EUROPEAN PHARMACOPOEIA 5.6 INDEX To aid users the index includes a reference to the supplement where the latest version of a text can be found. For example: Acetone...............................................5.1-2875 means the monograph Acetone can be found on page 2875 of Supplement 5.1. Note that where no reference for a supplement is made, the text can be found in the principal volume. Monographs deleted from the 5 th edition are not included in the index; the list of deleted texts is found in the Contents of this supplement, page xxxiii. General Notices (1) apply to all monographs and other texts 4729
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EUROPEAN PHARMACOPOEIA 5.6
INDEXTo aid users the index includes a reference to the supplement where the latest version of a text can be found.
For example: Acetone...............................................5.1-2875
means the monograph Acetone can be found on page 2875 of Supplement 5.1.
Note that where no reference for a supplement is made, the text can be found in the principal volume.
Monographs deleted from the 5th edition are not included in the index; the list of deleted texts is found in the Contents ofthis supplement, page xxxiii.
General Notices (1) apply to all monographs and other texts 4729
EUROPEAN PHARMACOPOEIA 5.6
4730 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 5.6 Index
Numerics1. General notices .............................................................5.6-43732.1.1. Droppers ..............................................................................172.1.2. Comparative table of porosity of sintered-glassfilters..............................................................................................17
2.1.3. Ultraviolet ray lamps for analytical purposes..............172.1.4. Sieves ...................................................................................182.1.5. Tubes for comparative tests ............................................192.1.6. Gas detector tubes.............................................................192.1. Apparatus ...............................................................................172.2.10. Viscosity - Rotating viscometer method .........5.3-33372.2.11. Distillation range ............................................................ 302.2.12. Boiling point ....................................................................312.2.13. Determination of water by distillation....................... 322.2.14. Melting point - capillary method................................. 322.2.15. Melting point - open capillary method ...................... 332.2.16. Melting point - instantaneous method ...................... 332.2.17. Drop point ........................................................................ 332.2.18. Freezing point................................................................. 342.2.19. Amperometric titration ................................................. 342.2.1. Clarity and degree of opalescence of liquids.............. 232.2.20. Potentiometric titration ................................................ 352.2.21. Fluorimetry...................................................................... 352.2.22. Atomic emission spectrometry .................................... 352.2.23. Atomic absorption spectrometry ................................ 362.2.24. Absorption spectrophotometry, infrared .................. 372.2.25. Absorption spectrophotometry, ultraviolet andvisible.................................................................................5.6-4383
2.2.26. Paper chromatography ................................................. 402.2.27. Thin-layer chromatography ...............................5.2-30902.2.28. Gas chromatography ..................................................... 422.2.29. Liquid chromatography ................................................ 432.2.2. Degree of coloration of liquids...................................... 242.2.30. Size-exclusion chromatography .................................. 452.2.31. Electrophoresis ............................................................... 452.2.32. Loss on drying ................................................................ 502.2.33. Nuclear magnetic resonance spectrometry ...............512.2.34. Thermal analysis............................................................. 522.2.35. Osmolality ........................................................................ 542.2.36. Potentiometric determination of ionicconcentration using ion-selective electrodes....................... 55
2.2.37. X-ray fluorescence spectrometry................................. 562.2.38. Conductivity .........................................................5.1-27832.2.39. Molecular mass distribution in dextrans .................. 572.2.3. Potentiometric determination of pH............................ 262.2.40. Near-infrared spectrophotometry ............................... 592.2.41. Circular dichroism.......................................................... 632.2.42. Density of solids ............................................................. 642.2.43. Mass spectrometry ......................................................... 652.2.44. Total organic carbon in water for pharmaceuticaluse................................................................................................. 68
2.2.45. Supercritical fluid chromatography........................... 682.2.46. Chromatographic separation techniques.................. 692.2.47. Capillary electrophoresis ...............................................742.2.48. Raman spectrometry ..................................................... 792.2.49. Falling ball viscometer method................................... 802.2.4. Relationship between reaction of solution,approximate pH and colour of certain indicators .............. 27
2.3.2. Identification of fatty oils by thin-layerchromatography......................................................................... 98
2.3.3. Identification of phenothiazines by thin-layerchromatography......................................................................... 99
2.3.4. Odour .................................................................................. 992.3. Identification......................................................................... 952.4.10. Lead in sugars............................................................... 1072.4.11. Phosphates..................................................................... 1082.4.12. Potassium....................................................................... 1082.4.13. Sulphates ....................................................................... 1082.4.14. Sulphated ash ......................................................5.6-43892.4.15. Nickel in polyols ........................................................... 1082.4.16. Total ash......................................................................... 1082.4.17. Aluminium...................................................................... 1082.4.18. Free formaldehyde ....................................................... 1092.4.19. Alkaline impurities in fatty oils ................................. 1092.4.1. Ammonium....................................................................... 1032.4.21. Foreign oils in fatty oils by thin-layerchromatography....................................................................... 109
2.4.22. Composition of fatty acids by gas chroma-tography............................................................................5.6-4389
2.4.23. Sterols in fatty oils ..............................................5.1-27872.4.24. Identification and control of residual solvents...... 1132.4.25. Ethylene oxide and dioxan..........................................1182.4.26. N,N-Dimethylaniline .....................................................1192.4.27. Heavy metals in herbal drugs and fatty oils ............1192.4.28. 2-Ethylhexanoic acid ................................................... 1202.4.29. Composition of fatty acids in oils rich inomega-3-acids...................................................................5.5-4107
2.4.2. Arsenic .............................................................................. 1032.4.30. Ethylene glycol and diethylene glycol in ethoxylatedsubstances ........................................................................5.2-3095
2.4.3. Calcium............................................................................. 1032.4.4. Chlorides .......................................................................... 1042.4.5. Fluorides .......................................................................... 1042.4.6. Magnesium....................................................................... 1042.4.7. Magnesium and alkaline-earth metals ....................... 1042.4.8. Heavy metals ................................................................... 1042.4.9. Iron .................................................................................... 1072.4. Limit tests ............................................................................ 1032.5.10. Oxygen-flask method................................................... 1302.5.11. Complexometric titrations.......................................... 1302.5.12. Water: semi-micro determination ............................. 1302.5.13. Aluminium in adsorbed vaccines...............................1312.5.14. Calcium in adsorbed vaccines ....................................1312.5.15. Phenol in immunosera and vaccines ........................1312.5.16. Protein in polysaccharide vaccines ...........................1312.5.17. Nucleic acids in polysaccharide vaccines ................ 1322.5.18. Phosphorus in polysaccharide vaccines.................. 1322.5.19. O-Acetyl in polysaccharide vaccines......................... 1322.5.1. Acid value................................................................5.2-30992.5.20. Hexosamines in polysaccharide vaccines................ 1322.5.21. Methylpentoses in polysaccharide vaccines ........... 1332.5.22. Uronic acids in polysaccharide vaccines ................. 1332.5.23. Sialic acid in polysaccharide vaccines ..................... 1332.5.24. Carbon dioxide in gases.............................................. 1342.5.25. Carbon monoxide in gases ......................................... 1342.5.26. Nitrogen monoxide and nitrogen dioxide ingases ........................................................................................... 135
2.5.27. Oxygen in gases ............................................................ 1362.5.28. Water in gases............................................................... 1362.5.29. Sulphur dioxide ............................................................ 1362.5.2. Ester value ....................................................................... 1272.5.30. Oxidising substances................................................... 1372.5.31. Ribose in polysaccharide vaccines............................ 1372.5.32. Water: micro determination ...................................... 1372.5.33. Total protein.................................................................. 1382.5.34. Acetic acid in synthetic peptides ...............................1412.5.35. Nitrous oxide in gases ..................................................141
General Notices (1) apply to all monographs and other texts 4731
Index EUROPEAN PHARMACOPOEIA 5.6
2.5.36. Anisidine value ............................................................. 1422.5.3. Hydroxyl value ................................................................ 1272.5.4. Iodine value ..................................................................... 1272.5.5. Peroxide value................................................................. 1282.5.6. Saponification value ...................................................... 1292.5.7. Unsaponifiable matter ................................................... 1292.5.8. Determination of primary aromaticamino-nitrogen ......................................................................... 129
2.5.9. Determination of nitrogen by sulphuric aciddigestion .................................................................................... 129
2.6.13. Microbiological examination of non-sterile products :test for specified micro-organisms ..............................5.6-4404
2.6.14. Bacterial endotoxins .....................................................1612.6.15. Prekallikrein activator........................................5.5-41112.6.16. Tests for extraneous agents in viral vaccines forhuman use................................................................................. 169
2.6.17. Test for anticomplementary activity ofimmunoglobulin....................................................................... 170
2.6.18. Test for neurovirulence of live virus vaccines........ 1722.6.19. Test for neurovirulence of poliomyelitis vaccine(oral) ........................................................................................... 172
2.6.1. Sterility ............................................................................. 1452.6.20. Anti-A and anti-B haemagglutinins(indirect method) ......................................................................174
2.6.25. Avian live virus vaccines : tests for extraneous agentsin batches of finished product .....................................5.3-3345
2.6.26. Test for anti-D antibodies in human immunoglobulinfor intravenous administration ....................................5.3-3348
2.6.27. Microbiological control of cellular products ..5.6-44142.6.2. Mycobacteria ................................................................... 1492.6.7. Mycoplasmas...........................................................5.6-43952.6.8. Pyrogens........................................................................... 1522.6.9. Abnormal toxicity ........................................................... 1532.6. Biological tests ................................................................... 1452.7.10. Assay of human coagulation factor VII ..........5.6-44192.7.11. Assay of human coagulation factor IX ............5.5-41202.7.12. Assay of heparin in coagulation factors .................. 2042.7.13. Assay of human anti-D immunoglobulin................. 2052.7.14. Assay of hepatitis A vaccine ..............................5.1-27952.7.15. Assay of hepatitis B vaccine (rDNA)......................... 2072.7.16. Assay of pertussis vaccine (acellular)....................... 2082.7.17. Assay of human antithrombin III .............................. 2092.7.18. Assay of human coagulation factor II ...................... 2092.7.19. Assay of human coagulation factor X .......................2102.7.1. Immunochemical methods ........................................... 1872.7.20. In vivo assay of poliomyelitis vaccine(inactivated) .....................................................................5.6-4420
2.7.21. Assay of human von Willebrand factor...........5.5-41202.7.22. Assay of human coagulation factor XI............5.5-41212.7.23. Numeration of CD34/CD45+ cells in haematopoieticproducts ............................................................................5.6-4421
2.7.24. Flow cytometry ....................................................5.6-44232.7.27. Flocculation value (Lf) of diphtheria and tetanustoxins and toxoids (Ramon assay)...............................5.6-4424
2.7.2. Microbiological assay of antibiotics ............................ 1882.7.4. Assay of human coagulation factor VIII ...........5.5-41192.7.5. Assay of heparin.....................................................5.6-44192.7.6. Assay of diphtheria vaccine (adsorbed) ..................... 1962.7.7. Assay of pertussis vaccine............................................. 1972.7.8. Assay of tetanus vaccine (adsorbed)..................5.1-2791
2.7.9. Test for Fc function of immunoglobulin ................... 2022.7. Biological assays ................................................................ 1872.8.10. Solubility in alcohol of essential oils ........................2162.8.11. Assay of 1,8-cineole in essential oils .........................2162.8.12. Determination of essential oils in vegetabledrugs............................................................................................217
2.8.13. Pesticide residues..........................................................2182.8.14. Determination of tannins in herbal drugs .............. 2212.8.15. Bitterness value ............................................................ 2212.8.16. Dry residue of extracts................................................ 2222.8.17. Loss on drying of extracts .......................................... 2222.8.1. Ash insoluble in hydrochloric acid ............................. 2152.8.2. Foreign matter ................................................................ 2152.8.3. Stomata and stomatal index ........................................ 2152.8.4. Swelling index ................................................................. 2152.8.5. Water in essential oils.....................................................2162.8.6. Foreign esters in essential oils .....................................2162.8.7. Fatty oils and resinified essential oils in essentialoils................................................................................................216
2.8.8. Odour and taste of essential oils..................................2162.8.9. Residue on evaporation of essential oils ....................2162.8. Methods in pharmacognosy ............................................ 2152.9.10. Ethanol content and alcoholimetric tables ............ 2372.9.11. Test for methanol and 2-propanol ...................5.3-33622.9.12. Sieve test ........................................................................ 2392.9.14. Specific surface area by air permeability ................ 2392.9.15. Apparent volume .......................................................... 2412.9.16. Flowability...................................................................... 2422.9.17. Test for extractable volume of parenteralpreparations .....................................................................5.3-3363
2.9.18. Preparations for inhalation : aerodynamic assessmentof fine particles ...............................................................5.2-3103
2.9.19. Particulate contamination : sub-visible particles... 2532.9.1. Disintegration of tablets and capsules..............5.3-33512.9.20. Particulate contamination : visible particles .......... 2552.9.22. Softening time determination of lipophilicsuppositories............................................................................. 256
2.9.23. Pycnometric density of solids.................................... 2572.9.24. Resistance to rupture of suppositories andpessaries .................................................................................... 258
2.9.25. Dissolution test for medicated chewinggums .................................................................................. 5.2-3116
2.9.26. Specific surface area by gas adsorption.........5.1-28112.9.27. Uniformity of mass of delivered doses from multidosecontainers.................................................................................. 263
2.9.28. Test for deliverable mass or volume of liquid andsemi-solid preparations........................................................... 263
2.9.29. Intrinsic dissolution............................................5.4-37052.9.2. Disintegration of suppositories and pessaries ......... 2272.9.31. Particle size analysis by laser lightdiffraction .........................................................................5.6-4429
2.9.33. Characterisation of crystalline and partially crystallinesolids by X-ray powder diffraction (XRPD)................5.6-4432
2.9.36. Powder flow..........................................................5.3-33632.9.37. Optical microscopy..............................................5.3-33662.9.38. Particle-size distribution estimation by analyticalsieving ...............................................................................5.3-3368
2.9.3. Dissolution test for solid dosage forms ............5.3-33532.9.40. Uniformity of dosage units................................5.3-33702.9.42. Dissolution test for lipophilic solid dosageforms..................................................................................5.3-3373
2.9.43. Apparent dissolution ..........................................5.6-44382.9.4. Dissolution test for transdermal patches .................. 2312.9.5. Uniformity of mass of single-dose preparations....... 2332.9.6. Uniformity of content of single-dose preparations.. 2342.9.7. Friability of uncoated tablets ..............................5.2-31032.9.8. Resistance to crushing of tablets................................ 2352.9.9. Measurement of consistency by penetrometry ........ 2352.9. Pharmaceutical technical procedures ........................... 225
4732 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 5.6 Index
3.1.10. Materials based on non-plasticised poly(vinyl chloride)for containers for non-injectable, aqueous solutions ...... 289
3.1.11. Materials based on non-plasticised poly(vinylchloride) for containers for dry dosage forms for oraladministration .......................................................................... 291
3.1.1.1. Materials based on plasticised poly(vinyl chloride) forcontainers for human blood and blood components....... 269
3.1.1.2. Materials based on plasticised poly(vinyl chloride)for tubing used in sets for the transfusion of blood andblood components ................................................................... 272
3.1.13. Plastic additives ............................................................ 2933.1.14. Materials based on plasticised poly(vinyl chloride)for containers for aqueous solutions for intravenousinfusion ...................................................................................... 296
3.1.15. Polyethylene terephthalate for containers forpreparations not for parenteral use..................................... 298
3.1.1. Materials for containers for human blood and bloodcomponents............................................................................... 269
3.1.3. Polyolefines...................................................................... 2743.1.4. Polyethylene without additives for containersfor parenteral preparations and for ophthalmicpreparations .............................................................................. 278
3.1.5. Polyethylene with additives for containersfor parenteral preparations and for ophthalmicpreparations .............................................................................. 279
3.1.6. Polypropylene for containers and closures forparenteral preparations and ophthalmic preparations ... 282
3.1.7. Poly(ethylene - vinyl acetate) for containers and tubingfor total parenteral nutrition preparations ........................ 285
3.1.8. Silicone oil used as a lubricant ................................... 2873.1.9. Silicone elastomer for closures and tubing .............. 2883.1. Materials used for the manufacture of containers ..... 2693.2.1. Glass containers for pharmaceutical use .................. 3033.2.2.1. Plastic containers for aqueous solutions forparenteral infusion .................................................................. 309
3.2.2. Plastic containers and closures for pharmaceuticaluse............................................................................................... 308
3.2.3. Sterile plastic containers for human blood and bloodcomponents............................................................................... 309
3.2.4. Empty sterile containers of plasticised poly(vinylchloride) for human blood and blood components...........311
3.2.5. Sterile containers of plasticised poly (vinyl chloride)for human blood containing anticoagulant solution....... 312
3.2.6. Sets for the transfusion of blood and bloodcomponents................................................................................313
3.2.8. Sterile single-use plastic syringes ................................3143.2.9. Rubber closures for containers for aqueous parenteralpreparations, for powders and for freeze-dried powders ..316
3.2. Containers ..................................................................5.6-44434.1.1. Reagents ..................................................................5.4-37094.1.1. Reagents ..................................................................5.5-41254.1.1. Reagents ..................................................................5.6-44474.1.2. Standard solutions for limit tests.......................5.4-38174.1.2. Standard solutions for limit tests.......................5.5-41264.1.3. Buffer solutions .....................................................5.4-38214.1.3. Buffer solutions .....................................................5.5-41264.1. Reagents, standard solutions, buffer solutions ..5.4-37094.2.1. Primary standards for volumetric solutions....5.4-38274.2.2. Volumetric solutions.............................................5.4-38274.2.2. Volumetric solutions.............................................5.5-41274.2.2. Volumetric solutions.............................................5.6-44484.2. Volumetric analysis...................................................5.4-38274. Reagents.........................................................................5.4-37095.10. Control of impurities in substances for pharmaceuticaluse......................................................................................5.5-4145
5.11. Characters section in monographs .............................. 5655.1.1. Methods of preparation of sterile products .............. 4455.1.2. Biological indicators of sterilisation........................... 4475.12. Reference standards...............................................5.6-4455
5.1.3. Efficacy of antimicrobial preservation ....................... 4475.14. Gene transfer medicinal products for humanuse......................................................................................5.6-4461
5.1.4. Microbiological quality of pharmaceuticalpreparations .....................................................................5.6-4451
5.1.5. Application of the F0 concept to steam sterilisation ofaqueous preparations ....................................................5.1-2821
5.1.6. Alternative methods for control of microbiologicalquality................................................................................5.5-4131
5.1. General texts on sterility .................................................. 4455.2.1. Terminology used in monographs on vaccines ....... 4535.2.2. Chicken flocks free from specified pathogens for theproduction and quality control of vaccines...............5.1-2825
5.2.3. Cell substrates for the production of vaccines forhuman use................................................................................. 455
5.2.4. Cell cultures for the production of veterinaryvaccines...................................................................................... 458
5.2.5. Substances of animal origin for the production ofveterinary vaccines.................................................................. 460
5.2.6. Evaluation of safety of veterinary vaccines andimmunosera ....................................................................5.1-2827
5.2.7. Evaluation of efficacy of veterinary vaccines andimmunosera .....................................................................5.1-2829
5.2.8. Minimising the risk of transmitting animal spongiformencephalopathy agents via human and veterinary medicinalproducts ..................................................................................... 463
5.2.9. Evaluation of safety of each batch of veterinaryvaccines and immunosera.............................................5.1-2830
5.2. General texts on vaccines................................................. 4535.3. Statistical analysis of results of biological assays andtests............................................................................................. 475
5.4. Residual solvents ............................................................... 5075.5. Alcoholimetric tables .........................................................5195.6. Assay of interferons..................................................5.3-33815.7. Table of physical characteristics of radionuclidesmentioned in the European Pharmacopoeia..................... 539
Animal spongiform encephalopathies, products with risk oftransmitting agents of............................................................. 577
Animal spongiform encephalopathy agents, minimising therisk of transmitting via human and veterinary medicinalproducts (5.2.8.) ....................................................................... 463
General Notices (1) apply to all monographs and other texts 4735
Index EUROPEAN PHARMACOPOEIA 5.6
Anthrax vaccine for human use (adsorbed, prepared fromculture filtrates) ..............................................................5.6-4479
Anti-A and anti-B haemagglutinins (indirect method)(2.6.20.) .......................................................................................174
Antibiotics, microbiological assay of (2.7.2.) ........................ 188Anticoagulant and preservative solutions for human blood................................................................................................... 1007
Anticomplementary activity of immunoglobulin (2.6.17.).. 170Anticorpora monoclonalia ad usum humanum ......5.2-3127Anti-D antibodies in human immunoglobulins for intravenousadministration, test for (2.6.26.) ..................................5.3-3348
Anti-D immunoglobulin, human ....................................5.6-4595Anti-D immunoglobulin, human, assay of (2.7.13.)............. 205Anti-D immunoglobulin, human, for intravenousadministration .................................................................5.6-4595
Antimicrobial preservation, efficacy of (5.1.3.) .................... 447Antiserum, European viper venom ........................................ 806Antithrombin III concentrate, human ................................. 1733Antithrombin III, human, assay of (2.7.17.) .......................... 209Antithrombinum III humanum densatum ....................... 1733Anti-T lymphocyte immunoglobulin for human use,animal................................................................................5.6-4506
Apis mellifera ad praeparationes homoeopathicas.......... 898Apomorphine hydrochloride ..................................................1014Apomorphini hydrochloridum .............................................1014Apparatus (2.1.) .............................................................................17Apparent dissolution (2.9.43.) ........................................5.6-4438Apparent volume (2.9.15.)........................................................ 241Application of the F0 concept to steam sterilisation ofaqueous preparations (5.1.5.).......................................5.1-2821
Asparaginum monohydricum.............................................. 1027Aspartame.................................................................................. 1028Aspartamum ............................................................................. 1028Aspartic acid.............................................................................. 1029Assay of 1,8-cineole in essential oils (2.8.11.) .......................216Assay of diphtheria vaccine (adsorbed) (2.7.6.) ................... 196Assay of heparin (2.7.5.) ..................................................5.6-4419Assay of heparin in coagulation factors (2.7.12.) ................ 204Assay of hepatitis A vaccine (2.7.14.) ............................5.1-2795Assay of hepatitis B vaccine (rDNA) (2.7.15.) ...................... 207Assay of human anti-D immunoglobulin (2.7.13.)............... 205Assay of human antithrombin III (2.7.17.) ............................ 209Assay of human coagulation factor II (2.7.18.).................... 209Assay of human coagulation factor IX (2.7.11.)..........5.5-4120Assay of human coagulation factor VII (2.7.10.) ........5.6-4419Assay of human coagulation factor VIII (2.7.4.).........5.5-4119Assay of human coagulation factor X (2.7.19.) .....................210Assay of human coagulation factor XI (2.7.22.) .........5.5-4121Assay of human von Willebrand factor (2.7.21.) ........5.5-4120Assay of interferons (5.6.)................................................5.3-3381Assay of pertussis vaccine (2.7.7.)........................................... 197Assay of pertussis vaccine (acellular) (2.7.16.) .................... 208Assay of poliomyelitis vaccine (inactivated), in vivo(2.7.20.) .............................................................................5.6-4420
Azaperone for veterinary use ................................................ 1036Azaperonum ad usum veterinarium..................................1036Azathioprine.............................................................................. 1037Azathioprinum......................................................................... 1037Azelastine hydrochloride........................................................ 1037Azelastini hydrochloridum ................................................... 1037Azithromycin......................................................................5.6-4513Azithromycinum...............................................................5.6-4513
4736 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 5.6 Index
BBacampicillin hydrochloride.................................................. 1043Bacampicillini hydrochloridum.......................................... 1043Bacitracin................................................................................... 1045Bacitracinum............................................................................ 1045Bacitracinum zincum ............................................................ 1047Bacitracin zinc .......................................................................... 1047Baclofen ..................................................................................... 1050Baclofenum............................................................................... 1050Bacterial cells used for the manufacture of plasmid vectorsfor human use .................................................................5.6-4468
General Notices (1) apply to all monographs and other texts 4737
Index EUROPEAN PHARMACOPOEIA 5.6
Bitter fennel ..............................................................................1580Bitter-fennel fruit oil................................................................ 1108Bitterness value (2.8.15.).......................................................... 221Bitter-orange epicarp and mesocarp.................................... 1110Bitter-orange-epicarp and mesocarp tincture .................... 1110Bitter-orange flower .................................................................1111Bitter-orange-flower oil ....................................................5.3-3562Black horehound ..................................................................... 1113Bleomycini sulfas .............................................................5.2-3179Bleomycin sulphate ..........................................................5.2-3179Blood and blood components, empty sterile containers ofplasticised poly(vinyl chloride) for (3.2.4.) ..........................311
Blood and blood components, materials for containers for(3.1.1.)......................................................................................... 269
Blood and blood components, sets for the transfusion of(3.2.6.) .........................................................................................313
Blood and blood components, sterile plastic containers for(3.2.3.) ........................................................................................ 309
Blood, anticoagulant and preservative solutions for .......1007Blood, sterile containers of plasticised poly (vinyl chloride)containing anticoagulant solution (3.2.5.) ......................... 312
Bogbean leaf ............................................................................. 1115Boiling point (2.2.12.) ..................................................................31Boldi folium .......................................................................5.3-3450Boldo leaf............................................................................5.3-3450Borage (starflower) oil, refined......................................5.1-2889Borago officinalis oleum raffinatum ..........................5.1-2889Borax .......................................................................................... 1116Boric acid....................................................................................1117Botulinum antitoxin .................................................................. 801Botulinum toxin type A for injection....................................1117Bovine infectious rhinotracheitis vaccine (live),freeze-dried................................................................................ 768
Cell substrates for the production of vaccines for human use(5.2.3.) ........................................................................................ 455
Cellulae stirpes haematopoieticae humanae............5.6-4598Cellular products, microbiological control of(2.6.27.) .............................................................................5.6-4414
Ceylon cinnamon bark oil ......................................................1295Ceylon cinnamon leaf oil........................................................1296Chamomile flower, Roman.....................................................1245Chamomillae romanae flos ..................................................1245Characterisation of crystalline and partially crystalline solidsby X-ray powder diffraction (XRPD) (2.9.33.) ...........5.6-4432
Characters section in monographs (5.11.)............................ 565Charcoal, activated ..................................................................1246Chelidonii herba...................................................................... 1690Chenodeoxycholic acid ..........................................................1247Chewing gum, medicated, dissolution test for(2.9.25.) .............................................................................5.2-3116
Chewing gums, medicated ..............................................5.2-3136Chicken flocks free from specified pathogens forthe production and quality control of vaccines(5.2.2.) ...............................................................................5.1-2825
Ciprofloxacinum .....................................................................1300Circular dichroism (2.2.41.) ....................................................... 63Cisapride monohydrate...........................................................1303Cisapride tartrate .....................................................................1304Cisapridi tartras ......................................................................1304Cisapridum monohydricum .................................................1303Cisplatin .....................................................................................1306Cisplatinum ..............................................................................1306Citric acid, anhydrous .............................................................1306Citric acid monohydrate .........................................................1307Citri reticulatae aetheroleum........................................5.6-4630Citronellae aetheroleum........................................................1308Citronella oil..............................................................................1308Cladribine ...........................................................................5.6-4556Cladribinum ......................................................................5.6-4556Clarithromycin...................................................................5.1-2900Clarithromycinum ...........................................................5.1-2900Clarity and degree of opalescence of liquids (2.2.1.)............ 23Clary sage oil............................................................................. 1311Clazuril for veterinary use ..................................................... 1312Clazurilum ad usum veterinarium..................................... 1312Clebopride malate .................................................................... 1314Clebopridi malas ..................................................................... 1314Clemastine fumarate ............................................................... 1315Clemastini fumaras ................................................................ 1315Clenbuterol hydrochloride..............................................5.1-2902Clenbuteroli hydrochloridum .......................................5.1-2902Clindamycin hydrochloride.............................................5.4-3920Clindamycini hydrochloridum .....................................5.4-3920Clindamycini phosphas......................................................... 1319Clindamycin phosphate .......................................................... 1319Clioquinol .................................................................................. 1321Clioquinolum ........................................................................... 1321Clobazam ...................................................................................1322Clobazamum ............................................................................1322Clobetasoli propionas .....................................................5.5-4208Clobetasol propionate......................................................5.5-4208Clobetasone butyrate ..............................................................1323Clobetasoni butyras ................................................................1323Clofazimine................................................................................1324Clofaziminum ..........................................................................1324Clofibrate ...................................................................................1325Clofibratum ...............................................................................1325Clomifene citrate ......................................................................1326Clomifeni citras .......................................................................1326Clomipramine hydrochloride.................................................1328Clomipramini hydrochloridum ...........................................1328Clonazepam...............................................................................1330Clonazepamum .......................................................................1330Clonidine hydrochloride......................................................... 1331Clonidini hydrochloridum.................................................... 1331Closantel sodium dihydrate for veterinary use ..........5.1-2903Closantelum natricum dihydricumad usum veterinarium ..................................................5.1-2903
Clostridium botulinum vaccine for veterinary use ............. 745Clostridium chauvoei vaccine for veterinary use................ 745Clostridium novyi alpha antitoxin for veterinary use ........5.1-2865
Clostridium novyi (type B) vaccine for veterinary use....... 746Clostridium perfringens beta antitoxin for veterinary use............................................................................................5.1-2866
Clostridium perfringens epsilon antitoxin for veterinary use............................................................................................5.1-2867
Clostridium perfringens vaccine for veterinary use ........... 747Clostridium septicum vaccine for veterinary use................ 749Closures and containers for parenteral preparations andophthalmic preparations, polypropylene for (3.1.6.)........ 282
Closures and containers for pharmaceutical use, plastic(3.2.2.) ........................................................................................ 308
General Notices (1) apply to all monographs and other texts 4741
Index EUROPEAN PHARMACOPOEIA 5.6
Closures and tubing, silicone elastomer for (3.1.9.) ........... 288Closures for containers for aqueous parenteral preparations,for powders and for freeze-dried powders, rubber(3.2.9.) .........................................................................................316
Comparative table of porosity of sintered-glass filters(2.1.2.)............................................................................................17
Complexometric titrations (2.5.11.)........................................ 130Composition of fatty acids by gas chromatography(2.4.22.) .............................................................................5.6-4389
Composition of fatty acids in oils rich in omega-3-acids(2.4.29.) .............................................................................5.5-4107
Compressed lozenges.......................................................5.4-3846Compressi...........................................................................5.5-4166Concentrated solutions for haemodialysis ......................... 1700Concentrates for injections or infusions......................5.2-3145Concentrates for intrauterine solutions.......................5.3-3397Conductivity (2.2.38.) .......................................................5.1-2783Coneflower herb, purple .................................................5.6-4666Coneflower root, narrow-leaved.....................................5.2-3246Coneflower root, pale.......................................................5.2-3257Coneflower root, purple ..................................................5.6-4668Conjugated estrogens .............................................................1539Containers (3.2.)................................................................5.6-4443Containers and closures for parenteral preparations andophthalmic preparations, polypropylene for (3.1.6.)........ 282
Containers and closures for pharmaceutical use, plastic(3.2.2.) ........................................................................................ 308
Containers and tubing for total parenteral nutritionpreparations, poly(ethylene - vinyl acetate) for (3.1.7.) ... 285
Containers for aqueous solutions for intravenous infusion,materials based on plasticised poly(vinyl chloride) for(3.1.14.) ...................................................................................... 296
Containers for aqueous solutions for parenteral infusion,plastic (3.2.2.1.) ........................................................................ 309
Containers for dry dosage forms for oral administration,materials based on non-plasticised poly(vinyl chloride) for(3.1.11.)....................................................................................... 291
Containers for human blood and blood components,materials based on plasticised poly(vinyl chloride) for(3.1.1.1.) ..................................................................................... 269
Containers for human blood and blood components,materials for (3.1.1.) ................................................................ 269
Containers for human blood and blood components, plastic,sterile (3.2.3.) ............................................................................ 309
Containers for non-injectable aqueous solutions, materialsbased on non-plasticised poly(vinyl chloride) for(3.1.10.) ...................................................................................... 289
Containers for parenteral preparations and for ophthalmicpreparations, polyethylene with additives for (3.1.5.) ..... 279
Containers for parenteral preparations and for ophthalmicpreparations, polyethylene without additives for(3.1.4.)......................................................................................... 278
Containers for pharmaceutical use, glass (3.2.1.)............... 303Containers for preparations not for parenteral use,polyethylene terephthalate for (3.1.15) .............................. 298
Containers of plasticised poly(vinyl chloride) for humanblood and blood components, empty sterile (3.2.4.) .........311
Containers of plasticised poly (vinyl chloride) for humanblood containing anticoagulant solution, sterile (3.2.5.).. 312
Contamination, microbial: test for specified micro-organisms(2.6.13.) .............................................................................5.6-4404
Contamination, microbial: total viable aerobic count(2.6.12.) .............................................................................5.6-4398
Content uniformity of single-dose preparations (2.9.6.).... 234Control of impurities in substances for pharmaceutical use(5.10.).................................................................................5.5-4145
Control of microbiological quality, alternative methods for(5.1.6.)................................................................................5.5-4131
DDalteparin sodium ............................................................5.4-3925Dalteparinum natricum .................................................5.4-3925Danaparoid sodium ..........................................................5.5-4215Danaparoidum natricum ...............................................5.5-4215Dapsone .....................................................................................1388Dapsonum .................................................................................1388Daunorubicin hydrochloride .................................................1389Daunorubicini hydrochloridum..........................................1389D-Camphor ................................................................................. 1170D-Camphora .............................................................................. 1170Decylis oleas .............................................................................1390Decyl oleate ...............................................................................1390Deferoxamine mesilate............................................................1390Deferoxamini mesilas ............................................................1390Degree of coloration of liquids (2.2.2.).................................... 24Deliverable mass or volume of liquid and semi-solidpreparations, test for (2.9.28.)............................................... 263
Dembrexine hydrochloride monohydrate for veteri-nary use ............................................................................5.6-4563
Dembrexini hydrochloridum monohydricum ad usumveterinarium ...................................................................5.6-4563
Demeclocycline hydrochloride..............................................1392Demeclocyclini hydrochloridum ........................................1392Density of solids (2.2.42.) ........................................................... 64Density, relative (2.2.5.) .............................................................. 27Dental type silica...................................................................... 2411Depressor substances (2.6.11.)................................................ 153Deptropine citrate....................................................................1393Deptropini citras .....................................................................1393Dequalinii chloridum.............................................................1394Dequalinium chloride..............................................................1394Desipramine hydrochloride ...................................................1395Desipramini hydrochloridum ..............................................1395Deslanoside ...............................................................................1396Deslanosidum ..........................................................................1396Desmopressin............................................................................1397Desmopressinum.....................................................................1397Desogestrel .........................................................................5.5-4217Desogestrelum...................................................................5.5-4217Desoxycortone acetate............................................................1399Desoxycortoni acetas .............................................................1399Detector tubes, gas (2.1.6.) .........................................................19Determination of essential oils in vegetable drugs(2.8.12.) .......................................................................................217
Determination of nitrogen by sulphuric acid digestion(2.5.9.) ........................................................................................ 129
Determination of primary aromatic amino-nitrogen(2.5.8.) ........................................................................................ 129
Determination of tannins in herbal drugs (2.8.14.)............ 221Determination of water by distillation (2.2.13.) .................... 32Detomidine hydrochloride for veterinary use ................... 1400Detomidini hydrochloridum ad usum veterinarium ..... 1400Devil’s claw root ....................................................................... 1401Dexamethasone ........................................................................ 1402Dexamethasone acetate.......................................................... 1403Dexamethasone isonicotinate ........................................5.4-3927Dexamethasone sodium phosphate ..................................... 1404Dexamethasoni acetas ........................................................... 1403Dexamethasoni isonicotinas .........................................5.4-3927Dexamethasoni natrii phosphas ......................................... 1404Dexamethasonum ................................................................... 1402Dexchlorpheniramine maleate .............................................. 1406Dexchlorpheniramini maleas .............................................. 1406Dexpanthenol............................................................................ 1407Dexpanthenolum..................................................................... 1407
General Notices (1) apply to all monographs and other texts 4743
Index EUROPEAN PHARMACOPOEIA 5.6
Dextran 1 for injection............................................................ 1408Dextran 40 for injection ......................................................... 1409Dextran 60 for injection ......................................................... 1410Dextran 70 for injection ..........................................................1411Dextrans, molecular mass distribution in (2.2.39.) .............. 57Dextranum 1 ad iniectabile ................................................. 1408Dextranum 40 ad iniectabile ............................................... 1409Dextranum 60 ad iniectabile ............................................... 1410Dextranum 70 ad iniectabile ................................................1411Dextrin........................................................................................ 1412Dextrinum ................................................................................. 1412Dextromethorphan hydrobromide ....................................... 1412Dextromethorphani hydrobromidum ................................ 1412Dextromoramide tartrate ........................................................1414Dextromoramidi tartras..........................................................1414Dextropropoxyphene hydrochloride.....................................1414Dextropropoxypheni hydrochloridum................................1414Diazepam ............................................................................5.6-4564Diazepamum .....................................................................5.6-4564Diazoxide ................................................................................... 1416Diazoxidum .............................................................................. 1416Dibrompropamidine diisetionate ...................................5.4-3928Dibrompropamidini diisetionas ...................................5.4-3928Dibutylis phthalas ....................................................................1417Dibutyl phthalate ......................................................................1417Dichloromethane...................................................................... 2017Diclazuril for veterinary use.................................................. 1418Diclazurilum ad usum veterinarium ................................. 1418Diclofenac potassium .............................................................. 1419Diclofenac sodium ................................................................... 1420Diclofenacum kalicum........................................................... 1419Diclofenacum natricum ........................................................ 1420Dicloxacillin sodium ................................................................ 1422Dicloxacillinum natricum..................................................... 1422Dicycloverine hydrochloride.................................................. 1423Dicycloverini hydrochloridum ............................................ 1423Didanosine..........................................................................5.2-3193Didanosinum.....................................................................5.2-3193Dienestrol .................................................................................. 1424Dienestrolum ............................................................................ 1424Diethylcarbamazine citrate .................................................... 1426Diethylcarbamazini citras .................................................... 1426Diethylene glycol and ethylene glycol in ethoxylatedsubstances (2.4.30.)........................................................5.2-3095
Diphtheria and tetanus vaccine (adsorbed) ......................... 639Diphtheria and tetanus vaccine (adsorbed) for adults andadolescents.......................................................................5.6-4480
Diphtheria and tetanus vaccine (adsorbed, reduced antigen(s)content).............................................................................5.6-4480
Diphtheria antitoxin .................................................................. 801Diphtheria, tetanus and hepatitis B (rDNA) vaccine(adsorbed).................................................................................. 641
Diphtheria, tetanus and pertussis (acellular, component)vaccine (adsorbed)..........................................................5.4-3851
Diphtheria, tetanus and pertussis vaccine (adsorbed) ..... 643Diphtheria, tetanus and poliomyelitis (inactivated) vaccine(adsorbed, reduced antigen(s) content) .....................5.6-4481
Diphtheria, tetanus, pertussis (acellular, component) andhaemophilus type b conjugate vaccine (adsorbed) ..5.4-3852
Dissolution test for medicated chewing gums (2.9.25.)............................................................................................5.2-3116
Dissolution test for solid dosage forms (2.9.3.) ..........5.3-3353Dissolution test for transdermal patches (2.9.4.)................ 231Distemper vaccine (live), canine, freeze-dried...................... 740Distemper vaccine (live) for mustelids, freeze-dried........... 751Distillation range (2.2.11.).......................................................... 30Distribution estimation by analytical sieving, particle-size(2.9.38.) .............................................................................5.3-3368
Essential oils, foreign esters in (2.8.6.) ..................................216Essential oils in vegetable drugs, determination of(2.8.12.) .......................................................................................217
Essential oils, odour and taste (2.8.8.) ...................................216Essential oils, residue on evaporation (2.8.9.) ......................216Essential oils, solubility in alcohol (2.8.10.)..........................216Essential oils, water in (2.8.5.) .................................................216Ester value (2.5.2.) ..................................................................... 127
4746 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 5.6 Index
Eucalyptus oil ....................................................................5.2-3203Eugenol ...................................................................................... 1571Eugenolum................................................................................ 1571European Goldenrod........................................................5.3-3507European viper venom antiserum.......................................... 806Evaluation of efficacy of veterinary vaccines and immunosera(5.2.7.)................................................................................5.1-2829
Evaluation of safety of each batch of veterinary vaccines andimmunosera (5.2.9.) .......................................................5.1-2830
Evaluation of safety of veterinary vaccines and immunosera(5.2.6.) ...............................................................................5.1-2827
Evening primrose oil, refined.........................................5.5-4227Extracta........................................................................................ 570Extractable volume of parenteral preparations, test for(2.9.17.)..............................................................................5.3-3363
Extracta fluida ........................................................................... 571Extracta sicca ............................................................................. 572Extracta spissa ........................................................................... 572Extracts ........................................................................................ 570Extracts, dry ................................................................................ 572Extracts, dry residue of (2.8.16.)............................................. 222Extracts, liquid............................................................................ 571Extracts, loss on drying of (2.8.17.)........................................ 222Extracts, soft ............................................................................... 572Extraneous agents in viral vaccines for human use, tests for(2.6.16.) ...................................................................................... 169
Extraneous agents : tests in batches of finished product ofavian live virus vaccines (2.6.25.)................................5.3-3345
Extraneous agents : tests in seed lots of avian viral vaccines(2.6.24.) .............................................................................5.4-3699
FF0 concept to steam sterilisation of aqueous preparations,application of (5.1.5.) .....................................................5.1-2821
Factor humanus von Willebrandi ................................5.6-4606Factor II, human coagulation, assay of (2.7.18.) ................. 209Factor IX coagulationis humanus ...................................... 1738Factor IX, human coagulation .............................................. 1738Factor IX, human coagulation, assay of (2.7.11.) .......5.5-4120Factor VII coagulationis humanus .................................... 1734Factor VII, human coagulation............................................. 1734Factor VII, human coagulation, assay of (2.7.10.) .....5.6-4419Factor VIII coagulationis humanus............................5.6-4596Factor VIII coagulationis humanus (ADNr) .................... 1737Factor VIII, human coagulation ....................................5.6-4596Factor VIII, human coagulation, assay of (2.7.4.) ......5.5-4119Factor VIII (rDNA), human coagulation ............................. 1737Factor X, human coagulation, assay of (2.7.19.) ..................210Factor XI coagulationis humanus ...............................5.5-4246Factor XI, human coagulation .......................................5.5-4246Factor XI, human coagulation, assay of (2.7.22.).......5.5-4121Fagopyri herba .................................................................5.4-3906Falling ball viscometer method (2.2.49.) ................................ 80Famotidine.................................................................................1575Famotidinum............................................................................1575Fatty acids, composition by gas chromatography(2.4.22.) .............................................................................5.6-4389
Fatty oils, alkaline impurities in (2.4.19.) ............................. 109Fatty oils and herbal drugs, heavy metals in (2.4.27.) ........119Fatty oils and resinified essential oils in essential oils(2.8.7.)..........................................................................................216
Fatty oils, foreign oils in, by thin-layer chromatography(2.4.21.) ...................................................................................... 109
Fatty oils, identification by thin-layer chromatography(2.3.2.) .......................................................................................... 98
Fatty oils, sterols in (2.4.23.) ..........................................5.1-2787Fc function of immunoglobulin, test for (2.7.9.) ................. 202Febantel for veterinary use.............................................5.5-4231Febantelum ad usum veterinarium.............................5.5-4231Feline calicivirosis vaccine (inactivated) ............................... 757Feline calicivirosis vaccine (live), freeze-dried ..................... 758Feline chlamydiosis vaccine (inactivated)....................5.6-4489Feline infectious enteritis (feline panleucopenia) vaccine(inactivated) .............................................................................. 759
Filum ethyleni polyterephthalici sterile in fuso ad usumveterinarium ............................................................................ 887
Filum lini sterile in fuso ad usum veterinarium .............. 886Filum polyamidicum-6/6 sterile in fuso ad usumveterinarium ............................................................................ 887
Filum polyamidicum-6 sterile in fuso ad usumveterinarium ............................................................................ 886
General Notices (1) apply to all monographs and other texts 4747
Index EUROPEAN PHARMACOPOEIA 5.6
Fish oil, rich in omega-3-acids........................................5.4-3941Flecainide acetate ....................................................................1598Flecainidi acetas .....................................................................1598Flocculation value (Lf) of diphtheria and tetanus toxins andtoxoids (Ramon assay) (2.7.27.) ...................................5.6-4424
HHaematopoietic products, numeration of CD34/CD45+ cellsin (2.7.23.).........................................................................5.6-4421
Haematopoietic stem cells, human ...............................5.6-4598Haemodiafiltration and for haemofiltration, solutionsfor .............................................................................................. 1703
Haemodialysis, concentrated solutions for ........................ 1700Haemodialysis solutions, concentrated, water fordiluting..................................................................................... 1699
Haemodialysis, solutions for.................................................. 1700Haemofiltration and for haemodiafiltration, solutionsfor .............................................................................................. 1703
Haemophilus type b (conjugate), diphtheria, tetanusand pertussis (acellular, component) vaccine(adsorbed).........................................................................5.4-3852
Haemophilus type b (conjugate), diphtheria, tetanus,pertussis (acellular, component) and poliomyelitis(inactivated) vaccine (adsorbed) ..................................5.4-3861
Haemophilus type b (conjugate), diphtheria, tetanus,pertussis (acellular, component), hepatitis B (rDNA) andpoliomyelitis (inactivated) vaccine (adsorbed) .........5.4-3858
General Notices (1) apply to all monographs and other texts 4749
Index EUROPEAN PHARMACOPOEIA 5.6
Haemophilus type b (conjugate), diphtheria, tetanus,pertussis and poliomyelitis (inactivated) vaccine(adsorbed).........................................................................5.4-3866
Haemophilus type b conjugate vaccine................................. 662Halofantrine hydrochloride ................................................... 1705Halofantrini hydrochloridum .............................................. 1705Haloperidol................................................................................ 1706Haloperidol decanoate............................................................ 1708Haloperidoli decanoas........................................................... 1708Haloperidolum ......................................................................... 1706Halothane .................................................................................. 1709Halothanum.............................................................................. 1709Hamamelidis folium ............................................................... 1711Hamamelis leaf ......................................................................... 1711Hard capsules.....................................................................5.5-4155Hard fat ...................................................................................... 1711Hard paraffin............................................................................. 2186Harpagophyti radix ................................................................ 1401Hawthorn berries ..................................................................... 1712Hawthorn leaf and flower ...................................................... 1713Hawthorn leaf and flower dry extract ................................. 1714Hawthorn leaf and flower liquid extract, quantified ..5.3-3511Heavy bismuth subnitrate ...................................................... 1107Heavy kaolin..............................................................................1869Heavy magnesium carbonate .........................................5.3-3547Heavy magnesium oxide..................................................5.6-4629Heavy metals (2.4.8.) ................................................................. 104Heavy metals in herbal drugs and fatty oils (2.4.27.)..........119Hederae folium .................................................................5.6-4613Hedera helix ad praeparationes homoeopathicas...5.2-3163Hedera helix for homoeopathic preparations.............5.2-3163Helianthi annui oleum raffinatum.....................................2524Heparina massae molecularis minoris ..............................1717Heparin, assay of (2.7.5.) .................................................5.6-4419Heparin calcium ................................................................5.5-4245Heparin in coagulation factors, assay of (2.7.12.) ............... 204Heparins, low-molecular-mass ................................................1717Heparin sodium.................................................................5.5-4245Heparinum calcicum ......................................................5.5-4245Heparinum natricum ......................................................5.5-4245Hepatitis A immunoglobulin, human ...................................1741Hepatitis A (inactivated) and hepatitis B (rDNA) vaccine(adsorbed).................................................................................. 664
Hepatitis A vaccine, assay of (2.7.14.) ...........................5.1-2795Hepatitis A vaccine (inactivated, adsorbed) ......................... 665Hepatitis A vaccine (inactivated, virosome) ......................... 667Hepatitis B immunoglobulin for intravenous administration,human .......................................................................................1741
Hepatitis B immunoglobulin, human ...................................1741Hepatitis B (rDNA), diphtheria and tetanus vaccine(adsorbed).................................................................................. 641
Hepatitis B (rDNA), diphtheria, tetanus and pertussis(acellular, component) vaccine (adsorbed) ...............5.4-3854
Hepatitis B (rDNA), diphtheria, tetanus, pertussis (acellular,component), poliomyelitis (inactivated) and haemophilustype b conjugate vaccine (adsorbed) ..........................5.4-3858
Hepatitis B vaccine (rDNA)...................................................... 670Hepatitis B vaccine (rDNA), assay of (2.7.15.) ..................... 207Hepatitis C virus (HCV), validation of nucleic acidamplification techniques for the detection of HCV RNA inplasma pools : Guidelines..............................................5.5-4113
Heptaminol hydrochloride ..................................................... 1719Heptaminoli hydrochloridum .............................................. 1719Herbal drug preparations......................................................... 572Herbal drugs ............................................................................... 572Herbal drugs and fatty oils, heavy metals in (2.4.27.).........119Herbal drugs, determination of tannins (2.8.14.) ............... 221Herbal drugs for homoeopathic preparations ............5.2-3161Herbal teas................................................................................... 573
Homoeopathic preparations, copper for............................... 896Homoeopathic preparations, garlic for ................................. 897Homoeopathic preparations, hedera helix for............5.2-3163Homoeopathic preparations, herbal drugs for ...........5.2-3161Homoeopathic preparations, honey bee for......................... 898Homoeopathic preparations, hyoscyamus for ............5.2-3164Homoeopathic preparations, hypericum for ........................ 898Homoeopathic preparations, iron for .................................... 899Homoeopathic preparations, mother tinctures for............. 894Homoeopathic preparations, saffron for............................... 900Honey ..................................................................................5.1-2946Honey bee for homoeopathic preparations.......................... 898Hop strobile............................................................................... 1730Human albumin injection, iodinated (125I)............................ 827Human albumin solution ................................................5.3-3511Human anti-D immunoglobulin .....................................5.6-4595Human anti-D immunoglobulin, assay of (2.7.13.).............. 205Human anti-D immunoglobulin for intravenousadministration .................................................................5.6-4595
Human antithrombin III, assay of (2.7.17.) ........................... 209Human antithrombin III concentrate .................................. 1733Human coagulation factor II, assay of (2.7.18.)................... 209Human coagulation factor IX................................................ 1738Human coagulation factor IX, assay of (2.7.11.).........5.5-4120Human coagulation factor VII .............................................. 1734Human coagulation factor VII, assay of (2.7.10.) .......5.6-4419Human coagulation factor VIII ......................................5.6-4596Human coagulation factor VIII, assay of (2.7.4.)........5.5-4119Human coagulation factor VIII (rDNA)............................... 1737Human coagulation factor X, assay of (2.7.19.) ....................210Human coagulation factor XI .........................................5.5-4246Human coagulation factor XI, assay of (2.7.22.) ........5.5-4121Human fibrinogen.............................................................5.6-4597Human haematopoietic stem cells ................................5.6-4598Human hepatitis A immunoglobulin ....................................1741Human hepatitis B immunoglobulin ....................................1741
4750 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 5.6 Index
Human hepatitis B immunoglobulin for intravenousadministration .........................................................................1741
Human insulin ..........................................................................1800Human measles immunoglobulin......................................... 1742Human normal immunoglobulin...................................5.6-4599Human normal immunoglobulin for intravenousadministration .................................................................5.6-4601
Human plasma for fractionation....................................5.6-4603Human plasma (pooled and treated for virusinactivation) .....................................................................5.6-4604
IIbuprofen ................................................................................... 1785Ibuprofenum............................................................................. 1785Iceland moss.......................................................................5.3-3525ICH (5.8.)...................................................................................... 551Ichthammol ............................................................................... 1787Ichthammolum ........................................................................ 1787Identification (2.3.) ...................................................................... 95Identification and control of residual solvents (2.4.24.).... 113Identification of fatty oils by thin-layer chromatography(2.3.2.) .......................................................................................... 98
Identification of phenothiazines by thin-layerchromatography (2.3.3.) ........................................................... 99
Identification reactions of ions and functional groups(2.3.1.)................................................................................ 5.5-4101
Immunoglobulin for intravenous administration, humanhepatitis B ................................................................................1741
Immunoglobulin for intravenous administration, humannormal ...............................................................................5.6-4601
Immunoglobulin for intravenous administration, humanvaricella.................................................................................... 1753
Immunoglobulin, human anti-D ....................................5.6-4595Immunoglobulin, human anti-D, assay of (2.7.13.) ............. 205Immunoglobulin, human anti-D, for intravenousadministration .................................................................5.6-4595
Immunoglobulin, human hepatitis A....................................1741Immunoglobulin, human hepatitis B ...................................1741Immunoglobulin, human measles ........................................ 1742Immunoglobulin, human normal ..................................5.6-4599Immunoglobulin, human rabies ........................................... 1750Immunoglobulin, human rubella ......................................... 1751Immunoglobulin, human tetanus......................................... 1751
General Notices (1) apply to all monographs and other texts 4751
Index EUROPEAN PHARMACOPOEIA 5.6
Immunoglobulin, human varicella ....................................... 1752Immunoglobulin, test for anticomplementary activity of(2.6.17.)....................................................................................... 170
Immunoglobulin, test for Fc function of (2.7.9.)................. 202Immunoglobulinum anti-T lymphocytorum ex animale adusum humanum .............................................................5.6-4506
Immunoglobulinum humanum anti-D.......................5.6-4595Immunoglobulinum humanum anti-D ad usumintravenosum ..................................................................5.6-4595
Immunoglobulinum humanum hepatitidis A ..................1741Immunoglobulinum humanum hepatitidis B ..................1741Immunoglobulinum humanum hepatitidis B ad usumintravenosum ..........................................................................1741
Immunosera ad usum veterinarium ...........................5.4-3835Immunosera and vaccines, phenol in (2.5.15.) .....................131Immunosera and vaccines, veterinary, evaluation of safety(5.2.6.) ...............................................................................5.1-2827
Immunosera and vaccines, veterinary, evaluation of theefficacy (5.2.7) .................................................................5.1-2829
Immunosera and vaccines, veterinary, evaluation of thesafety of each batch (5.2.9.) ..........................................5.1-2830
Immunosera ex animale ad usum humanum ................... 573Immunosera for human use, animal...................................... 573Immunosera for veterinary use......................................5.4-3835Immunoserum botulinicum ................................................... 801Immunoserum clostridii novyi alpha ad usumveterinarium ...................................................................5.1-2865
Immunoserum clostridii perfringentis beta ad usumveterinarium ...................................................................5.1-2866
Immunoserum clostridii perfringentis epsilon ad usumveterinarium ...................................................................5.1-2867
Immunoserum contra venena viperarumeuropaearum ........................................................................... 806
Immunoserum gangraenicum (Clostridium septicum) .. 804Immunoserum gangraenicum mixtum ............................... 802Immunoserum tetanicum ad usum humanum................. 805Immunoserum tetanicum ad usum veterinarium...5.1-2868Implants ..............................................................................5.2-3146Impurities in substances for pharmaceutical use, control of(5.10.).................................................................................5.5-4145
Indapamide.........................................................................5.3-3525Indapamidum ...................................................................5.3-3525Indicators, relationship between approximate pH and colour(2.2.4.) .......................................................................................... 27
Lichen islandicus .............................................................5.3-3525Lidocaine ................................................................................... 1913Lidocaine hydrochloride......................................................... 1914Lidocaini hydrochloridum ................................................... 1914Lidocainum .............................................................................. 1913Light liquid paraffin ................................................................ 2186Light magnesium carbonate...........................................5.3-3548Light magnesium oxide ...................................................5.6-4629Lime flower ............................................................................... 1914Limit tests (2.4.).......................................................................... 103Limit tests, standard solutions for (4.1.2.)...................5.4-3817Limit tests, standard solutions for (4.1.2.)...................5.5-4126Limonis aetheroleum ............................................................. 1895Lincomycin hydrochloride ..............................................5.4-3968Lincomycini hydrochloridum.......................................5.4-3968Lindane ...................................................................................... 1916Lindanum ................................................................................. 1916Linen thread, sterile, in distributor for veterinary use ..... 886Lini oleum virginale .............................................................. 1918Lini semen .........................................................................5.1-2960Linoleoyl macrogolglycerides.........................................5.5-4265Linseed ................................................................................5.1-2960Linseed oil, virgin .................................................................... 1918Liothyronine sodium............................................................... 1919Liothyroninum natricum ..................................................... 1919Lipophilic solid dosage forms, dissolution test for(2.9.42.) .............................................................................5.3-3373
Liquid and semi-solid preparations, test for deliverable massor volume (2.9.28.) .................................................................. 263
Mass uniformity of single-dose preparations (2.9.5.) ......... 233Mastic..........................................................................................1975Masticabilia gummis medicata.....................................5.2-3136Mastix .........................................................................................1975Materials based on non-plasticised poly(vinyl chloride) forcontainers for dry dosage forms for oral administration(3.1.11.)....................................................................................... 291
Materials based on non-plasticised poly(vinyl chloride)for containers for non-injectable, aqueous solutions(3.1.10.) ...................................................................................... 289
Materials based on plasticised poly(vinyl chloride) forcontainers for aqueous solutions for intravenous infusion(3.1.14.) ...................................................................................... 296
Materials based on plasticised poly(vinyl chloride) forcontainers for human blood and blood components(3.1.1.1.) ..................................................................................... 269
General Notices (1) apply to all monographs and other texts 4755
Index EUROPEAN PHARMACOPOEIA 5.6
Materials based on plasticised poly(vinyl chloride) fortubing used in sets for the transfusion of blood and bloodcomponents (3.1.1.2.).............................................................. 272
Materials for containers for human blood and bloodcomponents (3.1.1.) ................................................................. 269
Materials used for the manufacture of containers (3.1.) ... 269Matricariae aetheroleum................................................5.1-2967Matricariae extractum fluidum ....................................5.1-2966Matricariae flos ................................................................5.1-2965Matricaria flower ...............................................................5.1-2965Matricaria liquid extract ..................................................5.1-2966Matricaria oil ......................................................................5.1-2967Maydis amylum ................................................................5.1-2965Maydis oleum raffinatum......................................................1964Meadowsweet ............................................................................1980Measles immunoglobulin, human ........................................ 1742Measles, mumps and rubella vaccine (live) .......................... 678Measles vaccine (live) ................................................................ 679Measurement of consistency by penetrometry (2.9.9.) ...... 235Mebendazole ............................................................................. 1981Mebendazolum......................................................................... 1981Meclozine hydrochloride ........................................................1982Meclozini hydrochloridum ...................................................1982Medicated chewing gum, dissolution test for(2.9.25.) .............................................................................5.2-3116
Medicated chewing gums ................................................5.2-3136Medicated feeding stuffs for veterinary use, premixes for ..617Medicated foams......................................................................... 604Medicated plasters ............................................................5.5-4165Medicated tampons.................................................................... 628Medicated vaginal tampons ............................................5.5-4170Medicinal air................................................................................ 929Medicinal air, synthetic............................................................. 932Medium-chain triglycerides....................................................2623Medroxyprogesterone acetate ........................................5.3-3551Medroxyprogesteroni acetas .........................................5.3-3551Mefenamic acid .........................................................................1984Mefloquine hydrochloride......................................................1986Mefloquini hydrochloridum .................................................1986Megestrol acetate .....................................................................1987Megestroli acetas .....................................................................1987Meglumine..........................................................................5.4-3976Megluminum .....................................................................5.4-3976Mel........................................................................................5.1-2946Melaleucae aetheroleum .......................................................2534Melilot..................................................................................5.3-3552Meliloti herba ....................................................................5.3-3552Melissae folium ........................................................................1989Melissa leaf ................................................................................1989Melting point - capillary method (2.2.14.)............................... 32Melting point - instantaneous method (2.2.16.) .................... 33Melting point - open capillary method (2.2.15.) .................... 33Menadione .................................................................................1990Menadionum ............................................................................1990Meningococcal group C conjugate vaccine.......................... 680Meningococcal polysaccharide vaccine................................. 682Menthae arvensis aetheroleum partim mentholumdepletum...........................................................................5.2-3235
Microbiological assay of antibiotics (2.7.2.).......................... 188Microbiological control of cellular products(2.6.27.) .............................................................................5.6-4414
Microbiological examination of non-sterile products : test forspecified micro-organisms (2.6.13.) ............................5.6-4404
Microbiological quality, alternative methods for control of(5.1.6.)................................................................................5.5-4131
Microbiological quality of pharmaceutical preparations(5.1.4.)................................................................................5.6-4451
Microcrystalline cellulose.......................................................1228Micro determination of water (2.5.32.).................................. 137Microscopy, optical (2.9.37.) ...........................................5.3-3366Midazolam ..........................................................................5.4-3979Midazolamum ...................................................................5.4-3979Milk thistle dry extract, refined and standardised.....5.6-4635Milk-thistle fruit........................................................................2046Millefolii herba.........................................................................2723Minimising the risk of transmitting animal spongiformencephalopathy agents via human and veterinary medicinalproducts (5.2.8.) ....................................................................... 463
Modified-release tablets ...................................................5.5-4167Molecular mass distribution in dextrans (2.2.39.) ................ 57Molgramostim concentrated solution .................................2054Molgramostimi solutio concentrata ...................................2054Mometasone furoate.........................................................5.3-3555Mometasoni furoas ..........................................................5.3-3555Monoclonal antibodies for human use.........................5.2-3127Morantel hydrogen tartrate for veterinary use .................2059Moranteli hydrogenotartras ad usum veterinarium ......2059Morphine hydrochloride..................................................5.2-3237Morphine sulphate............................................................5.2-3238Morphini hydrochloridum .............................................5.2-3237Morphini sulfas.................................................................5.2-3238Moss, Iceland .....................................................................5.3-3525Mother tinctures for homoeopathic preparations .............. 894Motherwort ...............................................................................2063Mouthwashes .....................................................................5.4-3845Moxonidine ................................................................................2064Moxonidinum ...........................................................................2064Mucoadhesive preparations ............................................5.4-3847Mullein flower...........................................................................2065Multidose containers, uniformity of mass of delivered doses(2.9.27.) ...................................................................................... 263
Parenteralia .......................................................................5.2-3144Parenteral preparations...................................................5.2-3144Parenteral preparations, test for extractable volume of(2.9.17.)..............................................................................5.3-3363
Particle size analysis by laser light diffraction(2.9.31.) .............................................................................5.6-4429
Particle-size distribution estimation by analytical sieving(2.9.38.) .............................................................................5.3-3368
Plasma (pooled and treated for virus inactivation),human ...............................................................................5.6-4604
Plasmid vectors for human use......................................5.6-4466Plasmid vectors for human use, bacterial cells used for themanufacture of ................................................................5.6-4468
Plasters, medicated...........................................................5.5-4164Plastic additives (3.1.13.).......................................................... 293Plastic containers and closures for pharmaceutical use(3.2.2.) ........................................................................................ 308
Plastic containers for aqueous solutions for parenteralinfusion (3.2.2.1.) ..................................................................... 309
Plastic containers for human blood and blood components,sterile (3.2.3.) ............................................................................ 309
Poliomyelitis (inactivated), diphtheria, tetanus and pertussisvaccine (adsorbed)..........................................................5.4-3864
Poliomyelitis (inactivated), diphtheria, tetanus, pertussis(acellular, component) and haemophilus type b conjugatevaccine (adsorbed)..........................................................5.4-3861
Poliomyelitis (inactivated), diphtheria, tetanus, pertussis(acellular, component), hepatitis B (rDNA) and haemophilustype b conjugate vaccine (adsorbed) ..........................5.4-3858
Poliomyelitis (inactivated), diphtheria, tetanus, pertussis andhaemophilus type b conjugate vaccine (adsorbed) ..5.4-3866
Poliomyelitis vaccine (inactivated) ................................5.4-3868Poliomyelitis vaccine (inactivated), in vivo assay of(2.7.20.) .............................................................................5.6-4420
Poliomyelitis vaccine (oral) .............................................5.3-3410Poliomyelitis vaccine (oral), test for neurovirulence(2.6.19.) ...................................................................................... 172
Poloxamera ...............................................................................2264Poloxamers ................................................................................2264Polyacrylate dispersion 30 per cent.....................................2265Polyacrylatis dispersio 30 per centum..............................2265Poly(alcohol vinylicus) ..........................................................2272Polyamide 6/6 suture, sterile, in distributor for veterinaryuse .............................................................................................. 887
Polyamide 6 suture, sterile, in distributor for veterinary use..................................................................................................... 886
Polyethyleneglycols .................................................................1950Polyethylene terephthalate for containers for preparationsnot for parenteral use (3.1.15.) ............................................. 298
Poly(ethylene terephthalate) suture, sterile, in distributor forveterinary use .......................................................................... 887
Poly(ethylene - vinyl acetate) for containers and tubing fortotal parenteral nutrition preparations (3.1.7.) ................. 285
Polyethylene with additives for containers for parenteralpreparations and for ophthalmic preparations (3.1.5.) ... 279
Polyethylene without additives for containers for parenteralpreparations and for ophthalmic preparations (3.1.4.) ... 278
Polygalae radix ........................................................................ 2401Polygoni avicularis herba ..................................................... 1877Polymorphism (5.9.) .................................................................. 555Polymyxin B sulphate ......................................................5.3-3595Polymyxini B sulfas.........................................................5.3-3595Polyolefines (3.1.3.) ................................................................... 274Polyoxyl castor oil.............................................................5.3-3547Polyoxyl hydrogenated castor oil ..................................5.2-3231Polypropylene for containers and closures for parenteralpreparations and ophthalmic preparations (3.1.6.).......... 282
Polysaccharide vaccines, hexosamines in (2.5.20.)............. 132Polysaccharide vaccines, methylpentoses in (2.5.21.) ........ 133Polysaccharide vaccines, nucleic acids in (2.5.17.) ............. 132Polysaccharide vaccines, O-acetyl in (2.5.19.)...................... 132Polysaccharide vaccines, phosphorus in (2.5.18.)............... 132Polysaccharide vaccines, protein in (2.5.16.) ........................131Polysaccharide vaccines, ribose in (2.5.31.) ......................... 137Polysaccharide vaccines, sialic acid in (2.5.23.) .................. 133Polysaccharide vaccines, uronic acids in (2.5.22.) .............. 133Polysorbate 20 ..........................................................................2267Polysorbate 40 ..........................................................................2268Polysorbate 60 ..........................................................................2269Polysorbate 80 ...................................................................5.4-4007Polysorbatum 20 .....................................................................2267Polysorbatum 40 .....................................................................2268Polysorbatum 60 .....................................................................2269Polysorbatum 80 ..............................................................5.4-4007Poly(vinyl acetate)....................................................................2271Poly(vinyl alcohol) ...................................................................2272Poly(vinyl chloride), non-plasticised, materials based on forcontainers for dry dosage forms for oral administration(3.1.11.)....................................................................................... 291
Poly(vinyl chloride), non-plasticised, materials based onfor containers for non-injectable aqueous solutions(3.1.10.) ...................................................................................... 289
Poly(vinyl chloride), plasticised, empty sterile containers offor human blood and blood components (3.2.4.) ..............311
Poly(vinyl chloride), plasticised, materials based on forcontainers for aqueous solutions for intravenous infusion(3.1.14.) ...................................................................................... 296
Poly(vinyl chloride), plasticised, materials based on forcontainers for human blood and blood components(3.1.1.1.) ..................................................................................... 269
Poly(vinyl chloride), plasticised, materials based on fortubing used in sets for the transfusion of blood and bloodcomponents (3.1.1.2.).............................................................. 272
Potentiometric determination of pH (2.2.3.).......................... 26Potentiometric titration (2.2.20.).............................................. 35Poultices..............................................................................5.5-4165Pour-on preparations ................................................................ 631Povidone .............................................................................5.2-3262Povidone, iodinated ................................................................. 2291Povidonum.........................................................................5.2-3262Povidonum iodinatum ........................................................... 2291Powdered cellulose ..................................................................1232Powder flow (2.9.36.) .......................................................5.3-3363Powders and granules for oral solutions andsuspensions......................................................................5.6-4472
Powders and granules for syrups ..................................5.6-4472Powders and tablets for rectal solutions andsuspensions......................................................................5.5-4163
Powders, ear.......................................................................5.5-4157Powders, effervescent.......................................................5.2-3148Powders for cutaneous application...............................5.2-3147Powders for eye drops and powders for eye lotions ..5.5-4159Powders for inhalation.....................................................5.1-2845Powders for injections or infusions ..............................5.2-3145Powders for oral drops.....................................................5.6-4472Powders, nasal ...................................................................5.6-4474Powders, oral .....................................................................5.2-3147Poxvirus vectors for human use ....................................5.6-4464Praeadmixta ad alimenta medicataad usum veterinarium ............................................................617
Praeparationes ad irrigationem...................................5.6-4474Praeparationes buccales ................................................5.4-3844Praeparationes homoeopathicas .......................................... 893Praeparationes insulini iniectabiles ...........................5.4-3957Praeparationes intramammariaead usum veterinarium ........................................................... 606
Praeparationes intraruminales .................................... 5.2-3141Praeparationes intra-uterinae ad usum veterinarium ....5.3-3397
Praeparationes liquidae ad usum dermicum ...........5.5-4159Praeparationes liquidae peroraliae.............................5.6-4471Praeparationes liquidae veterinariae ad usum dermicum..................................................................................................... 630
Praeparationes molles ad usum dermicum ..............5.5-4164Praeparationes pharmaceuticae in vasis cum pressu..... 622
Pravastatin sodium..................................................................2292Pravastatinum natricum .......................................................2292Prazepam ...................................................................................2293Prazepamum ............................................................................2293Praziquantel ..............................................................................2294Praziquantelum .......................................................................2294Prazosin hydrochloride ..........................................................2295Prazosini hydrochloridum ...................................................2295Prednicarbate............................................................................2297Prednicarbatum.......................................................................2297Prednisolone .............................................................................2298Prednisolone acetate........................................................5.6-4664Prednisolone pivalate.............................................................. 2301Prednisolone sodium phosphate ..........................................2302Prednisoloni acetas .........................................................5.6-4664Prednisoloni natrii phosphas ..............................................2302Prednisoloni pivalas............................................................... 2301Prednisolonum ........................................................................2298Prednisone.................................................................................2303Prednisonum ............................................................................2303Prekallikrein activator (2.6.15.) .....................................5.5-4111Premixes for medicated feeding stuffs for veterinary use ..617Preparations for inhalation.............................................5.1-2843Preparations for inhalation : aerodynamic assessment of fineparticles (2.9.18.) ............................................................5.2-3103
Products of fermentation ......................................................... 576Products of recombinant DNA technology .......................... 584Products with risk of transmitting agents of animalspongiform encephalopathies............................................... 577
QQuality of pharmaceutical preparations, microbiological(5.1.4.)................................................................................5.6-4451
RRabies immunoglobulin, human .......................................... 1750Rabies vaccine for human use prepared in cellcultures .............................................................................5.4-3871
Rabies vaccine (inactivated) for veterinary use................... 790Rabies vaccine (live, oral) for foxes ........................................ 792Racemic camphor..................................................................... 1172Racemic ephedrine hydrochloride .......................................1509Racemic menthol ..................................................................... 1991Raclopride ([11C]methoxy) injection....................................... 838Raclopridi ([11C]methoxy) solutio iniectabilis ................... 838Radionuclides, table of physical characteristics (5.7.) ....... 539Radiopharmaceutica ................................................................ 578Radiopharmaceutical preparations ........................................ 578Raman spectrometry (2.2.48.) ................................................... 79Ramipril......................................................................................2355Ramiprilum ..............................................................................2355Ramon assay, flocculation value (Lf) of diphtheria andtetanus toxins and toxoids (2.7.27.) ............................5.6-4424
Recombinant DNA technology, products of......................... 584Rectal capsules ..................................................................5.5-4163Rectal foams.......................................................................5.5-4164Rectalia ...............................................................................5.5-4162Rectal preparations...........................................................5.5-4162Rectal preparations, semi-solid ......................................5.5-4164Rectal solutions and suspensions, powders and tabletsfor .......................................................................................5.5-4162
Rectal solutions, emulsions and suspensions.............5.5-4163Rectal tampons..................................................................5.5-4164Red poppy petals......................................................................2359Reference standards (5.12.) ............................................5.6-4455Refractive index (2.2.6.) .............................................................. 28Relationship between reaction of solution, approximate pHand colour of certain indicators (2.2.4.) ............................... 27
Relative density (2.2.5.)............................................................... 27Repaglinide.........................................................................5.2-3267Repaglinidum....................................................................5.2-3267Reserpine ...................................................................................2360Reserpinum ..............................................................................2360Residual solvents (5.4.) ............................................................. 507Residual solvents, identification and control (2.4.24.) ...... 113Residue on evaporation of essential oils (2.8.9.)..................216Resistance to crushing of tablets (2.9.8.) ............................. 235Resistance to rupture of suppositories and pessaries(2.9.24.) ...................................................................................... 258
4764 See the information section on general monographs (cover pages)
Semi-micro determination of water (2.5.12.) ....................... 130Semi-solid and liquid preparations, test for deliverable massor volume (2.9.28.) .................................................................. 263
General Notices (1) apply to all monographs and other texts 4765
Index EUROPEAN PHARMACOPOEIA 5.6
Sieves (2.1.4.) .................................................................................18Sieve test (2.9.12.)...................................................................... 239Sieving, analytical, particle-size distribution estimation by(2.9.38.) .............................................................................5.3-3368
SI (International System) units (1.) ..............................5.6-4373Silica ad usum dentalem....................................................... 2411Silica, colloidal anhydrous ..................................................... 2410Silica, colloidal hydrated ........................................................ 2411Silica colloidalis anhydrica.................................................. 2410Silica colloidalis hydrica....................................................... 2411Silica, dental type..................................................................... 2411Silica hydrophobica colloidalis anhydrica ...............5.5-4297Silica, hydrophobic colloidal anhydrous......................5.5-4297Silicone elastomer for closures and tubing (3.1.9.) ............ 288Silicone oil used as a lubricant (3.1.8.) ................................. 287Silk suture, sterile, braided, in distributor for veterinary use..................................................................................................... 887
Silver, colloidal, for external use ...................................5.3-3613Silver nitrate ............................................................................. 2412Silybi mariani extractum siccum raffinatum etnormatum ........................................................................5.6-4635
Soft extracts ................................................................................ 572Soiae oleum hydrogenatum .................................................2475Soiae oleum raffinatum ........................................................ 2476Solani amylum ........................................................................2288Solidaginis herba .............................................................5.2-3213Solidaginis virgaureae herba........................................5.3-3507Solid dosage forms, dissolution test for (2.9.3.) .........5.3-3353Solids, density of (2.2.42.) .......................................................... 64Solids, pycnometric density of (2.9.23.) ................................ 257Solubility in alcohol of essential oils (2.8.10.) ......................216Soluble tablets ...................................................................5.5-4167Solutiones ad conservationem partium corporis ...........2458Solutiones ad haemocolaturamhaemodiacolaturamque ...................................................... 1703
Solutiones ad haemodialysim ............................................. 1700Solutiones ad peritonealem dialysim ................................ 2212Solutiones anticoagulantes et sanguinem humanumconservantes .......................................................................... 1007
Solutions, emulsions and suspensions, oral ...............5.6-4471Solutions for haemodialysis................................................... 1700Solutions for haemodialysis, concentrated, water fordiluting..................................................................................... 1699
Solutions for haemofiltration and for haemodiafiltra-tion............................................................................................ 1703
Solutions for organ preservation..........................................2458Solutions for peritoneal dialysis ........................................... 2212Solutions, suspensions, intrauterine ............................5.3-3397Solvents, residual (5.4.) ............................................................ 507Solvents, residual, identification and control (2.4.24.) ...... 113Somatostatin .............................................................................2459Somatostatinum ......................................................................2459Somatropin.........................................................................5.3-3614Somatropin bulk solution ...............................................5.3-3616
4766 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 5.6 Index
Somatropin for injection .................................................5.3-3619Somatropini solutio ad praeparationem ...................5.3-3616Somatropinum ..................................................................5.3-3614Somatropinum ad iniectabilium..................................5.3-3619Sorbic acid.................................................................................2467Sorbitani lauras .......................................................................2467Sorbitani oleas .........................................................................2468Sorbitani palmitas ..................................................................2468Sorbitani sesquioleas .............................................................2468Sorbitani stearas .....................................................................2469Sorbitani trioleas ....................................................................2469Sorbitan laurate .......................................................................2467Sorbitan oleate .........................................................................2468Sorbitan palmitate ...................................................................2468Sorbitan sesquioleate..............................................................2468Sorbitan stearate......................................................................2469Sorbitan trioleate .....................................................................2469Sorbitol.......................................................................................2470Sorbitol, liquid (crystallising)................................................2471Sorbitol, liquid (non-crystallising)........................................2472Sorbitol, liquid, partially dehydrated...................................2473Sorbitolum ................................................................................2470Sorbitolum liquidum cristallisabile....................................2471Sorbitolum liquidum non cristallisabile ...........................2472Sorbitolum liquidum partim deshydricum ......................2473Sotalol hydrochloride ............................................................. 2474Sotaloli hydrochloridum ....................................................... 2474Soya-bean oil, hydrogenated..................................................2475Soya-bean oil, refined.............................................................. 2476Specific surface area by air permeability (2.9.14.).............. 239Specific surface area by gas adsorption (2.9.26.) ......5.1-2811Spectinomycin dihydrochloride pentahydrate ...........5.4-4020Spectinomycin hydrochloride.........................................5.4-4020Spectinomycini dihydrochloridum pentahydricum ........5.4-4020
Stearic acid.........................................................................5.6-4681Stearoyl macrogolglycerides ..........................................5.2-3274Stearyl alcohol...................................................................5.3-3621Stem cells, human haematopoietic ...............................5.6-4598Sterile braided silk suture in distributor for veterinaryuse............................................................................................... 887
Sterile catgut............................................................................... 873Sterile catgut in distributor for veterinary use ................... 885Sterile containers of plasticised poly (vinyl chloride)for human blood containing anticoagulant solution(3.2.5.) ........................................................................................ 312
Sterile linen thread in distributor for veterinary use......... 886Sterile non-absorbable strands in distributor for veterinaryuse............................................................................................... 888
Sterile non-absorbable sutures ......................................5.3-3423Sterile plastic containers for human blood and bloodcomponents (3.2.3.) ................................................................. 309
Sterile polyamide 6/6 suture in distributor for veterinaryuse............................................................................................... 887
Sterile polyamide 6 suture in distributor for veterinaryuse............................................................................................... 886
Sterile poly(ethylene terephthalate) suture in distributor forveterinary use ........................................................................... 887
Sublingual tablets and buccal tablets ..........................5.4-3847Substances for pharmaceutical use ..............................5.5-4151
General Notices (1) apply to all monographs and other texts 4767
Index EUROPEAN PHARMACOPOEIA 5.6
Substances for pharmaceutical use, control of impurities in(5.10.).................................................................................5.5-4145
Substances of animal origin for the production of veterinaryvaccines (5.2.5.) ........................................................................ 460
Sub-visible particles, particulate contamination (2.9.19.) .. 253Succinylsulfathiazole ..............................................................2498Succinylsulfathiazolum .........................................................2498Sucrose................................................................................5.5-4299Sufentanil .................................................................................. 2501Sufentanil citrate .....................................................................2502Sufentanili citras .....................................................................2502Sufentanilum............................................................................ 2501Sugars, lead in (2.4.10.) ............................................................ 107Sugar spheres ...........................................................................2503Sulbactam sodium ............................................................5.5-4300Sulbactamum natricum..................................................5.5-4300Sulfacetamide sodium.............................................................2504Sulfacetamidum natricum ....................................................2504Sulfadiazine...............................................................................2505Sulfadiazinum .........................................................................2505Sulfadimidine............................................................................2506Sulfadimidinum.......................................................................2506Sulfadoxine................................................................................2507Sulfadoxinum...........................................................................2507Sulfafurazole.............................................................................2508Sulfafurazolum ........................................................................2508Sulfaguanidine...................................................................5.5-4302Sulfaguanidinum .............................................................5.5-4302Sulfamerazine...........................................................................2509Sulfamerazinum......................................................................2509Sulfamethizole.......................................................................... 2510Sulfamethizolum ..................................................................... 2510Sulfamethoxazole .............................................................5.3-3623Sulfamethoxazolum.........................................................5.3-3623Sulfamethoxypyridazine for veterinary use ....................... 2512Sulfamethoxypyridazinum ad usum veterinarium ....... 2512Sulfanilamide ............................................................................ 2513Sulfanilamidum....................................................................... 2513Sulfasalazine ............................................................................. 2514Sulfasalazinum ........................................................................ 2514Sulfathiazole ............................................................................. 2516Sulfathiazolum ........................................................................ 2516Sulfinpyrazone ......................................................................... 2517Sulfinpyrazonum .................................................................... 2517Sulfisomidine ............................................................................ 2518Sulfisomidinum ....................................................................... 2518Sulfur ad usum externum .....................................................2520Sulfuris colloidalis et technetii (99mTc) solutioiniectabilis ................................................................................ 852
Suppositories and pessaries, disintegration of (2.9.2.)...... 227Suppositories and pessaries, resistance to rupture(2.9.24.) ...................................................................................... 258
Suppositories, lipophilic, softening time determination(2.9.22.) ...................................................................................... 256
Test for anti-D antibodies in human immunoglobulin forintravenous administration (2.6.26.) ..........................5.3-3348
Test for deliverable mass or volume of liquid and semi-solidpreparations (2.9.28.).............................................................. 263
Test for extractable volume of parenteral preparations(2.9.17.)..............................................................................5.3-3363
Test for Fc function of immunoglobulin (2.7.9.) ................. 202Test for methanol and 2-propanol (2.9.11.) .................5.3-3362Test for neurovirulence of live virus vaccines (2.6.18.) ..... 172Test for neurovirulence of poliomyelitis vaccine (oral)(2.6.19.) ...................................................................................... 172
Test for specified micro-organisms (microbiologicalexamination of non-sterile products) (2.6.13.) .........5.6-4404
Testosterone..............................................................................2542Testosterone enantate.............................................................2544Testosterone propionate.........................................................2545Testosteroni enantas ..............................................................2544Testosteroni propionas ..........................................................2545Testosteronum..........................................................................2542Tests for extraneous agents in viral vaccines for human use(2.6.16.) ...................................................................................... 169
Tetanus and diphtheria toxins and toxoids, flocculation value(Lf) of, (Ramon assay) (2.7.27.) ....................................5.6-4424
Tetanus and diphtheria vaccine (adsorbed, reducedantigen(s) content) .........................................................5.6-4480
Tetanus antitoxin for human use ........................................... 805Tetanus antitoxin for veterinary use.............................5.1-2868Tetanus, diphtheria and hepatitis B (rDNA) vaccine(adsorbed).................................................................................. 641
Tetanus, diphtheria and pertussis (acellular, component)vaccine (adsorbed)..........................................................5.4-3851
Tetanus, diphtheria and poliomyelitis (inactivated) vaccine(adsorbed, reduced antigen(s) content) .....................5.6-4481
Tetanus, diphtheria, pertussis (acellular, component) andhaemophilus type b conjugate vaccine (adsorbed) ..5.4-3852
TSE, animal, products with risk of transmitting agentsof.................................................................................................. 577
Tuberculin for human use, old..............................................2638Tuberculini aviarii derivatum proteinosumpurificatum.............................................................................2640
Tuberculini derivatum proteinosum purificatum ad usumhumanum ...............................................................................2642
Tuberculin purified protein derivative, avian ....................2640Tuberculin purified protein derivative, bovine.................. 2641Tuberculin purified protein derivative for human use ....2642Tuberculinum pristinum ad usum humanum ................2638Tubes for comparative tests (2.1.5.) ..........................................19Tubing and closures, silicone elastomer for (3.1.9.)........... 288Tubing and containers for total parenteral nutritionpreparations, poly(ethylene - vinyl acetate) for (3.1.7.) ... 285
Tubing used in sets for the transfusion of blood and bloodcomponents, materials based on plasticised poly(vinylchloride) for (3.1.1.2.) ............................................................. 272
Tubocurarine chloride ............................................................2644Tubocurarini chloridum........................................................2644Turmeric, javanese...................................................................2645Turpentine oil, Pinus pinaster type ..............................5.6-4703Tylosin for veterinary use ...............................................5.4-4035Tylosini phosphatis solutio ad usum veterinarium .........5.4-4037
Tylosini tartras ad usum veterinarium ......................5.4-4039Tylosin phosphate bulk solution for veterinary use ..5.4-4037Tylosin tartrate for veterinary use ................................5.4-4039Tylosinum ad usum veterinarium ...............................5.4-4035Typhoid polysaccharide vaccine ............................................. 705Typhoid vaccine.......................................................................... 707Typhoid vaccine, freeze-dried.................................................. 707Typhoid vaccine (live, oral, strain Ty 21a)............................ 708Tyrosine...................................................................................... 2651Tyrosinum................................................................................. 2651Tyrothricin..........................................................................5.1-3028Tyrothricinum...................................................................5.1-3028
Udder-washes .............................................................................. 631Ultraviolet and visible absorption spectrophotometry(2.2.25.) .............................................................................5.6-4383
Ultraviolet ray lamps for analytical purposes (2.1.3.)............17Uncoated tablets................................................................5.5-4166Undecylenic acid ......................................................................2658Uniformity of content of single-dose preparations(2.9.6.) ........................................................................................ 234
Uniformity of dosage units (2.9.40.) .............................5.3-3370Uniformity of mass of delivered doses from multidosecontainers (2.9.27.) .................................................................. 263
Uniformity of mass of single-dose preparations (2.9.5.) .... 233Units of the International System (SI) used in thePharmacopoeia and equivalence with other units(1.) ......................................................................................5.6-4373
VVaccina ad usum humanum .........................................5.4-3838Vaccina ad usum veterinarium ....................................5.3-3387Vaccines, adsorbed, aluminium in (2.5.13.)...........................131Vaccines, adsorbed, calcium in (2.5.14.).................................131Vaccines and immunosera, phenol in (2.5.15.) .....................131Vaccines and immunosera, veterinary, evaluation of efficacy(5.2.7.)................................................................................5.1-2829
Vaccines and immunosera, veterinary, evaluation of safety(5.2.6.) ...............................................................................5.1-2827
Vaccines and immunosera, veterinary, evaluation of thesafety of each batch (5.2.9.) ..........................................5.1-2830
Vaccines for human use...................................................5.4-3838Vaccines for human use, cell substrates for the production of(5.2.3.) ........................................................................................ 455
Vaccines for human use, viral, extraneous agents in(2.6.16.) ...................................................................................... 169
Vaccines for veterinary use.............................................5.3-3387Vaccines, polysaccharide, hexosamines in (2.5.20.)............ 132Vaccines, polysaccharide, methylpentoses in (2.5.21.)....... 133Vaccines, polysaccharide, nucleic acids in (2.5.17.) ............ 132Vaccines, polysaccharide, O-acetyl in (2.5.19.)..................... 132Vaccines, polysaccharide, phosphorus in (2.5.18.) ............. 132Vaccines, polysaccharide, protein in (2.5.16.) .......................131Vaccines, polysaccharide, ribose in (2.5.31.) ........................ 137Vaccines, polysaccharide, sialic acid in (2.5.23.) ................. 133Vaccines, polysaccharide, uronic acids in (2.5.22.)............. 133Vaccines, SPF chicken flocks for the production and qualitycontrol of (5.2.2.) ...........................................................5.1-2825
Vaccines, terminology (5.2.1.) ................................................. 453Vaccines, veterinary, cell cultures for the production of(5.2.4.) ........................................................................................ 458
Vaccines, veterinary, substances of animal origin for theproduction of (5.2.5.) .............................................................. 460
Vaccines, viral live, test for neurovirulence (2.6.18.).......... 172Vaccinum actinobacillosis inactivatum ad suem ............. 784Vaccinum adenovirosidis caninae vivum........................... 738Vaccinum adenovirosis caninae inactivatum ................... 738Vaccinum anaemiae infectivae pulli vivum....................... 769Vaccinum anthracis adsorbatum ab colato culturarum adusum humanum .............................................................5.6-4479
General Notices (1) apply to all monographs and other texts 4771
Index EUROPEAN PHARMACOPOEIA 5.6
Vaccinum anthracis vivum ad usum veterinarium.......... 715Vaccinum aphtharum epizooticarum inactivatum adruminantes ......................................................................5.1-2860
Vaccinum diphtheriae et tetani adsorbatum ..................... 639Vaccinum diphtheriae et tetani, antigeni-o(-is) minutum,adsorbatum......................................................................5.6-4480
Vaccinum diphtheriae, tetani et hepatitidis B (ADNr)adsorbatum............................................................................... 641
Vaccinum diphtheriae, tetani et pertussis adsorbatum .. 643Vaccinum diphtheriae, tetani et pertussis sine cellulis exelementis praeparatum adsorbatum.........................5.4-3851
Vaccinum diphtheriae, tetani et poliomyelitidisinactivatum, antigeni-o(-is) minutum, adsorbatum.......5.6-4481
Vaccinum diphtheriae, tetani, pertussis et poliomyelitidisinactivatum adsorbatum ..............................................5.4-3864
Vaccinum diphtheriae, tetani, pertussis, poliomyelitidisinactivatum et haemophili stirpe b coniugatumadsorbatum......................................................................5.4-3866
Vaccinum diphtheriae, tetani, pertussis sine cellulis exelementis praeparatum et haemophili stirpe b coniugatumadsorbatum......................................................................5.4-3852
Vaccinum diphtheriae, tetani, pertussis sine cellulisex elementis praeparatum et hepatitidis B (ADNr)adsorbatum......................................................................5.4-3854
Vaccinum diphtheriae, tetani, pertussis sine cellulis exelementis praeparatum et poliomyelitidis inactivatumadsorbatum......................................................................5.4-3856
Vaccinum diphtheriae, tetani, pertussis sine cellulis exelementis praeparatum et poliomyelitidis inactivatum,antigeni-o(-is) minutum, adsorbatum.......................5.6-4483
Vaccinum diphtheriae, tetani, pertussis sine cellulisex elementis praeparatum, hepatitidis B (ADNr),poliomyelitidis inactivatum et haemophili stirpe bconiugatum adsorbatum ..............................................5.4-3858
Vaccinum diphtheriae, tetani, pertussis sine cellulis exelementis praeparatum, poliomyelitidis inactivatum ethaemophili stirpe b coniugatum adsorbatum ........5.4-3861
Vaccinum furunculosidis ad salmonidas inactivatum cumadiuvatione oleosa ad iniectionem .................................... 767
Vaccinum haemophili stirpe b coniugatum ....................... 662Vaccinum hepatitidis A inactivatum adsorbatum ............ 665Vaccinum hepatitidis A inactivatum et hepatitidis B (ADNr)adsorbatum............................................................................... 664
Vaccinum hepatitidis A inactivatum virosomale .............. 667Vaccinum hepatitidis B (ADNr)............................................. 670Vaccinum hepatitidis viralis anatis stirpe I vivum .......... 751Vaccinum herpesviris equini inactivatum ......................... 754Vaccinum inactivatum diarrhoeae vituli coronaviroillatae ......................................................................................... 736
Vaccinum viri syncytialis meatus spiritus bovini vivumcryodesiccatum ....................................................................... 733
Vaginal capsules ................................................................5.5-4169Vaginal foams.....................................................................5.5-4169Vaginalia ............................................................................5.5-4168Vaginal preparations ........................................................5.5-4168Vaginal preparations, semi-solid ....................................5.5-4169Vaginal solutions and suspensions, tablets for...........5.5-4169Vaginal solutions, emulsions and suspensions...........5.5-4169Vaginal tablets ...................................................................5.5-4169Vaginal tampons, medicated...........................................5.5-4170Valerianae radix ......................................................................2667Valerian root..............................................................................2667Validation of nucleic acid amplification techniques for thedetection of hepatitis C virus (HCV) RNA in plasma pools :Guidelines.........................................................................5.5-4113
Valine ..........................................................................................2668Valinum .....................................................................................2668Valnemulin hydrochloride for veterinary use ............5.6-4707Valnemulini hydrochloridum ad usum veterinarium .....5.6-4707
Vaselinum album..................................................................... 2187Vaselinum flavum ................................................................... 2188Vectors for human use, adenovirus ..............................5.6-4462Vectors for human use, plasmid ....................................5.6-4466Vectors for human use, plasmid, bacterial cells used for themanufacture of ................................................................5.6-4468
Vectors for human use, poxvirus ...................................5.6-4464Vecuronii bromidum .......................................................5.4-4044Vecuronium bromide........................................................5.4-4044Vegetable drugs, determination of essential oils in vegetabledrugs (2.8.12.) ...........................................................................217
Visible particles, particulate contamination (2.9.20.) ........ 255Vitamin A ............................................................................5.6-4710Vitamin A concentrate (oily form), synthetic ..............5.6-4711Vitamin A concentrate (powder form), synthetic .......5.6-4713Vitamin A concentrate (solubilisate/emulsion),synthetic ...........................................................................5.6-4714
Vitaminum A .....................................................................5.6-4710Vitaminum A densatum oleosum ................................5.6-4711Vitaminum A in aqua dispergibile ..............................5.6-4714Vitaminum A pulvis.........................................................5.6-4713Volumetric analysis (4.2.) ................................................5.4-3827Volumetric solutions (4.2.2.)...........................................5.4-3827Volumetric solutions (4.2.2.)...........................................5.5-4127Volumetric solutions (4.2.2.)...........................................5.6-4448Volumetric solutions, primary standards for (4.2.1.) ..5.4-3827von Willebrand factor, human .......................................5.6-4606Von Willebrand factor, human, assay of (2.7.21.).......5.5-4120
Water for injections .................................................................2692
General Notices (1) apply to all monographs and other texts 4773
Index EUROPEAN PHARMACOPOEIA 5.6
Water for pharmaceutical use, total organic carbon in(2.2.44.) ........................................................................................ 68
Xylazine hydrochloride for veterinary use ......................... 2716Xylazini hydrochloridum ad usum veterinarium .......... 2716Xylitol...................................................................................5.3-3647Xylitolum ............................................................................5.3-3647Xylometazoline hydrochloride .......................................5.6-4723Xylometazolini hydrochloridum ..................................5.6-4723