) ...................................................................................... 126
General Notices (1) apply to all monographs and other texts 4647
Index EUROPEAN PHARMACOPOEIA 9.2
Identification of phenothiazines by thin-layer chromatography(2.3.3.) ...................................................................................... 127
Identification reactions of ions and functional groups(2.3.1.) ...................................................................................... 123
Idoxuridine .............................................................................. 2748Ifosfamide ................................................................................ 2749Ignatia for homoeopathic preparations ............................... 1606Imatinib mesilate ............................................................. 9.2-4561Imipenem monohydrate ........................................................ 2753Imipramine hydrochloride .................................................... 2754Immunochemical methods (2.7.1.) ........................................ 239Immunoglobulin for human use, anti-T lymphocyte,animal .................................................................................... 1741
Immunoglobulin for intramuscular administration, humannormal.................................................................................... 2685
Immunoglobulin for intravenous administration, humananti-D ..................................................................................... 2663
Immunoglobulin for intravenous administration, humanhepatitis B.............................................................................. 2684
Immunoglobulin for intravenous administration, humannormal.................................................................................... 2687
Immunoglobulin for intravenous administration, humanvaricella .................................................................................. 2700
Immunoglobulin for subcutaneous administration, humannormal.................................................................................... 2689
Immunoglobulin, human anti-D.......................................... 2662Immunoglobulin, human anti-D, assay of (2.7.13.) ............. 260Immunoglobulin, human hepatitis A .................................. 2683Immunoglobulin, human hepatitis B................................... 2684Immunoglobulin, human measles ........................................ 2685Immunoglobulin, human rabies ........................................... 2696Immunoglobulin, human rubella ......................................... 2698Immunoglobulin, human tetanus......................................... 2698Immunoglobulin, human varicella ....................................... 2700Immunoglobulin, test for anticomplementary activity of(2.6.17.) .................................................................................... 210
Immunoglobulin, test for Fc function of (2.7.9.).................. 257Immunological veterinary medicinal products, substances ofanimal origin for the production of (5.2.5.)........................ 608
Immunonephelometry for vaccine component assay(2.7.35.) .................................................................................... 279
Immunosera and vaccines, phenol in (2.5.15.) ..................... 166Immunosera and vaccines, veterinary, evaluation of efficacyof (5.2.7.).................................................................................. 612
Immunosera and vaccines, veterinary, evaluation of safety(5.2.6.) ...................................................................................... 610
Immunosera for human use, animal ...................................... 821Immunosera for veterinary use............................................... 823Immunosera for veterinary use, evaluation of the safety ofeach batch (5.2.9.)................................................................... 625
Implants ..................................................................................... 873Impurities in substances for pharmaceutical use, control of(5.10.) ....................................................................................... 723
Inactivated vaccines for veterinary use, healthy chicken flocksfor the production of (5.2.13.) .............................................. 630
Indapamide.............................................................................. 2755Indian frankincense................................................................ 1392Indicators, approximate pH of solutions (2.2.4.) .................... 25Indigo plant leaf ...................................................................... 1393Indinavir sulfate ...................................................................... 2757Indium (111In) chloride solution ........................................... 1153Indium (111In) oxine solution ................................................ 1154Indium (111In) pentetate injection ........................................ 1154Indometacin ............................................................................ 2759Inductively coupled plasma-atomic emission spectrometry(2.2.57.) .................................................................................... 100
Inductively coupled plasma-mass spectrometry (2.2.58.) ... 101Infectious bovine rhinotracheitis vaccine (inactivated)..... 1067Infectious bovine rhinotracheitis vaccine (live).................. 1068Infectious bronchitis vaccine (inactivated), avian .............. 1007Infectious bronchitis vaccine (live), avian ........................... 1008Infectious bursal disease vaccine (inactivated), avian........ 1010Infectious bursal disease vaccine (live), avian..................... 1011
Infectious chicken anaemia vaccine (live) ........................... 1069Infectious encephalomyelitis vaccine (live), avian.............. 1013Infectious enteritis vaccine (inactivated), feline ................. 1056Infectious enteritis vaccine (live), feline .............................. 1057Infectious laryngotracheitis vaccine (live), avian ............... 1014Infectious rhinotracheitis vaccine (live), turkey ................. 1107Influenza vaccine (inactivated), equine ............................... 1051Influenza vaccine (inactivated), porcine.............................. 1087Influenza vaccine (live, nasal) ................................................. 939Influenza vaccine (split virion, inactivated) .......................... 942Influenza vaccine (surface antigen, inactivated)................... 943Influenza vaccine (surface antigen, inactivated, prepared incell cultures) ............................................................................ 945
Influenza vaccine (surface antigen, inactivated, virosome).. 947Influenza vaccine (whole virion, inactivated) ....................... 949Influenza vaccine (whole virion, inactivated, prepared in cellcultures) ................................................................................... 950
Infrared absorption spectrophotometry (2.2.24.)................... 39Infusions .................................................................................... 872Inhalation gas, krypton (81mKr)............................................. 1159Inhalation powders................................................................... 878Inhalation, preparations for .................................................... 875Inhalation, preparations for : aerodynamic assessment of fineparticles (2.9.18.) .................................................................... 323
Injectable insulin preparations.............................................. 2776Injections ................................................................................... 871Injections, gels for..................................................................... 873Injections or infusions, concentrates for ............................... 872Injections or infusions, powders for....................................... 872Inositol, myo- .......................................................................... 2761Inserts, ophthalmic................................................................... 858Instant herbal teas .................................................................... 820Insulin aspart........................................................................... 2762Insulin, bovine ........................................................................ 2763Insulin glargine ....................................................................... 2766Insulin, human........................................................................ 2768Insulin injection, biphasic ..................................................... 2770Insulin injection, biphasic isophane..................................... 2770Insulin injection, isophane .................................................... 2771Insulin injection, soluble ....................................................... 2771Insulin lispro ........................................................................... 2771Insulin, porcine ....................................................................... 2774Insulin preparations, injectable............................................. 2776Insulin zinc injectable suspension ........................................ 2778Insulin zinc injectable suspension (amorphous) ................ 2779Insulin zinc injectable suspension (crystalline) .................. 2779Interferon alfa-2 concentrated solution ............................... 2780Interferon beta-1a concentrated solution ............................ 2782Interferon gamma-1b concentrated solution ...................... 2785Interferons, assay of (5.6.)........................................................ 689International System (SI) units (1.) ............................... 9.2-4275Intramammary preparations for veterinary use ................... 861Intraruminal devices ................................................................ 861Intrauterine capsules ................................................................ 862Intrauterine foams .................................................................... 862Intrauterine preparations for veterinary use ......................... 862Intrauterine solutions, suspensions ........................................ 862Intrauterine sticks ..................................................................... 862Intrauterine tablets ................................................................... 862Intrinsic dissolution (2.9.29.) .................................................. 347In vivo assay of poliomyelitis vaccine (inactivated)(2.7.20.) .................................................................................... 267
Iobenguane (123I) injection .................................................... 1155Iobenguane (131I) injection for diagnostic use..................... 1156Iobenguane (131I) injection for therapeutic use................... 1157Iobenguane sulfate for radiopharmaceutical preparations.. 9.2-4435
Iodinated (125I) human albumin injection ........................... 1152Iodinated povidone ................................................................ 3394Iodine ....................................................................................... 2788Iodine value (2.5.4.).................................................................. 161Iodixanol .................................................................................. 2788
4648 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 9.2 Index
Iodohippurate (sodium) dihydrate for radiopharmaceuticalpreparations ................................................................... 9.2-4438
Iodomethylnorcholesterol (131I) injection............................ 1159Iohexol...................................................................................... 2791Ionic concentration, potentiometric determination of usingion-selective electrodes (2.2.36.)............................................. 60
Ions and functional groups, identification reactions of(2.3.1.) ...................................................................................... 123
Ion-selective electrodes, potentiometric determination ofionic concentration (2.2.36.) ................................................... 60
Iopamidol................................................................................. 2795Iopanoic acid ........................................................................... 2797Iopromide ................................................................................ 2798Iotrolan .................................................................................... 2801Ioxaglic acid............................................................................. 2803Ipecacuanha liquid extract, standardised ............................ 1395Ipecacuanha, prepared ........................................................... 1395Ipecacuanha root .................................................................... 1397Ipecacuanha tincture, standardised...................................... 1398Ipratropium bromide ............................................................. 2805Irbesartan................................................................................. 2807Irinotecan hydrochloride trihydrate..................................... 2808Iron (2.4.9.)................................................................................ 136Iron for homoeopathic preparations.................................... 1601Irrigation, preparations for...................................................... 880Isatis root ................................................................................. 1399Isoconazole .............................................................................. 2810Isoconazole nitrate.................................................................. 2811Isoelectric focusing (2.2.54.) ..................................................... 89Isoflurane ................................................................................. 2813Isoleucine................................................................................. 2814Isomalt ..................................................................................... 2815Isoniazid................................................................................... 2817Isophane insulin injection ..................................................... 2771Isoprenaline hydrochloride ................................................... 2817Isoprenaline sulfate................................................................. 2818Isopropyl alcohol .................................................................... 2819Isopropyl isostearate........................................................ 9.2-4563Isopropyl myristate................................................................. 2820Isopropyl palmitate................................................................. 2821Isosorbide dinitrate, diluted ................................................. 2821Isosorbide mononitrate, diluted .......................................... 2823Isotretinoin .............................................................................. 2825Isoxsuprine hydrochloride..................................................... 2826Ispaghula husk ........................................................................ 1400Ispaghula seed ......................................................................... 1400Isradipine ................................................................................. 2828Itraconazole ............................................................................. 2829Ivermectin................................................................................ 2832Ivy leaf ...................................................................................... 1401
JJavanese turmeric.................................................................... 1544Java tea ..................................................................................... 1402Josamycin................................................................................. 2837Josamycin propionate............................................................. 2839Juniper...................................................................................... 1404Juniper oil ................................................................................ 1404
KKalium bichromicum for homoeopathic preparations ...... 1608Kanamycin acid sulfate .......................................................... 2845Kanamycin monosulfate ........................................................ 2846Kaolin, heavy........................................................................... 2847Kelp........................................................................................... 1405Ketamine hydrochloride ........................................................ 2847Ketobemidone hydrochloride ............................................... 2848Ketoconazole ........................................................................... 2849Ketoprofen ............................................................................... 2851Ketorolac trometamol ............................................................ 2853Ketotifen hydrogen fumarate ................................................ 2854Knotgrass ................................................................................. 1406
Krypton (81mKr) inhalation gas ............................................. 1159Kudzuvine root ....................................................................... 1407Kudzuvine root, Thomson..................................................... 1537
LLabetalol hydrochloride......................................................... 2859Lactic acid................................................................................ 2860Lactic acid, (S)- ....................................................................... 2861Lactitol monohydrate ............................................................. 2862Lactobionic acid...................................................................... 2863Lactose ..................................................................................... 2864Lactose monohydrate ............................................................. 2866Lactulose .................................................................................. 2867Lactulose, liquid...................................................................... 2869Lamivudine.............................................................................. 2871Lamotrigine ............................................................................. 2873Lansoprazole ........................................................................... 2874Largehead atractylodes rhizome ........................................... 1260Laryngotracheitis vaccine (live), infectious, avian ............. 1014Laser light diffraction, particle size analysis by (2.9.31.) .... 349Laurilsulfate, sodium....................................................... 9.1-4200Lauromacrogol 400................................................................. 2876Lauroyl macrogolglycerides............................................ 9.1-4173Lavender flower ...................................................................... 1408Lavender oil ............................................................................. 1410Lavender oil, spike.................................................................. 1525Lead in sugars (2.4.10.) ............................................................ 136Leflunomide ............................................................................ 2879Lemon oil................................................................................. 1411Lemon verbena leaf ................................................................ 1412Leptospirosis vaccine (inactivated), bovine......................... 1019Leptospirosis vaccine (inactivated), canine ......................... 1030Letrozole .................................................................................. 2880Leucine..................................................................................... 2881Leukaemia vaccine (inactivated), feline............................... 1058Leuprorelin .............................................................................. 2883Levamisole for veterinary use ............................................... 2885Levamisole hydrochloride ..................................................... 2886Levetiracetam.......................................................................... 2887Levocabastine hydrochloride ................................................ 2888Levocarnitine........................................................................... 2890Levodopa ................................................................................. 2892Levodropropizine.................................................................... 2893Levofolinate pentahydrate, calcium...................................... 1926Levomenthol............................................................................ 2894Levomepromazine hydrochloride......................................... 2895Levomepromazine maleate.................................................... 2896Levomethadone hydrochloride ............................................. 2897Levonorgestrel......................................................................... 2899Levothyroxine sodium ........................................................... 2902Levulinate dihydrate, calcium ............................................... 1928Lidocaine ................................................................................. 2903Lidocaine hydrochloride........................................................ 2905Light liquid paraffin ............................................................... 3269Light magnesium carbonate .................................................. 2956Light magnesium oxide.......................................................... 2963Lime flower.............................................................................. 1414Limit tests (2.4.) ........................................................................ 131Limit tests, standard solutions for (4.1.2.) ............................. 555Limit tests, standard solutions for (4.1.2.) .................... 9.2-4324Lincomycin hydrochloride .................................................... 2906Linen thread, sterile, in distributor for veterinary use ..... 1220Linoleoyl macrogolglycerides......................................... 9.1-4174Linseed ..................................................................................... 1415Linseed oil, virgin ................................................................... 2908Liothyronine sodium.............................................................. 2909Lipophilic solid dosage forms, dissolution test for(2.9.42.) .................................................................................... 377
Liquid chromatography (2.2.29.) .............................................. 46Liquid extraction preparations ............................................... 817Liquid (fluid) extracts .............................................................. 817Liquid glucose ......................................................................... 2590
General Notices (1) apply to all monographs and other texts 4649
Index EUROPEAN PHARMACOPOEIA 9.2
Liquid glucose, spray-dried ................................................... 2591Liquid lactulose....................................................................... 2869Liquid maltitol ........................................................................ 2974Liquid paraffin ........................................................................ 3269Liquid preparations for cutaneous application ..................... 864Liquid preparations for cutaneous application, veterinary.. 889Liquid preparations for oral use ............................................. 864Liquids, clarity and degree of opalescence of (2.2.1.) .. 9.2-4285Liquid sorbitol (crystallising)................................................ 3626Liquid sorbitol (non-crystallising) ....................................... 3627Liquid sorbitol, partially dehydrated.................................... 3628Liquorice dry extract for flavouring purposes .................... 1415Liquorice root ......................................................................... 1416Lisinopril dihydrate ................................................................ 2910Lithium carbonate .................................................................. 2912Lithium citrate ........................................................................ 2913L-Methionine ([11C]methyl) injection .................................. 1161Lobeline hydrochloride.......................................................... 2913Lomustine ................................................................................ 2914Long pepper ............................................................................ 1417Loosestrife ............................................................................... 1419Loperamide hydrochloride.................................................... 2915Loperamide oxide monohydrate........................................... 2917Lopinavir.................................................................................. 2918Loratadine................................................................................ 2922Lorazepam ............................................................................... 2924Losartan potassium ................................................................ 2925Loss on drying (2.2.32.) ............................................................. 53Loss on drying of extracts (2.8.17.) ........................................ 289Lovage root .............................................................................. 1420Lovastatin ................................................................................ 2927Low-molecular-mass heparins.............................................. 2646Low-substituted hydroxypropylcellulose ............................. 2729Lozenges and pastilles .............................................................. 870Lozenges, compressed .............................................................. 870Lubricant, silicone oil (3.1.8.).................................................. 408Lufenuron for veterinary use ................................................ 2929Lutetium (177Lu) solution for radiolabelling................. 9.2-4436Lycopus lucidus herb....................................................... 9.1-4105Lymecycline............................................................................. 2930Lynestrenol .............................................................................. 2932Lyophilisates, oral ..................................................................... 887Lysine acetate .......................................................................... 2933Lysine hydrochloride.............................................................. 2935
MMacrogol 15 hydroxystearate ................................................ 2939Macrogol 20 glycerol monostearate...................................... 2940Macrogol 30 dipolyhydroxystearate ..................................... 2941Macrogol 40 sorbitol heptaoleate.......................................... 2941Macrogol 6 glycerol caprylocaprate...................................... 2939Macrogol cetostearyl ether .................................................... 2942Macrogolglycerol cocoates..................................................... 2948Macrogolglycerol hydroxystearate ........................................ 2949Macrogolglycerol ricinoleate ................................................. 2950Macrogol isotridecyl ether..................................................... 2943Macrogol lauryl ether............................................................. 2943Macrogol oleate....................................................................... 2944Macrogol oleyl ether............................................................... 2945Macrogol poly(vinyl alcohol) grafted copolymer ............... 2945Macrogols ................................................................................ 2950Macrogols, high-molecular-mass ......................................... 2952Macrogol stearate.................................................................... 2947Macrogol stearyl ether ........................................................... 2947Magaldrate ............................................................................... 2953Magnesium (2.4.6.)................................................................... 132Magnesium acetate tetrahydrate ........................................... 2954Magnesium aluminium silicate............................................. 1683Magnesium and alkaline-earth metals (2.4.7.)...................... 133Magnesium aspartate dihydrate............................................ 2955Magnesium carbonate, heavy................................................ 2955Magnesium carbonate, light .................................................. 2956
Magnesium chloride 4.5-hydrate .......................................... 2957Magnesium chloride hexahydrate ........................................ 2957Magnesium citrate .................................................................. 2958Magnesium citrate dodecahydrate........................................ 2959Magnesium citrate nonahydrate ........................................... 2959Magnesium fluoratum for homoeopathic preparations..... 1609Magnesium gluconate ............................................................ 2960Magnesium glycerophosphate............................................... 2960Magnesium hydroxide............................................................ 2961Magnesium lactate dihydrate ................................................ 2961Magnesium oxide, heavy ....................................................... 2962Magnesium oxide, light.......................................................... 2963Magnesium peroxide.............................................................. 2963Magnesium phosphoricum for homoeopathicpreparations .......................................................................... 1609
Magnesium pidolate ............................................................... 2964Magnesium stearate................................................................ 2965Magnesium sulfate heptahydrate .......................................... 2968Magnesium trisilicate ............................................................. 2968Magnolia officinalis bark ................................................ 9.2-4467Magnolia officinalis flower .................................................... 1423Maize oil, refined .................................................................... 2969Maize starch ............................................................................ 2969Malathion................................................................................. 2970Maleic acid............................................................................... 2971Malic acid ................................................................................ 2972Mallow flower.......................................................................... 1424Mallow leaf .............................................................................. 1425Maltitol..................................................................................... 2973Maltitol, liquid ........................................................................ 2974Maltodextrin............................................................................ 2975Mandarin epicarp and mesocarp.......................................... 1426Mandarin oil............................................................................ 1428Manganese gluconate ............................................................. 2976Manganese glycerophosphate, hydrated .............................. 2976Manganese sulfate monohydrate ................................... 9.2-4567Mannheimia vaccine (inactivated) for cattle....................... 1071Mannheimia vaccine (inactivated) for sheep ...................... 1072Mannitol ........................................................................... 9.2-4567Maprotiline hydrochloride .................................................... 2980Marbofloxacin for veterinary use ......................................... 2981Marek’s disease vaccine (live) ................................................ 1073Marshmallow leaf ................................................................... 1429Marshmallow root .................................................................. 1430Mass spectrometry (2.2.43.) ...................................................... 71Mass spectrometry, inductively coupled plasma- (2.2.58.).. 101Mass uniformity of delivered doses from multidose containers(2.9.27.) .................................................................................... 347
Mass uniformity of single-dose preparations (2.9.5.) .......... 311Mastic ....................................................................................... 1430Materials based on non-plasticised poly(vinyl chloride)for containers for non-injectable, aqueous solutions(3.1.10.) .................................................................................... 410
Materials based on non-plasticised poly(vinyl chloride) forcontainers for solid dosage forms for oral administration(3.1.11.) .................................................................................... 412
Materials based on plasticised poly(vinyl chloride) forcontainers for aqueous solutions for intravenous infusion(3.1.14.) .................................................................................... 416
Materials based on plasticised poly(vinyl chloride) forcontainers for human blood and blood components(3.1.1.1.) ................................................................................... 391
Materials based on plasticised poly(vinyl chloride) fortubing used in sets for the transfusion of blood and bloodcomponents (3.1.1.2.)............................................................. 393
Materials for containers for human blood and bloodcomponents (3.1.1.)................................................................ 391
Materials used for the manufacture of containers (3.1.)...... 391Matricaria flower .................................................................... 1431Matricaria liquid extract ........................................................ 1433Matricaria oil........................................................................... 1434Meadowsweet .......................................................................... 1436Measles immunoglobulin, human ........................................ 2685
4650 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 9.2 Index
Measles, mumps and rubella vaccine (live)........................... 952Measles, mumps, rubella and varicella vaccine (live) .......... 953Measles vaccine (live)............................................................... 955Measurement and detection of radioactivity (2.2.66.) ......... 113Measurement of consistency by penetrometry (2.9.9.)........ 313Mebendazole ........................................................................... 2983Meclozine dihydrochloride.................................................... 2984Medicated chewing gums ........................................................ 855Medicated chewing gums, dissolution test for (2.9.25.)....... 340Medicated feeding stuffs for veterinary use, premixes for .. 875Medicated foams....................................................................... 859Medicated plasters .................................................................... 884Medicated tampons .................................................................. 887Medicated vaginal tampons..................................................... 889Medicinal air ........................................................................... 1653Medicinal air, synthetic.......................................................... 1655Medium-chain triglycerides .................................................. 3839Medronic acid for radiopharmaceutical preparations.. 9.2-4437Medroxyprogesterone acetate................................................ 2985Mefenamic acid....................................................................... 2987Mefloquine hydrochloride..................................................... 2989Megestrol acetate .................................................................... 2990Meglumine............................................................................... 2992Meldonium dihydrate............................................................. 2993Melilot ...................................................................................... 1437Melissa leaf .............................................................................. 1438Melissa leaf dry extract .......................................................... 1439Meloxicam ............................................................................... 2994Melphalan ................................................................................ 2996Melting point - capillary method (2.2.14.) ................... 9.1-4037Melting point - instantaneous method (2.2.16.) ..................... 33Melting point - open capillary method (2.2.15.) .................... 32Menadione............................................................................... 2998Meningococcal group C and haemophilus type b conjugatevaccine ..................................................................................... 926
Meningococcal group C conjugate vaccine ........................... 956Meningococcal polysaccharide vaccine ................................. 958Menthol, racemic .................................................................... 2998Mepivacaine hydrochloride ................................................... 2999Meprobamate .......................................................................... 3001Mepyramine maleate.............................................................. 3001Mercaptopurine ...................................................................... 3003Mercuric chloride ................................................................... 3003Mercury porosimetry, porosity and pore-size distribution ofsolids by (2.9.32.) .................................................................... 352
Meropenem trihydrate ........................................................... 3004Mesalazine ............................................................................... 3005Mesna ................................................................................ 9.2-4569Mesterolone ............................................................................. 3009Mestranol ................................................................................. 3010Metabisulfite, potassium ........................................................ 3386Metabisulfite, sodium............................................................. 3591Metacresol................................................................................ 3011Metal catalyst or metal reagent residues (5.20.).................... 775Metal catalyst or metal reagent residues, determination of(2.4.20.) .................................................................................... 138
Metamizole sodium monohydrate........................................ 3012Metered-dose preparations for inhalation, non-pressurised............................................................................... 878
Metered-dose preparations for inhalation, pressurised ....... 876Metformin hydrochloride...................................................... 3014Methacrylate copolymer, basic butylated ............................ 1798Methacrylic acid - ethyl acrylate copolymer (1:1).............. 3015Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion30 per cent ............................................................................. 3017
Methacrylic acid - methyl methacrylate copolymer (1:1).. 3018Methacrylic acid - methyl methacrylate copolymer (1:2).. 3019Methadone hydrochloride ..................................................... 3020Methane ................................................................................... 3021Methanesulfonate (methyl, ethyl and isopropyl) in activesubstances (2.5.38.)................................................................. 177
Methanesulfonic acid, methanesulfonyl chloride in(2.5.39.) .................................................................................... 178
Methanesulfonic acid, methyl, ethyl and isopropylmethanesulfonate in (2.5.37.)................................................ 176
Methanesulfonyl chloride in methanesulfonic acid(2.5.39.) .................................................................................... 178
Methanol.................................................................................. 3022Methanol and 2-propanol, test for (2.9.11.) .......................... 318Methenamine .......................................................................... 3023Methionine .............................................................................. 3024Methionine ([11C]methyl) injection, L- ................................ 1161Methionine, DL- ...................................................................... 3025Methods in pharmacognosy (2.8.).......................................... 283Methods of preparation of homoeopathic stocks andpotentisation .................................................................. 9.2-4479
Methods of preparation of sterile products (5.1.1.) .... 9.2-4333Methotrexate ........................................................................... 3026Methylcellulose ....................................................................... 3031Methyldopa.............................................................................. 3033Methylene blue........................................................................ 3049Methylene chloride................................................................. 3034Methylergometrine maleate .................................................. 3035Methyl, ethyl and isopropyl benzenesulfonate in activesubstances (2.5.41).................................................................. 180
Methyl, ethyl and isopropyl methanesulfonate in activesubstances (2.5.38.)................................................................. 177
Methyl, ethyl and isopropyl methanesulfonate inmethanesulfonic acid (2.5.37.) .............................................. 176
Methyl, ethyl and isopropyl toluenesulfonate in activesubstances (2.5.40.)................................................................. 179
Methylhydroxyethylcellulose................................................. 3037Methyl methacrylate – methacrylic acid copolymer (1:1).. 3018Methyl methacrylate - methacrylic acid copolymer (1:2).. 3019Methyl nicotinate.................................................................... 3028Methyl parahydroxybenzoate................................................ 3029Methyl parahydroxybenzoate, sodium................................. 3591Methylpentoses in polysaccharide vaccines (2.5.21.) ........... 167Methylphenidate hydrochloride ........................................... 3037Methylphenobarbital .............................................................. 3039Methylprednisolone................................................................ 3040Methylprednisolone acetate................................................... 3042Methylprednisolone hydrogen succinate ............................. 3044Methylpyrrolidone, N- ........................................................... 3046Methylrosanilinium chloride ................................................ 3047Methyl salicylate ..................................................................... 3030Methyltestosterone ................................................................. 3048Methylthioninium chloride ................................................... 3049Metixene hydrochloride......................................................... 3050Metoclopramide...................................................................... 3051Metoclopramide hydrochloride ............................................ 3053Metolazone .............................................................................. 3053Metoprolol succinate .............................................................. 3055Metoprolol tartrate ................................................................. 3056Metrifonate .............................................................................. 3058Metronidazole ......................................................................... 3059Metronidazole benzoate......................................................... 3060Mexiletine hydrochloride ...................................................... 3062Mianserin hydrochloride ....................................................... 3063Miconazole .............................................................................. 3064Miconazole nitrate.................................................................. 3066Microbial enumeration tests (microbiological examination ofnon-sterile products) (2.6.12.) .............................................. 195
Microbiological assay of antibiotics (2.7.2.) .......................... 240Microbiological examination of cell-based preparations(2.6.27.) ........................................................................... 9.2-4297
Microbiological examination of herbal medicinal products fororal use and extracts used in their preparation (2.6.31.)... 232
Microbiological examination of non-sterile products :microbial enumeration tests (2.6.12.) .................................. 195
Microbiological examination of non-sterile products : test forspecified micro-organisms (2.6.13.) ..................................... 199
Microbiological quality, alternative methods for control of(5.1.6.) ............................................................................. 9.2-4339
Microbiological quality of herbal medicinal products for oraluse and extracts used in their preparation (5.1.8.)............. 591
General Notices (1) apply to all monographs and other texts 4651
Index EUROPEAN PHARMACOPOEIA 9.2
Microbiological quality of non-sterile pharmaceuticalpreparations and substances for pharmaceutical use(5.1.4.) ...................................................................................... 579
Microbiology, general texts on (5.1.) ..................................... 575Microcalorimetry and solution calorimetry, characterisationof crystalline solids by (2.2.61.) ............................................ 109
Microcrystalline cellulose ...................................................... 2010Microcrystalline cellulose and carmellose sodium ............ 3068Micro determination of water (2.5.32.).................................. 172Microscopic examination of herbal drugs (2.8.23) .............. 295Microscopy, optical (2.9.37.) ................................................... 365Midazolam............................................................................... 3069Milbemycin oxime for veterinary use ........................... 9.2-4570Milk thistle dry extract, refined and standardised ............. 1440Milk thistle fruit...................................................................... 1441Minimising the risk of transmitting animal spongiformencephalopathy agents via human and veterinary medicinalproducts (5.2.8.)...................................................................... 613
Minocycline hydrochloride dihydrate........................... 9.2-4573Minoxidil ................................................................................. 3072Mint oil, partly dementholised ............................................. 1443Mirtazapine ............................................................................. 3074Misoprostol.............................................................................. 3075Mites for allergen products ................................................... 3077Mitomycin ............................................................................... 3078Mitoxantrone hydrochloride ................................................. 3079Modafinil ................................................................................. 3081Modified-release capsules ........................................................ 854Modified-release granules........................................................ 860Modified-release tablets ........................................................... 886Mofetil mycophenolate .......................................................... 3104Molecular mass distribution in dextrans (2.2.39.).................. 62Molgramostim concentrated solution.................................. 3082Molsidomine ........................................................................... 3084Molybdate dihydrate, sodium ............................................... 3592Mometasone furoate............................................................... 3086Monoclonal antibodies for human use .................................. 826Monocyte-activation test (2.6.30.) ................................. 9.2-4299Monographs on herbal drug extracts (information chapter)(5.23.) ....................................................................................... 807
Monophosphoryl lipid A, 3-O-desacyl-4- .......................... 2207Montelukast sodium........................................................ 9.1-4179Morantel hydrogen tartrate for veterinary use ................... 3090Morphine hydrochloride ....................................................... 3091Morphine sulfate..................................................................... 3093Moss, Iceland........................................................................... 1392Mother tinctures for homoeopathic preparations .............. 1571Motherwort ............................................................................. 1444Moulds for allergen products ................................................ 3094Mouthwashes............................................................................. 869Moxidectin for veterinary use............................................... 3095Moxifloxacin hydrochloride .................................................. 3098Moxonidine ............................................................................. 3100Mucoadhesive preparations..................................................... 870Mullein flower ......................................................................... 1445Multidose containers, uniformity of mass of delivered doses(2.9.27.) .................................................................................... 347
Mumps, measles and rubella vaccine (live)........................... 952Mumps, measles, rubella and varicella vaccine (live) .......... 953Mumps vaccine (live) ............................................................... 959Mupirocin ................................................................................ 3101Mupirocin calcium ................................................................. 3102Mycobacteria (2.6.2.)................................................................ 188Mycophenolate mofetil .......................................................... 3104Mycophenolate sodium.......................................................... 3105Mycoplasma gallisepticum vaccine (inactivated) ............... 1075Mycoplasmas (2.6.7.)................................................................ 188myo-Inositol ............................................................................ 2761Myrrh ................................................................................ 9.2-4468Myrrh tincture ................................................................. 9.2-4469Myxomatosis vaccine (live) for rabbits ................................ 1076
NNabumetone ............................................................................ 3109N-Acetyltryptophan ............................................................... 1639N-Acetyltyrosine ..................................................................... 1641Nadolol..................................................................................... 3110Nadroparin calcium ............................................................... 3111Naftidrofuryl hydrogen oxalate ............................................ 3113Nalidixic acid .......................................................................... 3115Naloxone hydrochloride dihydrate....................................... 3116Naltrexone hydrochloride...................................................... 3118Names of herbal drugs used in traditional Chinese medicine(5.22.) ..............................................................................9.2-4415
Nandrolone decanoate ........................................................... 3120Naphazoline hydrochloride ................................................... 3122Naphazoline nitrate ................................................................ 3123Naproxen ................................................................................. 3124Naproxen sodium ................................................................... 3126Narrow-leaved coneflower root ............................................ 1447Nasal drops and liquid nasal sprays ....................................... 867Nasal powders ........................................................................... 867Nasal preparations .................................................................... 866Nasal preparations, semi-solid................................................ 868Nasal sprays (liquid) and nasal drops .................................... 866Nasal sticks ................................................................................ 868Nasal washes.............................................................................. 868Nateglinide .............................................................................. 3128Near-infrared spectroscopy (2.2.40.)........................................ 64Nebulisation, characterisation of preparations for(2.9.44.) .................................................................................... 378
Nebulisation, liquid preparations for ..................................... 876Neohesperidin-dihydrochalcone .......................................... 3130Neomycin sulfate .................................................................... 3132Neonatal piglet colibacillosis vaccine (inactivated)............ 1077Neonatal ruminant colibacillosis vaccine (inactivated)..... 1079Neostigmine bromide............................................................. 3134Neostigmine metilsulfate ....................................................... 3135Neroli oil .................................................................................. 1449Netilmicin sulfate............................................................. 9.2-4579Nettle leaf................................................................................. 1450Nettle root................................................................................ 1452Neurovirulence test of live viral vaccines (2.6.18.) ............... 212Nevirapine ............................................................................... 3138Nevirapine hemihydrate ........................................................ 3139Newcastle disease vaccine (inactivated)............................... 1080Newcastle disease vaccine (live)............................................ 1082Niaouli oil, cineole type ......................................................... 1453Nicergoline .............................................................................. 3140Nickel in hydrogenated vegetable oils (2.4.31.) .................... 157Nickel in polyols (2.4.15.) ........................................................ 137Niclosamide............................................................................. 3142Niclosamide monohydrate .................................................... 3143Nicorandil................................................................................ 3144Nicotinamide........................................................................... 3145Nicotine.................................................................................... 3146Nicotine ditartrate dihydrate................................................. 3147Nicotine resinate ..................................................................... 3148Nicotinic acid .......................................................................... 3150Nifedipine ................................................................................ 3151Niflumic acid........................................................................... 3152Nifuroxazide............................................................................ 3154Nikethamide............................................................................ 3155Nilutamide............................................................................... 3156Nimesulide............................................................................... 3157Nimodipine ............................................................................. 3158Nitrazepam .............................................................................. 3159Nitrendipine ............................................................................ 3160Nitric acid ................................................................................ 3161Nitric oxide.............................................................................. 3162Nitrofural ................................................................................. 3163Nitrofurantoin......................................................................... 3164Nitrogen ................................................................................... 3165Nitrogen determination by sulfuric acid digestion (2.5.9.).. 164
4652 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 9.2 Index
Nitrogen determination, primary aromatic amino (2.5.8.).. 163Nitrogen, low-oxygen............................................................. 3166Nitrogen monoxide and nitrogen dioxide in gases(2.5.26.) .................................................................................... 170
Nitroprusside, sodium ........................................................... 3593Nitrous oxide........................................................................... 3166Nitrous oxide in gases (2.5.35.)............................................... 176Nizatidine ................................................................................ 3167N-Methylpyrrolidone ............................................................. 3046NMR spectrometry (2.2.33.) ..................................................... 54NMR spectrometry, peptide identification by (2.2.64.)....... 112N,N-Dimethylaniline (2.4.26.) ................................................ 152Nomegestrol acetate ............................................................... 3169Nonoxinol 9............................................................................. 3170Non-sterile pharmaceutical preparations and substances forpharmaceutical use, microbiological quality of (5.1.4.)..... 579
Non-sterile products, microbiological examination of(microbial enumeration tests) (2.6.12.) ............................... 195
Non-sterile products, microbiological examination of (test forspecified micro-organisms) (2.6.13.).................................... 199
Noradrenaline hydrochloride................................................ 3171Noradrenaline tartrate ........................................................... 3172Norepinephrine hydrochloride ............................................. 3171Norepinephrine tartrate......................................................... 3172Norethisterone ........................................................................ 3174Norethisterone acetate ........................................................... 3175Norfloxacin.............................................................................. 3177Norflurane ............................................................................... 3179Norgestimate ........................................................................... 3184Norgestrel ................................................................................ 3185Normal immunoglobulin for intramuscular administration,human .................................................................................... 2685
Normal immunoglobulin for intravenous administration,human .................................................................................... 2687
Normal immunoglobulin for subcutaneous administration,human .................................................................................... 2689
Nortriptyline hydrochloride.................................................. 3185Noscapine ................................................................................ 3187Noscapine hydrochloride hydrate......................................... 3188Notoginseng root .................................................................... 1454Nuclear magnetic resonance spectrometry (2.2.33.).............. 54Nuclear magnetic resonance spectrometry, peptideidentification by (2.2.64.)....................................................... 112
Nucleated cell count and viability (2.7.29.) ........................... 275Nucleic acid amplification techniques (2.6.21.) .................... 214Nucleic acids in polysaccharide vaccines (2.5.17.) ............... 166Numeration of CD34/CD45+ cells in haematopoietic products(2.7.23.) .................................................................................... 269
Nutmeg oil ............................................................................... 1455Nux-vomica for homoeopathic preparations ...................... 1610Nystatin.................................................................................... 3189
OO-Acetyl in polysaccharide vaccines (2.5.19.)....................... 167Oak bark .................................................................................. 1456Octoxinol 10............................................................................ 3193Octyldodecanol ....................................................................... 3194Octyl gallate............................................................................. 3193Odour (2.3.4.)............................................................................ 127Odour and taste of essential oils (2.8.8.)................................ 284Ofloxacin.................................................................................. 3195Oils, essential............................................................................. 814Oils, fatty, identification by thin-layer chromatography(2.3.2.) ...................................................................................... 126
Oils, fatty, vegetable.................................................................. 848Oils rich in omega-3 acids, composition of fatty acids in(2.4.29.) .................................................................................... 155
Oils rich in omega-3 acids, total cholesterol in (2.4.32.) ..... 157Ointments .................................................................................. 883Olanzapine............................................................................... 3196Oleic acid ................................................................................. 3197Oleoresins .................................................................................. 818
Oleoyl macrogolglycerides ............................................. 9.1-4185Oleyl alcohol............................................................................ 3199Olive leaf .................................................................................. 1456Olive leaf dry extract .............................................................. 1458Olive oil, refined ..................................................................... 3199Olive oil, virgin ....................................................................... 3200Olmesartan medoxomil ......................................................... 3201Olsalazine sodium .................................................................. 3203Omega-3-acid ethyl esters 60 ................................................ 3205Omega-3-acid ethyl esters 90 ......................................... 9.2-4583Omega-3 acids, composition of fatty acids in oils rich in(2.4.29.) .................................................................................... 155
Omega-3 acids, fish oil rich in .............................................. 2474Omega-3 acids, total cholesterol in oils rich in (2.4.32.) ..... 157Omega-3-acid triglycerides ................................................... 3209Omeprazole ............................................................................. 3211Omeprazole magnesium........................................................ 3213Omeprazole sodium ............................................................... 3214Ondansetron hydrochloride dihydrate ................................ 3216Opalescence of liquids, clarity and degree of (2.2.1.) .. 9.2-4285Ophthalmic inserts ................................................................... 858Opium dry extract, standardised.......................................... 1459Opium, prepared .................................................................... 1460Opium, raw.............................................................................. 1461Opium tincture, standardised ............................................... 1463Optical microscopy (2.9.37.) ................................................... 365Optical rotation (2.2.7.) ............................................................. 26Oral drops.................................................................................. 865Oral lyophilisates ...................................................................... 887Oral powders............................................................................. 874Oral solutions, emulsions and suspensions........................... 865Oral use, liquid preparations for ............................................ 864Oral use, veterinary semi-solid preparations for .................. 890Orbifloxacin for veterinary use............................................. 3217Orciprenaline sulfate .............................................................. 3219Oregano ................................................................................... 1464Organ preservation, solutions for......................................... 3612Oriental cashew for homoeopathic preparations ............... 1591Orientvine stem ...................................................................... 1466Orodispersible films ................................................................. 870Orodispersible tablets .............................................................. 887Oromucosal capsules................................................................ 870Oromucosal drops, oromucosal sprays and sublingualsprays........................................................................................ 869
Oromucosal preparations ........................................................ 868Oromucosal preparations, semi-solid .................................... 869Oromucosal solutions and oromucosal suspensions............ 869Oromucosal sprays, oromucosal drops and sublingualsprays........................................................................................ 868
Oromucosal suspensions and oromucosal solutions............ 868Orphenadrine citrate.............................................................. 3220Orphenadrine hydrochloride ................................................ 3222Oseltamivir phosphate .................................................... 9.2-4585Osmolality (2.2.35.) .................................................................... 59Ouabain ................................................................................... 3225Oxacillin sodium monohydrate ............................................ 3226Oxaliplatin ............................................................................... 3228Oxazepam................................................................................ 3231Oxcarbazepine......................................................................... 3232Oxeladin hydrogen citrate ..................................................... 3234Oxfendazole for veterinary use ............................................. 3235Oxidising substances (2.5.30.)................................................. 171Oxitropium bromide .............................................................. 3236Oxolinic acid ........................................................................... 3237Oxprenolol hydrochloride ..................................................... 3239Oxybuprocaine hydrochloride .............................................. 3239Oxybutynin hydrochloride .................................................... 3241Oxycodone hydrochloride ..................................................... 3242Oxygen ..................................................................................... 3243Oxygen (15O) ........................................................................... 1163Oxygen (93 per cent).............................................................. 3244Oxygen-flask method (2.5.10.)................................................ 164Oxygen in gases (2.5.27.) ......................................................... 170
General Notices (1) apply to all monographs and other texts 4653
Index EUROPEAN PHARMACOPOEIA 9.2
Oxymetazoline hydrochloride............................................... 3245Oxytetracycline dihydrate...................................................... 3247Oxytetracycline hydrochloride.............................................. 3249Oxytocin .................................................................................. 3250Oxytocin concentrated solution............................................ 3251
PPaclitaxel .................................................................................. 3255Pale coneflower root............................................................... 1467Palmitic acid............................................................................ 3259Pamidronate disodium pentahydrate................................... 3259Pancreas powder ..................................................................... 3260Pancuronium bromide ........................................................... 3263Panleucopenia vaccine (inactivated), feline ........................ 1056Panleucopenia vaccine (live), feline ..................................... 1057Pansy, wild (flowering aerial parts)...................................... 1558Pantoprazole sodium sesquihydrate..................................... 3264Pantothenate, calcium............................................................ 1929Papaverine hydrochloride...................................................... 3265Paper chromatography (2.2.26.) ............................................... 42Papillomavirus vaccine (rDNA), human .............................. 936Paraben, butyl ......................................................................... 1892Paraben, ethyl.......................................................................... 2428Paraben, methyl ...................................................................... 3029Paraben, propyl ....................................................................... 3436Paraben, sodium ethyl............................................................ 3577Paraben, sodium methyl ........................................................ 3591Paraben, sodium propyl......................................................... 3599Paracetamol ............................................................................. 3267Paraffin, hard........................................................................... 3268Paraffin, light liquid ............................................................... 3269Paraffin, liquid ........................................................................ 3269Paraffin, white soft.................................................................. 3270Paraffin, yellow soft ................................................................ 3271Parahydroxybenzoate, butyl .................................................. 1892Parahydroxybenzoate, ethyl .................................................. 2428Parahydroxybenzoate, methyl ............................................... 3029Parahydroxybenzoate, propyl................................................ 3436Parahydroxybenzoate, sodium ethyl .................................... 3577Parahydroxybenzoate, sodium methyl................................. 3591Parahydroxybenzoate, sodium propyl.................................. 3599Parainfluenza virus vaccine (live), bovine ........................... 1021Parainfluenza virus vaccine (live), canine ........................... 1032Paraldehyde ............................................................................. 3271Paramyxovirus 1 (Newcastle disease) vaccine (inactivated),avian ....................................................................................... 1080
Paramyxovirus 1 (Newcastle disease) vaccine (live),avian ....................................................................................... 1082
Paramyxovirus 3 vaccine (inactivated) for turkeys, avian.. 1016Parenteral preparations............................................................ 871Parenteral preparations, test for extractable volume of(2.9.17.) .................................................................................... 322
Parnaparin sodium................................................................. 3272Paroxetine hydrochloride ...................................................... 3272Paroxetine hydrochloride hemihydrate ............................... 3275Particles, fine, aerodynamic assessment of in preparations forinhalation (2.9.18.) ................................................................. 323
Particle size analysis by laser light diffraction (2.9.31.) ....... 349Particle-size distribution estimation by analytical sieving(2.9.38.) .................................................................................... 367
Particulate contamination : sub-visible particles (2.9.19.) ... 335Particulate contamination : visible particles (2.9.20.)........... 337Parvovirosis vaccine (inactivated), canine........................... 1033Parvovirosis vaccine (inactivated), porcine......................... 1089Parvovirosis vaccine (live), canine........................................ 1034Passion flower ......................................................................... 1469Passion flower dry extract ..................................................... 1470Pastes .......................................................................................... 884Pasteurella vaccine (inactivated) for sheep.......................... 1084Pastilles and lozenges ............................................................... 870Patches, cutaneous.................................................................... 882Patches, transdermal ................................................................ 873
Patches, transdermal, dissolution test for (2.9.4.)................. 309Pea starch................................................................................. 3277Pefloxacin mesilate dihydrate................................................ 3277Pelargonium root .................................................................... 1470Pemetrexed disodium heptahydrate..................................... 3279Penbutolol sulfate ................................................................... 3281Penetrometry, measurement of consistency by (2.9.9.) ....... 313Penicillamine........................................................................... 3282Penicillin G, benzathine......................................................... 1822Penicillin G potassium.................................................... 9.2-4505Penicillin G, procaine...................................................... 9.2-4506Penicillin G sodium......................................................... 9.2-4508Penicillin V....................................................................... 9.1-4189Penicillin V potassium .................................................... 9.1-4190Pentaerythrityl tetranitrate, diluted...................................... 3284Pentamidine diisetionate ....................................................... 3286Pentazocine.............................................................................. 3287Pentazocine hydrochloride .................................................... 3287Pentazocine lactate ................................................................. 3288Pentetate sodium calcium for radiopharmaceuticalpreparations .......................................................................... 1164
Pentobarbital ........................................................................... 3289Pentobarbital sodium ............................................................. 3289Pentoxifylline .......................................................................... 3290Pentoxyverine hydrogen citrate ............................................ 3292Peony root, red........................................................................ 1471Peony root, white .................................................................... 1472Pepper ...................................................................................... 1474Pepper, long............................................................................. 1417Peppermint leaf................................................................ 9.2-4469Peppermint leaf dry extract............................................ 9.2-4471Peppermint oil ........................................................................ 1478Pepsin powder......................................................................... 3293Peptide identification by nuclear magnetic resonancespectrometry (2.2.64.) ............................................................ 112
Peptide mapping (2.2.55.).......................................................... 90Peptides, synthetic, acetic acid in (2.5.34.) ............................ 175Perborate, hydrated sodium .................................................. 3594Pergolide mesilate ................................................................... 3295Perindopril tert-butylamine .................................................. 3296Peritoneal dialysis, solutions for ........................................... 3299Permethrin (25:75) ................................................................. 3301Peroxide value (2.5.5.) .............................................................. 162Perphenazine........................................................................... 3303Pertussis (acellular, component), diphtheria and tetanusvaccine (adsorbed) ................................................................. 902
Pertussis (acellular, component), diphtheria and tetanusvaccine (adsorbed, reduced antigen(s) content)................. 903
Pertussis (acellular, component), diphtheria, tetanus andhaemophilus type b conjugate vaccine (adsorbed) ............ 908
Pertussis (acellular, component), diphtheria, tetanus andhepatitis B (rDNA) vaccine (adsorbed) ............................... 910
Pertussis (acellular, component), diphtheria, tetanus andpoliomyelitis (inactivated) vaccine (adsorbed)................... 911
Pertussis (acellular, component), diphtheria, tetanus andpoliomyelitis (inactivated) vaccine (adsorbed, reducedantigen(s) content) ................................................................. 913
Pertussis (acellular, component), diphtheria, tetanus,hepatitis B (rDNA), poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) ............ 915
Pertussis (acellular, component), diphtheria, tetanus,poliomyelitis (inactivated) and haemophilus type b conjugatevaccine (adsorbed) ................................................................. 917
Pertussis toxin (residual) and pertussis toxoid (irreversibilityof) (2.6.33.).............................................................................. 235
Pertussis vaccine (acellular), assay of (2.7.16.)...................... 263Pertussis vaccine (acellular, component, adsorbed)............. 960Pertussis vaccine (acellular, co-purified, adsorbed) ............. 962Pertussis vaccine (whole cell, adsorbed)................................ 963Pertussis vaccine (whole cell), assay of (2.7.7.) ..................... 252Pertussis (whole cell), diphtheria and tetanus vaccine(adsorbed) ............................................................................... 905
4654 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 9.2 Index
Pertussis (whole cell), diphtheria, tetanus and poliomyelitis(inactivated) vaccine (adsorbed) .......................................... 920
Pertussis (whole cell), diphtheria, tetanus, poliomyelitis(inactivated) and haemophilus type b conjugate vaccine(adsorbed) ............................................................................... 922
Peru balsam ............................................................................. 1479Pessaries ..................................................................................... 888Pessaries and suppositories, disintegration of (2.9.2.) ......... 301Pesticide residues (2.8.13.)....................................................... 286Pethidine hydrochloride ........................................................ 3304Petroleum rectificatum for homoeopathic preparations ... 1612Pharmaceutical preparations................................................... 828Pharmaceutical technical procedures (2.9.) .......................... 299Pharmacognosy, methods in (2.8.)......................................... 283Pharmacopoeial harmonisation (5.8.) .......................... 9.2-4395Phenazone................................................................................ 3305Pheniramine maleate.............................................................. 3306Phenobarbital .......................................................................... 3307Phenobarbital sodium............................................................ 3309Phenol ...................................................................................... 3310Phenol in immunosera and vaccines (2.5.15.) ...................... 166Phenolphthalein...................................................................... 3311Phenolsulfonphthalein ........................................................... 3311Phenothiazines, identification by thin-layer chromatography(2.3.3.) ...................................................................................... 127
Phenoxyethanol ...................................................................... 3312Phenoxymethylpenicillin ................................................ 9.1-4189Phenoxymethylpenicillin potassium ............................. 9.1-4190Phentolamine mesilate ........................................................... 3317Phenylalanine .......................................................................... 3318Phenylbutazone....................................................................... 3319Phenylbutyrate, sodium ......................................................... 3595Phenylephrine ......................................................................... 3321Phenylephrine hydrochloride................................................ 3322Phenylmercuric acetate .......................................................... 3324Phenylmercuric borate........................................................... 3324Phenylmercuric nitrate .......................................................... 3325Phenylpropanolamine hydrochloride .................................. 3325Phenytoin................................................................................. 3326Phenytoin sodium................................................................... 3327Phloroglucinol......................................................................... 3329Phloroglucinol dihydrate ....................................................... 3330pH of solutions, approximate (2.2.4.)....................................... 25Pholcodine monohydrate ............................................... 9.1-4192Phosphates (2.4.11.).................................................................. 136Phospholipids for injection, egg .................................... 9.2-4533Phosphoric acid, concentrated.............................................. 3333Phosphoric acid, dilute .......................................................... 3334Phosphorus in polysaccharide vaccines (2.5.18.) ................. 166pH, potentiometric determination of (2.2.3.) ......................... 24Phthalylsulfathiazole .............................................................. 3334Physical and physicochemical methods (2.2.) ........................ 21Physostigmine salicylate ........................................................ 3335Phytomenadione ..................................................................... 3336Phytosterol............................................................................... 3337Picosulfate, sodium ................................................................ 3596Picotamide monohydrate....................................................... 3338Picric acid for homoeopathic preparations ......................... 1587Piglet colibacillosis vaccine (inactivated), neonatal ........... 1077Pillules for homoeopathic preparations............................... 1586Pillules, homoeopathic, coated ............................................. 1587Pillules, homoeopathic, impregnated............................ 9.1-4118Pilocarpine hydrochloride ..................................................... 3339Pilocarpine nitrate .................................................................. 3340Pimobendan ............................................................................ 3342Pimozide .................................................................................. 3343Pindolol.................................................................................... 3344Pine (dwarf) oil....................................................................... 1340Pine sylvestris oil .................................................................... 1480Pioglitazone hydrochloride ................................................... 3345Pipemidic acid trihydrate ...................................................... 3346Piperacillin............................................................................... 3347Piperacillin sodium ................................................................ 3349
Piperazine adipate .................................................................. 3351Piperazine citrate .................................................................... 3352Piperazine hydrate .................................................................. 3352Piracetam................................................................................. 3353Pirenzepine dihydrochloride monohydrate ........................ 3354Piretanide................................................................................. 3356Pirfenidone .............................................................................. 3357Piroxicam................................................................................. 3358Pivampicillin ........................................................................... 3359Pivmecillinam hydrochloride................................................ 3361Plasma for fractionation, human.......................................... 2691Plasma (pooled and treated for virus inactivation),human ............................................................................. 9.2-4555
Plasmid vectors for human use, bacterial cells used for themanufacture of........................................................................ 741
Plasmin inhibitor, assay of human (2.7.25.).......................... 272Plasters, medicated ................................................................... 882Plastic additives (3.1.13.) ......................................................... 414Plastic containers and closures for pharmaceutical use(3.2.2.) ...................................................................................... 428
Plastic containers for aqueous solutions for infusion(3.2.2.1.) ................................................................................... 429
Plastic containers for human blood and blood components,sterile (3.2.3.)........................................................................... 430
Plastic syringes, single-use, sterile (3.2.8.)............................. 434Pneumococcal polysaccharide conjugate vaccine(adsorbed) ............................................................................... 965
Pneumococcal polysaccharide vaccine .................................. 967Pneumonia vaccine (inactivated), porcine enzootic .......... 1086Poliomyelitis (inactivated), diphtheria and tetanus vaccine(adsorbed, reduced antigen(s) content)............................... 906
Poliomyelitis (inactivated), diphtheria, tetanus and pertussis(acellular, component) vaccine (adsorbed) ......................... 911
Poliomyelitis (inactivated), diphtheria, tetanus and pertussis(acellular, component) vaccine (adsorbed, reduced antigen(s)content).................................................................................... 913
Poliomyelitis (inactivated), diphtheria, tetanus and pertussis(whole cell) vaccine (adsorbed) ............................................ 920
Poliomyelitis (inactivated), diphtheria, tetanus, pertussis(acellular, component) and haemophilus type b conjugatevaccine (adsorbed) ................................................................. 917
Poliomyelitis (inactivated), diphtheria, tetanus, pertussis(acellular, component), hepatitis B (rDNA) and haemophilustype b conjugate vaccine (adsorbed) .................................... 915
Poliomyelitis (inactivated), diphtheria, tetanus, pertussis(whole cell) and haemophilus type b conjugate vaccine(adsorbed) ............................................................................... 922
Poliomyelitis vaccine (inactivated) ......................................... 969Poliomyelitis vaccine (inactivated), in vivo assay of(2.7.20.) .................................................................................... 267
Poliomyelitis vaccine (oral) ............................................ 9.1-4091Pollens for allergen products................................................. 3362Poloxamers .............................................................................. 3363Polyacrylate dispersion 30 per cent ...................................... 3365Polyamide 6/6 suture, sterile, in distributor for veterinary use................................................................................................ 1221
Polyamide 6 suture, sterile, in distributor for veterinary use................................................................................................ 1220
Polyethyleneglycols................................................................. 2950Polyethyleneglycols, high-molecular-mass.......................... 2952Polyethylene oxides, high-molecular-mass ......................... 2952Polyethylene terephthalate for containers for preparations notfor parenteral use (3.1.15.) .................................................... 419
Poly(ethylene terephthalate) suture, sterile, in distributor forveterinary use ....................................................................... 1221
Poly(ethylene - vinyl acetate) for containers and tubing fortotal parenteral nutrition preparations (3.1.7.).......... 9.2-4318
Polyethylene with additives for containers for parenteralpreparations and for ophthalmic preparations(3.1.5.) ............................................................................. 9.2-4311
Polyethylene without additives for containers forparenteral preparations and for ophthalmic preparations(3.1.4.) ............................................................................. 9.2-4310
General Notices (1) apply to all monographs and other texts 4655
Index EUROPEAN PHARMACOPOEIA 9.2
Polygonum cuspidatum rhizome and root.......................... 1481Polygonum orientale fruit .............................................. 9.2-4472Polymorphism (5.9.)................................................................. 719Polymyxin B sulfate ................................................................ 3366Polyolefins (3.1.3.) ........................................................... 9.2-4307Polyoxyl castor oil................................................................... 2950Polyoxyl hydrogenated castor oil .......................................... 2949Polyoxypropylene stearyl ether ............................................. 3367Polypropylene for containers and closures for parenteralpreparations and ophthalmic preparations (3.1.6.)... 9.2-4314
Polysaccharide vaccines for human use, conjugated, carrierproteins for the production of (5.2.11.) ............................... 626
Polysaccharide vaccines, hexosamines in (2.5.20.) ............... 167Polysaccharide vaccines, methylpentoses in (2.5.21.) .......... 167Polysaccharide vaccines, nucleic acids in (2.5.17.) ............... 166Polysaccharide vaccines, O-acetyl in (2.5.19.)....................... 167Polysaccharide vaccines, phosphorus in (2.5.18.)................. 166Polysaccharide vaccines, protein in (2.5.16.)......................... 166Polysaccharide vaccines, ribose in (2.5.31.) .......................... 171Polysaccharide vaccines, sialic acid in (2.5.23.) .................... 168Polysaccharide vaccines, uronic acids in (2.5.22.) ................ 168Polysorbate 20 ......................................................................... 3368Polysorbate 40 ......................................................................... 3369Polysorbate 60 ......................................................................... 3370Polysorbate 80 .................................................................. 9.2-4591Polystyrene sulfonate, sodium .............................................. 3597Poly(vinyl acetate) .................................................................. 3372Poly(vinyl acetate) dispersion 30 per cent ........................... 3373Poly(vinyl alcohol).................................................................. 3374Poly(vinyl alcohol) macrogol grafted copolymer ............... 2945Poly(vinyl chloride) (non-plasticised) for containers for soliddosage forms for oral administration, materials based on(3.1.11.) .................................................................................... 412
Poly(vinyl chloride), non-plasticised, materials based on forcontainers for non-injectable aqueous solutions (3.1.10.).. 410
Poly(vinyl chloride), plasticised, empty sterile containers offor human blood and blood components (3.2.4.) .............. 432
Poly(vinyl chloride), plasticised, materials based on forcontainers for aqueous solutions for intravenous infusion(3.1.14.) .................................................................................... 416
Poly(vinyl chloride), plasticised, materials based on forcontainers for human blood and blood components(3.1.1.1.) ................................................................................... 391
Poly(vinyl chloride), plasticised, materials based on fortubing used in sets for the transfusion of blood and bloodcomponents (3.1.1.2.)............................................................. 393
Poly(vinyl chloride), plasticised, sterile containers of forhuman blood containing anticoagulant solution (3.2.5.) .. 432
Poppy petals, red..................................................................... 1492Porcine actinobacillosis vaccine (inactivated) .................... 1085Porcine enzootic pneumonia vaccine (inactivated) ........... 1086Porcine influenza vaccine (inactivated) ............................... 1087Porcine insulin ........................................................................ 2774Porcine parvovirosis vaccine (inactivated).......................... 1089Porcine progressive atrophic rhinitis vaccine(inactivated) .......................................................................... 1090
Pore-size distribution of solids by mercury porosimetry,porosity and (2.9.32.) ............................................................. 352
Poria ......................................................................................... 1484Porosimetry, mercury, porosity and pore-size distribution ofsolids by (2.9.32.) .................................................................... 352
Porosity and pore-size distribution of solids by mercuryporosimetry (2.9.32.).............................................................. 352
Porosity of sintered-glass filters (2.1.2.) ................................... 15Porous solids including powders, wettability of (2.9.45.) .... 381Potassium (2.4.12.) ................................................................... 136Potassium acetate.................................................................... 3375Potassium bromide................................................................. 3376Potassium carbonate............................................................... 3377Potassium chloride ................................................................. 3377Potassium citrate..................................................................... 3378Potassium clavulanate ............................................................ 3378Potassium clavulanate, diluted.............................................. 3381
Potassium dichromate for homoeopathic preparations..... 1608Potassium dihydrogen phosphate......................................... 3382Potassium disulfite.................................................................. 3386Potassium hydrogen aspartate hemihydrate ....................... 3383Potassium hydrogen carbonate ............................................. 3384Potassium hydrogen tartrate ................................................. 3384Potassium hydroxide .............................................................. 3385Potassium iodide..................................................................... 3385Potassium metabisulfite ......................................................... 3386Potassium nitrate .................................................................... 3386Potassium perchlorate............................................................ 3387Potassium permanganate....................................................... 3388Potassium sodium tartrate tetrahydrate .............................. 3388Potassium sorbate ................................................................... 3389Potassium sulfate .................................................................... 3389Potato starch............................................................................ 3390Potentiometric determination of ionic concentration usingion-selective electrodes (2.2.36.)............................................. 60
Potentiometric determination of pH (2.2.3.) .......................... 24Potentiometric titration (2.2.20.).............................................. 35Potentisation, methods of preparation of homoeopathic stocksand................................................................................... 9.2-4479
Poultices ..................................................................................... 884Pour-on preparations ............................................................... 889Povidone ........................................................................... 9.2-4592Povidone, iodinated................................................................ 3394Powdered cellulose ................................................................. 2013Powder fineness (2.9.35.) ......................................................... 362Powder flow (2.9.36.)................................................................ 362Powders and granules for oral solutions and suspensions .. 865Powders and granules for syrups ............................................ 866Powders and tablets for rectal solutions and suspensions... 882Powders, bulk density and tapped density of (2.9.34.)......... 359Powders, ear .............................................................................. 856Powders, effervescent ............................................................... 875Powders for cutaneous application......................................... 874Powders for eye drops and powders for eye lotions ............. 858Powders for injections or infusions........................................ 872Powders for oral drops............................................................. 866Powders, inhalation .................................................................. 878Powders, nasal ........................................................................... 867Powders, oral ............................................................................. 874Powders, wettability of porous solids including (2.9.45.) .... 381Pramipexole dihydrochloride monohydrate ....................... 3394Pravastatin sodium................................................................. 3396Prazepam ................................................................................. 3397Praziquantel............................................................................. 3398Prazosin hydrochloride.......................................................... 3400Prednicarbate .......................................................................... 3401Prednisolone............................................................................ 3403Prednisolone acetate............................................................... 3404Prednisolone pivalate ............................................................. 3406Prednisolone sodium phosphate........................................... 3407Prednisone............................................................................... 3409Pregabalin ......................................................................... 9.2-4595Pregelatinised hydroxypropyl starch .................................... 3647Pregelatinised starch............................................................... 3649Prekallikrein activator (2.6.15.)............................................... 208Premixes for medicated feeding stuffs for veterinary use ... 875Preparations for inhalation ..................................................... 875Preparations for inhalation : aerodynamic assessment of fineparticles (2.9.18.) .................................................................... 323
Preparations for irrigation....................................................... 880Preparations for nebulisation : characterisation (2.9.44.) .... 378Pressurised pharmaceutical preparations .............................. 880Prilocaine................................................................................. 3412Prilocaine hydrochloride ....................................................... 3413Primaquine diphosphate........................................................ 3415Primary aromatic amino-nitrogen, determination of(2.5.8.) ...................................................................................... 163
Primary standards for volumetric solutions (4.2.1.) ... 9.2-4324Primidone ................................................................................ 3416Primula root ............................................................................ 1485
4656 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 9.2 Index
Probenecid............................................................................... 3417Procainamide hydrochloride................................................. 3418Procaine benzylpenicillin ............................................... 9.2-4506Procaine hydrochloride.......................................................... 3419Prochlorperazine maleate ...................................................... 3420Products of fermentation......................................................... 830Products of recombinant DNA technology........................... 836Products with risk of transmitting agents of animal spongiformencephalopathies .................................................................... 832
Progenitor cells, human haematopoietic, colony-forming cellassay for (2.7.28.) .................................................................... 274
Progesterone............................................................................ 3420Progressive atrophic rhinitis vaccine (inactivated),porcine ................................................................................... 1090
Proguanil hydrochloride................................................. 9.2-4597Proline...................................................................................... 3424Promazine hydrochloride ...................................................... 3425Promethazine hydrochloride................................................. 3426Propacetamol hydrochloride................................................. 3427Propafenone hydrochloride................................................... 3428Propanol................................................................................... 3430Propanol and methanol, 2-, test for (2.9.11.) ........................ 318Propantheline bromide .......................................................... 3431Propofol ................................................................................... 3432Propranolol hydrochloride .................................................... 3434Propylene glycol...................................................................... 3437Propylene glycol dicaprylocaprate........................................ 3438Propylene glycol dilaurate .............................................. 9.2-4598Propylene glycol monolaurate............................................... 3439Propylene glycol monopalmitostearate................................ 3440Propylene glycol monostearate ............................................. 3440Propyl gallate........................................................................... 3435Propyl parahydroxybenzoate................................................. 3436Propyl parahydroxybenzoate, sodium ................................. 3599Propylthiouracil ...................................................................... 3441Propyphenazone ..................................................................... 3442Protamine sulfate .................................................................... 3443Protein assays, host-cell (2.6.34.) ................................... 9.1-4041Protein C, human, assay of (2.7.30.)....................................... 276Protein in polysaccharide vaccines (2.5.16.) ......................... 166Protein S, human, assay of (2.7.31.) ....................................... 277Protein, total (2.5.33.) .............................................................. 172Prothrombin complex, human.............................................. 2695Protirelin.................................................................................. 3444Proxyphylline .......................................................................... 3445Pseudoephedrine hydrochloride........................................... 3446Psyllium seed........................................................................... 1486Pullulan.................................................................................... 3447Purified water .......................................................................... 3935Purified water, highly............................................................. 3933Purple coneflower herb.......................................................... 1486Purple coneflower root .......................................................... 1488Pycnometric density of solids, gas (2.9.23.) .......................... 339Pygeum africanum bark ........................................................ 1490Pyrantel embonate.................................................................. 3448Pyrazinamide .......................................................................... 3449Pyridostigmine bromide ........................................................ 3450Pyridoxine hydrochloride...................................................... 3451Pyrimethamine ....................................................................... 3453Pyrogens (2.6.8.) ....................................................................... 193Pyrophosphate (sodium) decahydrate for radiopharmaceuticalpreparations ................................................................... 9.2-4439
Pyrrolidone.............................................................................. 3453
QQuality of non-sterile pharmaceutical preparations andsubstances for pharmaceutical use, microbiological(5.1.4.) ...................................................................................... 579
Quantified hawthorn leaf and flower liquid extract ........... 1387Quetiapine fumarate .............................................................. 3457Quillaia bark............................................................................ 1491Quinapril hydrochloride........................................................ 3459
Quinidine sulfate .................................................................... 3461Quinine hydrochloride .......................................................... 3463Quinine sulfate........................................................................ 3464
RRabbit haemorrhagic disease vaccine (inactivated) ........... 1092Rabeprazole sodium............................................................... 3469Rabeprazole sodium hydrate................................................. 3470Rabies immunoglobulin, human .......................................... 2696Rabies vaccine for human use prepared in cell cultures...... 976Rabies vaccine (inactivated) for veterinary use .................. 1093Rabies vaccine (live, oral) for foxes and raccoon dogs ...... 1096Racecadotril............................................................................. 3472Racementhol............................................................................ 2998Racemic camphor ................................................................... 1934Racemic ephedrine hydrochloride ....................................... 2363Racemic menthol .................................................................... 2998Racephedrine hydrochloride................................................. 2363Raclopride ([11C]methoxy) injection.................................... 1165Radioactivity, detection and measurement of (2.2.66.) ....... 113Radionuclides, table of physical characteristics (5.7.) .. 9.2-4385Radiopharmaceutical preparations ........................................ 832Radiopharmaceutical preparations, chemical precursorsfor ............................................................................................. 813
Radiopharmaceutical preparations, copper tetramibitetrafluoroborate for...................................................... 9.2-4435
Radiopharmaceutical preparations, iobenguane sulfatefor .................................................................................... 9.2-4435
Radiopharmaceutical preparations, medronic acidfor .................................................................................... 9.2-4437
Radiopharmaceutical preparations, pentetate sodium calciumfor ........................................................................................... 1164
Radiopharmaceutical preparations, sodium iodohippuratedihydrate for................................................................... 9.2-4438
Radiopharmaceutical preparations, sodium pyrophosphatedecahydrate for .............................................................. 9.2-4439
Radiopharmaceutical preparations, tetra-O-acetyl-mannosetriflate for ....................................................................... 9.2-4443
Radiopharmaceuticals, extemporaneous preparation of(5.19.) ....................................................................................... 767
Raloxifene hydrochloride ...................................................... 3473Raman spectroscopy (2.2.48.) ................................................... 86Ramipril ................................................................................... 3475Ramon assay, flocculation value (Lf) of diphtheria and tetanustoxins and toxoids (2.7.27.) ................................................... 273
Ranitidine hydrochloride................................................ 9.2-4603Rapeseed oil, refined .............................................................. 3479Raw materials of biological origin for the production ofcell-based and gene therapymedicinal products (5.2.12.).. 627
Reagents (4.) .............................................................................. 441Reagents (4.1.1.)........................................................................ 441Reagents (4.1.1.)............................................................... 9.1-4061Reagents (4.1.1.)............................................................... 9.2-4323Reagents, standard solutions, buffer solutions (4.1.) ........... 441Recombinant DNA technology, products of......................... 836Recommendations on dissolution testing (5.17.1.) .............. 761Recommendations on methods for dosage forms testing(5.17.) ....................................................................................... 761
Rectal capsules .......................................................................... 882Rectal foams .............................................................................. 882Rectal preparations................................................................... 881Rectal preparations, semi-solid............................................... 882Rectal solutions and suspensions, powders and tablets for.. 881Rectal solutions, emulsions and suspensions........................ 882Rectal tampons.......................................................................... 882Red peony root........................................................................ 1471Red poppy petals..................................................................... 1492Reference standards (5.12.) ..................................................... 733Refractive index (2.2.6.) ............................................................. 26Relative density (2.2.5.) .............................................................. 25Remifentanil hydrochloride ........................................... 9.2-4604Repaglinide.............................................................................. 3479
General Notices (1) apply to all monographs and other texts 4657
Index EUROPEAN PHARMACOPOEIA 9.2
Reserpine ................................................................................. 3481Residual pertussis toxin and irreversibility of pertussis toxoid(2.6.33.) .................................................................................... 235
Residual solvents (5.4.) ............................................................ 665Residual solvents, identification and control (2.4.24.) ......... 146Residue on evaporation of essential oils (2.8.9.)................... 284Resistance to crushing of tablets (2.9.8.) ............................... 313Resorcinol ................................................................................ 3481Respiratory syncytial virus vaccine (live), bovine .............. 1022Restharrow root ...................................................................... 1493Retroviridae-derived vectors for human use......................... 746Rhatany root............................................................................ 1494Rhatany tincture ..................................................................... 1495Rhinotracheitis vaccine (inactivated), bovine, infectious.. 1067Rhinotracheitis vaccine (inactivated), viral, feline ............. 1059Rhinotracheitis vaccine (live), bovine, infectious............... 1068Rhinotracheitis vaccine (live), infectious, turkey ............... 1107Rhinotracheitis vaccine (live), viral, feline .......................... 1060Rhubarb ................................................................................... 1496Ribavirin .................................................................................. 3482Riboflavin................................................................................. 3484Riboflavin sodium phosphate ............................................... 3485Ribose in polysaccharide vaccines (2.5.31.) .......................... 171Ribwort plantain ..................................................................... 1497Rice starch ............................................................................... 3487Rifabutin .................................................................................. 3488Rifampicin ............................................................................... 3489Rifamycin sodium................................................................... 3490Rifaximin ................................................................................. 3492Rilmenidine dihydrogen phosphate ..................................... 3494Risedronate sodium 2.5-hydrate........................................... 3495Risperidone ............................................................................. 3496Ritonavir .................................................................................. 3498Rivastigmine............................................................................ 3501Rivastigmine hydrogen tartrate ............................................ 3503Rizatriptan benzoate .............................................................. 3504Rocuronium bromide............................................................. 3506Roman chamomile flower...................................................... 1313Ropinirole hydrochloride ...................................................... 3508Ropivacaine hydrochloride monohydrate ........................... 3509Roselle ...................................................................................... 1498Rosemary leaf.......................................................................... 1499Rosemary oil ........................................................................... 1500Rosuvastatin calcium.............................................................. 3511Rotating viscometer method - viscosity (2.2.10.) ................... 28Rotation, optical (2.2.7.) ............................................................ 26Rotavirus diarrhoea vaccine (inactivated), calf .................. 1026Rotavirus vaccine (live, oral)................................................... 978Round amomum fruit ............................................................ 1502Roxithromycin ........................................................................ 3513RRR-α-Tocopherol.................................................................. 3801RRR-α-Tocopheryl acetate..................................................... 3804RRR-α-Tocopheryl hydrogen succinate ............................... 3808Rubber closures for containers for aqueous parenteralpreparations, for powders and for freeze-dried powders(3.2.9.) ...................................................................................... 435
Rubella immunoglobulin, human ........................................ 2698Rubella, measles and mumps vaccine (live) .......................... 952Rubella, measles, mumps and varicella vaccine (live).......... 953Rubella vaccine (live) ............................................................... 981Ruminant colibacillosis vaccine (inactivated), neonatal.... 1079Rutoside trihydrate ................................................................. 3516
SSaccharin.................................................................................. 3521Saccharin sodium ................................................................... 3522Safety, viral (5.1.7.) ................................................................... 591Safflower flower ...................................................................... 1503Safflower oil, refined............................................................... 3523Saffron for homoeopathic preparations............................... 1599Sage leaf (Salvia officinalis) ................................................... 1505Sage leaf, three-lobed ............................................................. 1506
Sage oil, Spanish...................................................................... 1524Sage tincture ............................................................................ 1507Salbutamol ............................................................................... 3523Salbutamol sulfate................................................................... 3526Salicylic acid ............................................................................ 3528Salmeterol xinafoate ............................................................... 3529Salmonella Enteritidis vaccine (inactivated) for chickens.. 1097Salmonella Enteritidis vaccine (live, oral) for chickens ..... 1098Salmonella Typhimurium vaccine (inactivated) forchickens ................................................................................. 1100
Salmonella Typhimurium vaccine (live, oral) forchickens ................................................................................. 1101
Salmon oil, farmed ................................................................. 3531Salvia miltiorrhiza root and rhizome............................ 9.1-4108Sanguisorba root..................................................................... 1509Saponification value (2.5.6.) .................................................... 163Saquinavir mesilate................................................................. 3533Saw palmetto extract .............................................................. 1509Saw palmetto fruit .................................................................. 1512Schisandra fruit................................................................ 9.1-4110Scopolamine ............................................................................ 2733Scopolamine butylbromide ................................................... 2734Scopolamine hydrobromide .................................................. 2735Selamectin for veterinary use................................................ 3535Selegiline hydrochloride ........................................................ 3537Selenium disulfide .................................................................. 3538Selenium for homoeopathic preparations .................... 9.2-4494Selfheal fruit-spike, common ................................................ 1327Semi-micro determination of water (2.5.12.)........................ 165Semi-solid ear preparations..................................................... 856Semi-solid eye preparations .................................................... 858Semi-solid intrauterine preparations ..................................... 862Semi-solid nasal preparations ................................................. 868Semi-solid oromucosal preparations...................................... 869Semi-solid preparations for cutaneous application.............. 882Semi-solid preparations for oral use, veterinary .................. 890Semi-solid rectal preparations ................................................ 882Semi-solid vaginal preparations ............................................. 889Senega root .............................................................................. 1515Senna leaf................................................................................. 1516Senna leaf dry extract, standardised .................................... 1517Senna pods, Alexandrian....................................................... 1518Senna pods, Tinnevelly .......................................................... 1519Separation techniques, chromatographic (2.2.46.) ...... 9.2-4286Serine........................................................................................ 3539Sertaconazole nitrate .............................................................. 3540Sertraline hydrochloride........................................................ 3541Sesame oil, refined...........................................................9.1-4197Sets for the transfusion of blood and blood components(3.2.6.) ...................................................................................... 433
Sevoflurane .............................................................................. 3545Shampoos .................................................................................. 864Shellac ..................................................................................... 3547Shingles (herpes zoster) vaccine (live) ................................... 982Sialic acid in polysaccharide vaccines (2.5.23.)..................... 168Siam benzoin........................................................................... 1272Siam benzoin tincture ............................................................ 1274Sieves (2.1.4.)............................................................................... 16Sieve test (2.9.12.) ..................................................................... 319Sieving, analytical, particle-size distribution estimation by(2.9.38.) .................................................................................... 367
SI (International System) units (1.) ............................... 9.2-4275Sildenafil citrate ............................................................... 9.2-4611Silica, colloidal anhydrous..................................................... 3549Silica, colloidal hydrated........................................................ 3550Silica, dental type.................................................................... 3550Silica, hydrophobic colloidal ................................................. 3551Silicate, aluminium magnesium............................................ 1683Silicate, aluminium sodium................................................... 1686Silicone elastomer for closures and tubing (3.1.9.)............... 409Silicone oil used as a lubricant (3.1.8.)................................... 408Silk suture, sterile, braided, in distributor for veterinary use................................................................................................ 1221
4658 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 9.2 Index
Silver, colloidal, for external use........................................... 3552Silver nitrate ............................................................................ 3552Simeticone ............................................................................... 3553Simvastatin .............................................................................. 3554Single-dose preparations, uniformity of content (2.9.6.)..... 312Single-dose preparations, uniformity of mass (2.9.5.) ......... 311Sintered-glass filters (2.1.2.) ...................................................... 15Sitagliptin phosphate monohydrate .............................. 9.1-4198Sitagliptin tablets .................................................................... 3557Size-exclusion chromatography (2.2.30.)................................. 47(S)-Lactic acid ......................................................................... 2861Smallpox vaccine (live) ............................................................ 983Sodium acetate ([1-11C]) injection........................................ 1166Sodium acetate trihydrate...................................................... 3558Sodium alendronate trihydrate ............................................. 3559Sodium alginate ...................................................................... 3560Sodium aluminium silicate.................................................... 1686Sodium amidotrizoate............................................................ 3561Sodium aminosalicylate dihydrate ....................................... 3562Sodium ascorbate ................................................................... 3563Sodium aurothiomalate ......................................................... 3565Sodium benzoate .................................................................... 3566Sodium bromide ..................................................................... 3567Sodium calcium edetate......................................................... 3568Sodium calcium pentetate for radiopharmaceuticalpreparations .......................................................................... 1164
Sodium caprylate .................................................................... 3569Sodium carbonate................................................................... 3570Sodium carbonate decahydrate............................................. 3570Sodium carbonate monohydrate .......................................... 3571Sodium carboxymethylcellulose ........................................... 1958Sodium carboxymethylcellulose, cross-linked.................... 2174Sodium carboxymethylcellulose, low-substituted .............. 1958Sodium cetostearyl sulfate..................................................... 3571Sodium chloride...................................................................... 3573Sodium chromate (51Cr) sterile solution.............................. 1167Sodium citrate ......................................................................... 3574Sodium cromoglicate ............................................................. 3574Sodium cyclamate................................................................... 3576Sodium dihydrogen phosphate dihydrate ........................... 3577Sodium disulfite ...................................................................... 3591Sodium ethyl parahydroxybenzoate..................................... 3577Sodium fluoride ...................................................................... 3579Sodium fluoride (18F) injection............................................. 1168Sodium fusidate ...................................................................... 3579Sodium glycerophosphate, hydrated .................................... 3582Sodium hyaluronate ............................................................... 3583Sodium hydrogen carbonate ................................................. 3585Sodium hydroxide .................................................................. 3585Sodium iodide......................................................................... 3586Sodium iodide (123I) injection ............................................... 1169Sodium iodide (123I) solution for radiolabelling ................. 1170Sodium iodide (131I) capsules for diagnostic use ................ 1170Sodium iodide (131I) capsules for therapeutic use .............. 1171Sodium iodide (131I) solution ................................................ 1172Sodium iodide (131I) solution for radiolabelling ................. 1173Sodium iodohippurate (123I) injection ................................. 1175Sodium iodohippurate (131I) injection ................................. 1176Sodium iodohippurate dihydrate for radiopharmaceuticalpreparations ................................................................... 9.2-4438
Sodium lactate solution ......................................................... 3586Sodium laurilsulfate ........................................................ 9.1-4200Sodium lauroylsarcosinate for external use......................... 3589Sodium metabisulfite ............................................................. 3591Sodium methyl parahydroxybenzoate ................................. 3591Sodium molybdate (99Mo) solution (fission) ...................... 1176Sodium molybdate dihydrate ................................................ 3592Sodium nitrite ......................................................................... 3593Sodium nitroprusside............................................................. 3593Sodium perborate, hydrated.................................................. 3594Sodium pertechnetate (99mTc) injection (fission) ............... 1178Sodium pertechnetate (99mTc) injection (non-fission) ....... 1180Sodium phenylbutyrate.......................................................... 3595
Sodium phosphate (32P) injection......................................... 1180Sodium picosulfate ................................................................. 3596Sodium polystyrene sulfonate ............................................... 3597Sodium propionate ................................................................. 3598Sodium propyl parahydroxybenzoate .................................. 3599Sodium pyrophosphate decahydrate for radiopharmaceuticalpreparations ................................................................... 9.2-4439
Sodium risedronate 2.5-hydrate ........................................... 3495Sodium salicylate .................................................................... 3601Sodium selenite....................................................................... 3601Sodium selenite pentahydrate ............................................... 3602Sodium (S)-lactate solution................................................... 3587Sodium starch glycolate (type A)................................... 9.1-4200Sodium starch glycolate (type B) ................................... 9.1-4202Sodium starch glycolate (type C).......................................... 3604Sodium stearate....................................................................... 3605Sodium stearyl fumarate........................................................ 3606Sodium sulfate, anhydrous .................................................... 3607Sodium sulfate decahydrate................................................... 3607Sodium sulfite ......................................................................... 3608Sodium sulfite heptahydrate.................................................. 3608Sodium tetrachloroaurate dihydrate for homoeopathicpreparations .......................................................................... 1593
Sodium thiosulfate.................................................................. 3609Sodium valproate.................................................................... 3609Soft capsules .............................................................................. 854Softening time determination of lipophilic suppositories(2.9.22.) .................................................................................... 338
Soft extracts ............................................................................... 817Solid dosage forms, dissolution test for (2.9.3.).................... 302Solid dosage forms, recommendations on dissolution testingof (5.17.1.)................................................................................ 761
Solids by mercury porosimetry, porosity and pore-sizedistribution of (2.9.32.) .......................................................... 352
Solids, density of (2.2.42.).......................................................... 70Solids, gas pycnometric density of (2.9.23.) .......................... 339Solids (porous) including powders, wettability of (2.9.45.).. 381Solifenacin succinate .............................................................. 3611Solubility in alcohol of essential oils (2.8.10.) ....................... 284Soluble tablets ........................................................................... 886Solution calorimetry and microcalorimetry, characterisationof crystalline solids by (2.2.61.) ............................................ 109
Solutions, emulsions and suspensions, oral .......................... 865Solutions for haemodialysis................................................... 2628Solutions for haemodialysis, concentrated, water fordiluting................................................................................... 2627
Solutions for haemofiltration and haemodiafiltration ....... 2631Solutions for organ preservation .......................................... 3612Solutions for peritoneal dialysis............................................ 3299Solutions, suspensions, intrauterine....................................... 862Solvents, residual (5.4.) ............................................................ 665Solvents, residual, identification and control (2.4.24.)......... 146Somatostatin............................................................................ 3613Somatropin .............................................................................. 3614Somatropin concentrated solution ....................................... 3616Somatropin for injection ....................................................... 3618Somatropin solution for injection ........................................ 3620Sophora flower ........................................................................ 1520Sophora flower-bud................................................................ 1522Sorbic acid ............................................................................... 3622Sorbitan laurate................................................................ 9.1-4203Sorbitan oleate.................................................................. 9.1-4203Sorbitan palmitate ........................................................... 9.1-4204Sorbitan sesquioleate....................................................... 9.1-4205Sorbitan stearate .............................................................. 9.1-4205Sorbitan trioleate ............................................................. 9.1-4206Sorbitol..................................................................................... 3625Sorbitol, liquid (crystallising) ............................................... 3626Sorbitol, liquid (non-crystallising) ....................................... 3627Sorbitol, liquid, partially dehydrated ................................... 3628Sotalol hydrochloride............................................................. 3629Soya-bean oil, hydrogenated ................................................. 3630Soya-bean oil, refined............................................................. 3631
General Notices (1) apply to all monographs and other texts 4659
Index EUROPEAN PHARMACOPOEIA 9.2
Spanish sage oil ....................................................................... 1524Specific surface area by air permeability (2.9.14.) ....... 9.1-4053Specific surface area by gas adsorption (2.9.26.) .................. 344Spectinomycin dihydrochloride pentahydrate.................... 3631Spectinomycin sulfate tetrahydrate for veterinary use ...... 3633Spectrometry, atomic absorption (2.2.23.) .............................. 37Spectrometry, atomic emission (2.2.22.) ................................. 36Spectrometry, mass (2.2.43.) ..................................................... 71Spectrometry, nuclear magnetic resonance (2.2.33.) ............. 54Spectrometry, X-ray fluorescence (2.2.37.) ............................. 61Spectrophotometry, infrared absorption (2.2.24.) ................. 39Spectrophotometry, ultraviolet and visible absorption(2.2.25.) ...................................................................................... 41
Spectroscopy, near-infrared (2.2.40.) ....................................... 64Spectroscopy, Raman (2.2.48.).................................................. 86SPF chicken flocks for the production and quality control ofvaccines (5.2.2.)....................................................................... 599
Spheroids and granules, friability of (2.9.41.) ....................... 375Spike lavender oil.................................................................... 1525Spiramycin........................................................................ 9.2-4612Spirapril hydrochloride monohydrate ................................. 3638Spironolactone ........................................................................ 3639Spot-on preparations................................................................ 889Sprays (liquid nasal) and drops (nasal).................................. 867Sprays, veterinary ..................................................................... 889Squalane................................................................................... 3641Standard solutions for limit tests (4.1.2.)............................... 555Standard solutions for limit tests (4.1.2.)...................... 9.2-4324Standards, reference (5.12.) ..................................................... 733Stannous chloride dihydrate.................................................. 3644Stanozolol ................................................................................ 3644Staphysagria for homoeopathic preparations ..................... 1612Star anise.................................................................................. 1529Star anise oil ............................................................................ 1530Starches, hydroxyethyl ........................................................... 3649Starch glycolate (type A), sodium.................................. 9.1-4200Starch glycolate (type B), sodium.................................. 9.1-4202Starch glycolate (type C), sodium......................................... 3604Starch, hydroxypropyl ............................................................ 3645Starch, hydroxypropyl, pregelatinised.................................. 3647Starch, maize ........................................................................... 2969Starch, pea ............................................................................... 3277Starch, potato .......................................................................... 3390Starch, pregelatinised ............................................................. 3649Starch, rice ............................................................................... 3487Starch, wheat ........................................................................... 3937Starflower (borage) oil, refined ............................................. 1858Statistical analysis of results of biological assays and tests(5.3.) ................................................................................ 9.2-4353
Stavudine ................................................................................. 3653Steam sterilisation of aqueous preparations, application of theF0 concept (5.1.5.) ................................................................... 580
Stearic acid............................................................................... 3655Stearoyl macrogolglycerides ........................................... 9.1-4206Stearyl alcohol ......................................................................... 3657Stem cells, human haematopoietic ....................................... 2682Stephania root, fourstamen ................................................... 1357Sterile braided silk suture in distributor for veterinaryuse........................................................................................... 1221
Sterile catgut ............................................................................ 1207Sterile catgut in distributor for veterinary use.................... 1219Sterile containers of plasticised poly(vinyl chloride) for humanblood containing anticoagulant solution (3.2.5.) ............... 432
Sterile linen thread in distributor for veterinary use ......... 1220Sterile non-absorbable strands in distributor for veterinaryuse........................................................................................... 1222
Sterile non-absorbable sutures .............................................. 1208Sterile plastic containers for human blood and bloodcomponents (3.2.3.)................................................................ 430
Sterile polyamide 6/6 suture in distributor for veterinaryuse........................................................................................... 1221
Sterile polyamide 6 suture in distributor for veterinaryuse........................................................................................... 1220
Sterile poly(ethylene terephthalate) suture in distributor forveterinary use........................................................................ 1221
Sterile products, biological indicators and related microbialpreparations used in the manufacture of (5.1.2.) ...... 9.2-4336
Sterile products, methods of preparation of (5.1.1.) ... 9.2-4333Sterile single-use plastic syringes (3.2.8.) .............................. 434Sterile synthetic absorbable braided sutures ....................... 1212Sterile synthetic absorbable monofilament sutures ............ 1213Sterility (2.6.1.).......................................................................... 185Sterility, guidelines for using the test for (5.1.9.).................. 592Sterols in fatty oils (2.4.23.) ..................................................... 144Sticks .......................................................................................... 884Sticks, intrauterine.................................................................... 862Sticks, nasal ............................................................................... 868St. John’s wort.......................................................................... 1526St. John’s wort dry extract, quantified.................................. 1527Stomata and stomatal index (2.8.3.) ....................................... 283Stramonium leaf .............................................................. 9.2-4473Stramonium, prepared .................................................... 9.2-4475Strands, sterile non-absorbable, in distributor for veterinaryuse .......................................................................................... 1222
Streptokinase concentrated solution .................................... 3658Streptomycin sulfate ............................................................... 3660Strontium (89Sr) chloride injection....................................... 1181Strychnos ignatii for homoeopathic preparations .............. 1606Subdivision of tablets ............................................................... 885Sublingual sprays, oromucosal drops and oromucosalsprays........................................................................................ 868
Sublingual tablets and buccal tablets...................................... 870Substances for pharmaceutical use................................ 9.1-4085Substances for pharmaceutical use, control of impurities in(5.10.) ....................................................................................... 723
Substances of animal origin for the production ofimmunological veterinary medicinal products (5.2.5.) ..... 608
Sub-visible particles, particulate contamination (2.9.19.) ... 335Sucralfate ................................................................................. 3661Sucralose ........................................................................... 9.2-4615Sucrose ..................................................................................... 3664Sucrose monopalmitate.......................................................... 3665Sucrose stearate....................................................................... 3666Sufentanil ................................................................................. 3668Sufentanil citrate ..................................................................... 3669Sugars, lead in (2.4.10.) ............................................................ 136Sugar spheres........................................................................... 3670Sulbactam sodium .................................................................. 3671Sulfacetamide sodium............................................................ 3673Sulfadiazine ............................................................................. 3674Sulfadimethoxine.................................................................... 3676Sulfadimethoxine sodium for veterinary use ...................... 3677Sulfadimidine .......................................................................... 3678Sulfadoxine .............................................................................. 3680Sulfafurazole............................................................................ 3681Sulfaguanidine ........................................................................ 3681Sulfamerazine.......................................................................... 3682Sulfamethizole......................................................................... 3683Sulfamethoxazole.................................................................... 3684Sulfamethoxypyridazine for veterinary use......................... 3685Sulfanilamide........................................................................... 3686Sulfasalazine .....................................................................9.2-4617Sulfated ash (2.4.14.) ................................................................ 136Sulfates (2.4.13.)........................................................................ 136Sulfathiazole ............................................................................ 3689Sulfinpyrazone......................................................................... 3689Sulfur dioxide (2.5.29.)............................................................. 171Sulfur for external use............................................................ 3691Sulfur for homoeopathic preparations................................. 1614Sulfuric acid............................................................................. 3691Sulindac.................................................................................... 3692Sulpiride................................................................................... 3693Sultamicillin ............................................................................ 3694Sultamicillin tosilate dihydrate ............................................. 3697Sumatra benzoin..................................................................... 1273Sumatra benzoin tincture ...................................................... 1274
4660 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 9.2 Index
Sumatriptan succinate............................................................ 3699Sunflower oil, refined ............................................................. 3701Supercritical fluid chromatography (2.2.45.) .......................... 74Suppositories ............................................................................. 881Suppositories and pessaries, disintegration of (2.9.2.) ......... 301Suppositories, lipophilic, softening time determination(2.9.22.) .................................................................................... 338
Suspensions, solutions and emulsions, oral .......................... 865Suspensions, solutions, intrauterine....................................... 862Sutures, sterile non-absorbable ............................................. 1208Sutures, sterile synthetic absorbable braided ..................... 1212Sutures, sterile synthetic absorbable monofilament .......... 1213Suxamethonium chloride ...................................................... 3701Suxibuzone .............................................................................. 3702Sweet fennel............................................................................. 1353Sweet orange oil ...................................................................... 1535Swelling index (2.8.4.) .............................................................. 284Swine erysipelas vaccine (inactivated) ................................. 1104Swine-fever vaccine (live, prepared in cell cultures),classical .................................................................................. 1104
Symbols and abbreviations (1.) ...................................... 9.2-4275Synthetic absorbable braided sutures, sterile ...................... 1212Synthetic absorbable monofilament sutures, sterile ........... 1213Syringes, plastic, sterile single-use (3.2.8.) ............................ 434Syrups......................................................................................... 866
TTable of physical characteristics of radionuclides mentioned inthe European Pharmacopoeia (5.7.)............................ 9.2-4385
Tablets ........................................................................................ 885Tablets and capsules, disintegration of (2.9.1.) ..................... 299Tablets and powders for rectal solutions and suspensions .. 882Tablets, buccal ........................................................................... 870Tablets, chewable ...................................................................... 887Tablets, coated........................................................................... 886Tablets, dispersible.................................................................... 886Tablets, effervescent.................................................................. 886Tablets for intrauterine solutions and suspensions .............. 862Tablets for use in the mouth.................................................... 887Tablets for vaginal solutions and suspensions ...................... 889Tablets, gastro-resistant............................................................ 886Tablets, intrauterine.................................................................. 862Tablets, modified-release ......................................................... 886Tablets, orodispersible.............................................................. 887Tablets, resistance to crushing (2.9.8.) ................................... 313Tablets, soluble .......................................................................... 886Tablets, subdivision of.............................................................. 885Tablets, sublingual .................................................................... 870Tablets, uncoated ...................................................................... 885Tablets, uncoated, friability of (2.9.7.) ................................... 312Tablets, vaginal.......................................................................... 888Tacalcitol monohydrate.......................................................... 3707Tadalafil.................................................................................... 3708Talc ........................................................................................... 3710Tamoxifen citrate .................................................................... 3712Tampons, ear ............................................................................. 856Tampons, medicated ............................................................... 887Tampons, rectal......................................................................... 882Tampons, vaginal, medicated.................................................. 889Tamsulosin hydrochloride..................................................... 3714Tannic acid .............................................................................. 3716Tannins in herbal drugs (2.8.14.)............................................ 288Tapped density and bulk density of powders (2.9.34.)......... 359Tartaric acid............................................................................. 3716Teat dips ..................................................................................... 890Tea tree oil ............................................................................... 1536Teat sprays ................................................................................. 890Technetium (99mTc) bicisate injection ........................... 9.2-4440Technetium (99mTc) colloidal rhenium sulfide injection ... 1183Technetium (99mTc) colloidal sulfur injection ..................... 1184Technetium (99mTc) colloidal tin injection .......................... 1185Technetium (99mTc) etifenin injection.................................. 1185
Technetium (99mTc) exametazime injection ........................ 1187Technetium (99mTc) gluconate injection .............................. 1188Technetium (99mTc) human albumin injection ................... 1189Technetium (99mTc) macrosalb injection ............................. 1190Technetium (99mTc) mebrofenin injection .................... 9.2-4440Technetium (99mTc) medronate injection ............................ 1192Technetium (99mTc) mertiatide injection ............................. 1193Technetium (99mTc) microspheres injection ........................ 1194Technetium (99mTc) oxidronate injection ............................ 1195Technetium (99mTc) pentetate injection ............................... 1196Technetium (99mTc) sestamibi injection........................ 9.2-4441Technetium (99mTc) succimer injection................................ 1199Technetium (99mTc) tin pyrophosphate injection ............... 1199Teicoplanin .............................................................................. 3717Telmisartan.............................................................................. 3718Temazepam.............................................................................. 3720Temozolomide......................................................................... 3722Tenosynovitis vaccine (live), viral, avian ............................. 1017Tenoxicam ............................................................................... 3723Terazosin hydrochloride dihydrate ...................................... 3724Terbinafine hydrochloride ..................................................... 3727Terbutaline sulfate .................................................................. 3728Terconazole.............................................................................. 3729Terfenadine.............................................................................. 3730Teriparatide ............................................................................. 3732Terlipressin ....................................................................... 9.2-4623Terminology used in monographs on biological products(5.2.1.) ...................................................................................... 599
Test for anticomplementary activity of immunoglobulin(2.6.17.) .................................................................................... 210
Test for anti-D antibodies in human immunoglobulin(2.6.26.) .................................................................................... 225
Test for aristolochic acids in herbal drugs (2.8.21) .............. 292Test for extractable volume of parenteral preparations(2.9.17.) .................................................................................... 322
Test for Fc function of immunoglobulin (2.7.9.) .................. 257Test for methanol and 2-propanol (2.9.11.) .......................... 318Test for neurovirulence of live virus vaccines (2.6.18.)........ 212Test for specified micro-organisms (microbiologicalexamination of non-sterile products) (2.6.13.) ................... 199
Testosterone............................................................................. 3734Testosterone decanoate .......................................................... 3736Testosterone enantate ............................................................. 3738Testosterone isocaproate ........................................................ 3740Testosterone propionate......................................................... 3741Tests for extraneous agents in viral vaccines for human use(2.6.16.) .................................................................................... 208
Tetanus and diphtheria toxins and toxoids, flocculation value(Lf) of, (Ramon assay) (2.7.27.)............................................ 273
Tetanus and diphtheria vaccine (adsorbed) .......................... 899Tetanus and diphtheria vaccine (adsorbed, reduced antigen(s)content).................................................................................... 900
Tetanus antitoxin for human use .......................................... 1119Tetanus antitoxin for veterinary use..................................... 1123Tetanus, diphtheria and hepatitis B (rDNA) vaccine(adsorbed) ............................................................................... 901
Tetanus, diphtheria and pertussis (acellular, component)vaccine (adsorbed) ................................................................. 902
Tetanus, diphtheria and pertussis (acellular, component)vaccine (adsorbed, reduced antigen(s) content)................. 903
Tetanus, diphtheria and pertussis (whole cell) vaccine(adsorbed) ............................................................................... 905
Tetanus, diphtheria and poliomyelitis (inactivated) vaccine(adsorbed, reduced antigen(s) content)............................... 906
Tetanus, diphtheria, pertussis (acellular, component) andhaemophilus type b conjugate vaccine (adsorbed) ............ 908
Tetanus, diphtheria, pertussis (acellular, component) andhepatitis B (rDNA) vaccine (adsorbed) ............................... 910
Tetanus, diphtheria, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed)................... 911
Tetanus, diphtheria, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed, reducedantigen(s) content) ................................................................. 913
General Notices (1) apply to all monographs and other texts 4661
Index EUROPEAN PHARMACOPOEIA 9.2
Tetanus, diphtheria, pertussis (acellular, component),hepatitis B (rDNA), poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) ............ 915
Tetanus, diphtheria, pertussis (acellular, component),poliomyelitis (inactivated) and haemophilus type b conjugatevaccine (adsorbed) ................................................................. 917
Tetanus, diphtheria, pertussis (whole cell) and poliomyelitis(inactivated) vaccine (adsorbed) .......................................... 920
Tetanus, diphtheria, pertussis (whole cell), poliomyelitis(inactivated) and haemophilus type b conjugate vaccine(adsorbed) ............................................................................... 922
Tetanus immunoglobulin, human ........................................ 2698Tetanus vaccine (adsorbed) ..................................................... 987Tetanus vaccine (adsorbed), assay of (2.7.8.) ........................ 253Tetanus vaccine for veterinary use ....................................... 1106Tetracaine hydrochloride....................................................... 3742Tetracosactide.......................................................................... 3743Tetracycline ............................................................................. 3744Tetracycline hydrochloride.................................................... 3746Tetra-O-acetyl-mannose triflate for radiopharmaceuticalpreparations ................................................................... 9.2-4443
Tetrazepam .............................................................................. 3747Tetryzoline hydrochloride ..................................................... 3749Thallous (201Tl) chloride injection ........................................ 1202Theobromine........................................................................... 3749Theophylline ........................................................................... 3750Theophylline-ethylenediamine ............................................. 3752Theophylline-ethylenediamine hydrate ............................... 3754Theophylline monohydrate ................................................... 3751Thermal analysis (2.2.34.).......................................................... 57Thermogravimetry (2.2.34.) ...................................................... 57Thiamazole .............................................................................. 3755Thiamine hydrochloride ........................................................ 3756Thiamine nitrate ..................................................................... 3758Thiamphenicol ........................................................................ 3760Thin-layer chromatography (2.2.27.) ....................................... 43Thiocolchicoside crystallised from ethanol ........................ 3760Thiocolchicoside hydrate....................................................... 3763Thioctic acid............................................................................ 3765Thiomersal............................................................................... 3766Thiopental sodium and sodium carbonate ......................... 3767Thioridazine ............................................................................ 3768Thioridazine hydrochloride .................................................. 3770Thomson kudzuvine root ...................................................... 1537Three-lobed sage leaf ............................................................. 1506Threonine ................................................................................ 3771Thyme ...................................................................................... 1538Thyme oil, thymol type.......................................................... 1540Thyme, wild............................................................................. 1559Thymol..................................................................................... 3772Thymol type thyme oil........................................................... 1540Tiabendazole ........................................................................... 3773Tiamulin for veterinary use................................................... 3774Tiamulin hydrogen fumarate for veterinary use................. 3777Tianeptine sodium.................................................................. 3779Tiapride hydrochloride .......................................................... 3781Tiaprofenic acid ...................................................................... 3782Tibolone................................................................................... 3783Ticarcillin sodium .................................................................. 3784Tick-borne encephalitis vaccine (inactivated) ...................... 988Ticlopidine hydrochloride ..................................................... 3786Tilidine hydrochloride hemihydrate .................................... 3788Timolol maleate ...................................................................... 3789Tinctures .................................................................................... 817Tinidazole ................................................................................ 3791Tinnevelly senna pods............................................................ 1519Tinzaparin sodium ................................................................. 3792Tioconazole ............................................................................. 3793Tiotropium bromide monohydrate ...................................... 3794Titanium dioxide .................................................................... 3796Titration, amperometric (2.2.19.) ............................................. 35Titration, potentiometric (2.2.20.)............................................ 35Titrations, complexometric (2.5.11.)...................................... 164
Titration, voltametric (2.2.65.)................................................ 112Tizanidine hydrochloride ...................................................... 3797Tobramycin.............................................................................. 3799Tocopherol, all-rac-α-............................................................. 3800Tocopherol, RRR-α-................................................................ 3801Tocopheryl acetate, all-rac-α- ............................................... 3802α-Tocopheryl acetate concentrate (powder form).............. 3805Tocopheryl acetate, RRR-α-................................................... 3804Tocopheryl hydrogen succinate, DL-α- ................................ 3806Tocopheryl hydrogen succinate, RRR-α- ............................. 3808Tolbutamide............................................................................. 3810Tolfenamic acid ....................................................................... 3811Tolnaftate ................................................................................. 3812Tolterodine tartrate................................................................. 3813Tolu balsam ............................................................................. 1541Toluenesulfonate (methyl, ethyl and isopropyl) in activesubstances (2.5.40.)................................................................. 179
Torasemide .............................................................................. 3815Tormentil ................................................................................. 1542Tormentil tincture .................................................................. 1542Tosylchloramide sodium ....................................................... 3816Total ash (2.4.16.)...................................................................... 137Total cholesterol in oils rich in omega-3 acids (2.4.32.) ...... 157Total organic carbon in water for pharmaceutical use(2.2.44.) ...................................................................................... 73
Total protein (2.5.33.)............................................................... 172Toxicity, abnormal (2.6.9.)....................................................... 194Traditional Chinese medicine, names of herbal drugs used in(5.22.) .............................................................................. 9.2-4415
Tragacanth ............................................................................... 1543Tramadol hydrochloride ........................................................ 3817Tramazoline hydrochloride monohydrate........................... 3818Trandolapril............................................................................. 3819Tranexamic acid...................................................................... 3821Transdermal patches ................................................................ 873Transdermal patches, dissolution test for (2.9.4.)................. 309Trapidil..................................................................................... 3822Trehalose dihydrate ................................................................ 3823Tretinoin .................................................................................. 3824Triacetin ................................................................................... 3825Triamcinolone ......................................................................... 3826Triamcinolone acetonide ....................................................... 3827Triamcinolone hexacetonide ................................................. 3829Triamterene ............................................................................. 3830Tribenoside.............................................................................. 3832Tributyl acetylcitrate............................................................... 3833Trichloroacetic acid ................................................................ 3835Triclabendazole for veterinary use ....................................... 3836Triethanolamine...................................................................... 3849Triethyl citrate ......................................................................... 3837Trifluoperazine hydrochloride .............................................. 3837Triflusal .................................................................................... 3838Triglycerides, medium-chain ................................................ 3839Triglycerides, omega-3-acid .................................................. 3209Triglycerol diisostearate ......................................................... 3841Trihexyphenidyl hydrochloride ............................................ 3841Trimebutine maleate .............................................................. 3842Trimeprazine hemitartrate .................................................... 1666Trimetazidine dihydrochloride ............................................. 3843Trimethadione......................................................................... 3845Trimethoprim.......................................................................... 3846Trimipramine maleate............................................................ 3848Tri-n-butyl phosphate ............................................................ 3834Tritiated (3H) water injection ................................................ 1202Trolamine................................................................................. 3849Trometamol ............................................................................. 3851Tropicamide............................................................................. 3852Tropisetron hydrochloride..................................................... 3853Trospium chloride .................................................................. 3855Troxerutin................................................................................ 3856Trypsin ..................................................................................... 3857Tryptophan .............................................................................. 3858
4662 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 9.2 Index
TSE, animal, minimising the risk of transmitting via humanand veterinary medicinal products (5.2.8.) ......................... 613
TSE, animal, products with risk of transmitting agents of.. 832Tuberculin for human use, old.............................................. 3861Tuberculin purified protein derivative, avian ..................... 3862Tuberculin purified protein derivative, bovine ................... 3863Tuberculin purified protein derivative for human use....... 3864Tuberculosis (BCG) vaccine, freeze-dried............................. 895Tubes for comparative tests (2.1.5.).......................................... 17Tubing and closures, silicone elastomer for (3.1.9.) ............. 409Tubing and containers for total parenteral nutritionpreparations, poly(ethylene - vinyl acetate) for(3.1.7.) ............................................................................. 9.2-4318
Tubing used in sets for the transfusion of blood and bloodcomponents, materials based on plasticised poly(vinylchloride) for (3.1.1.2.) ............................................................ 393
Turkey infectious rhinotracheitis vaccine (live) ................. 1107Turmeric, Javanese.................................................................. 1544Turmeric rhizome................................................................... 1545Turpentine oil.......................................................................... 1547Tylosin for veterinary use ...................................................... 3866Tylosin phosphate bulk solution for veterinary use ........... 3867Tylosin tartrate for veterinary use ........................................ 3869Typhoid polysaccharide and hepatitis A (inactivated,adsorbed) vaccine ................................................................... 929
Typhoid polysaccharide vaccine ............................................. 990Typhoid vaccine ........................................................................ 992Typhoid vaccine, freeze-dried ................................................. 992Typhoid vaccine (live, oral, strain Ty 21a) ............................ 992Tyrosine ................................................................................... 3870Tyrothricin............................................................................... 3871
UUbidecarenone ........................................................................ 3875Udder-washes............................................................................ 890Ultraviolet and visible absorption spectrophotometry(2.2.25.) ...................................................................................... 41
Ultraviolet ray lamps for analytical purposes (2.1.3.) ............ 15Uncaria stem with hooks ....................................................... 1548Uncoated tablets ....................................................................... 885Undecylenic acid..................................................................... 3876Uniformity of content of single-dose preparations (2.9.6.).. 312Uniformity of dosage units (2.9.40.) ............................. 9.1-4055Uniformity of dosage units, demonstration using large samplesizes (2.9.47.) ........................................................................... 384
Uniformity of mass of delivered doses from multidosecontainers (2.9.27.) ................................................................. 347
Uniformity of mass of single-dose preparations (2.9.5.) ..... 311Units of the International System (SI) used in thePharmacopoeia and equivalence with other units(1.) ................................................................................... 9.2-4275
Unsaponifiable matter (2.5.7.)................................................. 163Urea .......................................................................................... 3877Urofollitropin .......................................................................... 3877Urokinase................................................................................. 3879Uronic acids in polysaccharide vaccines (2.5.22.) ................ 168Ursodeoxycholic acid ............................................................ 3880Urtica dioica for homoeopathic preparations..................... 1614
VVaccine component assay by immunonephelometry(2.7.35.) .................................................................................... 279
Vaccines, adsorbed, aluminium in (2.5.13.) .......................... 165Vaccines, adsorbed, calcium in (2.5.14.)................................ 166Vaccines and immunosera, phenol in (2.5.15.)..................... 166Vaccines and immunosera, veterinary, evaluation of efficacyof (5.2.7.).................................................................................. 612
Vaccines and immunosera, veterinary, evaluation of safety(5.2.6.) ...................................................................................... 610
Vaccines for human use ........................................................... 840Vaccines for human use, cell substrates for the production of(5.2.3.) ...................................................................................... 602
Vaccines for human use, conjugated polysaccharide, carrierproteins for the production of (5.2.11.) ............................... 626
Vaccines for human use, viral, tests for extraneous agents in(2.6.16.) .................................................................................... 208
Vaccines for veterinary use...................................................... 843Vaccines for veterinary use, inactivated, healthy chicken flocksfor the production of (5.2.13.) .............................................. 630
Vaccines, polysaccharide, hexosamines in (2.5.20.) ............. 167Vaccines, polysaccharide, methylpentoses in (2.5.21.)......... 167Vaccines, polysaccharide, nucleic acids in (2.5.17.) ............. 166Vaccines, polysaccharide, O-acetyl in (2.5.19.) ..................... 167Vaccines, polysaccharide, phosphorus in (2.5.18.) ............... 166Vaccines, polysaccharide, protein in (2.5.16.) ....................... 166Vaccines, polysaccharide, ribose in (2.5.31.)......................... 171Vaccines, polysaccharide, sialic acid in (2.5.23.) .................. 168Vaccines, polysaccharide, uronic acids in (2.5.22.) .............. 168Vaccines, SPF chicken flocks for the production and qualitycontrol of (5.2.2.) ................................................................... 599
Vaccines, veterinary, cell cultures for the production of(5.2.4.) ...................................................................................... 606
Vaccines, viral live, test for neurovirulence (2.6.18.) ........... 212Vaginal capsules ........................................................................ 888Vaginal foams............................................................................ 889Vaginal preparations ................................................................ 887Vaginal preparations, semi-solid ............................................ 889Vaginal solutions and suspensions, tablets for...................... 889Vaginal solutions, emulsions and suspensions...................... 888Vaginal tablets ........................................................................... 888Vaginal tampons, medicated ................................................... 889Valaciclovir hydrochloride .................................................... 3885Valaciclovir hydrochloride, hydrated ................................... 3888Valerian dry aqueous extract ............................................... 1549Valerian dry hydroalcoholic extract ..................................... 1550Valerian root..................................................................... 9.1-4111Valerian root, cut ............................................................. 9.1-4113Valerian tincture ..................................................................... 1554Validation of nucleic acid amplification techniques for thedetection of B19 virus (B19V) DNA in plasma pools :guidelines................................................................................. 214
Validation of nucleic acid amplification techniques for thedetection of hepatitis C virus (HCV) RNA in plasma pools :guidelines................................................................................. 214
Valine ....................................................................................... 3890Valnemulin hydrochloride for veterinary use .................... 3892Valproate, sodium................................................................... 3609Valproic acid............................................................................ 3893Valsartan .................................................................................. 3895Vancomycin hydrochloride ................................................... 3896Vanillin..................................................................................... 3898Vapour, preparations to be converted into............................ 876Vardenafil hydrochloride trihydrate..................................... 3898Varicella immunoglobulin for intravenous administration,human .................................................................................... 2700
Varicella immunoglobulin, human ...................................... 2700Varicella, measles, mumps and rubella vaccine (live) .......... 953Varicella vaccine (live) ............................................................. 994Vectors for human use, adenovirus ........................................ 742Vectors for human use, plasmid ............................................. 740Vectors for human use, plasmid, bacterial cells used for themanufacture of........................................................................ 741
Vectors for human use, poxvirus ............................................ 744Vecuronium bromide ...................................................... 9.1-4211Vedaprofen for veterinary use............................................... 3901Vegetable fatty oils .................................................................... 848Venlafaxine hydrochloride .................................................... 3902Verapamil hydrochloride ....................................................... 3904Verbena herb ........................................................................... 1555Veterinary liquid preparations for cutaneous application... 889Veterinary medicinal products, immunological, substances ofanimal origin for the production of (5.2.5.)........................ 608
Veterinary semi-solid preparations for oral use ................... 890Veterinary vaccines and immunosera, evaluation of efficacy of(5.2.7.) ...................................................................................... 612
General Notices (1) apply to all monographs and other texts 4663
Index EUROPEAN PHARMACOPOEIA 9.2
Viability, nucleated cell count and (2.7.29.) .......................... 275Vibriosis (cold-water) vaccine (inactivated) forsalmonids........................................................................ 9.2-4428
Vibriosis vaccine (inactivated) for salmonids ..............9.2-4429VICH (5.8.)....................................................................... 9.2-4395Vigabatrin ................................................................................ 3906Vinblastine sulfate .................................................................. 3907Vincristine sulfate ................................................................... 3908Vindesine sulfate..................................................................... 3910Vinorelbine tartrate ................................................................ 3912Vinpocetine ............................................................................. 3914Viper venom antiserum, European ...................................... 1119Viral diarrhoea vaccine (inactivated), bovine ..................... 1023Viral hepatitis type I vaccine (live), duck ............................ 1047Viral rhinotracheitis vaccine (inactivated), feline .............. 1059Viral rhinotracheitis vaccine (live), feline ........................... 1060Viral safety (5.1.7.).................................................................... 591Viral tenosynovitis vaccine (live), avian .............................. 1017Viral vaccines for human use, tests for extraneous agents in(2.6.16.) .................................................................................... 208
Viscometer method, capillary (2.2.9.) ...................................... 27Viscometer method, falling ball (2.2.49.) ................................ 88Viscose wadding, absorbent .................................................. 3915Viscosity (2.2.8.).......................................................................... 27Viscosity - rotating viscometer method (2.2.10.) ................... 28Visible and ultraviolet absorption spectrophotometry(2.2.25.) ...................................................................................... 41
Visible particles, particulate contamination (2.9.20.) .......... 337Vitamin A ................................................................................ 3917Vitamin A concentrate (oily form), synthetic ..................... 3918Vitamin A concentrate (powder form), synthetic .............. 3919VitaminA concentrate (solubilisate/emulsion), synthetic.. 3920Voltametric titration (2.2.65.) ................................................. 112Volumetric analysis (4.2.) ........................................................ 565Volumetric solutions (4.2.2.) .......................................... 9.2-4325Volumetric solutions, primary standards for (4.2.1.) .. 9.2-4324von Willebrand factor, human.............................................. 2701von Willebrand factor, human, assay of (2.7.21.) ................. 268Voriconazole............................................................................ 3921
WWarfarin sodium..................................................................... 3927Warfarin sodium clathrate..................................................... 3928Washes, nasal............................................................................. 868Water (15O) injection .............................................................. 1203Water, determination by distillation (2.2.13.) ......................... 31Water for diluting concentrated haemodialysis solutions.. 2627Water for injections ......................................................... 9.1-4215Water for pharmaceutical use, total organic carbon in(2.2.44.) ...................................................................................... 73
Water for preparation of extracts.......................................... 3932Water, highly purified ............................................................ 3933Water in essential oils (2.8.5.) ................................................. 284Water in gases (2.5.28.) ............................................................ 170Water : micro determination (2.5.32.) .................................... 172Water, purified ........................................................................ 3935Water : semi-micro determination (2.5.12.) .......................... 165Water-solid interactions: determination of sorption-desorption isotherms and of water activity (2.9.39) .......... 369
Wettability of porous solids including powders (2.9.45.) .... 381
Wheat-germ oil, refined......................................................... 3937Wheat-germ oil, virgin........................................................... 3938Wheat starch............................................................................ 3937White beeswax ........................................................................ 1804White horehound ................................................................... 1557White peony root.................................................................... 1472White soft paraffin.................................................................. 3270Wild pansy (flowering aerial parts)...................................... 1558Wild thyme.............................................................................. 1559Willow bark ............................................................................. 1561Willow bark dry extract ......................................................... 1562Wool alcohols .......................................................................... 3938Wool fat.................................................................................... 3939Wool fat, hydrogenated.......................................................... 3943Wool fat, hydrous.................................................................... 3944Wormwood.............................................................................. 1563
XXanthan gum.................................................................... 9.2-4627Xenon (133Xe) injection .......................................................... 1204X-ray fluorescence spectrometry (2.2.37.)............................... 61X-ray powder diffraction (XRPD), characterisation ofcrystalline and partially crystalline solids by (2.9.33.)....... 354
Xylazine hydrochloride for veterinary use .......................... 3948Xylitol ....................................................................................... 3949Xylometazoline hydrochloride.............................................. 3951Xylose ....................................................................................... 3953
YYarrow ...................................................................................... 1564Yeasticidal, bactericidal or fungicidal activity of antisepticmedicinal products, determination of (5.1.11.) ......... 9.2-4348
Yellow beeswax........................................................................ 1805Yellow fever vaccine (live) ....................................................... 996Yellow soft paraffin................................................................. 3271Yersiniosis vaccine (inactivated) for salmonids ........... 9.2-4430Yohimbine hydrochloride ...................................................... 3957
ZZanamivir hydrate .................................................................. 3961Zanthoxylum bungeanum pericarp...................................... 1565Zidovudine .............................................................................. 3962Zinc acetate dihydrate ............................................................ 3964Zinc acexamate ....................................................................... 3965Zinc chloride ........................................................................... 3967Zinc gluconate......................................................................... 3967Zinc oxide ................................................................................ 3968Zinc stearate ............................................................................ 3968Zinc sulfate heptahydrate ...................................................... 3969Zinc sulfate hexahydrate ........................................................ 3970Zinc sulfate monohydrate...................................................... 3970Zinc undecylenate .................................................................. 3970Ziprasidone hydrochloride monohydrate............................ 3971Ziprasidone mesilate trihydrate ............................................ 3973Zolpidem tartrate.................................................................... 3975Zopiclone ................................................................................. 3976Zoster (shingles) vaccine (live), herpes.................................. 982Zuclopenthixol decanoate...................................................... 3978
4664 See the information section on general monographs (cover pages)