欧洲药典7.4索引(现行版)

EUROPEAN PHARMACOPOEIA

7.4

INDEX

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

For example:Amikacin sulfate...............................................7.1-3377

means the monograph Amikacin sulfate can be found on page 3377of Supplement 7.1.

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

English index ........................................................................4401Latin index .................................................................................4433https://www.doczj.com/doc/0f13805056.html,/forum.php?mod=viewthread&tid=21456&fromuid=1023

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EUROPEAN PHARMACOPOEIA7.4

EUROPEAN PHARMACOPOEIA 7.4

Index Numerics 1.General https://www.doczj.com/doc/0f13805056.html,parative table of porosity of sintered-glass filters...152.1.3.Ultraviolet ray lamps for analytical purposes...................152.1.4.Sieves.........................................................................................162.1.5.Tubes for comparative tests..................................................172.1.6.Gas detector tubes...................................................................172.1.Apparatus....................................................................................152.2.10.Viscosity -Rotating

viscometer method..........................282.2.11.Distillation range (30)

2.2.12.Boiling point..........................................................................312.2.13.Determination of water by distillation (31)

2.2.14.Melting point -capillary method........................................312.2.15.Melting point -open capillary method............................322.2.16.Melting

point -instantaneous method (32)

2.2.17.Drop point..............................................................................322.2.18.Freezing point.......................................................................342.2.19.Amperometric

titration (34)

2.2.1.Clarity and degree of opalescence of liquids.....................212.2.20.Potentiometric titration......................................................342.2.21.Fluorimetry. (35)

2.2.22.Atomic emission spectrometry..........................................352.2.23.Atomic absorption spectrometry......................................362.2.24.Absorption spectrophotometry,infrared........................382.2.25.Absorption spectrophotometry,ultraviolet and visible..................................................................................................402.2.26.Paper chromatography.. (41)

2.2.27.Thin-layer chromatography................................................422.2.28.Gas chromatography...........................................................432.2.29.Liquid

chromatography......................................................452.2.2.Degree of coloration of liquids............................................222.2.30.Size-exclusion chromatography........................................462.2.31.Electrophoresis (46)

2.2.31.Electrophoresis (5.8.)................................................7.1-33452.2.32.Loss on drying.......................................................................512.2.33.Nuclear magnetic resonance spectrometry.. (52)

2.2.34.Thermal analysis...................................................................542.2.35.Osmolality...................................................................7.3-37772.2.36.Potentiometric determination of ionic concentration using ion-selective electrodes.............................572.2.37.X-ray fluorescence spectrometry.......................................582.2.38.Conductivity.. (59)

2.2.39.Molecular mass distribution in dextrans........................602.2.3.Potentiometric determination of pH..................................242.2.40.Near-infrared spectrophotometry.. (61)

2.2.41.Circular dichroism................................................................652.2.42.Density of solids...................................................................662.2.43.Mass spectrometry (67)

2.2.44.Total organic carbon in water for pharmaceutical use.......................................................................................................692.2.45.Supercritical fluid chromatography.................................702.2.46.Chromatographic separation techniques........................702.2.47.Capillary electrophoresis (5.8.)...............................7.1-33452.2.47.Capillary electrophoresis.........................................7.1-33132.2.48.Raman spectrometry...........................................................822.2.49.Falling ball viscometer method.........................................832.2.4.Relationship between reaction of solution,approximate pH and colour of certain indicators...................................................252.2.54.Isoelectric focusing..............................................................832.2.54.Isoelectric focusing (5.8.)........................................7.1-33452.2.55.Peptide mapping...................................................................852.2.55.Peptide mapping (5.8.).............................................7.1-33452.2.56.Amino acid

analysis (88)

2.2.56.Amino acid analysis (5.8.)........................................7.1-33452.2.57.Inductively coupled plasma-atomic emission spectrometry.....................................................................................942.2.58.Inductively coupled plasma-mass spectrometry............962.2.59.Glycan analysis of glycoproteins.......................................972.2.5.Relative density.......................................................................252.2.60.Melting point -instrumental method.............................102 2.2.64.

Peptide identification by nuclear magnetic resonance spectrometry..........................................................................7.2-3531

2.2.6.Refractive

index......................................................................262.2.7.Optical rotation.......................................................................262.2.8.Viscosity (27)

2.2.9.

Capillary

viscometer method (27)

2.2.Physical and physicochemical methods.................................212.

3.1.Identification reactions of ions and functional groups..107

2.3.2.Identification of fatty oils by thin-layer chromato-

graphy (110)

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

2.3.4.Odour......................................................................................1102.3.Identification.. (107)

2.4.10.

Lead in sugars (117)

2.4.11.Phosphates............................................................................1172.4.12.Potassium (117)

2.4.1

3.

Sulfates........................................................................

7.3-3781

2.4.14.Sulfated ash (118)

2.4.14.Sulfated ash (5.8.).....................................................7.1-33462.4.15.

Nickel in polyols (118)

2.4.16.Total ash...............................................................................1182.4.17.Aluminium. (118)

2.4.18.

Free formaldehyde (118)

2.4.19.Alkaline impurities in fatty oils.......................................1192.4.1.Ammonium.. (113)

2.4.21.Foreign oils in fatty oils by

thin-layer chromato-

https://www.doczj.com/doc/0f13805056.html,position of fatty acids by gas chromatography (119)

2.4.2

3.Sterols in fatty oils....................................................7.2-3535

2.4.24.

Identification and control of residual solvents...7.2-35372.4.25.Ethylene oxide and dioxan.. (127)

2.4.26.

N,N -Dimethylaniline (128)

2.4.27.Heavy metals in herbal drugs and fatty oils.................1292.4.28.2-Ethylhexanoic acid (130)

https://www.doczj.com/doc/0f13805056.html,position of fatty acids in oils rich in omega-3

acids..................................................................................................1302.4.2.Arsenic (113)

2.4.30.Ethylene glycol and diethylene glycol in

ethoxylated

substances.......................................................................................1322.4.31.Nickel in hydrogenated vegetable oils (132)

2.4.32.

Total cholesterol in oils rich in omega-3acids (133)

2.4.

3.

Calcium...................................................................................1132.4.4.Chlorides.. (113)

2.4.5.

Fluorides (114)

2.4.6.Magnesium..............................................................................1142.4.7.Magnesium and alkaline-earth metals (114)

2.4.8.

Heavy metals (114)

2.4.9.Iron...........................................................................................1172.4.Limit tests. (113)

2.5.10.

Oxygen-flask

method (139)

https://www.doczj.com/doc/0f13805056.html,plexometric titrations................................................1402.5.12.Water:semi-micro determination.. (140)

2.5.1

3.

Aluminium in adsorbed vaccines (141)

2.5.14.Calcium in adsorbed vaccines..........................................1412.5.15.Phenol in immunosera and vaccines (141)

2.5.16.

Protein in polysaccharide vaccines (141)

2.5.17.Nucleic acids in polysaccharide vaccines......................1422.5.18.Phosphorus in polysaccharide vaccines (142)

2.5.19.

O -Acetyl

in polysaccharide vaccines (142)

2.5.1.

Acid value...............................................................................1372.5.20.Hexosamines in polysaccharide vaccines. (142)

2.5.21.

Methylpentoses in polysaccharide vaccines.................

1432.5.22.Uronic acids in polysaccharide vaccines.......................1432.5.23.Sialic acid in polysaccharide vaccines (143)

2.5.24.Carbon

dioxide in gases (143)

2.5.25.Carbon monoxide in gases...............................................1442.5.26.Nitrogen monoxide and nitrogen dioxide in gases.. (145)

2.5.27.

Oxygen

in

gases..................................................................1452.5.28.Water in gases.....................................................................1452.5.29.Sulfur dioxide.....................................................................1452.5.2.Ester value.............................................................................1372.5.30.Oxidising substances (146)

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Index EUROPEAN PHARMACOPOEIA

7.4

2.5.31.Ribose in polysaccharide vaccines (146)

2.5.32.Water:micro determination (146)

2.5.33.Total protein (147)

2.5.34.Acetic acid in synthetic peptides (150)

2.5.35.Nitrous oxide in gases (150)

2.5.36.Anisidine value (150)

2.5.37.Methyl,ethyl and isopropyl methanesulfonate in methanesulfonic acid...........................................................7.1-3321 2.5.38.Methyl,ethyl and isopropyl methanesulfonate in active substances..............................................................................7.3-3785 2.5.39.Methanesulfonyl chloride in methanesulfonic acid...........................................................................................7.4-4093 2.5.3.Hydroxyl value. (137)

2.5.4.Iodine value (137)

2.5.5.Peroxide value (138)

2.5.6.Saponification value (139)

2.5.7.Unsaponifiable matter (139)

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

2.5.9.Determination of nitrogen by sulfuric acid digestion..139 2.5.Assays (137)

2.6.10.Histamine (162)

2.6.11.Depressor substances (162)

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

2.6.12.Microbiological examination of non-sterile products: microbial enumeration tests(5.8.)....................................7.1-3346 2.6.13.Microbiological examination of non-sterile products:test for specified micro-organisms.. (167)

2.6.13.Microbiological examination of non-sterile products:test for specified micro-organisms(5.8.)..................................7.1-3346 2.6.14.Bacterial endotoxins. (171)

2.6.15.Prekallikrein activator (175)

2.6.16.Tests for extraneous agents in viral vaccines for human use (176)

2.6.17.Test for anticomplementary activity of immunoglobulin (177)

2.6.18.Test for neurovirulence of live virus vaccines (179)

2.6.19.Test for neurovirulence of poliomyelitis vaccine (oral) (179)

2.6.1.Sterility(5.8.)................................................................7.1-3346 2.6.1.Sterility..........................................................................7.1-3325 2.6.20.Anti-A and anti-B haemagglutinins.......................7.2-3545 2.6.21.Nucleic acid amplification techniques (181)

2.6.22.Activated coagulation factors (185)

2.6.24.Avian viral vaccines:tests for extraneous agents in seed lots (185)

2.6.25.Avian live virus vaccines:tests for extraneous agents in batches of finished product (188)

2.6.26.Test for anti-D antibodies in human immunoglobu-lin.............................................................................................7.2-3546 2.6.27.Microbiological control of cellular products. (191)

2.6.2.Mycobacteria (156)

2.6.30.Monocyte-activation test (192)

2.6.31.Microbiological examination of herbal medicinal products for oral use (197)

2.6.7.Mycoplasmas (156)

2.6.8.Pyrogens (161)

2.6.9.Abnormal toxicity (162)

2.6.Biological tests (153)

2.7.10.Assay of human coagulation factor VII (219)

2.7.11.Assay of human coagulation factor IX (219)

2.7.12.Assay of heparin in coagulation factors (220)

2.7.13.Assay of human anti-D immunoglobulin (220)

2.7.14.Assay of hepatitis A vaccine (222)

2.7.15.Assay of hepatitis B vaccine(rDNA)......................7.3-3794 2.7.16.Assay of pertussis vaccine(acellular).. (223)

2.7.17.Assay of human antithrombin III (224)

2.7.18.Assay of human coagulation factor II (224)

2.7.19.Assay of human coagulation factor X (225)

2.7.19.Assay of human coagulation factor X(2.7.19.) (225)

2.7.1.Immunochemical methods (201)

2.7.20.In vivo assay of poliomyelitis vaccine(inactivated) (225)

2.7.21.Assay of human von Willebrand factor..........................2262.7.22.Assay of human coagulation factor XI (227)

2.7.23.Numeration of CD34/CD45+cells in haemato-poietic products (228)

2.7.24.Flow cytometry (229)

2.7.25.Assay of human plasmin inhibitor (230)

2.7.27.Flocculation value(Lf)of diphtheria and tetanus toxins and toxoids(Ramon assay) (231)

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

2.7.29.Nucleated cell count and viability (233)

2.7.2.Microbiological assay of antibiotics.........................7.3-3789 2.7.30.Assay of human protein C (234)

2.7.31.Assay of human protein S (235)

2.7.32.Assay of humanα-1-proteinase inhibitor (236)

2.7.4.Assay of human coagulation factor VIII (207)

2.7.5.Assay of heparin (208)

2.7.6.Assay of diphtheria vaccine(adsorbed) (209)

2.7.7.Assay of pertussis vaccine(whole cell)...................7.2-3549 2.7.8.Assay of tetanus vaccine(adsorbed) (214)

2.7.9.Test for Fc function of immunoglobulin (217)

2.7.Biological assays (201)

2.8.10.Solubility in alcohol of essential oils (240)

2.8.11.Assay of1,8-cineole in essential oils (240)

2.8.12.Determination of essential oils in herbal drugs (241)

2.8.13.Pesticide residues (242)

2.8.14.Determination of tannins in herbal drugs (243)

2.8.15.Bitterness value (244)

2.8.16.Dry residue of extracts (244)

2.8.17.Loss on drying of extracts (244)

2.8.18.Determination of aflatoxin B

1

in herbal drugs (244)

2.8.1.Ash insoluble in hydrochloric acid (239)

2.8.20.Herbal drugs:sampling and sample preparation (246)

2.8.21.Test for aristolochic acids in herbal drugs (247)

2.8.22.Determination of ochratoxin A in herbal drugs (249)

2.8.23.Microscopic examination of herbal drugs (250)

2.8.2.Foreign matter (239)

2.8.3.Stomata and stomatal index (239)

2.8.4.Swelling index (239)

2.8.5.Water in essential oils (239)

2.8.6.Foreign esters in essential oils (239)

2.8.7.Fatty oils and resinified essential oils in essential oils..239 2.8.8.Odour and taste of essential oils (240)

2.8.9.Residue on evaporation of essential oils (240)

2.8.Methods in pharmacognosy (239)

2.9.10.Ethanol content and alcoholimetric tables (268)

2.9.11.Test for methanol and2-propanol (270)

2.9.12.Sieve test (270)

2.9.14.Specific surface area by air permeability (271)

2.9.16.Flowability (272)

2.9.17.Test for extractable volume of parenteral preparations (273)

2.9.17.Test for extractable volume of parenteral preparations (5.8.).........................................................................................7.1-3346 2.9.18.Preparations for inhalation:aerodynamic assessment of fine particles.. (274)

2.9.19.Particulate contamination:sub-visible particles

(5.8.).........................................................................................7.1-3347 2.9.19.Particulate contamination:sub-visible particles..................................................................................7.1-3333 2.9.1.Disintegration of tablets and capsules(5.8.).........7.1-3346 2.9.1.Disintegration of tablets and capsules....................7.1-3331 2.9.20.Particulate contamination:visible particles. (287)

2.9.22.Softening time determination of lipophilic suppositories (288)

2.9.23.Gas pycnometric density of solids (288)

2.9.25.Dissolution test for medicated chewing gums....7.4-4097 2.9.26.Specific surface area by gas adsorption (291)

2.9.26.Specific surface area by gas adsorption(5.8.)....7.1-3347 2.9.27.Uniformity of mass of delivered doses from multidose containers. (294)

2.9.29.Intrinsic dissolution (294)

2.9.2.Disintegration of suppositories and pessaries (255)

2.9.31.Particle size analysis by laser light diffraction (295)

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EUROPEAN PHARMACOPOEIA 7.4

Index

2.9.32.Porosity and pore-size distribution of solids by mercury porosimetry.....................................................................................2992.9.3

3.Characterisation of crystalline and partially crystalline

solids by X-ray powder diffraction (XRPD)...............................3012.9.34.Bulk density and tapped density of powders...............3052.9.35.Powder fineness.................................................................3082.9.36.Powder flow.........................................................................3082.9.36.Powder flow (5.8.).....................................................7.1-33472.9.37.Optical microscopy.. (311)

2.9.37.Optical microscopy (5.8.).........................................7.1-33472.9.38.Particle-size distribution estimation by analytical sieving. (313)

2.9.38.Particle-size distribution estimation by analytical sieving (5.8.).........................................................................................7.1-33472.9.39.Water-solid interactions:

determination of sorption-desorption isotherms and of water activity....7.1-33352.9.3.Dissolution test for solid dosage forms..................7.3-37972.9.40.Uniformity of dosage units......................................7.4-4101

2.9.41.Friability of granules and spheroids.....................7.4-41032.9.42.Dissolution test for lipophilic solid dosage forms.......3192.9.43.Apparent dissolution.........................................................3202.9.44.Preparations for nebulisation:characterisation.........7.3-38032.9.45.Wettability of porous solids including powders..........3212.9.4.Dissolution test for transdermal patches........................2632.9.5.Uniformity of mass of single-dose preparations.............2652.9.6.Uniformity of content of single-dose preparations........2662.9.7.Friability of uncoated tablets.............................................2662.9.7.Friability of uncoated tablets (5.8.)..........................7.1-33462.9.8.Resistance to crushing of tablets......................................2672.9.9.Measurement of consistency by penetrometry.. (267)

2.9.Pharmaceutical technical procedures.................................253

3.1.10.Materials based on non-plasticised poly(vinyl chloride)

for containers for non-injectable,aqueous solutions............3493.1.11.Materials based on non-plasticised poly(vinyl chloride)for containers for dry dosage forms for oral administration (350)

3.1.1.1.Materials based on plasticised poly(vinyl chloride)for containers for human blood and blood components.............3293.1.1.2.Materials based on plasticised poly(vinyl chloride)for tubing used in sets for the transfusion of blood and blood components.....................................................................................3323.1.13.Plastic additives (352)

3.1.1

4.Materials based on plasticised poly(vinyl chloride)for containers for aqueous solutions for intravenous infusion..3553.1.1

5.Polyethylene terephthalate for containers for

preparations not for parenteral use...........................................3573.1.1.Materials for containers for human blood and blood components.....................................................................................3293.1.3.Polyolefines............................................................................3343.1.4.Polyethylene without additives for containers for parenteral

preparations

and for ophthalmic preparations (337)

3.1.5.Polyethylene with additives for containers for parenteral preparations and for ophthalmic preparations.......................3383.1.6.Polypropylene for containers and closures for parenteral

preparations and ophthalmic preparations..............................3423.1.7.Poly(ethylene -vinyl acetate)for containers and tubing for total

parenteral

nutrition

preparations (345)

3.1.8.Silicone oil used as a lubricant.........................................3473.1.9.Silicone elastomer for closures and tubing....................3473.1.Materials used for

the manufacture of containers (329)

3.2.1.Glass containers for pharmaceutical use........................3633.2.2.1.Plastic containers for aqueous solutions for infusion............................................................................................3683.2.2.Plastic containers and closures for pharmaceutical use.....................................................................................................3683.2.3.Sterile plastic containers for human blood and

blood components.........................................................................3693.2.4.Empty sterile containers of plasticised poly(vinyl chloride)for human blood and blood components.................................3703.2.5.Sterile containers of plasticised poly(vinyl chloride)for human blood containing anticoagulant solution...................3713.2.6.Sets for the transfusion of blood and blood components.....................................................................................371 3.2.8.Sterile single-use plastic syringes.....................................3733.2.9.Rubber closures for containers for aqueous parenteral

preparations,

for powders and for freeze-dried powders (374)

3.2.Containers.................................................................................3633-O -Desacyl-4′-monophosphoryl lipid A.............................7.2-3639

4.1.1.Reagents........................................................................7.4-41094.1.2.Standard solutions for limit tests.............................7.4-42164.1.3.

Buffer

solutions...........................................................

7.4

-4220

4.1.Reagents,standard solutions,buffer solutions........7.4-4109

4.2.1.Primary standards for volumetric solutions..........7.4-42254.2.2.

Volumetric solutions...................................................7.4-4225

4.2.Volumetric analysis.........................................................7.4-4225

4-Aminobenzoic acid.....................................................................13714.

Reagents...............................................................................

7.4-4109

5.10.Control of impurities in substances for pharmaceutical use............................................................................................7.4-42475.1.10.

Guidelines for using the test for

bacterial endotoxins..520

5.11.Characters section in monographs....................................6375.1.1.Methods of preparation of sterile products....................5035.1.2.

Biological indicators of sterilisation (504)

5.12.Reference standards (641)

5.1.3.Efficacy of antimicrobial preservation.............................5055.14.

Gene

transfer medicinal

products for human use (647)

5.1.4.Microbiological quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use...........5075.1.4.

Microbiological quality of

non-sterile pharmaceutical preparations and substances for pharmaceutical use (5.8.).........................................................................................7.1-33475.1.5.Application of the F 0concept to steam

sterilisation of

aqueous preparations...................................................................5085.15.Functionality-related characteristics of excipients.........6615.1.6.Alternative methods for control of

microbiological

quality...............................................................................................5085.16.Crystallinity....................................................................7.4-4253

5.17.1.

Recommendations on dissolution testing.....................6655.17.

Recommendations on methods for dosage forms testing...............................................................................................6655.1.7.

Viral

safety (518)

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

5.1.9.

Guidelines for using the test for sterility (519)

5.1.General texts on microbiology..............................................5035.2.1.Terminology used in monographs on biological

products (527)

5.2.2.Chicken flocks free from specified pathogens for the

production and quality control of vaccines.............................5275.2.3.

Cell substrates for the production of vaccines for human

use.....................................................................................................5305.2.4.Cell cultures for the production of veterinary

vaccines (533)

5.2.5.Substances of animal origin for the production of

immunological veterinary medicinal products........................5355.2.6.Evaluation of safety of veterinary vaccines and

immunosera ...................................................................................5365.2.7.Evaluation of efficacy of veterinary vaccines and

immunosera (538)

5.2.8.Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal

products..................................................................................

7.4-4233

5.2.9.Evaluation of safety of each batch of veterinary vaccines and immunosera............................................................................5475.2.

General

texts on biological products...................................5275.3.Statistical analysis of results of biological assays and tests...................................................................................................5515.4.

Residual solvents (583)

5.5.Alcoholimetric tables (593)

5.6.Assay of interferons.................................................................6075.7.Table of physical characteristics of radionuclides

mentioned

in the European Pharmacopoeia (611)

5.8.Pharmacopoeial harmonisation..................................7.1-33455.9.Polymorphism...........................................................................627https://www.doczj.com/doc/0f13805056.html,/forum.php?mod=viewthread&tid=21456&fromuid=1023

Index EUROPEAN PHARMACOPOEIA

7.4A Abbreviations and symbols (1.)............................................7.4-4083Abnormal toxicity (2.6.9.)...............................................................162Absorption spectrophotometry,infrared (2.2.24.). (38)

Absorption spectrophotometry,ultraviolet and visible (2.2.25.)..............................................................................................40Acacia................................................................................................1043Acacia,spray-dried.........................................................................1301Acamprosate calcium....................................................................1301Acanthopanax bark................................................................7.3-3855Acarbose...........................................................................................1302Acebutolol hydrochloride.............................................................1304Aceclofenac......................................................................................1306Acemetacin......................................................................................1307Acesulfame potassium..................................................................1309Acetate trihydrate,sodium...........................................................2908Acetazolamide.................................................................................1310Acetic acid,glacial.........................................................................1311Acetic acid in synthetic peptides (2.5.34.)..................................150Acetone.............................................................................................1312Acetylcholine chloride..................................................................1313Acetylcysteine.................................................................................1313β-Acetyldigoxin...............................................................................1315Acetylsalicylic acid.........................................................................1317Acetyltryptophan,N - (1319)

Acetyltyrosine,N -....................................................................7.2-3605Aciclovir...........................................................................................1321Acid value (2.5.1.).............................................................................137Acitretin............................................................................................1323Actinobacillosis vaccine (inactivated),porcine..........................926Activated charcoal..........................................................................1649Activated coagulation factors (2.6.22.)........................................185Adapalene........................................................................................1324Additives,plastic (3.1.13.)...............................................................352Adenine............................................................................................1326Adeno-associated-virus vectors for human use.........................656Adenosine........................................................................................1327Adipic acid.......................................................................................1328Adrenaline.......................................................................................1329Adrenaline tartrate........................................................................1330Adsorption,gas,specific surface area by (2.9.26.)....................291Adsorption,gas,specific surface area by (2.9.26.)(5.8.).........................................................................................7.1-3347

Aerodynamic assessment of fine particles in preparations for inhalation (2.9.18.)........................................................................274Aflatoxin B 1in herbal drugs,determination of (2.8.18.).........244Agar...................................................................................................1044Agnus castus fruit..........................................................................1044Agrimony.........................................................................................1046Air,medicinal..................................................................................1331Air,synthetic medicinal................................................................1333Alanine.............................................................................................1334Albendazole.....................................................................................1335Albumin solution,human.............................................................2165Alchemilla........................................................................................1047Alcoholimetric tables (2.9.10.)......................................................268Alcoholimetric tables (5.5.)............................................................593Alcuronium chloride......................................................................1336Alendronate,sodium.....................................................................2908Alexandrian senna pods...............................................................1238Alfacalcidol...............................................................................7.2-3606Alfadex.......................................................................................7.3-3889Alfentanil hydrochloride...............................................................1339Alfuzosin hydrochloride...............................................................1341Alginate,sodium.............................................................................2909Alginic acid......................................................................................1342Alkaline-earth metals and magnesium (2.4.7.)...........................114Alkaline impurities in fatty oils (2.4.19.).....................................119Allantoin...........................................................................................1342Allergen products....................................................................7.3-3813Allopurinol.......................................................................................1343all-rac-α-Tocopherol................................................................7.2-3718all-

rac-α-Tocopheryl acetate.................................................7.2-3720Almagate..........................................................................................1345Almond

oil,

refined........................................................................1346Almond oil,virgin.. (1347)

Aloes,Barbados..............................................................................1047Aloes,

Cape......................................................................................1048Aloes

dry extract,standardised...................................................1049Alphacyclodextrin...................................................................7.3-3889Alprazolam......................................................................................1347Alprenolol

hydrochloride.............................................................1349Alprostadil.......................................................................................1350Alteplase

for injection............................................................7.3-3890Alternative methods for control of microbiological quality (5.1.6.)...............................................................................................508Altizide.............................................................................................1356Alum..................................................................................................1357Aluminium (2.4.17.).........................................................................118Aluminium

chloride

hexahydrate (1357)

Aluminium hydroxide,hydrated,for adsorption (1357)

Aluminium in adsorbed vaccines (2.5.13.)...................................141Aluminium

magnesium silicate...................................................1358Aluminium oxide,hydrated..........................................................1359Aluminium phosphate gel............................................................1360Aluminium

phosphate,hydrated................................................1361Aluminium sodium silicate..........................................................1361Aluminium sulfate..........................................................................1362Alverine

citrate...............................................................................1363Amantadine hydrochloride..........................................................1364Ambroxol hydrochloride...............................................................1365Amfetamine

sulfate........................................................................1366Amidotrizoate,sodium..................................................................2910Amidotrizoic acid dihydrate.........................................................1366Amikacin..........................................................................................1367Amikacin

sulfate......................................................................7.1-3377Amiloride hydrochloride...............................................................1370Amino

acid

analysis (2.2.56.) (88)

Amino acid analysis (2.2.56.)(5.8.).....................................7.1-3345

Aminobenzoic acid,4-...................................................................1371Aminocaproic

acid.........................................................................1373Aminoglutethimide........................................................................1373Aminophylline,anhydrous...........................................................3068Aminophylline hydrate..................................................................3069Aminosalicylate dihydrate,sodium............................................2911Amiodarone hydrochloride..........................................................1375Amisulpride. (1376)

Amitriptyline

hydrochloride........................................................1377Amlodipine besilate................................................................7.4-4275Ammonia (13

N)injection (965)

Ammonia

solution,concentrated...............................................1380Ammonio methacrylate copolymer (type A). (1381)

Ammonio

methacrylate

copolymer (type B) (1382)

Ammonium (2.4.1.) (113)

Ammonium bromide......................................................................1382Ammonium

chloride......................................................................1383Ammonium glycyrrhizate.............................................................1384Ammonium hydrogen carbonate................................................1385Amobarbital.....................................................................................1385Amobarbital

sodium......................................................................1386Amoxicillin sodium........................................................................1386Amoxicillin

trihydrate...................................................................1389Amperometric titration (2.2.19.).....................................................34Amphotericin B..............................................................................1391Ampicillin,

anhydrous (1393)

Ampicillin

sodium..........................................................................1395Ampicillin trihydrate (1397)

Amylmetacresol..............................................................................1399Anaemia

vaccine (live),chicken,infectious................................910Anaesthetic ether...........................................................................1968Analysis,

thermal (2.2.34.) (54)

Analytical sieving,particle-size distribution estimation by (2.9.38.) (313)

Analytical sieving,particle-size distribution estimation by (2.9.38.)(5.8.)........................................................................7.1-3347https://www.doczj.com/doc/0f13805056.html,/forum.php?mod=viewthread&tid=21456&fromuid=1023

EUROPEAN PHARMACOPOEIA 7.4

Index Angelica dahurica root...........................................................7.3-3855Angelica pubescens root........................................................7.3-3857Angelica root.. (1049)

Animal anti-T lymphocyte immunoglobulin for human use..1404Animal immunosera for human use.............................................678Animal spongiform encephalopathies,products with risk of

transmitting agents of...................................................................686Animal spongiform encephalopathy agents,minimising the risk of transmitting via human and veterinary medicinal products (5.2.8.).....................................................................................7.4-4233Aniseed......................................................................................7.3-3858Anise oil............................................................................................1050Anisidine value (2.5.36.).................................................................150Antazoline hydrochloride.............................................................1401Anthrax spore vaccine

(live)for veterinary use.........................847Anthrax vaccine for human use (adsorbed,prepared from culture filtrates).............................................................................745Anti-A and anti-B haemagglutinins (2.6.20.).....................7.2-3545Antibiotics,microbiological assay of (2.7.2.).....................7.3-3789Antibodies (anti-D)in human immunoglobulin,test for (2.6.26.)...................................................................................7.2-3546

Antibodies for human use,monoclonal.............................7.3-3815Anticoagulant and preservative solutions for human blood (1401)

Anticomplementary activity of immunoglobulin (2.6.17.).......177Anti-D antibodies in human immunoglobulin,test for (2.6.26.)...................................................................................7.2-3546

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

2166

Anti-D immunoglobulin,human,assay of (2.7.13.)...................220Antimicrobial preservation,efficacy of (5.1.3.)..........................505Antiserum,European viper venom. (953)

Antithrombin III concentrate,human................................7.3-3952Antithrombin III,human,assay of (2.7.17.)................................224Anti-T lymphocyte immunoglobulin for human use,animal..1404

Apomorphine hydrochloride.......................................................1407Apparatus (2.1.)..................................................................................15Apparent dissolution (2.9.43.). (320)

Application of the F 0concept to steam sterilisation of aqueous preparations (5.1.5.)......................................................................508Aprotinin..........................................................................................1408Aprotinin concentrated solution.................................................1411Arachis oil,hydrogenated............................................................1413Arachis oil,refined..................................................................7.2-3607Arginine............................................................................................1414Arginine aspartate.........................................................................1415Arginine hydrochloride.................................................................1415Argon................................................................................................1416Aristolochic acids in herbal drugs,test for (2.8.21).................247Arnica flower............................................................................7.3-3859Arnica tincture................................................................................1055Arsenic (2.4.2.)..................................................................................113Arsenious trioxide for homoeopathic preparations. (1286)

Articaine hydrochloride.........................................................7.4-4276Artichoke leaf...........................................................................7.3-3861Artichoke leaf

dry extract (1058)

Ascorbate,calcium.........................................................................1548Ascorbate,sodium.........................................................................2912Ascorbic acid...................................................................................1418Ascorbyl palmitate.........................................................................1420Ash insoluble in hydrochloric acid (2.8.1.).................................239Ash leaf.............................................................................................1059Ash,sulfated (2.4.14.)......................................................................118Ash,sulfated (2.4.14.)(5.8.)..................................................7.1-3346Ash,total (2.4.16.). (118)

Asparagine monohydrate.............................................................1421Aspartame........................................................................................1421Aspartic acid....................................................................................1423Assay of 1,8-cineole in essential oils (2.8.11.)............................240Assay of diphtheria vaccine (adsorbed)(2.7.6.).........................209Assay of heparin (2.7.5.).................................................................208Assay of heparin in coagulation factors (2.7.12.)......................220Assay of hepatitis A vaccine (2.7.14.)...........................................222Assay of hepatitis B vaccine (rDNA)(2.7.15.)...................7.3-3794Assay

of human anti-D immunoglobulin (2.7.13.) (220)

Assay of human antithrombin III (2.7.17.)..................................224Assay of human coagulation factor II (2.7.18.)..........................224Assay

of human coagulation factor IX (2.7.11.) (219)

Assay of human coagulation factor VII (2.7.10.) (219)

Assay of human coagulation factor VIII (2.7.4.)........................207Assay

of human coagulation factor X

(2.7.19.)..........................225Assay of human coagulation factor XI (2.7.22.) (227)

Assay of human plasmin inhibitor (2.7.25.)................................230Assay

of

human protein C (2.7.30.) (234)

Assay of human protein S (2.7.31.)...............................................235Assay of human von Willebrand factor (2.7.21.).......................226Assay

of

interferons

(5.6.) (607)

Assay of pertussis vaccine (acellular)(2.7.16.)..........................223Assay of pertussis vaccine (whole cell)(2.7.7.).................7.2-3549Assay

of

poliomyelitis

vaccine (inactivated),in vivo (2.7.20.)..225

Assay of tetanus vaccine (adsorbed)(2.7.8.) (214)

Assays (2.5.).......................................................................................137Astragalus

mongholicus root (1060)

Atenolol............................................................................................1424Atomic absorption spectrometry (2.2.23.) (36)

Atomic

emission spectrometry (2.2.22.) (35)

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

Atorvastatin

calcium trihydrate...........................................7.1-3380

Atracurium besilate (1425)

Atropine...........................................................................................1427Atropine

sulfate (1429)

Aujeszky’s disease vaccine (inactivated)for pigs......................847Aujeszky’s disease vaccine (live)for pigs for parenteral administration.. (849)

Avian infectious bronchitis vaccine (inactivated) (851)

Avian infectious bronchitis vaccine (live)...................................852Avian

infectious

bursal

disease

vaccine (inactivated) (854)

Avian infectious bursal disease vaccine (live)............................856Avian infectious encephalomyelitis vaccine (live).....................857Avian infectious laryngotracheitis vaccine

(live).......................859Avian live virus vaccines:tests for extraneous agents in batches of finished product (2.6.25.)........................................................188Avian paramyxovirus 1(Newcastle disease)vaccine

(inactivated) (921)

Avian paramyxovirus 3vaccine (inactivated).............................860Avian tuberculin purified

protein derivative (3161)

Avian viral tenosynovitis vaccine (live) (861)

Avian viral vaccines:tests for extraneous agents in seed lots (2.6.24.)............................................................................................185Azaperone for veterinary use......................................................1430Azathioprine....................................................................................1431Azelastine hydrochloride..............................................................1433Azithromycin...................................................................................1434B

B19virus (B19V),validation of nucleic acid amplification

techniques for the quantification of B19V DNA in plasma pools:guidelines (181)

Bacampicillin hydrochloride........................................................1439Bacitracin.........................................................................................1440Bacitracin

zinc................................................................................1443Baclofen...........................................................................................1445Bacterial

endotoxins

(2.6.14.)........................................................171Bacterial endotoxins,guidelines for using the test for (5.1.10.)............................................................................................520Baical

skullcap root................................................................7.1-3355Bambuterol hydrochloride.. (1446)

Barbados aloes...............................................................................1047Barbital.............................................................................................1447Barium

chloride dihydrate for homoeopathic preparations..1287Barium sulfate................................................................................1448Basic

butylated methacrylate copolymer..................................1448BCG for immunotherapy................................................................746https://www.doczj.com/doc/0f13805056.html,/forum.php?mod=viewthread&tid=21456&fromuid=1023

Index EUROPEAN PHARMACOPOEIA

7.4

BCG vaccine,freeze-dried.....................................................7.3-3833 Bearberry leaf..........................................................................7.1-3356 Beclometasone dipropionate,anhydrous (1449)

Beclometasone dipropionate monohydrate (1451)

Bee for homoeopathic preparations,honey (1292)

Beeswax,white (1453)

Beeswax,yellow (1454)

Belladonna leaf........................................................................7.3-3863 Belladonna leaf dry extract,standardised.. (1064)

Belladonna leaf tincture,standardised (1065)

Belladonna,prepared (1066)

Benazepril hydrochloride (1454)

Bendroflumethiazide (1456)

Benperidol................................................................................7.2-3611 Benserazide hydrochloride. (1459)

Bentonite (1460)

Benzalkonium chloride..........................................................7.1-3385 Benzalkonium chloride solution.........................................7.1-3386 Benzathine benzylpenicillin.. (1471)

Benzbromarone (1465)

Benzethonium chloride (1466)

Benzocaine (1466)

Benzoic acid (1467)

Benzoin,Siam (1067)

Benzoin,Sumatra (1068)

Benzoin tincture,Siam (1069)

Benzoin tincture,Sumatra (1069)

Benzoyl peroxide,hydrous (1468)

Benzyl alcohol (1469)

Benzyl benzoate (1470)

Benzylpenicillin,benzathine (1471)

Benzylpenicillin potassium (1473)

Benzylpenicillin,procaine (1474)

Benzylpenicillin sodium (1476)

Betacarotene (1477)

Betacyclodextrin (1478)

Betacyclodextrin,poly(hydroxypropyl)ether...................7.3-3953 Betadex.. (1478)

Betahistine dihydrochloride (1479)

Betahistine mesilate (1480)

Betamethasone (1481)

Betamethasone acetate (1483)

Betamethasone dipropionate...............................................7.4-4281 Betamethasone sodium phosphate.. (1486)

Betamethasone valerate (1488)

Betaxolol hydrochloride........................................................7.2-3612 Bezafibrate.. (1490)

Bicalutamide............................................................................7.4-4283 Bifonazole.................................................................................7.4-4284 Bilberry fruit,dried.. (1070)

Bilberry fruit dry extract,fresh,refined and standardised (1130)

Bilberry fruit,fresh (1070)

Biological assays(2.7.) (201)

Biological assays and tests,statistical analysis of results of (5.3.) (551)

Biological indicators of sterilisation(5.1.2.) (504)

Biological products,general texts on(5.2.) (527)

Biological products,terminology used in monographs on (5.2.1.) (527)

Biological tests(2.6.) (153)

Biotin (1492)

Biperiden hydrochloride (1493)

Biphasic insulin injection (2243)

Biphasic isophane insulin injection (2244)

Birch leaf (1071)

Bisacodyl (1495)

Bismuth subcarbonate (1496)

Bismuth subgallate (1497)

Bismuth subnitrate,heavy (1498)

Bismuth subsalicylate (1498)

Bisoprolol fumarate................................................................7.3-3897 Bistort rhizome (1072)

Bitter fennel....................................................................................1124Bitter-fennel fruit oil. (1073)

Bitter-fennel herb oil (1075)

Bitterness value(2.8.15.) (244)

Bitter-orange epicarp and mesocarp (1077)

Bitter-orange-epicarp and mesocarp tincture (1078)

Bitter-orange flower...............................................................7.3-3865 Bitter-orange-flower oil.. (1194)

Black horehound....................................................................7.2-3583 Bleomycin sulfate (1502)

Blood and blood components,empty sterile containers of plasticised poly(vinyl chloride)for(3.2.4.) (370)

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

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

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

Blood,anticoagulant and preservative solutions for (1401)

Blood,sterile containers of plasticised poly(vinyl chloride) containing anticoagulant solution(3.2.5.) (371)

Bogbean leaf (1080)

Boiling point(2.2.12.) (31)

Boldo leaf (1081)

Boldo leaf dry extract (1083)

Borage(starflower)oil,refined (1503)

Borax (1503)

Boric acid (1504)

Botulinum antitoxin (949)

Botulinum toxin type A for injection..................................7.3-3898 Botulinum toxin type B for injection..................................7.2-3615 Bovine infectious rhinotracheitis vaccine(live) (908)

Bovine insulin (2239)

Bovine leptospirosis vaccine(inactivated) (862)

Bovine parainfluenza virus vaccine(live) (864)

Bovine respiratory syncytial virus vaccine(live) (865)

Bovine serum (1506)

Bovine tuberculin purified protein derivative (3161)

Bovine viral diarrhoea vaccine(inactivated) (866)

Bromazepam (1507)

Bromhexine hydrochloride (1508)

Bromocriptine mesilate (1509)

Bromperidol.............................................................................7.2-3616 Bromperidol decanoate.........................................................7.2-3618 Brompheniramine maleate.. (1514)

Brotizolam (1515)

Brucellosis vaccine(live)(Brucella melitensis Rev.1strain)for veterinary use (867)

Buccal tablets and sublingual tablets.................................7.4-4259 Buckwheat herb.. (1084)

Budesonide (1516)

Bufexamac (1518)

Buffer solutions(4.1.3.).........................................................7.4-4220 Buflomedil hydrochloride (1519)

Bulk density and tapped density of powders(2.9.34.) (305)

Bumetanide (1520)

Bupivacaine hydrochloride (1521)

Buprenorphine (1523)

Buprenorphine hydrochloride (1524)

Buserelin...................................................................................7.2-3620 Buspirone hydrochloride.. (1527)

Busulfan (1529)

Butcher’s broom (1085)

Butylated methacrylate copolymer,basic (1448)

Butylhydroxyanisole (1531)

Butylhydroxytoluene (1531)

Butyl parahydroxybenzoate..................................................7.2-3621 C Cabergoline. (1535)

Cachets (709)

Cadmium sulfate hydrate for homoeopathic preparations (1287)

Caffeine (1536)

https://www.doczj.com/doc/0f13805056.html,/forum.php?mod=viewthread&tid=21456&fromuid=1023

EUROPEAN PHARMACOPOEIA 7.4

Index Caffeine monohydrate...................................................................1537Calcifediol.................................................................................7.3-3903Calcipotriol,anhydrous................................................................1539Calcipotriol monohydrate............................................................1542Calcitonin (salmon)........................................................................1544Calcitriol....................................................................................7.3-3904Calcium (2.4.3.).................................................................................113Calcium acetate,anhydrous..................................................7.3-3905Calcium ascorbate..........................................................................1548Calcium carbonate.........................................................................1549Calcium carboxymethylcellulose................................................1589Calcium chloride dihydrate..........................................................1550Calcium chloride hexahydrate....................................................1550Calcium dobesilate monohydrate...............................................1551Calcium edetate,sodium.. (2916)

Calcium folinate.............................................................................1552Calcium glucoheptonate...............................................................1554Calcium gluconate.........................................................................1555Calcium gluconate,anhydrous...................................................1555Calcium gluconate for injection..................................................1556Calcium glycerophosphate...........................................................1557Calcium hydrogen phosphate,anhydrous................................1558Calcium hydrogen phosphate dihydrate...................................1559Calcium hydroxide.........................................................................1560Calcium in adsorbed vaccines (2.5.14.)........................................141Calcium iodide tetrahydrate for homoeopathic prepara-tions................................................................................................1288Calcium lactate,anhydrous.........................................................1561Calcium lactate monohydrate.....................................................1561Calcium lactate pentahydrate.....................................................1562Calcium lactate trihydrate............................................................1562Calcium levofolinate pentahydrate............................................1563Calcium levulinate dihydrate.......................................................1565Calcium pantothenate...................................................................1566Calcium pentetate (sodium)for radiopharmaceutical preparations....................................................................................987Calcium phosphate........................................................................1567Calcium stearate.............................................................................1567Calcium sulfate dihydrate (1569)

Calendula flower............................................................................1086Calf coronavirus diarrhoea vaccine (inactivated)......................868Calf rotavirus diarrhoea

vaccine (inactivated) (869)

Calicivirosis vaccine (inactivated),feline.....................................895Calicivirosis vaccine (live),feline..................................................896Camphor,D -.....................................................................................1569Camphor,racemic..........................................................................1571Candesartan cilexetil..............................................................7.3-3906Canine adenovirus

vaccine

(inactivated) (870)

Canine adenovirus vaccine (live)..................................................871Canine distemper vaccine (live)....................................................872Canine leptospirosis vaccine

(inactivated) (874)

Canine parainfluenza virus vaccine (live)...................................875Canine parvovirosis vaccine (inactivated)...................................876Canine parvovirosis vaccine (live)................................................877Cape aloes........................................................................................1048Capillary electrophoresis (2.2.47.)(5.8.)............................7.1-3345Capillary electrophoresis (2.2.47.).......................................7.1-3313

Capillary viscometer method (2.2.9.).............................................27Caprylate,sodium..........................................................................2917Caprylic acid....................................................................................1571Caprylocaproyl macrogolglycerides...........................................1572Capsicum..........................................................................................1087Capsicum oleoresin,refined and quantified............................1089Capsicum tincture,standardised................................................1090Capsules.............................................................................................707Capsules and tablets,disintegration of (2.9.1.)(5.8.).....7.1-3346Capsules and tablets,disintegration of (2.9.1.)................7.1-3331Capsules,gastro-resistant...............................................................708Capsules,hard..................................................................................708Capsules,intrauterine.....................................................................715Capsules,modified-release.............................................................708Capsules,oromucosal............................................................7.4-4259Capsules,rectal.................................................................................733Capsules,soft....................................................................................708Capsules,vaginal..............................................................................739Captopril...................................................................................7.4-4289

Caraway fruit...................................................................................1090Caraway oil......................................................................................1091Carbachol.. (1575)

Carbamazepine...............................................................................1576Carbasalate calcium.......................................................................1577Carbidopa........................................................................................1579Carbimazole....................................................................................1580Carbocisteine..................................................................................1581Carbomers.......................................................................................1581Carbon dioxide...............................................................................1583Carbon dioxide in gases (2.5.24.).................................................143Carbon

monoxide (15

O) (965)

Carbon monoxide....................................................................7.2-3625Carbon monoxide in gases (2.5.25.).............................................144Carboplatin.. (1585)

Carboprost trometamol................................................................1586Carboxymethylcellulose................................................................1588Carboxymethylcellulose

calcium (1589)

Carboxymethylcellulose sodium.................................................1589Carboxymethylcellulose sodium,cross-linked.........................1770Carboxymethylcellulose

sodium,low-substituted (1590)

Carisoprodol....................................................................................1587Carmellose (1588)

Carmellose

calcium (1589)

Carmellose sodium........................................................................1589Carmellose sodium and microcrystalline cellulose.........7.4-4335Carmellose

sodium,low-substituted (1590)

Carmustine (1591)

Carnauba wax.................................................................................1592Carprofen

for veterinary use (1592)

Carrageenan....................................................................................1593Carteolol hydrochloride. (1594)

Carvedilol..................................................................................7.4-4291

Cascara......................................................................................7.1-3357

Cascara dry extract,standardised..............................................1094Cassia

oil (1095)

Castor oil,hydrogenated..............................................................1596Castor oil,polyoxyl........................................................................2398Castor

oil,

polyoxyl

hydrogenated (2397)

Castor oil,refined..........................................................................1597Castor oil,virgin.............................................................................1598Catgut,

sterile (1027)

Catgut,sterile,in distributor for veterinary use.....................1037CD34/CD45+cells in haematopoietic products,numeration of (2.7.23.).. (228)

Cefaclor............................................................................................1599Cefadroxil monohydrate...............................................................1600Cefalexin

monohydrate (1602)

Cefalotin sodium............................................................................1603Cefamandole nafate.......................................................................1605Cefapirin

sodium (1606)

Cefatrizine propylene glycol (1607)

Cefazolin sodium............................................................................1608Cefepime

dihydrochloride monohydrate...........................7.2-3626

Cefixime...........................................................................................1612Cefoperazone sodium...................................................................1613Cefotaxime

sodium (1615)

Cefoxitin sodium............................................................................1617Cefpodoxime proxetil....................................................................1618Cefprozil

monohydrate..........................................................7.2-3628

Cefradine..........................................................................................1620Ceftazidime pentahydrate............................................................1622Ceftazidime pentahydrate with sodium carbonate for

injection.........................................................................................1624Ceftriaxone sodium........................................................................1626Cefuroxime

axetil (1627)

Cefuroxime sodium (1629)

Celiprolol hydrochloride...............................................................1630Cell count and viability,nucleated (2.7.29.)...............................233https://www.doczj.com/doc/0f13805056.html,/forum.php?mod=viewthread&tid=21456&fromuid=1023

Index EUROPEAN PHARMACOPOEIA

7.4

Cell cultures for the production of veterinary vaccines

(5.2.4.) (533)

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

Cellular products,microbiological control of(2.6.27.) (191)

Cellulose acetate (1631)

Cellulose acetate butyrate (1632)

Cellulose acetate phthalate...................................................7.3-3908 Cellulose,microcrystalline.. (1634)

Cellulose(microcrystalline)and carmellose sodium.......7.4-4335 Cellulose,powdered. (1638)

Centaury (1095)

Centella (1096)

Cetirizine dihydrochloride....................................................7.3-3909 Cetostearyl alcohol (1643)

Cetostearyl alcohol(type A),emulsifying..........................7.1-3391 Cetostearyl alcohol(type B),emulsifying..........................7.1-3392 Cetostearyl isononanoate. (1646)

Cetostearyl sulfate,sodium..................................................7.1-3465 Cetrimide.. (1646)

Cetyl alcohol (1647)

Cetyl palmitate (1648)

Cetylpyridinium chloride (1648)

Ceylon cinnamon bark oil.....................................................7.1-3359 Ceylon cinnamon leaf oil.. (1102)

CFC assay for human haematopoietic progenitor cells

(2.7.28.) (232)

Chamomile flower,Roman (1098)

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

Characterisation of preparations for nebulisation

(2.9.44.)...................................................................................7.3-3803 Characters section in monographs(5.11.). (637)

Charcoal,activated (1649)

Chenodeoxycholic acid (1650)

Chewing gums,medicated (709)

Chewing gums,medicated,dissolution test for

(2.9.25.)...................................................................................7.4-4097 Chicken anaemia vaccine(live),infectious (910)

Chicken flocks free from specified pathogens for the production and quality control of vaccines(5.2.2.) (527)

Chitosan hydrochloride (1651)

Chlamydiosis vaccine(inactivated),feline (897)

Chloral hydrate (1652)

Chlorambucil............................................................................7.1-3393 Chloramine.. (3118)

Chloramphenicol (1653)

Chloramphenicol palmitate (1654)

Chloramphenicol sodium succinate (1655)

Chlorcyclizine hydrochloride (1656)

Chlordiazepoxide (1657)

Chlordiazepoxide hydrochloride (1658)

Chlorhexidine diacetate (1659)

Chlorhexidine digluconate solution (1660)

Chlorhexidine dihydrochloride (1662)

Chlorides(2.4.4.) (113)

Chlorobutanol,anhydrous (1663)

Chlorobutanol hemihydrate (1663)

Chlorocresol (1664)

Chloroquine phosphate (1665)

Chloroquine sulfate (1665)

Chlorothiazide (1666)

Chlorphenamine maleate (1667)

Chlorpromazine hydrochloride (1668)

Chlorpropamide (1669)

Chlorprothixene hydrochloride (1670)

Chlortalidone (1671)

Chlortetracycline hydrochloride (1673)

Cholecalciferol (1674)

Cholecalciferol concentrate(oily form) (1675)

Cholecalciferol concentrate(powder form) (1677)

Cholecalciferol concentrate(water-dispersible form) (1678)

Cholera vaccine................................................................................748Cholera vaccine,freeze-dried.. (749)

Cholera vaccine(inactivated,oral) (749)

Cholesterol (1680)

Cholesterol for parenteral use.............................................7.3-3910 Cholesterol in oils rich in omega-3acids,total(2.4.32.) (133)

Chondroitin sulfate sodium (1681)

Chromatographic separation techniques(2.2.46.) (70)

Chromatography,gas(2.2.28.) (43)

Chromatography,liquid(2.2.29.) (45)

Chromatography,paper(2.2.26.) (41)

Chromatography,size-exclusion(2.2.30.) (46)

Chromatography,supercritical fluid(2.2.45.) (70)

Chromatography,thin-layer(2.2.27.) (42)

Chromium(51Cr)edetate injection (966)

Chymotrypsin (1683)

Ciclopirox (1684)

Ciclopirox olamine (1686)

Ciclosporin (1687)

Cilastatin sodium (1688)

Cilazapril (1690)

Cimetidine (1691)

Cimetidine hydrochloride (1693)

Cinchocaine hydrochloride (1694)

Cinchona bark (1098)

Cinchona liquid extract,standardised (1100)

Cineole (1695)

Cineole in essential oils,1,8-,assay of(2.8.11.) (240)

Cinnamon.................................................................................7.1-3359 Cinnamon bark oil,Ceylon...................................................7.1-3359 Cinnamon leaf oil,Ceylon (1102)

Cinnamon tincture (1103)

Cinnarizine...............................................................................7.2-3630 Ciprofibrate. (1697)

Ciprofloxacin (1698)

Ciprofloxacin hydrochloride.................................................7.4-4292 Circular dichroism(2.2.41.). (65)

Cisplatin (1701)

Citalopram hydrobromide.....................................................7.1-3396 Citalopram hydrochloride (1704)

Citric acid,anhydrous (1705)

Citric acid monohydrate (1706)

Citronella oil (1103)

Cladribine (1707)

Clarithromycin (1708)

Clarity and degree of opalescence of liquids(2.2.1.) (21)

Clary sage oil (1104)

Classical swine-fever vaccine(live,prepared in cell cultures)..940 Clazuril for veterinary use (1710)

Clebopride malate (1712)

Clemastine fumarate (1713)

Clenbuterol hydrochloride (1715)

Clindamycin hydrochloride (1716)

Clindamycin phosphate (1717)

Clioquinol (1718)

Clobazam (1719)

Clobetasol propionate (1720)

Clobetasone butyrate (1722)

Clodronate disodium tetrahydrate (1723)

Clofazimine (1724)

Clofibrate (1725)

Clomifene citrate (1726)

Clomipramine hydrochloride (1727)

Clonazepam (1729)

Clonidine hydrochloride (1730)

Clopamide (1731)

Clopidogrel hydrogen sulfate...............................................7.1-3397 Clorazepate,dipotassium. (1869)

Closantel sodium dihydrate for veterinary use (1732)

Clostridium botulinum vaccine for veterinary use (878)

Clostridium chauvoei vaccine for veterinary use (879)

Clostridium novyi alpha antitoxin for veterinary use (957)

Clostridium novyi(type B)vaccine for veterinary use (879)

Clostridium perfringens beta antitoxin for veterinary use (958)

https://www.doczj.com/doc/0f13805056.html,/forum.php?mod=viewthread&tid=21456&fromuid=1023

Clostridium perfringens epsilon antitoxin for veterinary use (959)

Clostridium perfringens vaccine for veterinary use (881)

Clostridium septicum vaccine for veterinary use (883)

Closures and containers for parenteral preparations and ophthalmic preparations,polypropylene for(3.1.6.) (342)

Closures and containers for pharmaceutical use,plastic

(3.2.2.) (368)

Closures and tubing,silicone elastomer for(3.1.9.) (347)

Closures for containers for aqueous parenteral preparations,for powders and for freeze-dried powders,rubber(3.2.9.) (374)

Clotrimazole (1734)

Clove (1105)

Clove oil (1106)

Cloxacillin sodium (1735)

Clozapine (1737)

Coagulation factor II,assay of(2.7.18.) (224)

Coagulation factor IX,human (2172)

Coagulation factor IX,human,assay of(2.7.11.) (219)

Coagulation factors,activated(2.6.22.) (185)

Coagulation factors,assay of heparin(2.7.12.) (220)

Coagulation factor VII,human (2169)

Coagulation factor VII,human,assay of(2.7.10.) (219)

Coagulation factor VIII,human (2170)

Coagulation factor VIII,human,assay of(2.7.4.) (207)

Coagulation factor VIII(rDNA),human (2171)

Coagulation factor X,assay of(2.7.19.) (225)

Coagulation factor XI,human (2173)

Coagulation factor XI,human,assay of(2.7.22.) (227)

Coated granules (714)

Coated tablets (737)

Cocaine hydrochloride (1738)

Coccidiosis vaccine(live)for chickens (884)

Coconut oil,refined (1739)

Cocoyl caprylocaprate (1740)

Codeine (1740)

Codeine hydrochloride dihydrate (1742)

Codeine phosphate hemihydrate (1743)

Codeine phosphate sesquihydrate (1745)

Codergocrine mesilate (1747)

Cod-liver oil,farmed (1748)

Cod-liver oil(type A) (1752)

Cod-liver oil(type B) (1756)

Cola (1107)

Colchicine.................................................................................7.2-3631 Cold-water vibriosis vaccine(inactivated)for salmonids (943)

Colestyramine (1761)

Colibacillosis vaccine(inactivated),neonatal piglet (918)

Colibacillosis vaccine(inactivated),neonatal ruminant (920)

Colistimethate sodium (1762)

Colistin sulfate (1763)

Colloidal anhydrous silica (2901)

Colloidal hydrated silica (2902)

Colloidal silica,hydrophobic (2903)

Colloidal silver,for external use (2904)

Colony-forming cell assay for human haematopoietic progenitor cells(2.7.28.) (232)

Colophony (1107)

Coloration of liquids(2.2.2.) (22)

Common stinging nettle for homoeopathic preparations (1288)

Comparative table of porosity of sintered-glass filters(2.1.2.)..15 Complexometric titrations(2.5.11.) (140)

Composition of fatty acids by gas chromatography(2.4.22.)..119 Composition of fatty acids in oils rich in omega-3acids

(2.4.29.) (130)

Compressed lozenges.............................................................7.4-4259 Concentrated solutions for haemodialysis. (2136)

Concentrates for injections or infusions (725)

Concentrates for intrauterine solutions (715)

Conductivity(2.2.38.) (59)

Coneflower herb,purple (1218)

Coneflower root,narrow-leaved (1193)

Coneflower root,pale....................................................................1208Coneflower root,purple (1219)

Conjugated estrogens (1958)

Consistency by penetrometry,measurement of(2.9.9.) (267)

Containers(3.2.) (363)

Containers and closures for parenteral preparations and ophthalmic preparations,polypropylene for(3.1.6.) (342)

Containers and closures for pharmaceutical use,plastic

(3.2.2.) (368)

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

Containers for aqueous solutions for infusion,plastic

(3.2.2.1.) (368)

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

(3.1.14.) (355)

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

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

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

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

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

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

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

Containers for pharmaceutical use,glass(3.2.1.) (363)

Containers for preparations not for parenteral use,polyethylene terephthalate for(3.1.15) (357)

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

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

Contamination,microbial:microbial enumeration tests

(2.6.12.) (163)

Contamination,microbial:microbial enumeration tests(2.6.12.)

(5.8.).........................................................................................7.1-3346 Contamination,microbial:test for specified micro-organisms (2.6.13.).. (167)

Contamination,microbial:test for specified micro-organisms (2.6.13.)(5.8.)........................................................................7.1-3346 Content uniformity of single-dose preparations(2.9.6.). (266)

Control of impurities in substances for pharmaceutical use (5.10.).......................................................................................7.4-4247 Control of microbiological quality,alternative methods for (5.1.6.).. (508)

Copolymer,basic butylated methacrylate (1448)

Copolymer,grafted,macrogol poly(vinyl alcohol) (2401)

Copolymer,methacrylic acid-ethyl acrylate(1:1) (2459)

Copolymer,methacrylic acid-ethyl acrylate(1:1)dispersion 30per cent.............................................................................7.2-3679 Copolymer,methacrylic acid-methyl methacrylate

(1:1)..........................................................................................7.2-3680 Copolymer,methacrylic acid-methyl methacrylate

(1:2)..........................................................................................7.2-3681 Copolymer(type A),ammonio methacrylate (1381)

Copolymer(type B),ammonio methacrylate (1382)

Copovidone...............................................................................7.2-3633 Copper acetate monohydrate for homoeopathic prepara-tions (1289)

Copper for homoeopathic preparations (1289)

Copper sulfate,anhydrous (1766)

Copper sulfate pentahydrate (1766)

Coriander (1108)

Coriander oil (1108)

Cortisone acetate (1767)

Cotton,absorbent (1768)

Cottonseed oil,hydrogenated (1769)

Couch grass rhizome.............................................................7.1-3360

Creams................................................................................................735Cresol,crude...................................................................................1770Cromoglicate,sodium............................................................7.4-4368

Croscarmellose sodium.................................................................1770Crospovidone...........................................................................7.4-4294Crotamiton......................................................................................1773Crystalline and partially crystalline solids,characterisation by X-ray powder diffraction (XRPD)of (2.9.33.).....................301Crystallinity (5.16.).................................................................7.4-4253Cutaneous application,liquid preparations for.........................717Cutaneous application,powders for............................................726Cutaneous application,semi-solid preparations for.. (734)

Cutaneous application,veterinary liquid preparations for.............................................................................................7.4-4259Cutaneous foams..............................................................................717Cutaneous patches..........................................................................734Cyanocobalamin.............................................................................1774Cyanocobalamin (57Co)

capsules..................................................967Cyanocobalamin (57Co)solution...................................................968Cyanocobalamin (58Co)capsules..................................................968Cyanocobalamin (58Co)solution...................................................969Cyclamate,sodium.........................................................................2924Cyclizine hydrochloride................................................................1775Cyclopentolate hydrochloride.....................................................1776Cyclophosphamide.........................................................................1777Cyproheptadine hydrochloride...................................................1778Cyproterone acetate...............................................................7.4-4295Cysteine hydrochloride monohydrate.......................................1781Cystine..............................................................................................1782Cytarabine.......................................................................................1783D Dacarbazine.....................................................................................1787Dalteparin sodium.........................................................................1788Danaparoid sodium.. (1789)

Dandelion herb with root.............................................................1110Dandelion root................................................................................1111Dapsone...........................................................................................1792Daunorubicin hydrochloride.......................................................1792D -Camphor.......................................................................................1569Decyl oleate.....................................................................................1794Deferoxamine mesilate..................................................................1794Degree of coloration of liquids (2.2.2.)..........................................22Dembrexine hydrochloride monohydrate for veteri-

nary use.........................................................................................1795Demeclocycline hydrochloride....................................................1796Density of powders,bulk density and tapped (2.9.34.)...........305Density of solids (2.2.42.).................................................................66Density of solids,gas pycnometric (2.9.23.)...............................288Density,relative (2.2.5.)....................................................................25Dental type silica............................................................................2903Depressor substances (2.6.11.)......................................................162Deptropine citrate..........................................................................1797Dequalinium chloride....................................................................1798Desacyl-4′-monophosphoryl lipid A,3-O -...........................7.2-3639Desflurane.......................................................................................1800Desipramine hydrochloride.........................................................1801Deslanoside.....................................................................................1802Desmopressin..................................................................................1803Desogestrel......................................................................................1804Desoxycortone acetate..................................................................1805Detector tubes,gas

(2.1.6.) (17)

Determination of aflatoxin B 1in herbal drugs (2.8.18.)..........244Determination of essential oils in herbal drugs (2.8.12.)........241Determination of nitrogen

by sulfuric acid digestion (2.5.9.)..139

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

Determination of tannins in herbal drugs (2.8.14.)..................243Determination of water by distillation (2.2.13.)...........................31Detomidine hydrochloride for veterinary use.........................1806Devil’s claw dry extract.................................................................1112Devil’s claw root.............................................................................1113Dexamethasone..............................................................................1807Dexamethasone acetate................................................................1809Dexamethasone isonicotinate.....................................................1811Dexamethasone

sodium

phosphate...........................................1812Dexchlorpheniramine maleate....................................................1814Dexpanthenol..................................................................................1815Dextran

1

for

injection (1816)

Dextran 40for injection...............................................................1817Dextran 60for injection...............................................................1818Dextran

70for injection (1819)

Dextranomer...................................................................................1819Dextrans,molecular mass distribution in (2.2.39.)....................60Dextrin. (1820)

Dextromethorphan hydrobromide (1821)

Dextromoramide tartrate.............................................................1822Dextropropoxyphene

hydrochloride (1823)

Diazepam.........................................................................................1824Diazoxide.........................................................................................1825Dibrompropamidine

diisetionate (1826)

Dibutyl phthalate...........................................................................1827Dichloromethane............................................................................2474Diclazuril

for veterinary use (1828)

Diclofenac potassium....................................................................1829Diclofenac sodium.........................................................................1830Dicloxacillin

sodium (1831)

Dicycloverine hydrochloride (1833)

Didanosine.......................................................................................1833Dienestrol........................................................................................1835Diethylcarbamazine citrate..........................................................1836Diethylene glycol and ethylene glycol in ethoxylated substances (2.4.30.)............................................................................................132Diethylene glycol monoethyl ether............................................1837Diethylene glycol palmitostearate..............................................1839Diethyl

phthalate...........................................................................1835Diethylstilbestrol............................................................................1839Diffraction,laser light,particle size analysis by (2.9.31.).......295Difloxacin

hydrochloride trihydrate for veterinary use..7.4-4301

Diflunisal..........................................................................................1840Digitalis leaf.............................................................................7.2-3584Digitoxin...........................................................................................1841Digoxin.............................................................................................1842Dihydralazine sulfate,hydrated..................................................1844Dihydrocodeine

hydrogen

tartrate (1845)

Dihydroergocristine mesilate......................................................1846Dihydroergotamine mesilate.......................................................1849Dihydroergotamine

tartrate (1850)

Dihydrostreptomycin sulfate for veterinary use......................1851Dihydrotachysterol........................................................................1853Diltiazem

hydrochloride........................................................7.4-4302Dimenhydrinate..............................................................................1856Dimercaprol.....................................................................................1858Dimethylacetamide........................................................................1859Dimethylaniline,

N,N -(2.4.26.)......................................................128Dimethyl sulfoxide.........................................................................1858Dimeticone...............................................................................7.2-3640Dimetindene maleate....................................................................1860Dinoprostone..................................................................................1863Dinoprost

trometamol...................................................................1862Diosmin............................................................................................1864Dioxan and ethylene oxide (2.4.25.)............................................127Dip

concentrates.....................................................................7.4-4260

Diphenhydramine hydrochloride................................................1866Diphenoxylate hydrochloride...............................................7.4-4304

Diphtheria and tetanus toxins and toxoids,flocculation value (Lf)of,(Ramon assay)(2.7.27.)...................................................231Diphtheria and tetanus vaccine (adsorbed). (751)

Diphtheria and tetanus vaccine

(adsorbed,reduced antigen(s)

content)............................................................................................752Diphtheria antitoxin (949)

Diphtheria,tetanus and hepatitis B (rDNA)

vaccine

(adsorbed)........................................................................................753Diphtheria,tetanus and pertussis (acellular,component)

vaccine (adsorbed) (754)

Diphtheria,tetanus and pertussis(whole cell)vaccine(adsorbed) ..................................................................................................7.2-3569 Diphtheria,tetanus and poliomyelitis(inactivated)vaccine (adsorbed,reduced antigen(s)content) (756)

Diphtheria,tetanus,pertussis(acellular,component)and haemophilus type b conjugate vaccine(adsorbed) (758)

Diphtheria,tetanus,pertussis(acellular,component)and hepatitis B(rDNA)vaccine(adsorbed) (760)

Diphtheria,tetanus,pertussis(acellular,component)and poliomyelitis(inactivated)vaccine(adsorbed) (762)

Diphtheria,tetanus,pertussis(acellular,component)and poliomyelitis(inactivated)vaccine(adsorbed,reduced antigen(s)content) (763)

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

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

Diphtheria,tetanus,pertussis(whole cell)and poliomyelitis (inactivated)vaccine(adsorbed)........................................7.2-3570 Diphtheria,tetanus,pertussis(whole cell),poliomyelitis (inactivated)and haemophilus type b conjugate vaccine (adsorbed)...............................................................................7.2-3572 Diphtheria vaccine(adsorbed) (774)

Diphtheria vaccine(adsorbed),assay of(2.7.6.) (209)

Diphtheria vaccine(adsorbed,reduced antigen content) (776)

Dipivefrine hydrochloride (1867)

Dipotassium clorazepate (1869)

Dipotassium phosphate (1870)

Diprophylline...........................................................................7.3-3915 Dipyridamole.. (1871)

Dirithromycin (1872)

Disintegration of suppositories and pessaries(2.9.2.) (255)

Disintegration of tablets and capsules(2.9.1.)(5.8.)......7.1-3346 Disintegration of tablets and capsules(2.9.1.).................7.1-3331 Disodium clodronate tetrahydrate (1723)

Disodium edetate (1874)

Disodium etidronate (1979)

Disodium pamidronate pentahydrate (2660)

Disodium phosphate,anhydrous.........................................7.2-3641 Disodium phosphate dihydrate............................................7.2-3641 Disodium phosphate dodecahydrate..................................7.2-3642 Disopyramide. (1876)

Disopyramide phosphate (1877)

Dispersible tablets (737)

Dissolution,apparent(2.9.43.) (320)

Dissolution,intrinsic(2.9.29.) (294)

Dissolution test for lipophilic solid dosage forms(2.9.42.) (319)

Dissolution test for solid dosage forms(2.9.3.)................7.3-3797 Dissolution test for transdermal patches(2.9.4.). (263)

Dissolution testing,recommendations on(5.17.1.) (665)

Distemper vaccine(live),canine (872)

Distemper vaccine(live)for mustelids (887)

Distillation range(2.2.11.) (30)

Distribution estimation by analytical sieving,particle-size (2.9.38.) (313)

Distribution estimation by analytical sieving,particle-size (2.9.38.)(5.8.)........................................................................7.1-3347 Disulfiram. (1878)

Dithranol (1879)

DL-Methionine (2466)

DL-α-Tocopheryl hydrogen succinate (3110)

Dobesilate monohydrate,calcium (1551)

Dobutamine hydrochloride (1880)

Docetaxel trihydrate (1881)

Docusate sodium (1883)

Dodecyl gallate (1884)

Dog rose (1115)

Domperidone...........................................................................7.2-3643 Domperidone maleate. (1886)

Dopamine hydrochloride (1887)

Dopexamine dihydrochloride......................................................1889Dorzolamide hydrochloride (1890)

Dosage forms(glossary) (707)

Dosage units,uniformity of(2.9.40.)..................................7.4-4101 Dosulepin hydrochloride.. (1892)

Doxapram hydrochloride (1893)

Doxazosin mesilate (1894)

Doxepin hydrochloride (1895)

Doxorubicin hydrochloride (1897)

Doxycycline hyclate................................................................7.4-4305 Doxycycline monohydrate (1899)

Doxylamine hydrogen succinate (1901)

Droperidol.................................................................................7.2-3644 Droppers(2.1.1.) (15)

Drop point(2.2.17.) (32)

Drops(nasal)and sprays(liquid nasal) (720)

Drops,oral (719)

Drospirenone (1903)

Dry extracts (676)

Dry residue of extracts(2.8.16.) (244)

Duck plague vaccine(live) (888)

Duck viral hepatitis type I vaccine(live) (889)

Dwarf pine oil (1116)

Dydrogesterone (1905)

E

Ear drops and ear sprays.......................................................7.1-3351 Ear powders.............................................................................7.1-3352 Ear preparations......................................................................7.1-3351 Ear preparations,semi-solid.................................................7.1-3351 Ear sprays and ear drops.......................................................7.1-3351 Ear tampons.............................................................................7.1-3352 Ear washes................................................................................7.1-3352 Ebastine. (1909)

Econazole (1910)

Econazole nitrate (1911)

Edetate(chromium(51Cr))injection (966)

Edetate,disodium (1874)

Edetate,sodium calcium (2916)

Edetic acid (1912)

Edrophonium chloride (1913)

Effervescent granules (714)

Effervescent powders (727)

Effervescent tablets (737)

Efficacy of antimicrobial preservation(5.1.3.) (505)

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

Egg drop syndrome′76vaccine(inactivated) (891)

Elder flower (1117)

Electrophoresis(2.2.31.) (46)

Electrophoresis(2.2.31.)(5.8.).............................................7.1-3345 Electrophoresis,capillary(2.2.47.)(5.8.)...........................7.1-3345 Electrophoresis,capillary(2.2.47.)......................................7.1-3313 Eleutherococcus.. (1118)

Emedastine difumarate (1913)

Emetine hydrochloride heptahydrate (1914)

Emetine hydrochloride pentahydrate (1915)

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

Emulsifying cetostearyl alcohol(type A)...........................7.1-3391 Emulsifying cetostearyl alcohol(type B)...........................7.1-3392 Emulsions,solutions and suspensions,oral (718)

Enalaprilat dihydrate (1918)

Enalapril maleate (1916)

Encephalitis vaccine(inactivated),tick-borne (834)

Endotoxins,bacterial(2.6.14.) (171)

Endotoxins,bacterial,guidelines for using the test for

(5.1.10.) (520)

Enilconazole for veterinary use (1919)

Enoxaparin sodium (1920)

Enoxolone (1921)

Enrofloxacin for veterinary use (1922)

Entacapone...............................................................................7.3-3919

Enzootic pneumonia vaccine(inactivated),porcine (927)

Ephedra herb (1120)

Ephedrine,anhydrous (1925)

Ephedrine hemihydrate (1926)

Ephedrine hydrochloride (1927)

Ephedrine hydrochloride,racemic (1928)

Epinastine hydrochloride (1928)

Epinephrine (1329)

Epinephrine tartrate (1330)

Epirubicin hydrochloride (1929)

Equine herpesvirus vaccine(inactivated) (892)

Equine influenza vaccine(inactivated) (893)

Equisetum stem.......................................................................7.4-4267 Ergocalciferol. (1931)

Ergometrine maleate (1933)

Ergotamine tartrate (1934)

Erysipelas vaccine(inactivated),swine (939)

Erythritol (1935)

Erythromycin...........................................................................7.3-3920 Erythromycin estolate. (1938)

Erythromycin ethylsuccinate................................................7.3-3923 Erythromycin lactobionate. (1942)

Erythromycin stearate...........................................................7.3-3925 Erythropoietin concentrated solution (1946)

Eserine salicylate (2726)

Eserine sulfate (2727)

Esketamine hydrochloride (1950)

Esomeprazole magnesium trihydrate (1951)

Essential oils (673)

Essential oils,assay of1,8-cineole in(2.8.11.) (240)

Essential oils,fatty oils and resinified essential oils in

(2.8.7.) (239)

Essential oils,foreign esters in(2.8.6.) (239)

Essential oils in herbal drugs,determination of(2.8.12.) (241)

Essential oils,odour and taste(2.8.8.) (240)

Essential oils,residue on evaporation(2.8.9.) (240)

Essential oils,solubility in alcohol(2.8.10.) (240)

Essential oils,water in(2.8.5.) (239)

Ester value(2.5.2.) (137)

Estradiol benzoate (1953)

Estradiol hemihydrate (1954)

Estradiol valerate (1955)

Estriol........................................................................................7.2-3649 Estrogens,conjugated (1958)

Etacrynic acid (1960)

Etamsylate................................................................................7.1-3407 Ethacridine lactate monohydrate.. (1962)

Ethambutol hydrochloride (1963)

Ethanol(96per cent) (1964)

Ethanol,anhydrous (1966)

Ethanol content and alcoholimetric tables(2.9.10.) (268)

Ether (1968)

Ether,anaesthetic (1968)

Ethinylestradiol.......................................................................7.4-4311 Ethionamide (1970)

Ethosuximide (1971)

Ethoxylated substances,ethylene glycol and diethylene glycol in(2.4.30.) (132)

Ethyl acetate (1972)

Ethyl acrylate-methacrylic acid copolymer(1:1) (2459)

Ethyl acrylate-methacrylic acid copolymer(1:1)dispersion

30per cent.............................................................................7.2-3679 Ethylcellulose (1975)

Ethylenediamine (1977)

Ethylene glycol and diethylene glycol in ethoxylated substances (2.4.30.) (132)

Ethylene glycol monopalmitostearate (1976)

Ethylene glycol monostearate (1976)

Ethylene oxide and dioxan(2.4.25.) (127)

Ethylhexanoic acid,2-(2.4.28.) (130)

Ethylmorphine hydrochloride (1978)

Ethyl oleate (1973)

Ethyl parahydroxybenzoate.........................................................1973Ethyl parahydroxybenzoate sodium...................................7.3-4005 Etidronate disodium. (1979)

Etilefrine hydrochloride (1979)

Etodolac (1981)

Etofenamate (1982)

Etofylline (1984)

Etomidate (1985)

Etoposide..................................................................................7.1-3408 Eucalyptus leaf. (1122)

Eucalyptus oil (1123)

Eugenol (1990)

European goldenrod (1142)

European viper venom antiserum (953)

Evaluation of efficacy of veterinary vaccines and immunosera (5.2.7.) (538)

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

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

Evening primrose oil,refined (1991)

Extractable volume of parenteral preparations,test for

(2.9.17.) (273)

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

(5.8.).........................................................................................7.1-3346 Extracts. (674)

Extracts,dry (676)

Extracts,dry residue of(2.8.16.) (244)

Extracts,liquid (675)

Extracts,loss on drying of(2.8.17.) (244)

Extracts,soft (676)

Extracts,water for preparation of.......................................7.4-4391 Extraneous agents in viral vaccines for human use,tests for (2.6.16.).. (176)

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

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

Eye drops (711)

Eye lotions (711)

Eye preparations (710)

Eye preparations,semi-solid (712)

F

F

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

Factor II,human coagulation,assay of(2.7.18.) (224)

Factor IX,human coagulation (2172)

Factor IX,human coagulation,assay of(2.7.11.) (219)

Factor VII,human coagulation (2169)

Factor VII,human coagulation,assay of(2.7.10.) (219)

Factor VIII,human coagulation (2170)

Factor VIII,human coagulation,assay of(2.7.4.) (207)

Factor VIII(rDNA),human coagulation (2171)

Factor X,human coagulation,assay of(2.7.19.) (225)

Factor XI,human coagulation (2173)

Factor XI,human coagulation,assay of(2.7.22.) (227)

Falling ball viscometer method(2.2.49.) (83)

Famotidine (1995)

Fat,hard (2146)

Fatty acids,composition by gas chromatography(2.4.22.) (119)

Fatty acids in oils rich in omega-3acids,composition of

(2.4.29.) (130)

Fatty oils,alkaline impurities in(2.4.19.) (119)

Fatty oils and herbal drugs,heavy metals in(2.4.27.) (129)

Fatty oils and resinified essential oils in essential oils

(2.8.7.) (239)

Fatty oils,foreign oils in,by thin-layer chromatography

(2.4.21.) (119)

Fatty oils,identification by thin-layer chromatography

(2.3.2.) (110)

Fatty oils,sterols in(2.4.23.)................................................7.2-3535 Fatty oils,vegetable. (703)

Fc function of immunoglobulin,test for(2.7.9.) (217)

Febantel for veterinary use (1996)

Felbinac (1997)

Feline calicivirosis vaccine(inactivated) (895)

Feline calicivirosis vaccine(live) (896)

Feline chlamydiosis vaccine(inactivated) (897)

Feline infectious enteritis(feline panleucopenia)vaccine (inactivated) (898)

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

Feline leukaemia vaccine(inactivated) (900)

Feline panleucopenia vaccine(inactivated) (898)

Feline panleucopenia vaccine(live) (899)

Feline viral rhinotracheitis vaccine(inactivated) (901)

Feline viral rhinotracheitis vaccine(live) (902)

Felodipine (1998)

Felypressin (1999)

Fenbendazole for veterinary use (2000)

Fenbufen (2001)

Fennel,bitter (1124)

Fennel,sweet............................................................................7.1-3361 Fenofibrate.. (2002)

Fenoterol hydrobromide........................................................7.1-3415 Fentanyl. (2005)

Fentanyl citrate (2006)

Fenticonazole nitrate (2007)

Fenugreek (1126)

Fermentation,products of (685)

Ferric chloride hexahydrate (2008)

Ferrous fumarate (2009)

Ferrous gluconate (2010)

Ferrous sulfate,dried.............................................................7.2-3653 Ferrous sulfate heptahydrate...............................................7.2-3653 Feverfew. (1126)

Fexofenadine hydrochloride (2013)

Fibrinogen,human (2174)

Fibrin sealant kit (2014)

Filgrastim concentrated solution (2015)

Films,orodispersible..............................................................7.4-4259 Finasteride (2018)

Fineness,powder(2.9.35.) (308)

Fish oil,rich in omega-3acids (2019)

Flavoxate hydrochloride (2021)

Flecainide acetate...................................................................7.1-3416 Flocculation value(Lf)of diphtheria and tetanus toxins and toxoids(Ramon assay)(2.7.27.).. (231)

Flowability(2.9.16.) (272)

Flow cytometry(2.7.24.) (229)

Flubendazole (2024)

Flucloxacillin magnesium octahydrate (2025)

Flucloxacillin sodium (2026)

Fluconazole (2028)

Flucytosine (2029)

Fludarabine phosphate (2031)

Fludeoxyglucose(18F)injection (969)

Fludrocortisone acetate (2033)

Flumazenil (2035)

Flumazenil(N-[11C]methyl)injection (972)

Flumequine (2036)

Flumetasone pivalate (2037)

Flunarizine dihydrochloride (2038)

Flunitrazepam (2039)

Flunixin meglumine for veterinary use (2040)

Fluocinolone acetonide (2041)

Fluocortolone pivalate (2042)

Fluorescein (2044)

Fluorescein sodium (2045)

Fluoride(18F)solution for radiolabelling (973)

Fluorides(2.4.5.) (114)

Fluorimetry(2.2.21.) (35)

Fluorodopa(18F)(prepared by electrophilic substitution) injection (974)

Fluorouracil.....................................................................................2046Fluoxetine hydrochloride. (2048)

Flupentixol dihydrochloride (2049)

Fluphenazine decanoate (2051)

Fluphenazine dihydrochloride.............................................7.2-3654 Fluphenazine enantate.. (2054)

Flurazepam monohydrochloride (2055)

Flurbiprofen (2056)

Fluspirilene (2057)

Flutamide (2058)

Fluticasone propionate..........................................................7.3-3931 Flutrimazole (2061)

Fluvastatin sodium (2062)

Fluvoxamine maleate.............................................................7.2-3656 Foams,cutaneous. (717)

Foams,intrauterine (715)

Foams,medicated (712)

Foams,rectal (733)

Foams,vaginal (740)

Folic acid (2065)

Folinate,calcium (1552)

Foot-and-mouth disease(ruminants)vaccine(inactivated) (904)

Foreign esters in essential oils(2.8.6.) (239)

Foreign matter(2.8.2.) (239)

Foreign oils in fatty oils by thin-layer chromatography

(2.4.21.) (119)

Formaldehyde,free(2.4.18.) (118)

Formaldehyde solution(35per cent) (2066)

Formoterol fumarate dihydrate (2067)

Foscarnet sodium hexahydrate (2069)

Fosfomycin calcium................................................................7.3-3933 Fosfomycin sodium.................................................................7.3-3934 Fosfomycin trometamol. (2072)

Fosinopril sodium (2073)

Fourstamen stephania root (1127)

Fowl cholera vaccine(inactivated) (905)

Fowl-pox vaccine(live) (906)

Framycetin sulfate (2076)

Frangula bark..........................................................................7.1-3362 Frangula bark dry extract,standardised. (1129)

Frankincense,Indian (1152)

Free formaldehyde(2.4.18.) (118)

Freezing point(2.2.18.) (34)

Fresh bilberry fruit dry extract,refined and standardised (1130)

Friability of granules and spheroids(2.9.41.)...................7.4-4103 Friability of uncoated tablets(2.9.7.). (266)

Friability of uncoated tablets(2.9.7.)(5.8.).......................7.1-3346 Fructose. (2077)

Fucus (1161)

Fulvestrant...............................................................................7.3-3935 Fumitory (1132)

Functional groups and ions,identification reactions of

(2.3.1.) (107)

Furosemide (2078)

Furunculosis vaccine(inactivated,oil-adjuvanted,injectable)for salmonids (907)

Fusidate,sodium.....................................................................7.3-4006 Fusidic acid..............................................................................7.3-3936

G Gabapentin...............................................................................7.2-3661 Galactose (2083)

Galantamine hydrobromide (2083)

Gallium(67Ga)citrate injection (975)

Ganciclovir (2086)

Gargles.......................................................................................7.4-4257 Garlic for homoeopathic preparations.. (1290)

Garlic powder (1133)

Gas adsorption,specific surface area by(2.9.26.) (291)

Gas adsorption,specific surface area by(2.9.26.)(5.8.)..7.1-3347 Gas chromatography(2.2.28.) (43)

Gas detector tubes(2.1.6.) (17)

Gases,carbon dioxide in(2.5.24.) (143)

Gases,carbon monoxide in(2.5.25.) (144)

Gases,nitrogen monoxide and nitrogen dioxide in(2.5.26.)..145 Gases,nitrous oxide in(2.5.35.) (150)

Gases,oxygen in(2.5.27.) (145)

Gases,water in(2.5.28.) (145)

Gas-gangrene antitoxin,mixed (950)

Gas-gangrene antitoxin(novyi) (950)

Gas-gangrene antitoxin(perfringens) (951)

Gas-gangrene antitoxin(septicum) (952)

Gas pycnometric density of solids(2.9.23.) (288)

Gastro-resistant capsules (708)

Gastro-resistant granules (714)

Gastro-resistant tablets (738)

Gelatin (2087)

Gels (735)

Gels for injections (725)

Gemcitabine hydrochloride (2088)

Gemfibrozil (2090)

General notices(1.).................................................................7.4-4083 General texts on biological products(5.2.).. (527)

General texts on microbiology(5.1.) (503)

Gene transfer medicinal products for human use(5.14.) (647)

Gentamicin sulfate..................................................................7.4-4315 Gentian root (1133)

Gentian tincture (1134)

Gestodene (2092)

Ginger (1135)

Gingival solutions...................................................................7.4-4257 Ginkgo dry extract,refined and quantified (1136)

Ginkgo leaf (1138)

Ginseng (1140)

Glass containers for pharmaceutical use(3.2.1.) (363)

Glibenclamide (2094)

Gliclazide (2096)

Glimepiride (2097)

Glipizide (2098)

Glossary(dosage forms) (707)

Glucagon,human (2100)

Glucoheptonate,calcium (1554)

Glucosamine hydrochloride..................................................7.3-3945 Glucosamine sulfate sodium chloride................................7.3-3946 Glucose,anhydrous.. (2102)

Glucose,liquid (2103)

Glucose,liquid,spray-dried (2103)

Glucose monohydrate (2104)

Glutamic acid (2105)

Glutathione (2106)

Glycan analysis of glycoproteins(2.2.59.) (97)

Glycerol (2108)

Glycerol(85per cent) (2109)

Glycerol dibehenate................................................................7.4-4317 Glycerol distearate. (2111)

Glycerol formal........................................................................7.3-3947 Glycerol monocaprylate. (2112)

Glycerol monocaprylocaprate (2113)

Glycerol monolinoleate (2114)

Glycerol mono-oleate (2115)

Glycerol monostearate40-55 (2116)

Glycerol triacetate (3127)

Glyceryl trinitrate solution (2117)

Glycine (2118)

Glycoproteins,glycan analysis of(2.2.59.) (97)

Glycopyrronium bromide......................................................7.1-3423 Glycyrrhizate ammonium. (1384)

Goldenrod (1141)

Goldenrod,European (1142)

Goldenseal rhizome (1143)

Gonadorelin acetate (2119)

Gonadotrophin,chorionic (2120)

Gonadotrophin,equine serum,for veterinary use (2121)

Goserelin (2121)

Grafted copolymer,macrogol poly(vinyl alcohol) (2401)

Gramicidin.......................................................................................2123Granisetron hydrochloride.. (2124)

Granules (713)

Granules and powders for oral solutions and suspensions (718)

Granules and powders for syrups (719)

Granules and spheroids,friability of(2.9.41.)...................7.4-4103 Granules,coated. (714)

Granules,effervescent (714)

Granules,gastro-resistant (714)

Granules,modified-release (714)

Greater celandine (1145)

Griseofulvin (2126)

Guaiacol (2127)

Guaifenesin (2128)

Guanethidine monosulfate (2129)

Guar (1146)

Guar galactomannan (2130)

Guidelines for using the test for bacterial endotoxins

(5.1.10.) (520)

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

H

Haemagglutinins,anti-A and anti-B(2.6.20.)....................7.2-3545 Haematopoietic products,numeration of CD34/CD45+cells in (2.7.23.).. (228)

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

Haematopoietic stem cells,human (2175)

Haemodiafiltration and haemofiltration,solutions for (2138)

Haemodialysis,concentrated solutions for (2136)

Haemodialysis solutions,concentrated,water for diluting..2135 Haemodialysis,solutions for (2136)

Haemofiltration and haemodiafiltration,solutions for (2138)

Haemophilus type b(conjugate),diphtheria,tetanus and pertussis(acellular,component)vaccine(adsorbed) (758)

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

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

Haemophilus type b(conjugate),diphtheria,tetanus, pertussis(whole cell)and poliomyelitis(inactivated)vaccine (adsorbed)...............................................................................7.2-3572 Haemophilus type b conjugate vaccine (776)

Haemorrhagic disease vaccine(inactivated),rabbit (933)

Halofantrine hydrochloride (2141)

Haloperidol (2142)

Haloperidol decanoate...........................................................7.2-3665 Halothane. (2144)

Hamamelis leaf (1146)

Hard capsules (708)

Hard fat (2146)

Hard paraffin (2668)

Harmonisation,pharmacopoeial(5.8.)...............................7.1-3345 Hawthorn berries (1147)

Hawthorn leaf and flower (1148)

Hawthorn leaf and flower dry extract (1149)

Hawthorn leaf and flower liquid extract,quantified (1150)

Heavy bismuth subnitrate (1498)

Heavy kaolin (2314)

Heavy magnesium carbonate (2409)

Heavy magnesium oxide (2415)

Heavy metals(2.4.8.) (114)

Heavy metals in herbal drugs and fatty oils(2.4.27.) (129)

Hedera helix for homoeopathic preparations (1291)

Helium (2146)

Heparin,assay of(2.7.5.) (208)

Heparin calcium (2147)

Heparin in coagulation factors,assay of(2.7.12.) (220)

Heparins,low-molecular-mass (2151)

Heparin sodium (2149)

Hepatitis A immunoglobulin,human (2176)

Hepatitis A (inactivated,adsorbed)and typhoid polysaccharide vaccine.....................................................................................7.3-3834Hepatitis A (inactivated)and hepatitis B (rDNA)vaccine (adsorbed)........................................................................................779Hepatitis A vaccine,assay of (2.7.14.)..........................................222Hepatitis A

vaccine (inactivated,adsorbed) (780)

Hepatitis A vaccine (inactivated,virosome)...............................781Hepatitis B immunoglobulin for intravenous administration,human.....................................................................................

7.3-3953

Hepatitis B immunoglobulin,human........................................2176Hepatitis B (rDNA),diphtheria and tetanus vaccine (adsorbed)........................................................................................753Hepatitis B (rDNA),diphtheria,tetanus and pertussis (acellular,component)vaccine (adsorbed)..................................................760Hepatitis B (rDNA),diphtheria,tetanus,pertussis (acellular,

component),poliomyelitis (inactivated)and haemophilus type b conjugate vaccine (adsorbed).........................................765Hepatitis B vaccine (rDNA)...................................................7.2-3574Hepatitis B vaccine (rDNA),assay of (2.7.15.)..................7.3-3794Hepatitis C virus (HCV),validation of nucleic acid amplification techniques for the detection of HCV RNA in plasma pools:

guidelines........................................................................................181Heptaminol hydrochloride...........................................................2153Herbal drug preparations (676)

Herbal drugs............................................................................7.3-3815Herbal drugs and fatty oils,heavy metals in (2.4.27.)..............129Herbal drugs,determination of aflatoxin B 1in (2.8.18.).........244Herbal drugs,determination of essential oils in herbal drugs (2.8.12.)............................................................................................241Herbal drugs,determination of tannins (2.8.14.) (243)

Herbal drugs for homoeopathic preparations..................7.3-3883Herbal drugs,microscopic examination of (2.8.23).................250Herbal drugs:sampling

and sample preparation (2.8.20.) (246)

Herbal drugs,test for aristolochic acids in (2.8.21).................247Herbal medicinal products for oral use,microbial examination (2.6.31.)............................................................................................

197

Herbal medicinal products for oral use,microbiological quality (5.1.8.)...............................................................................................519Herbal preparations.........................................................................676Herbal substances...................................................................7.3-3815Herbal teas.........................................................................................677Herpes zoster (shingles)vaccine (live)........................................828Hexamidine diisetionate...............................................................2154Hexetidine........................................................................................2155Hexobarbital....................................................................................2156Hexosamines in polysaccharide vaccines (2.5.20.)...................142Hexylresorcinol...............................................................................2157Highly purified water.. (3222)

Histamine (2.6.10.)...........................................................................162Histamine dihydrochloride..........................................................2158Histamine phosphate....................................................................2159Histidine...........................................................................................2159Histidine hydrochloride monohydrate......................................2160Homatropine hydrobromide........................................................2161Homatropine methylbromide...............................................7.3-3951Homeopathic preparations,hydrastis canadensis for.....7.3-3884Homoeopathic pillules,impregnated..................................7.4-4271Homoeopathic preparations.................................................7.2-3591Homoeopathic preparations,arsenious trioxide for..............1286Homoeopathic preparations,calcium iodide tetrahydrate for....................................................................................................1288Homoeopathic preparations,common stinging nettle for....1288Homoeopathic preparations,copper acetate monohydrate for....................................................................................................1289Homoeopathic preparations,copper for...................................1289Homoeopathic preparations,garlic

for (1290)

Homoeopathic preparations,hedera helix for.........................1291Homoeopathic preparations,herbal drugs for.................7.3-3883Homoeopathic preparations,honey bee for.. (1292)

Homoeopathic preparations,hyoscyamus for.........................1292Homoeopathic preparations,hypericum for............................1293Homoeopathic preparations,iron for........................................1294Homoeopathic preparations,mother tinctures for..........7.3-3884Homoeopathic preparations,oriental cashew for...................1295Homoeopathic preparations,pillules for...........................7.4-4271Homoeopathic preparations,potassium

dichromate

for.............................................................................................7.1-3371

Homoeopathic preparations,saffron for...................................1296Homoeopathic preparations,sodium tetrachloroaurate

dihydrate for..........................................................................7.1-3372Homoeopathic preparations,sulfur for..............................7.1-3372Homoeopathic stocks (methods of preparation of)and potentisation..........................................................................7.2-3592Honey...............................................................................................2163Honey bee for homoeopathic

preparations (1292)

Hop strobile.....................................................................................1151Human α-1-proteinase inhibitor.................................................2184Human albumin injection,iodinated (125

I) (976)

Human albumin solution.............................................................2165Human anti-D immunoglobulin..................................................2166Human

anti-D immunoglobulin,assay

of (2.7.13.) (220)

Human anti-D immunoglobulin for intravenous administration..............................................................................2167Human

antithrombin III,assay of (2.7.17.) (224)

Human antithrombin III concentrate.................................7.3-3952

Human coagulation factor II,assay of (2.7.18.).........................224Human

coagulation factor IX (2172)

Human coagulation factor IX,assay of (2.7.11.) (219)

Human coagulation factor VII....................................................2169Human

coagulation factor VII,assay of (2.7.10.) (219)

Human coagulation factor VIII (2170)

Human coagulation factor VIII,assay of (2.7.4.).......................207Human

coagulation

factor

VIII

(rDNA) (2171)

Human coagulation factor X,assay of (2.7.19.).........................225Human coagulation factor XI......................................................2173Human

coagulation factor XI,assay

of (2.7.22.) (227)

Human fibrinogen (2174)

Human haematopoietic progenitor cells,colony-forming cell assay for

(2.7.28.) (232)

Human haematopoietic stem cells.............................................2175Human hepatitis A immunoglobulin.........................................2176Human

hepatitis

B immunoglobulin (2176)

Human hepatitis B immunoglobulin for intravenous administration.......................................................................7.3-3953Human

insulin (2241)

Human measles immunoglobulin (2177)

Human normal immunoglobulin.........................................7.2-3666Human

normal immunoglobulin for intravenous

administration.......................................................................7.2-3668Human papillomavirus vaccine (rDNA).............................7.2-3575Human

plasma for

fractionation.................................................

2181Human plasma (pooled and treated for virus inactivation)..2182

Human plasmin inhibitor,assay of (2.7.25.)...............................230Human

protein C,assay of (2.7.30.) (234)

Human protein S,assay of (2.7.31.).............................................235Human prothrombin complex.....................................................2185Human

rabies

immunoglobulin (2186)

Human rubella immunoglobulin (2187)

Human tetanus immunoglobulin........................................7.2-3670Human

varicella immunoglobulin (2188)

Human varicella immunoglobulin for intravenous administration..............................................................................2189Human

von

Willebrand factor.....................................................

2189

Human von Willebrand factor,assay of (2.7.21.)......................226Hyaluronate,sodium.....................................................................2927Hyaluronidase

................................................................................

2190

Hydralazine hydrochloride (2191)

Hydrastis canadensis for homoeopathic preparations....7.3-3884Hydrochloric

acid,

concentrated (2192)

Hydrochloric acid,dilute (2192)

Hydrochlorothiazide...............................................................7.4-4321Hydrocodone

hydrogen tartrate 2.5-hydrate (2194)

Hydrocortisone...............................................................................2196Hydrocortisone acetate.................................................................2198Hydrocortisone hydrogen succinate..........................................2200Hydrogenated arachis oil. (1413)

Hydrogenated castor oil (1596)

Hydrogenated cottonseed oil (1769)

Hydrogenated soya-bean oil (2968)

Hydrogenated vegetable oils,nickel in(2.4.31.) (132)

Hydrogenated wool fat...........................................................7.4-4396 Hydrogen peroxide solution(30per cent). (2202)

Hydrogen peroxide solution(3per cent) (2201)

Hydromorphone hydrochloride (2202)

Hydrophobic colloidal silica (2903)

Hydrous wool fat.....................................................................7.4-4397 Hydroxocobalamin acetate.. (2203)

Hydroxocobalamin chloride (2204)

Hydroxocobalamin sulfate (2205)

Hydroxycarbamide (2206)

Hydroxyethylcellulose (2208)

Hydroxyethylmethylcellulose (2476)

Hydroxyethyl salicylate (2207)

Hydroxyethyl starches (2984)

Hydroxyl value(2.5.3.) (137)

Hydroxypropylbetadex...........................................................7.3-3953 Hydroxypropylcellulose. (2211)

Hydroxypropylmethylcellulose (2219)

Hydroxypropylmethylcellulose phthalate (2221)

Hydroxypropyl starch (2981)

Hydroxyzine hydrochloride (2212)

Hymecromone (2213)

Hyoscine (2214)

Hyoscine butylbromide (2215)

Hyoscine hydrobromide (2216)

Hyoscyamine sulfate (2217)

Hyoscyamus for homoeopathic preparations (1292)

Hypericum (1241)

Hypericum for homoeopathic preparations (1293)

Hypromellose (2219)

Hypromellose phthalate (2221)

I Ibuprofen (2225)

Iceland moss (1152)

ICH(5.8.)...................................................................................7.1-3345 Ichthammol. (2227)

Identification(2.3.) (107)

Identification and control of residual solvents(2.4.24.)..7.2-3537 Identification of fatty oils by thin-layer chromatography

(2.3.2.) (110)

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

Identification reactions of ions and functional groups

(2.3.1.) (107)

Idoxuridine (2227)

Ifosfamide (2228)

Imipenem (2230)

Imipramine hydrochloride (2231)

Immunochemical methods(2.7.1.) (201)

Immunoglobulin for human use,anti-T lymphocyte, animal (1404)

Immunoglobulin for intravenous administration,human

anti-D (2167)

Immunoglobulin for intravenous administration,human hepatitis B..............................................................................7.3-3953 Immunoglobulin for intravenous administration,human normal.....................................................................................7.2-3668 Immunoglobulin for intravenous administration,human varicella (2189)

Immunoglobulin,human anti-D (2166)

Immunoglobulin,human anti-D,assay of(2.7.13.) (220)

Immunoglobulin,human hepatitis A (2176)

Immunoglobulin,human hepatitis B (2176)

Immunoglobulin,human measles (2177)

Immunoglobulin,human normal........................................7.2-3666 Immunoglobulin,human rabies. (2186)

Immunoglobulin,human rubella...............................................2187Immunoglobulin,human tetanus........................................7.2-3670 Immunoglobulin,human varicella (2188)

Immunoglobulin,test for anticomplementary activity of

(2.6.17.) (177)

Immunoglobulin,test for Fc function of(2.7.9.) (217)

Immunological veterinary medicinal products,substances of animal origin for the production of(5.2.5.) (535)

Immunosera and vaccines,phenol in(2.5.15.) (141)

Immunosera and vaccines,veterinary,evaluation of efficacy of (5.2.7.) (538)

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

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

Immunosera for human use,animal (678)

Immunosera for veterinary use (680)

Implants (725)

Impurities in substances for pharmaceutical use,control of (5.10.).......................................................................................7.4-4247 Indapamide.. (2232)

Indian frankincense (1152)

Indicators,relationship between approximate pH and colour (2.2.4.) (25)

Indinavir sulfate (2233)

Indium(111In)chloride solution (977)

Indium(111In)oxine solution (978)

Indium(111In)pentetate injection (979)

Indometacin (2235)

Inductively coupled plasma-atomic emission spectrometry (2.2.57.) (94)

Inductively coupled plasma-mass spectrometry(2.2.58.) (96)

Infectious bovine rhinotracheitis vaccine(live) (908)

Infectious bronchitis vaccine(inactivated),avian (851)

Infectious bronchitis vaccine(live),avian (852)

Infectious bursal disease vaccine(inactivated),avian (854)

Infectious bursal disease vaccine(live),avian (856)

Infectious chicken anaemia vaccine(live) (910)

Infectious encephalomyelitis vaccine(live),avian (857)

Infectious laryngotracheitis vaccine(live),avian (859)

Influenza vaccine(split virion,inactivated) (788)

Influenza vaccine(surface antigen,inactivated) (789)

Influenza vaccine(surface antigen,inactivated,prepared in cell cultures) (791)

Influenza vaccine(surface antigen,inactivated,virosome) (793)

Influenza vaccine(whole virion,inactivated) (795)

Influenza vaccine(whole virion,inactivated,prepared in cell cultures) (796)

Infrared absorption spectrophotometry(2.2.24.) (38)

Infusions (725)

Inhalation gas,krypton(81m Kr) (983)

Inhalation powders.................................................................7.3-3828 Inhalation,preparations for..................................................7.3-3825 Inhalation,preparations for:aerodynamic assessment of fine particles(2.9.18.) (274)

Injectable insulin preparations (2249)

Injections (724)

Injections,gels for (725)

Injections or infusions,concentrates for (725)

Injections or infusions,powders for (725)

Inositol,myo- (2236)

Inserts,ophthalmic (712)

Insulin aspart (2237)

Insulin,bovine (2239)

Insulin,human (2241)

Insulin injection,biphasic (2243)

Insulin injection,biphasic isophane (2244)

Insulin injection,isophane (2244)

Insulin injection,soluble (2244)

Insulin lispro (2245)

Insulin,porcine (2247)

Insulin preparations,injectable (2249)

Insulin zinc injectable suspension (2251)

Insulin zinc injectable suspension(amorphous) (2252)

Insulin zinc injectable suspension(crystalline) (2252)

Interferon alfa-2concentrated solution (2252)

Interferon beta-1a concentrated solution (2255)

Interferon gamma-1b concentrated solution (2257)

Interferons,assay of(5.6.) (607)

International System(SI)units(1.)....................................7.4-4083 Intramammary preparations for veterinary use (714)

Intraruminal devices (715)

Intrauterine capsules (715)

Intrauterine foams (715)

Intrauterine preparations for veterinary use (715)

Intrauterine solutions,suspensions (715)

Intrauterine sticks (715)

Intrauterine tablets (715)

Intrinsic dissolution(2.9.29.) (294)

In vivo assay of poliomyelitis vaccine(inactivated)(2.7.20.)..225 Iobenguane(123I)injection (979)

Iobenguane(131I)injection for diagnostic use (980)

Iobenguane(131I)injection for therapeutic use (981)

Iobenguane sulfate for radiopharmaceutical preparations (982)

Iodinated(125I)human albumin injection (976)

Iodinated povidone (2778)

Iodine (2261)

Iodine value(2.5.4.) (137)

Iodixanol (2261)

Iodomethylnorcholesterol(131I)injection (982)

Iohexol (2264)

Ionic concentration,potentiometric determination of using

ion-selective electrodes(2.2.36.) (57)

Ions and functional groups,identification reactions of

(2.3.1.) (107)

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

Iopamidol (2266)

Iopanoic acid (2268)

Iopromide (2269)

Iotalamic acid (2272)

Iotrolan (2273)

Ioxaglic acid (2275)

Ipecacuanha liquid extract,standardised (1153)

Ipecacuanha,prepared (1154)

Ipecacuanha root (1155)

Ipecacuanha tincture,standardised (1156)

Ipratropium bromide (2277)

Irbesartan (2278)

Iron(2.4.9.) (117)

Iron for homoeopathic preparations (1294)

Irrigation,preparations for (731)

Isatis root..................................................................................7.3-3866 Isoconazole.. (2279)

Isoconazole nitrate (2281)

Isoelectric focusing(2.2.54.) (83)

Isoelectric focusing(2.2.54.)(5.8.)......................................7.1-3345 Isoflurane.. (2282)

Isoleucine (2283)

Isomalt (2284)

Isoniazid (2285)

Isophane insulin injection (2244)

Isoprenaline hydrochloride (2286)

Isoprenaline sulfate (2287)

Isopropyl alcohol (2287)

Isopropyl myristate (2288)

Isopropyl palmitate (2289)

Isosorbide dinitrate,diluted (2289)

Isosorbide mononitrate,diluted (2291)

Isotretinoin (2293)

Isoxsuprine hydrochloride (2294)

Ispaghula husk (1156)

Ispaghula seed (1157)

Isradipine (2296)

Itraconazole (2297)

Ivermectin (2299)

Ivy leaf..............................................................................................1157J

Javanese turmeric (1257)

Java tea (1158)

Josamycin (2305)

Josamycin propionate (2307)

Juniper.......................................................................................7.2-3585 Juniper oil. (1160)

K

Kanamycin acid sulfate (2313)

Kanamycin monosulfate (2313)

Kaolin,heavy (2314)

Kelp (1161)

Ketamine hydrochloride........................................................7.2-3675 Ketobemidone hydrochloride (2316)

Ketoconazole (2317)

Ketoprofen (2318)

Ketorolac trometamol (2320)

Ketotifen hydrogen fumarate (2321)

Knotgrass (1162)

Krypton(81m Kr)inhalation gas (983)

Kudzuvine root........................................................................7.3-3867

L

Labetalol hydrochloride (2327)

Lactic acid (2328)

Lactic acid,(S)- (2328)

Lactitol monohydrate (2329)

Lactobionic acid (2331)

Lactose,anhydrous.................................................................7.3-3959 Lactose monohydrate.. (2333)

Lactulose (2334)

Lactulose,liquid (2336)

Lamivudine...............................................................................7.3-3960 Lamotrigine. (2339)

Lansoprazole (2341)

Laser light diffraction,particle size analysis by(2.9.31.) (295)

Laurilsulfate,sodium (2933)

Lauromacrogol400 (2342)

Lauroyl macrogolglycerides (2344)

Lavender flower.......................................................................7.1-3363 Lavender oil. (1164)

Lavender oil,spike (1240)

Lead in sugars(2.4.10.) (117)

Leflunomide (2345)

Lemon oil (1165)

Lemon verbena leaf................................................................7.3-3868 Leptospirosis vaccine(inactivated),bovine.. (862)

Leptospirosis vaccine(inactivated),canine (874)

Letrozole (2347)

Leucine (2348)

Leuprorelin (2348)

Levamisole for veterinary use (2350)

Levamisole hydrochloride (2351)

Levetiracetam..........................................................................7.3-3962 Levocabastine hydrochloride (2354)

Levocarnitine (2355)

Levodopa (2356)

Levodropropizine (2358)

Levofolinate pentahydrate,calcium (1563)

Levomenthol (2359)

Levomepromazine hydrochloride (2360)

Levomepromazine maleate (2361)

Levomethadone hydrochloride (2362)

Levonorgestrel.........................................................................7.4-4325 Levothyroxine sodium...........................................................7.3-3964 Levulinate dihydrate,calcium.. (1565)

Lidocaine (2365)

Lidocaine hydrochloride (2366)

Light liquid paraffin (2669)

Light magnesium carbonate (2409)

Light magnesium oxide (2416)

Lime flower (1168)

Limit tests(2.4.) (113)

Limit tests,standard solutions for(4.1.2.).........................7.4-4216 Lincomycin hydrochloride....................................................7.3-3965 Linen thread,sterile,in distributor for veterinary use (1038)

Linoleoyl macrogolglycerides (2368)

Linseed......................................................................................7.1-3364 Linseed oil,virgin.. (2369)

Liothyronine sodium (2370)

Lipophilic solid dosage forms,dissolution test for(2.9.42.) (319)

Liquid chromatography(2.2.29.) (45)

Liquid extracts (675)

Liquid glucose (2103)

Liquid glucose,spray-dried (2103)

Liquid lactulose (2336)

Liquid maltitol (2427)

Liquid paraffin (2669)

Liquid preparations for cutaneous application (717)

Liquid preparations for cutaneous application, veterinary...............................................................................7.4-4259 Liquid preparations for oral use (718)

Liquids,clarity and degree of opalescence of(2.2.1.) (21)

Liquid sorbitol(crystallising) (2965)

Liquid sorbitol(non-crystallising) (2965)

Liquid sorbitol,partially dehydrated (2966)

Liquorice dry extract for flavouring purposes.................7.3-3870 Liquorice ethanolic liquid extract,standardised.............7.3-3871 Liquorice root..........................................................................7.3-3872 Lisinopril dihydrate.. (2371)

Lithium carbonate (2372)

Lithium citrate (2373)

L-Methionine([11C]methyl)injection (985)

Lobeline hydrochloride (2373)

Lomustine (2375)

Loosestrife (1172)

Loperamide hydrochloride (2376)

Loperamide oxide monohydrate (2378)

Loratadine (2379)

Lorazepam (2381)

Losartan potassium (2382)

Loss on drying(2.2.32.) (51)

Loss on drying of extracts(2.8.17.) (244)

Lovage root (1172)

Lovastatin.................................................................................7.4-4327 Low-molecular-mass heparins.. (2151)

Lozenges and pastilles...........................................................7.4-4258 Lozenges,compressed...........................................................7.4-4259 Lubricant,silicone oil(3.1.8.).. (347)

Lufenuron(anhydrous)for veterinary use (2385)

Lymecycline (2387)

Lynestrenol (2389)

Lyophilisates,oral (736)

Lysine acetate (2390)

Lysine hydrochloride (2391)

M

Macrogol15hydroxystearate (2399)

Macrogol20glycerol monostearate (2397)

Macrogol30dipolyhydroxystearate....................................7.2-3679 Macrogol40sorbitol heptaoleate. (2404)

Macrogol6glycerol caprylocaprate (2395)

Macrogol cetostearyl ether (2395)

Macrogolglycerol cocoates (2396)

Macrogolglycerol hydroxystearate (2397)

Macrogolglycerol ricinoleate (2398)

Macrogol lauryl ether (2400)

Macrogol oleate (2400)

Macrogol oleyl ether (2401)

Macrogol poly(vinyl alcohol)grafted copolymer (2401)

Macrogols (2402)

Macrogol stearate (2405)

Macrogol stearyl ether..................................................................2405Magaldrate (2406)

Magnesium(2.4.6.) (114)

Magnesium acetate tetrahydrate (2407)

Magnesium aluminium silicate (1358)

Magnesium and alkaline-earth metals(2.4.7.) (114)

Magnesium aspartate dihydrate (2408)

Magnesium carbonate,heavy (2409)

Magnesium carbonate,light (2409)

Magnesium chloride4.5-hydrate.........................................7.3-3971 Magnesium chloride hexahydrate. (2411)

Magnesium citrate,anhydrous (2411)

Magnesium citrate dodecahydrate (2412)

Magnesium citrate nonahydrate (2412)

Magnesium gluconate (2413)

Magnesium glycerophosphate (2414)

Magnesium hydroxide (2414)

Magnesium lactate dihydrate (2415)

Magnesium oxide,heavy (2415)

Magnesium oxide,light (2416)

Magnesium peroxide (2417)

Magnesium pidolate (2417)

Magnesium stearate................................................................7.4-4333 Magnesium sulfate heptahydrate.. (2421)

Magnesium trisilicate (2421)

Maize oil,refined (2422)

Maize starch (2422)

Malathion (2423)

Maleic acid (2424)

Malic acid (2424)

Mallow flower (1173)

Mallow leaf................................................................................7.2-3586 Maltitol (2425)

Maltitol,liquid (2427)

Maltodextrin (2428)

Mandarin oil (1175)

Manganese gluconate (2428)

Manganese glycerophosphate,hydrated (2429)

Manganese sulfate monohydrate (2430)

Mannheimia vaccine(inactivated)for cattle (911)

Mannheimia vaccine(inactivated)for sheep (913)

Mannitol (2430)

Maprotiline hydrochloride (2432)

Marbofloxacin for veterinary use (2433)

Marek’s disease vaccine(live) (914)

Marshmallow leaf....................................................................7.3-3873 Marshmallow root...................................................................7.3-3874 Mass spectrometry(2.2.43.). (67)

Mass spectrometry,inductively coupled plasma-(2.2.58.) (96)

Mass uniformity of delivered doses from multidose containers (2.9.27.) (294)

Mass uniformity of single-dose preparations(2.9.5.) (265)

Mastic (1177)

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

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

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

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

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

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

Materials used for the manufacture of containers(3.1.) (329)

Matricaria flower (1178)

Matricaria liquid extract (1179)

Matricaria oil (1180)

Meadowsweet (1182)

Measles immunoglobulin,human (2177)

Measles,mumps and rubella vaccine(live) (798)

欧洲药典EP8.0-2.6.1无菌检验-sterility中英文翻译

2.6.1. STERILITY 2.6.1 无菌检查法 The test is applied to substances, preparations or articles which, according to the Pharmacopoeia, are required to be sterile. However, a satisfactory result only indicates that no contaminating micro-organism has been found in the sample examined in the conditions of the test. 本检查方法适用于按照药典要求应当无菌的原料、制剂或其他物质。但是，如果按照本无菌检查法的结果符合要求，仅表明在该检查条件下未发现微生物污染。 PRECAUTIONS AGAINST MICROBIAL CONTAMINATION 微生物污染防范 The test for sterility is carried out under aseptic conditions. In order to achieve such conditions, the test environment has to be adapted to the way in which the sterility test is performed. The precautions taken to avoid contamination are such that they do not affect any micro-organisms which are to be revealed in the test. The working conditions in which the tests are performed are monitored regularly by appropriate sampling of the working area and by carrying out appropriate controls. 无菌检测试验应在无菌的条件下进行。为了达到这样的条件，检测环境应当与无菌检测的操作要求相适应。避免污染的防范措施应当不对本检查方法进行检测的微生物造成影响（应并不影响用本检查法检测的微生物）。通过对工作区域的适当取样以及进行适当的控制来对无菌检查的工作环境进行例行监测。 CULTURE MEDIA AND INCUBATION TEMPERATURES 培养基和培养温度 Media for the test may be prepared as described below, or equivalent commercial media may be used provided that they comply with the growth promotion test. 应按下面描述的方法制备无菌检查的培养介质，如果满足生长促进试验要求，与本处所述培养基相当的商业化培养基也可以采用（也可采用与本处……）。 The following culture media have been found to be suitable for the test for sterility. Fluid thioglycollate medium is primarily intended for the culture of

欧洲药典 10.0 EP 10.0 长春西汀 中文翻译

01/2008:2139 修订：7.3 长春西汀 Vinpocetine 欧洲药典10.0 Ph.Eur. 10.0 EP 10.0 C22H26N2O2Mr 350.5 [42971-09-5] 定义 乙基(13as,13bs)13α-乙基-2, 3 ,5 ,6-13α 13b六氢-1H-吲哚3, 2, 1-d吡啶3, 2, 1-ij,l, 5-二痰杂萘-12-羧酸。（Ethyl (13aS,13bS)-13a-ethyl-2,3,5,6,13a,13b-hexahydro- 1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate.） 含量：98.5%- 101.5%（干品）。 特征 外观：白色或微黄色结晶性粉末。 溶解性：几乎不溶于水，可溶于二氯甲烷，微溶于无水乙醇。 鉴别 A.比旋度（见检测项）。 B.红外吸收光谱（2.2.24）。 对比：长春西汀CRS。

检测 比旋光度(2.2.7):+127到+134（干品）。 取0.25 g溶于二甲基甲酰胺R，并用相同的溶剂稀释至25.0 ml。 有关物质。液相色谱（2.2.29）. 供试溶液。取50.0mg供试品溶于流动相并用流动相稀释至50.0ml。 对照溶液(a).取1.0ml 供试品溶液用流动相稀释至50.0ml。 对照溶液(b).取5.0mg 长春西汀杂质B CRS，6.0mg长春西汀杂质A CRS，5.0mg 长春西汀杂质C CRS 5.0mg长春西汀杂质D CRS，溶于流动相，并用流动相稀释至50.0ml。 对照溶液(c).取1.0ml 对照溶液(a)和1.0 ml对照溶液(b)用流动相稀释至20.0ml。 色谱柱: －尺寸：l = 0.25m, ? = 4.6mm －固定相：色谱用末端封尾的十八烷基硅烷键和硅胶R(5μm)。 流动相：15.4g/l 的醋酸铵R溶液，乙腈R（45:55 V/V）。 流速：1.0ml/min。 检测器：分光光度计，280nm。 进样量：15 μl 运行时间：长春西汀保留时间的3倍。 相对保留时间，以长春西汀（保留时间=约16min）为参照：杂质A= 约0.4；杂质D=约0.68；杂质B= 约0.75；杂质C=约0.83。 系统适应性：对照品溶液(c): －分离度：杂质Ｂ和Ｄ之间的分离度不得少于为2.0。 限度： －杂质A：不得超过对照品溶液(c)色谱图中相应峰的峰面积（0.6%）； －杂质B, D：每种杂质不得超过对照品溶液(c)色谱图中相应峰的峰面积（0.5%）； －杂质C：不得超过对照品溶液(c)色谱图中相应峰的峰面积的0.6倍（0.3%）；

USP39 注射剂通则

tion as constituted for administration are not included in the individual monographs on sterile dry solids or liquid concentrates. However, in the interest of assuring the quality of injection preparations as they are actually administered, the following non-destructive tests are provided for demonstrating the suitability of constituted solutions when they are prepared just prior to use. Completeness and Clarity of Solution—Constitute the solution as directed in the labeling supplied by the manufacturer for the sterile dry dosage form. A:The solid dissolves completely, leaving no visible residue as undissolved matter. B:The constituted solution is not significantly less clear than an equal volume of the diluent or of Purified Water contained in a similar vessel and examined similarly. Particulate Matter—Constitute the solution as directed in the labeling supplied by the manufacturer for the sterile dry dos-age form: the solution is essentially free from particles of foreign matter that can be observed on visual inspection. á1? INJECTIONS AND IMPLANTED DRUG PRODUCTS (PARENTERALS)—PRODUCT QUALITY TESTS (Chapter to become official May 1, 2016) (Current chapter name is á1? Injections) INTRODUCTION Parenteral drug products include both injections and implanted drug products that are injected through the skin or other external boundary tissue, or implanted within the body to allow the direct administration of the active drug substance(s) into blood vessels, organs, tissues, or lesions. Injections may exist as either immediate- or extended-release dosage forms. Implan-ted parenteral drug products are long-acting dosage forms that provide continuous release of the active drug substance(s) of-ten for periods of months to years. For systemic delivery, they may be placed subcutaneously; for local delivery, they may be placed in a specific region of the body. Routes of administration for parenteral drug products include intravenous, intraventric-ular, intra-arterial, intra-articular, subcutaneous, intramuscular, intrathecal, intracisternal, and intraocular. Parenteral dosage forms include solutions, suspensions, emulsions, sterile powders for solutions and suspensions (including liposomes), implants (including microparticles), and products that consist of both a drug and a device such as drug-eluting stents. The reader is directed to Pharmaceutical Dosage Forms á1151?1 and to the later sections of this chapter for additional descriptions of dosage forms that fall into the general category of parenteral drug products. Nomenclature á1121?1 provides information on nomenclature used to establish USP names and monograph titles for parenteral drug products. Chapter á1? provides a framework to support the revision and the development of individual monographs, and is not meant to replace individual monographs. Chapter á1? provides lists of common product quality test requirements in a concise and a coherent fashion. The chapter is divided into four main sections: (1) universal product quality tests that are applicable to pa-rental dosage forms; (2) specific product quality tests, which are tests that should be considered in addition to Universal Tests; (3) product quality tests for specific dosage forms, which lists all the applicable tests (Universal and Specific) for the specific dosage form; and (4) product performance tests. If a monograph exists, it will reference á1? or indicated chapter parts. If a specific drug product monograph is missing (not in existence), the general chapters provide the quality tests that can be used by manufacturers until the dosage form monograph is developed by USP. The Pharmacopeial definitions for sterile preparations for parenteral use may not apply to some biologics because of their special nature and licensing requirements (see Biologics á1041?1). However, some biological finished drug products containing “Injection” in the monograph title must meet the requirements of á1? or indicated chapter subparts, where it is specified in the monograph. Drug Product Quality and Drug Product Performance Tests Procedures and acceptance criteria for testing parenteral drug products are divided into two categories: (1) those that assess product quality attributes, e.g., identification, sterility, and particulate matter, and are contained in this chapter and (2) those that assess product performance, e.g., in vitro release of the drug substance from the drug product. Whereas quality tests as-sess the integrity of the dosage form, the performance tests assess performance (bioavailability) after the product has been administered to the patient. A product performance test, i.e., drug release test for suspensions, emulsions, powder for suspen-sion (including microparticles and liposomes), and drug-eluting stents, should be carried out using appropriate test proce-dures. 1All listed chapters above á1000? are for information purposes only; they may be helpful but are not mandatory.

国内外药品包装体系及其包材相应试验

国内外药品包装体系及其包材相应试验（一） 药品包装是指直接接触药品的包装材料和容器，属于专用包装范畴，它具有包装的所有属性，并有其特殊性：1、能保护药品在贮藏、使用过程中不受环境的影响,保持药品原有属性2、药品包装材料自身在贮藏、使用过程中性质应有一定的稳定性3、药品包装材料在包裹药品时不能污染药品生产环境。4、药品包装材料不得带有在使用过程中不能消除的对所包装药物有影响的物质。5、药品包装材料与所包装的药品不能发生化学、生物意义上的反应。为了确认药品包装材料可被用于包裹药品,有必要对这些材料进行质量监控 一、药品包装分类 （一）按药品包装材料、容器所使用的成份可分为：塑料、橡胶（或弹性体）、玻璃、金属及其它类（如布类、陶瓷类、纸类、干燥剂类）等五类。 （二）按药品包装材料、容器的形状也可分为：容器（如口服固体药用高密度聚乙烯瓶等）、硬片或袋（如PVC固体药用硬片、药品包装用复合膜、袋等）、塞（如药用氯化丁基橡胶塞）、盖（如口服液瓶撕拉铝盖）、辅助用途（如输液接口）等五类。 二、药品包装材料标准体系 为确保药品的安全、有效使用，各国均对药品包装材料和容器进行质量控制，标准体系主要有 1、药典体系：各发达国家药典附录均收载有药品包装材料的技术要求 2、ISO体系:根据材料及形状制定标准(如铝盖、玻璃输液瓶) 3、各国工业标准体系:如英国工业标准BS等，已逐渐向ISO标准转化 4、国内标准体系:工业标准形式上与ISO标准相同,安全项目略少于先进国家药典。为有效控制药品包装材料的质量，国家食品药品监督管理局已于2002年始，制定并颁布相应的药品包装材料容器的质量标准，加强对材料的物理、机械性能、化学性能、安全性能的控制。 国际标准、各国药典都是药品包装国际市场共同遵循的技术依据，其中，药典侧重于材料、容器的安全性评价，国际标准侧重于产品使用性能的评价。 三、各国药品包装容器质量标准体系内容介绍 1、美国药典对玻璃产品控制的项目有：透光率试验、耐水性试验、砷浸出量试验等； 对PE或PET产品（适用于口服固体制剂）控制的项目有：红外测定、热分析、透光率试验、水蒸气透过量测定、重金属、不挥发物测定等。 2、日本药局方对注射剂用玻璃容器的检测项目有：封口要求、可溶性碱（耐水性）测定、铁测定（避光容器）、透光率测定；对塑料容器的特殊要求是（1）应考察容器的溶出或迁

欧洲药典附录3.1.3.-推荐下载

3.1.3. 聚烯烃 定义 聚烯烃是通过乙烯或丙烯的聚合而成，或是通过这些不超过25%的高同系物的物质或羧酸或酯的共聚作用获得。某些材料可能是聚烯烃的混合物。 成品 添加一定数量的添加剂到聚合物中是为了优化它们的化学性质，物理性质和机械性能，为了使它们适用于预定用途。所有的这些添加剂都是选自附件列表，并指出了每一种产品中的最大允许含量。产品中最多包含有三种抗氧化剂，一种或几种润滑剂或抗粘连剂以及当材料必须提供光照保护时，还要添加二氧化钛作为遮光剂。 – 二叔丁基对甲酚（增塑剂07）：限量：0.125% –四钛季戊四醇松香酸酯[3-(3,5-二叔丁基-4-羟苯基)丙酸酯]（增塑剂09）：限量：0.3%–1,3,5-三羟甲基氨基甲烷(3,5-二叔丁基-4-邻羟苄基)- 三嗪-2,4,6(1H,3H,5H)-三酮, (增塑剂 13): 限量： 0.3% – 二乙烯[3,3-二[3-(1,1-dimethylethyl)-4-羟苯基]丁酸甲酯] (增塑剂08)：限量：0.3%– 二（十八烷基）二硫化物（增塑剂15）限量：0.3% 4,4′,4″-(2,4,6-三甲基苯-1,3,5-triyltrismethylene) –三羟甲基氨基甲烷[2,6-二(1,1-dimethylethyl)苯酚]（增塑剂10）限量：0.3% 2,2′-二(octadecyloxy)-5,5′-spirobi[1,3,2-dioxaphosphinane](增塑剂 14): 限量：0.3 %; – didodecyl 3,3′-硫代二丙酸（增塑剂16): 限量： 0.3 %; – dioctadecyl3,3′-硫代二丙酸(增塑剂 17): 限量：0.3 %; – 三羟甲基氨基甲烷[2,4-二(1,1-dimethylethyl)苯基] 亚磷酸盐 (增塑剂 12): 限量：0.3 %; – 增塑剂 18: 限量： 0.1%; –琥珀酸二甲酯和 (4-hydroxy-2,2,6,6-tetramethylpiperidin-1-yl)乙醇的共聚物 (增塑剂 22): 限量：0.3% 上面列出的抗氧化添加剂总含量不超过0.3%。 –铝碳酸镁：限量：0.5%； –烷基酰胺：限量：0.5%； –烯烃酰胺：限量：0.5%； –硅铝酸钠：限量：0.5%；

药典注射剂通则

附录ⅠB 注射剂 注射剂系指药物与适宜的溶剂或分散介质制成的供注入体内的溶液，乳状液或混悬液及供注入体内的溶液、乳状液或混悬液及供临用前配制或稀释成溶液或混悬液的粉末或浓溶液的无菌制剂。 注射剂可分为注射液、注射用无菌粉末与注射用浓溶液。 注射液包括溶液型、乳状液型或混悬型注射液，可用于肌内注射、静脉注射、静脉滴注等。其中，供静脉注射用的大体积（除另有规定外，一般不小于100ml）注射液也称静脉输液。 注射用无菌粉末系指药物制成的供临用前用适宜的无菌溶液配制成澄清溶液或均匀混悬液的无菌粉末或无菌块状物。可用适宜的注射用溶剂配制后注射，也可用静脉输液配制后静脉滴注。无菌粉末用溶剂结晶法、喷雾干燥法或冷冻干燥法等制得。 注射用浓溶液系指药物制成的供临用前稀释后静脉滴注用的无菌浓溶液。 注射液在生产与贮藏期间应符合下列有关规定。 一、溶液型注射液应澄明；除另有规定外，混悬型注射液中药物粒度应控制在15μm以下，含15～20μm （间有个别20～50μm）者，不得超过10%，若有可见沉淀，振摇时应容易分散均匀，混悬型注射液不得用于静脉注射或椎管注射；乳状液型注射液应稳定，不得有相分离现象，不得用于椎管注射。静脉用乳状液型注射液中乳滴的粒度90%应在1μm以下，不得有大于5μm的乳滴。除另有规定外，静脉输液应尽可能与血液等渗。 二、注射剂所用的原辅料应从来源及工艺等生产环节进行严格控制并应符合注射用的质量要求。注射剂所用溶剂必须安全无害，并不得影响疗效额质量。一般分为水性溶剂和非水性溶剂。 （1）水性溶剂最常用的为注射用水，也可用0.9%氯化钠溶液或其他适宜的水溶液。 （2）非水性溶剂常用的为植物油，主要为供注射用大豆油，其他还有乙醇、丙二醇和聚乙二醇等溶剂。供注射用的非水性溶剂，应严格限制其用量，并应在品种项下进行相应的检查。 三、配制注射剂时，可根据药物的性质加入适宜的附加剂。如渗透压调节剂、pH值调节剂、增溶剂、助溶剂、抗氧剂、抑菌剂、乳化剂、助悬剂等。所用附加剂应不影响药物疗效，避免对检验产生干扰，使用浓度不得引起毒性或明显的刺激。常用的抗氧剂有亚硫酸钠、亚硫酸氢钠和焦亚硫酸钠等，一般浓度为01.%～0.2%；常用的抑菌剂为0.5%苯酚、0.3%甲酚和0.5%三氯叔丁醇等。多剂量包装的注射液可加适宜的抑菌剂，，抑菌剂的用量应能抑制注射液中微生物的生长，加有抑菌剂的注射液，仍应采用适宜的方法灭菌。静脉输液与脑池内、硬膜外、椎管内用的注射液均不得加抑菌剂。除另有规定外，一次注射量超过15ml

欧洲药典中英文翻译 EP8.0干燥失重

2.2.32. LOSS ON DRYING 干燥失重 Loss on drying is the loss of mass expressed as per cent m/m. 干燥失重指重量损失，表述为% 重量/重量 Method. Place the prescribed quantity of the substance to be examined in a weighing bottle previously dried under the conditions prescribed for the substance to be examined. Dry the substance to constant mass or for the prescribed time by one of the following procedures. Where the drying temperature is indicated by a single value rather than a range, drying is carried out at the prescribed temperature +/- 2?C. 方法：将要求数量的待检样品放置于预先干燥的称量瓶中，按要求条件进行干燥，直至样品干至恒重或下述程序指定的时长。如果干燥温度给定的是一个值而不是一个范围，则在指定温度+/- 2?C进行干燥。 a) “in a desiccator”: the drying is carried out over diphosphorus pentoxide R at atmospheric atmostpheric pressure and at room temperature; “在干燥器中”：指在室温常压下，用五氧化二磷试剂，进行干燥 b) “in vacuo”: the drying is carried out over diphosphorus pentoxide R, at a pressure of 1.5 kPa at room temperature; “真空”：在室温下，真空1.5kPa下，用五氧化二磷试剂进行干燥 c) “in vacuo within a specified temperature range”: the drying is carried out over diphosphorus pentoxide R, at a pressure of 1.5kPa to 2.5kPa within the temperature range prescribed in the monograph; “在指定温度范围内真空下”：真空1.5kPa至2.5kPa下，各论要求的温度范围内，用五氧化二磷进行干燥 d) “in an oven within a specified temperature range”: the drying is carrie d out in an oven within the temperature range prescribed in the monograph; “在烘箱里指定温度下”：在各论要求的温度范围内，用烘箱进行干燥 e) “under high vacuum”: the drying is carried out over diphosphorus pentoxide R at a pressure not exceeding 0.1kPa, at the temperature prescribed in the monograph. “在高真空下”：在各论要求的温度下，不超过0.1kPa的真空下用五氧化二磷进行干燥 If other conditions are prescribed, the procedure to be used is described in full in the monograph. 如果需要采用其它条件，则在各论中应进行详细描述。

欧洲药典附录

欧洲药典附录 Prepared on 22 November 2020

第二部分、附录 附录1 溶液的澄清度 在内径15～25mm，平底，无色、透明、中性玻璃管中，加入等量的供试溶液与浊度标准液，使液位的深度都为40mm，按如下所述方法进行比较。浊度标准液制备5分钟后，以色散自然光照射浊度标准溶液和供试溶液，在黑色背景下从垂直方向观察、比较澄清度或浑浊程度。色散自然光必须较容易区分浊度标准溶液Ⅰ与水，浊度标准溶液Ⅱ与浊度标准溶液Ⅰ。 如果供试溶液的澄清、透明程度与水相同，或者与所用溶剂相同，或者其澄清度不超过Ⅰ号浊度标准溶液，那么可判定该溶液为澄清。 试剂： 硫酸肼溶液：取硫酸肼溶于水，加水稀释至，静置4～6小时。 乌洛托品（六亚甲基四胺）溶液：在100ml容量平中，以水溶解乌洛托品。 浊度标准贮备液：在存放乌洛托品溶液的100ml容量瓶中，加的硫酸肼溶液。混合，静置24小时，贮存在无表面要求的玻璃容器中，可在2个月内使用。该浊度液不得黏附玻璃，用前必须充分摇匀。 浊度标准原液：取浊度标准贮备液15ml，加水稀释、定容至1000ml。该液临用前制备，至多保存24小时。 浊度标准液：由浊度标准原液与水按表1-1配制,即得。本液应临用前配制。

附录2 溶液颜色检查 按本药典规定，用下面两种方法之一可以检出溶液在棕色-黄色-红色范围内的颜色。 如果溶液A的外观与水或所用溶剂相同，或者颜色浅于标准比色液B 9 ，则可判定溶液A为无色。 方法I 用外径为12mm的无色、透明中性玻璃管取2ml的供试溶液，与相同玻璃管中的2ml的水，或2ml本文所规定的标准比色液（见标准比色液表）进行比较。在散射自然光，白色的背景下，水平观察比较颜色。 方法Ⅱ 用同样平底、内径为15～25mm的无色透明中性玻璃管，液位的深度为40mm，将供试溶液与水或溶剂或本文中规定的标准比色液（见标准比色液表）对比。在散射自然光，白色的背景下，垂直地观察比较颜色。 贮备液 黄色液称取46克氯化铁，加大约900ml盐酸溶液（25ml浓盐酸和975ml水混和）溶解，继续添加，并定容。 滴定并以上述盐酸溶液调整，使黄色液每毫升含 FeCl 3﹒6H 2 O。避光保存。 滴定在一个配有磨口塞的250ml锥形瓶内，加入黄色液，15ml 水，5ml浓盐酸和4g碘化钾，塞上瓶塞，在暗处放置15分钟，再加100ml 水。用的硫代硫酸钠标准溶液滴定游离的碘，在滴定接近终点时加淀粉试液作指示剂。 1ml 的硫代硫酸钠标准溶液相当于 FeCl 3﹒6H 2 O。 红色液称取60克氯化钴，加大约900ml盐酸溶液（25ml浓盐酸和975ml水混和）溶解，继续添加，并定容。 滴定并以上述盐酸溶液调整，使红色液每毫升含 CoCl 2﹒6H 2 O。 滴定在一个配有磨口塞的250ml锥形瓶内，加入红色液，5ml稀过氧化氢溶液和10ml 300g/l的氢氧化钠溶液，缓慢煮沸10分钟，冷却后，加60ml稀硫酸和2g碘化钾，塞上瓶塞，缓慢摇动锥形瓶，使沉淀溶解完全。用的硫代硫酸钠标准溶液滴定游离的碘，在滴定接近终点时加入淀粉试液作为指示剂。溶液变成粉红色时到达滴定终点。 的硫代硫酸钠标准溶液相当于 CoCl 2﹒6H 2 O。 蓝色液称取63克硫酸铜加大约900ml盐酸溶液（25ml浓盐酸和975ml水混和）溶解，继续添加，并定容。 滴定并以上述盐酸溶液调整，使蓝色液每毫升含 CuSO 4﹒5H 2 O。

小容量注射剂生产工艺规范通则

小容量注射剂生产工艺规程通则 目录 1．小容量注射剂生产工艺流程图、小容量注射剂车间概况（附图） 2．需要验证的关键工序及工艺验证（列表） 3．操作过程及工艺条件 4．技术安全、工艺卫生及劳动爱护 5．物料平衡及技经指标 6．设备一览表 7．岗位定员 8．附件目录（岗位操作、清洁规程）

1．可灭菌小容量注射剂的生产流程图 小容量注射剂车间概况（附图）讲明：由质监科按洁净厂房监操纵度SMP-ZL-014对洁净区进行监控，由工程设备科负责维修，车间应依照实际使用情况提出相应的建议，保证洁净厂房在使用中符合GMP的规定。 2．需要验证的关键工序及工艺验证（列表）

讲明：每年需按验证治理制度SMP-ZL-012对上述关键工序及工艺进行验证（再验证或回忆性验证）。若系统、设备设施 发生变更则必须进行相应的验证。 验证由厂验证小组负责。车间应依照情况及时提出相应的申请。 3．操作过程及工艺条件 3.1 工艺用水： 3.1.1 操作过程： 3.1.1.1 原水为符合国家饮用水的标准自来水。 3.1.1.2 纯化水由原水经石英砂过滤→精滤（PE棒）→阴床 →阳床→混床→紫外灯灭菌→进入贮罐。

3.1.1.3 注射用水由纯化水经多效蒸馏水机通过蒸馏而得。 3.1.2 工艺条件： 3.1.2.1 原水应符合国家饮用水标准。 3.1.2.2 原水的预处理的进水流量应≤3m3／h。 3.1.2.3 温床的流量为3m3／h。 3.1.2.4 多放蒸馏水机蒸气压力应在0.30~0.4Mpa之间，压 缩空气压力应在0.3~0.4MPa之间。 3.1.2.5 纯化水的电导率应≤2us／cm，离子检查符合?中 国药典?2005版二部“纯化水”的标准。 注射用水的电导率≤2us／cm，离子检查符合?中国药典?2005版二部“注射用水”的标准。 3.2 理瓶工序 3.2.1 本公司可灭菌小容量注射剂所选用直接接触药品的 容器为低硼硅玻璃安瓿，执行国家药品监督治理局国家药用 包装容器（材料）标准（试行）YBB00332002，以下均可简 称安瓿。 3.2.2 操作过程： 按批生产指令领取安瓿并除去外包装，烧字安瓿要核对批号、品名、规格、数量。在理瓶间逐盘理好后送入联动机 清洗或送入粗洗间用纯化水粗洗后送入精洗间超声，注射用 水甩干并检查清洁符合规定后送隧道烘房。

欧洲药典中文翻译

附录1溶液的澄清度 在内径15～25mm，平底，无色、透明、中性玻璃管中，加入等量的供试溶液与浊度标准液，使液位的深度都为40mm，按如下所述方法进行比较。浊度标准液制备5分钟后，以色散自然光照射浊度标准溶液和供试溶液，在黑色背景下从垂直方向观察、比较澄清度或浑浊程度。色散自然光必须较容易区分浊度标准溶液Ⅰ与水，浊度标准溶液Ⅱ与浊度标准溶液Ⅰ。 如果供试溶液的澄清、透明程度与水相同，或者与所用溶剂相同，或者其澄清度不超过Ⅰ号浊度标准溶液，那么可判定该溶液为澄清。 试剂： 硫酸肼溶液：取硫酸肼溶于水，加水稀释至，静置4～6小时。 乌洛托品（六亚甲基四胺）溶液：在100ml容量平中，以水溶解乌洛托品。 浊度标准贮备液：在存放乌洛托品溶液的100ml容量瓶中，加的硫酸肼溶液。混合，静置24小时，贮存在无表面要求的玻璃容器中，可在2个月内使用。该浊度液不得黏附玻璃，用前必须充分摇匀。 浊度标准原液：取浊度标准贮备液15ml，加水稀释、定容至1000ml。该液临用前制备，至多保存24小时。 浊度标准液：由浊度标准原液与水按表1-1配制,即得。本液应临用前配制。 表1-1

附录2 溶液颜色检查 按本药典规定，用下面两种方法之一可以检出溶液在棕色-黄色-红色范围内的颜色。 如果溶液A的外观与水或所用溶剂相同，或者颜色浅于标准比色液B9，则可判定溶液A为无色。 方法I

用外径为12mm的无色、透明中性玻璃管取2ml的供试溶液，与相同玻璃管中的2ml的水，或2ml本文所规定的标准比色液（见标准比色液表）进行比较。在散射自然光，白色的背景下，水平观察比较颜色。 方法Ⅱ 用同样平底、内径为15～25mm的无色透明中性玻璃管，液位的深度为40mm，将供试溶液与水或溶剂或本文中规定的标准比色液（见标准比色液表）对比。在散射自然光，白色的背景下，垂直地观察比较颜色。 贮备液 黄色液称取46克氯化铁，加大约900ml盐酸溶液（25ml浓盐酸和975ml水混和）溶解，继续添加，并定容。 滴定并以上述盐酸溶液调整，使黄色液每毫升含 FeCl3﹒6H2O。避光保存。 滴定在一个配有磨口塞的250ml锥形瓶内，加入黄色液，15ml 水，5ml浓盐酸和4g碘化钾，塞上瓶塞，在暗处放置15分钟，再加100ml 水。用的硫代硫酸钠标准溶液滴定游离的碘，在滴定接近终点时加淀粉试液作指示剂。 1ml 的硫代硫酸钠标准溶液相当于 FeCl3﹒6H2O。 红色液称取60克氯化钴，加大约900ml盐酸溶液（25ml浓盐酸和975ml水混和）溶解，继续添加，并定容。 滴定并以上述盐酸溶液调整，使红色液每毫升含 CoCl2﹒6H2O。

欧洲药典附录译文

第二部分、附录 附录1 溶液的澄清度 (2) 附录2 溶液颜色检查 (3) 附录3 旋光度 (6) 附录4 铵盐检查法 (8) 附录5 氯化物检查法 (9) 附录6 硫酸盐灰分 (10) 附录7 铁 (11) 附录8 重金属 (12) 附录9 干燥失重 (15) 附录10 硫酸盐检查法 (16) 附录11 红外吸收分光光度法 (17) 附录12 pH测定 (20) 附录13 滴定 (22) 附录14 氯化物鉴别反应 (23) 附录15 指示剂颜色与溶液pH 的关系 (24)

在内径15～25mm，平底，无色、透明、中性玻璃管中，加入等量的供试溶液与浊度标准液，使液位的深度都为40mm，按如下所述方法进行比较。浊度标准液制备5分钟后，以色散自然光照射浊度标准溶液和供试溶液，在黑色背景下从垂直方向观察、比较澄清度或浑浊程度。色散自然光必须较容易区分浊度标准溶液Ⅰ与水，浊度标准溶液Ⅱ与浊度标准溶液Ⅰ。 如果供试溶液的澄清、透明程度与水相同，或者与所用溶剂相同，或者其澄清度不超过Ⅰ号浊度标准溶液，那么可判定该溶液为澄清。 试剂： 硫酸肼溶液：取1.0g硫酸肼溶于水，加水稀释至100.0ml，静臵4～6小时。 乌洛托品（六亚甲基四胺）溶液：在100ml容量平中，以25.0ml水溶解2.5g乌洛托品。 浊度标准贮备液：在存放乌洛托品溶液的100ml容量瓶中，加25.0ml的硫酸肼溶液。混合，静臵24小时，贮存在无表面要求的玻璃容器中，可在2个月内使用。该浊度液不得黏附玻璃，用前必须充分摇匀。 浊度标准原液：取浊度标准贮备液15ml，加水稀释、定容至1000ml。该液临用前制备，至多保存24小时。 浊度标准液：由浊度标准原液与水按表1-1配制,即得。本液应临用前配制。

欧洲药典 10.0 5.1.8 50108 口服草药医疗产品及其制剂用提取物的微生物质量

04/2019:50108 5.1.8. 口服草药医疗产品及其制剂用提取物的微生物质量（MICROBIOLOGICAL QUALITY OF HERBAL MEDICINAL PRODUCTS FOR ORAL USE AND EXTRACTS USED IN THEIR PERPARATION） 该章节为草药医疗产品及其制剂用提取物提供推荐可接受标准。 非无菌产品的微生物检测按通用章节2.6.12、2.6.13和2.6.31给出的方法执行。下面给出了总需氧活菌计数(TAMC)和总酵母/霉菌计数(TYMC)的可接受标准。 可接受标准是基于单个结果或在进行了重复计数时重复计数结果的平均数。（例:直接平板计数法）。 某些特定微生物的可接受标准可见下表。该列表没有必要是详尽无遗的，对于给定的制剂需根据起始原料的性质、生产工艺及其使用目的进行必要的其他微生物测试。 含有活酵母菌药品的（活的生物治疗制品）不在此通论范围内。 草药医疗产品 A. 包含草药物质，含有或不含有赋形剂，意欲使用沸水制备浸剂和汤药的草药医疗产品（例如含有或不含有调味剂的草药茶） B. 含有例如提取物和/或草药物质，包含或不包含赋形剂，加工方法（例如，萃取），或者，如果合适的话，在这种情况下，草药物质的预处理能使微生物水平降低至下表列出的数目以下的草药医疗产品

C. 含有例如提取物和/或草药物质，包含或不包含赋形剂，加工方法（例如，使用低强度的乙醇或未沸腾的水进行萃取或低温度下制得的的浓缩液），或者在这种情况下，草药物质的预处理不能充分降低微生物水平至B下面要求的标准的草药医疗产品 提取物 提取物应符合类别B草药医疗产品的可接受标准。但是，当能够证明工艺方法不能使得微生物充分地减少到类别B的水平时，提取物应符合类别C草药医疗产品的要求。 该推荐可接受标准应用于意欲混合入口服草药医疗产品中的提取物。为了满足特定路径管理的可接受标准，对于意欲混合入通过其他路径管理的药用制剂的提取物，可提出更严格的可接受标准。 经认定，对于有些草药医疗产品和用于其制剂的提取物，由于微生物污染的典型水平，并不能满足上文所给TAMC, TYMC 和胆汁耐受革兰氏阴性菌的标准。可使用稍微宽松一些的可接受标准，前提是考虑到包括微生物污染的定性、定量特性和该草药医疗产品或提取物预期用途在内经过风险评估。如果指定的草药医疗产品或提取物方法不能在指定的微生物水平上有效计数，则可使用尽可能接近指定的可接受标准限度的经过验证的方法。

欧洲药典翻译一部分

5.4 残留溶剂 在活性物质、辅料和医药产品中限定残留溶剂水平 ICH采取了关于残留溶剂杂质指导原则，这个指导原则描述了在活性物质、辅料和医药产品中的溶剂浓度限定。指导原则排除了已存在的市场产品。EP采用了和这项指导原则同样的原则，不管存在的活性物质、辅料和医药产品是否是药典专论的内容。所有的物质和产品都要测定它们中可能出现的溶剂浓度。 其中限额适用遵从以下的，溶剂残留量测试在特定专论一般不提及，因为从一个制造商到另一个采用的溶剂可能会有所不同，这一总章的要求通过制药用物质（2034）适用。在产品生产过程中所采用的溶剂应告知主管，该信息也列于为EP专论的合格证而递交的卷宗，在证书中也提及。 其中只有使用第三类溶剂时，采用干燥损失测定或者进行溶剂的具体测定。如果采用了一种被确认可行的、权威的第三类溶剂，但高于限度0.5%，溶剂的具体测定是需要的。 当使用第一类或第二类溶剂（或第三类溶剂超过限度0.5%）时，用在一般方法中描述的方法，否则采用经证实的合适的方法。 当进行残留溶剂的定量测定时，在计算物质含量时，这个结果被考虑进去，除了干燥检验。 杂质：残留溶剂的指导原则 1.前言 该指导原则的目的是建议为了病人安全在药物中可允许的残留溶剂的量。该指导原则建议少使用有毒溶剂，描述了一些残留溶剂的毒性允许水平。 在这医药产品中的残留溶剂被定义为在活性物质或辅料的制造或医药产品的制剂中使用的或产生的有机挥发性物质。这些溶剂没有通过实用生产技术完全清除，在活性物质合成中合适地选择溶剂会提高产量，决定一些晶体的结构、纯度、溶解性等特征，因此有时溶剂会成为合成过程中的重要参数，该指导原则并没有指出辅料中使用的溶剂和溶剂化物，但是，这些产品中的溶剂含量应该评估并说明理由。 由于残留溶剂没有疗效，所有残留溶剂的去除都应该达到产品的标准或药品生产和管理规范或其他质量要求，医药产品不应包含比安全系数更高的水平的残留溶剂，一些溶剂会造成不允许的毒性，应该在生产中避免，除非他们的使用在风险效益评估中有强烈的理由。为了防止病人的副作用，一些低严重毒性的溶剂应该被限制。理论上，在生产中不应该使用有毒溶剂，所有在该指导原则中出现的溶剂列表在附录1中，该列表并不是详尽无漏的，其他溶剂可以使用可加到表中，其中第一类和第二类的限度或者溶剂的分类也可以随着新的安全数据而改变，含有新溶剂的新产品在市场上许可的安全数据的支持是以这个指导原则中的杂质限度概念为基础的。 2.指导原则的范围 活性物质、辅料和医药产品中的残留溶剂都在该范围内，因此当知道生产或纯化过程会导致这些溶剂的出现时，必须进行检测，只须检测在活性物质、辅料和医药产品生产纯化中的残留溶剂。虽然制造商会选择检测医药产品，但也可以从生产医药产品的组分水平用一种累积方法来计算医药产品中的残留溶剂水平。如果计算结果等于或小于该指导原则中规定的，就不需要考虑医药产品的检测了，但是如果高于这个水平，就需要检测医药产品来确定合成过程中是否要减少相关溶剂的水平到可允许的量，如果在制造中使用了一种溶剂医药产品也应检测。