List of European Pharmacopoeia Reference Standards-2013.07.28

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欧洲药典-凡例翻译

07/2010:10000 1. 凡例1.1. 概述凡例的内容适用于各论和欧洲药典中的其它章节。

欧洲药典以英语和法语形式发行，欧洲药典委员会的签署国可将药典内容译成其它语言，但若发生争议，应以英语和法语版为权威。

在欧洲药典中，如无特殊规定，“药典”是指欧洲药典，官方缩写Ph. Eur.也指欧洲药典。

文章中如果引用了各论中的标题和副标题意味着文章内容符合相关各论的要求。

文章参考药典中各论内容时，以斜体的各论题目或相关数字表示。

制剂在有效期内必须性质稳定，明确的有效期或说明书应由权力机构批准。

任何各论的物质也必须服从其使用期限。

任何药品的有效期和有效期的计算由权力机构经稳定性研究的试验结果决定。

除凡例和各论中另有说明，各论中的说明为强制要求；除了特定的引用信息，如果各论引用总论中内容时，该总论要求为法定要求。

各论中描述的有效成分（药用物质），辅料（辅助物质），药物制剂和其它成分用于人和兽的使用（除非明确限制不可使用）。

药品项目必须符合各论的要求，否则不符合药典质量。

但并不要求产品放行前，生产商要做各论中的每项试验以满足药典要求。

生产商可通过原始数据，例如生产过程验证，和中间体控制，确保药品是否符合药典要求。

公布的环境参数，权力机构可适当采信，但不排除故意满足药典要求的可能。

检测和试验方法应基于药典标准的官方方法。

经权利机构允许可采用其它替代的分析方法以达到控制目的，并证明该方法是否能达到各论各标准。

若出现争论或异议，应以药典方法为准。

药典各论中的某些物质有多个等级可满足各种需要，除各论中另有说明，要求适用于各等级。

在一些各论中，特别是辅料，一系列相关的功能特性都有介绍，其中给出了一些特性的检测方法。

质量体系：在适宜的质量体系架构下，产生有疑问的项目时，应以各论中的质量标准为法定标准。

通则：各论中介绍的药物和制剂也应符合通则中的相关要求。

交叉引用的通则在各论中不特别指出。

除非限定了适用条件，如规定适用于药典各论中的物质，通则的内容适用于各论定义范围内的所有药物和制剂。

欧洲药典标准 -回复

欧洲药典标准-回复药典是一种被广泛应用的药物品质标准，旨在确保药物的安全有效性和一致性。

在欧洲，欧洲药典（European Pharmacopoeia，简称EP）是药物品质标准的权威参考。

本文将详细介绍欧洲药典标准，并探讨其制定过程、应用范围和质量保证体系。

欧洲药典是一个权威的多语种国际标准，用于指导欧洲范围内的药品质量控制和动植物药材的使用。

它的主要目标是保护公众的健康和药物质量的一致性。

欧洲药典通过提供详细的技术要求和试验方法，确保药物的安全性、质量和有效性。

这些标准是法律要求的，对于药品的生产、检验、注册和销售等环节都具有强制性。

欧洲药典的制定过程是一个复杂而严格的过程，确保其科学性、可靠性和可操作性。

制定药典标准的首要任务是提供关于药物成分、成分含量、制剂质量和肆无忌惮等方面的详细要求。

制定标准的过程主要涉及以下几个步骤：1. 专家委员会的选任和组成：欧洲药典委员会由各成员国的专家组成，他们代表了各个与药品质量相关的领域。

委员会通过逐步审查和修订主题相关的信息以达成一致的看法。

2. 信息搜集和分析：药典编委会通过收集国内外研究成果、提取其他药典的信息以及接受专业机构的建议来获取丰富的药物信息。

然后对这些信息进行仔细分析，并根据实际需要确定关注的主题。

3. 提议书的准备和评议：基于对信息的分析和专家的经验意见，制定药典委员会针对具体主题的提议书。

这些提议书将被交给各个专家评审小组进行严格的评审和审查。

在评审期间，专家组将讨论并提出修改或澄清建议。

4. 决策和讨论：在评审小组的讨论和决策下，撰写新的或修改现有的章节，并形成正式的标准。

这些标准将提交给药典委员会的会议进行讨论和投票，以确保标准的内容是一致且明确的。

5. 公众咨询和意见征询：在标准定稿后，将公开征询公众、行业机构和利益相关者的意见。

这些意见将被认真分析，并对标准进行必要的修改和完善。

6. 标准的正式出版：最终的标准将被编写成正式的文档，并在欧洲药典的备案中登记。

欧洲药典凡例双语版

1 GENERAL NOTICES凡例1.1 GENERAL STATEMENTS概述The General Notices apply to all monographs and other texts of the European Pharmacopoeia.凡例的内容适用于各论和欧洲药典中的其它章节。

The official texts of the European Pharmacopoeia are published in English and French. Translations in other languages may be prepared by the signatoryStates of the European Pharmacopoeia Convention. In case of doubt or dispute, the English and French versions are alone authoritative.欧洲药典以英语和法语形式发行，欧洲药典委员会的签署国可将药典内容译成其它语言，但若发生争议，应以英语和法语版为权威。

In the texts of the European Pharmacopoeia, the word ‘Pharmacopoeia’ without qualification means the European Pharmacopoeia. The official abbreviation Ph.Eur. may be used to indicate the European Pharmacopoeia.在欧洲药典中，如无特殊规定，“药典”是指欧洲药典，官方缩写 Ph. Eur.也指欧洲药典。

The use of the title or the subtitle of a monograph implies that the articlecomplies with the requirements of the relevant monograph. Such references to monographs in the texts of the Pharmacopoeia are shown using themonograph title and reference number in italics.文章中如果引用了各论中的标题和副标题意味着文章内容符合相关各论的要求。

欧洲药典硫酸粘杆菌素标准

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EUROPEAN PHARMACOPOEIA 5.0
Reference solution (a). Dissolve 25.0 mg of colistin sulphate CRS in 40 ml of water R and dilute to 50.0 ml with acetonitrile R. Reference solution (b). Dilute 1.0 ml of reference solution (a) to 100.0 ml with a mixture of 20 volumes of acetonitrile R and 80 volumes of water R. Column : size : l = 0.15 m, = 4.6 mm, stationary phase: end-capped octadecylsilyl silica gel for chromatography R (3.5 m), temperature: 30 C. Mobile phase: mix 22 volumes of acetonitrile R and 78 volumes of a solution prepared as follows: dissolve 4.46 g of anhydrous sodium sulphate R in 900 ml of water R, add 2.5 ml of phosphoric acid R and dilute to 1000 ml with water R (pH 2.3 to 2.5). Flow rate : 1.0 ml/min. Detection : spectrophotometer at 215 nm. Injection : 20 l. Run time : 1.5 times the retention time of colistin E1. Relative retention with reference to colistin E1 (retention time = about 16 min): colistin E2 = about 0.45; colistin E3 = about 0.5; colistin E1-I = about 0.8; colistin E1-7MOA = about 1.1. System suitability : reference solution (a): resolution : minimum 8.0 between the peaks due to colistin E2 and colistin E1, minimum 6.0 between the peaks due to colistin E2 and colistin E1-I, minimum 2.5 between the peaks due to colistin E1-I and colistin E1, minimum 1.5 between the peaks due to colistin E1 and colistin E1-7MOA, the chromatogram obtained is concordant with the chromatogram supplied with colistin sulphate CRS. Limits : any impurity : maximum 4.0 per cent, total : maximum 23.0 per cent, disregard limit: the area of the peak due to colistin E1 in the chromatogram obtained with reference solution (b) ; disregard the peaks due to colistin E2, E3, E1-I, E1 and E1-7MOA. Sulphate : 16.0 per cent to 18.0 per cent (dried substance). Dissolve 0.250 g in 100 ml of water R and adjust to pH 11 using concentrated ammonia R. Add 10.0 ml of 0.1 M barium chloride and about 0.5 mg of phthalein purple R. Titrate with 0.1 M sodium edetate, adding 50 ml of alcohol R when the colour of the solution begins to change and continuing the titration until the violet-blue colour disappears. 1 ml of 0.1 M barium chloride is equivalent to 9.606 mg of SO4 . Loss on drying (2.2.32): maximum 3.5 per cent, determined on 1.000 g by drying at 60 C over diphosphorus pentoxide R at a pressure not exceeding 670 Pa for 3 h. Sulphated ash (2.4.14): maximum 1.0 per cent, determined on 1.0 g. ASSAY Liquid chromatography (2.2.29) as described in the test for related substances with the following modification. Injection : test solution and reference solution (a). Calculate the percentage content of the sum of colistins E2, E3, E1-I, E1 and E1-7MOA, the percentage content of colistin E3, the percentage content of colistin E1-I and 1362

《欧盟传统植物药(草药)注册程序指令》中英文

《欧盟传统植物药（草药）注册程序指令》DIRECTIVE 2004/24/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL欧洲议会和理事会2004/24/EC指令of 31 March 20042004年3月31日amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on theCommunity code relating to medicinal products for human use对欧共体人用药品2001/83/EC指令中关于传统草药产品部分的修订（中文由商务部科技司翻译整理，仅供参考）THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,Having regard to the proposal from the Commission (1),Having regard to the opinion of the European Economic andSocial Committee (2),Acting in accordance with the procedure laid down in Article 251 of the Treaty (3),欧盟欧洲议会和理事会遵照欧共体条约，特别是其中的第95条，遵照欧委会的提议遵照经济和社会委员会的意见依照条约第251条项下规定的程序Whereas:(1) Directive 2001/83/EC (4) requires that applications for authorisation to place a medicinal product on the market have to be accompanied by a dossier containing particulars and documents relating in particular to the results of physico-chemical, biological or microbiological tests as well as pharmacological and toxicological tests and clinical trials carried out on the product and thus proving its quality, safety and efficacy.鉴于：（1）2001/83/EC指令规定：欲获得药品市场准入的申请者，应提供详细技术资料和文件，它们应包括产品的理化，生物或微生物、药理、毒理和临床试验结果，以证明产品的质量、安全和有效性。

list_of_contents_supplement_pheur_8_6

EUROPEAN PHARMACOPOEIA8.6Contents of Supplement8.6 CONTENTS OF SUPPLEMENT8.6A vertical line in the margin indicates where part of a text has been revised or corrected.A horizontal line in the margin indicates where part of a text has been deleted.However,these indications,which are not necessarily exhaustive,are given for information and do not form an official part of the texts.Editorial changes are not indicated.Individual copies of texts will not be supplied.Subscribers to the current version(printed or electronic)of the European Pharmacopoeia have access to an archive version of all previous editions of the European Pharmacopoeia.NEW TEXTSThe texts below appear for the first time in the European Pharmacopoeia.They will be implemented on1January2016at the latest.MONOGRAPHSRadiopharmaceutical preparations and starting materials for radiopharmaceutical preparationsCopper tetramibi tetraﬂuoroborate for radiopharmaceutical preparations(2547)Herbal drugs and herbal drug preparations Anemarrhena asphodeloides rhizome(2661)Hamamelis bark(2532)Indigo plant leaf(2727)Homoeopathic preparationsBelladonna for homoeopathic preparations(2489)Petroleum rectiﬁcatum for homoeopathic preparations(2683) Staphysagria for homoeopathic preparations(2289) MonographsExemestane(2766)Nicorandil(2332)Pirfenidone(2856)Sodium selenite(2740)Solifenacin succinate(2779)Somatropin solution for injection(2370)REVISED TEXTSThe texts below have been technically revised since their last publication.They will be implemented on1January2016.GENERAL CHAPTERS2.2.4.Approximate pH of solutions2.2.19.Amperometric titration2.2.20.Potentiometric titration2.2.34.Thermal analysis2.2.36.Potentiometric determination of ionic concentrationusing ion-selective electrodesposition of fatty acids in oils rich in omega-3acids2.5.5.Peroxide value2.5.32.Water:micro determination2.9.3.Dissolution test for solid dosage forms2.9.40.Uniformity of dosage units4.Reagents(new,revised,corrected)5.2.4.Cell cultures for the production of veterinary vaccines 5.8.Pharmacopoeial harmonisations of herbal drugs used in traditional ChinesemedicineMONOGRAPHSVaccines for veterinary useBrucellosis vaccine(live)(Brucella melitensis Rev.1strain)for veterinary use(0793)Radiopharmaceutical preparations and starting materials for radiopharmaceutical preparationsPentetate sodium calcium for radiopharmaceutical preparations(2353)Technetium(99m Tc)medronate injection(0641)Herbal drugs and herbal drug preparationsBenzoin,Siam(2158)Bilberry fruit,dried(1588)Bilberry fruit,fresh(1602)Centella(1498)Fresh bilberry fruit dry extract,reﬁned and standardised (2394)Ginseng(1523)Java tea(1229)Homoeopathic preparationsMethods of preparation of homoeopathic stocks and potentisation(2371)MonographsAluminium phosphate,hydrated(1598)Amidotrizoic acid dihydrate(0873)Amiloride hydrochloride dihydrate(0651)Amlodipine besilate(1491)Anticoagulant and preservative solutions for human blood (0209)Aprotinin(0580)Aprotinin concentrated solution(0579)Bromhexine hydrochloride(0706)Buserelin(1077)Carbomers(1299)Carnauba wax(0597)Chymotrypsin(0476)Crospovidone(0892)Demeclocycline hydrochloride(0176)Dihydralazine sulfate,hydrated(1310) Diphenhydramine hydrochloride(0023)xxxviiContents of Supplement8.6EUROPEAN PHARMACOPOEIA8.6Dithranol(1007)Doxapram hydrochloride(1201)Filgrastim concentrated solution(2206)Fluticasone propionate(1750)Fructose(0188)Fulvestrant(2443)Galactose(1215)Glimepiride(2223)Glucose,anhydrous(0177)Glucose monohydrate(0178)Hexylresorcinol(1437)Human coagulation factor IX(rDNA)concentrated solution (2522)Hypromellose(0348)Iopanoic acid(0700)Ioxaglic acid(2009)Isoleucine(0770)Lactose,anhydrous(1061)Lactose monohydrate(0187)Leucine(0771)Lysine hydrochloride(0930)Methionine(1027)Methylcellulose(0345)Methylprednisolone acetate(0933) Methylprednisolone hydrogen succinate(1131) Methylthioninium chloride(1132)Naftidrofuryl hydrogen oxalate(1594)Nicotinamide(0047)Orphenadrine citrate(1759)Orphenadrine hydrochloride(1760) Oxeladin hydrogen citrate(1761)Oxolinic acid(1353)Pancreas powder(0350)Phenazone(0421)Phentolamine mesilate(1138) Polysorbate80(0428)Potassium hydroxide(0840)Povidone,iodinated(1142)Propylene glycol dicaprylocaprate(2122) Quinidine sulfate(0017)Quinine hydrochloride(0018)Quinine sulfate(0019)Risedronate sodium2.5-hydrate(2572) Rivastigmine hydrogen tartrate(2630) Sodium amidotrizoate(1150)Sodium hydroxide(0677)Sodium nitroprusside(0565)Sodium selenite pentahydrate(1677) Spirapril hydrochloride monohydrate(1766) Sucrose(0204)Sugar spheres(1570)Sulfacetamide sodium(0107) Theophylline-ethylenediamine hydrate(0301) Thiamine hydrochloride(0303)Thiamine nitrate(0531)Thiamphenicol(0109)Tribenoside(1740)Trypsin(0694)CORRECTED TEXTSThe texts below have been corrected and are republished in their entirety.These corrections are to be taken into account from the publication date of Supplement8.6(1July2015),unless otherwise indicated.GENERAL CHAPTERSposition of fatty acids by gas chromatography 2.5.1.Acid value2.7.14.Assay of hepatitis A vaccine2.8.13.Pesticide residues5.7.Table of physical characteristics of radionuclidesmentioned in the European PharmacopoieaMONOGRAPHSRadiopharmaceutical preparations and starting materials for radiopharmaceutical preparationsGallium(68Ga)edotreotide injection(2482)MonographsCimetidine(0756)Cimetidine hydrochloride(1500) Flucytosine(0766)Goserelin(1636)Human antithrombin III concentrate(0878)(1) Insulin,bovine(1637)Insulin,human(0838)Insulin,porcine(1638)Insulin preparations,injectable(0854) Isomalt(1531)Miconazole nitrate(0513)Nitric acid(1549)Oxaliplatin(2017)Polyoxypropylene stearyl ether(2602)(1)Correction to be taken into account from1January2015. xxxviiiEUROPEAN PHARMACOPOEIA8.6Contents of Supplement8.6HARMONISED TEXTSThe texts below have undergone pharmacopoeial harmonisation(see chapter5.8.Pharmacopoeial harmonisation).GENERAL CHAPTERS2.2.34.Thermal analysis2.9.3.Dissolution test for solid dosage forms 2.9.40.Uniformity of dosage unitsMONOGRAPHSMonographsCrospovidone(0892)Glucose,anhydrous(0177) Glucose monohydrate(0178) Hypromellose(0348) Methylcellulose(0345) Polysorbate80(0428)TEXTS WHOSE TITLE HAS CHANGED The titles of the following texts have been changed in Supplement8.6.GENERAL CHAPTERS2.2.4.Approximate pH of solutions(previously Relationshipbetween reaction of solution,approximate pH andcolour of certain indicators)MONOGRAPHSMonographsAmiloride hydrochloride dihydrate(0651)(previously Amiloride hydrochloride)DELETED TEXTSThe following texts are deleted as of1January2016.MONOGRAPHSImmunosera for veterinary useClostridium novyi alpha antitoxin for veterinary use(0339)Clostridium perfringens beta antitoxin for veterinary use(0340)Clostridium perfringens epsilon antitoxin for veterinary use(0341)The following text is deleted as of1April2015.MONOGRAPHSMonographsLiquorice ethanolic liquid extract,standardised(1536)xxxix。

欧洲药典索引版3

EUROPEAN PHARMACOPOEIA5.5INDEXTo aid users the index includes a reference to the supplement where the latest version of a text can be found.For example:Acetone...............................................5.1-2875means the monograph Acetone can be found on page2875of Supplement5.1.Note that where no reference for a supplement is made,the text can be found in the principal volume.Monographs deleted from the5th edition are not included in the index;the list of deleted texts is found in the Contents of this supplement,page xxx.EUROPEAN PHARMACOPOEIA5.5Numerics1.1.General statements (5)1.2.Other provisions applying to general chapters and monographs (5)1.3.General chapters (6)1.4.Monographs (7)1.5.Abbreviations and symbols (9)1.6.Units of the International System(SI)used in the Pharmacopoeia and equivalence with other units (10)1.General notices (5)2.1.1.Droppers (17)parative table of porosity of sintered-glass filters (17)2.1.3.Ultraviolet ray lamps for analytical purposes (17)2.1.4.Sieves (18)2.1.5.Tubes for comparative tests (19)2.1.6.Gas detector tubes (19)2.1.Apparatus (17)2.2.10.Viscosity-Rotating viscometer method.........5.3-3337 2.2.11.Distillation range (30)2.2.12.Boiling point (31)2.2.13.Determination of water by distillation (32)2.2.14.Melting point-capillary method (32)2.2.15.Melting point-open capillary method (33)2.2.16.Melting point-instantaneous method (33)2.2.17.Drop point (33)2.2.18.Freezing point (34)2.2.19.Amperometric titration (34)2.2.1.Clarity and degree of opalescence of liquids (23)2.2.20.Potentiometric titration (35)2.2.21.Fluorimetry (35)2.2.22.Atomic emission spectrometry (35)2.2.23.Atomic absorption spectrometry (36)2.2.24.Absorption spectrophotometry,infrared (37)2.2.25.Absorption spectrophotometry,ultraviolet and visible.................................................................................5.2-3089 2.2.26.Paper chromatography. (40)2.2.27.Thin-layer chromatography...............................5.2-3090 2.2.28.Gas chromatography.. (42)2.2.29.Liquid chromatography (43)2.2.2.Degree of coloration of liquids (24)2.2.30.Size-exclusion chromatography (45)2.2.31.Electrophoresis (45)2.2.32.Loss on drying (50)2.2.33.Nuclear magnetic resonance spectrometry (51)2.2.34.Thermal analysis (52)2.2.35.Osmolality (54)2.2.36.Potentiometric determination of ionic concentration using ion-selective electrodes (55)2.2.37.X-ray fluorescence spectrometry (56)2.2.38.Conductivity.........................................................5.1-2783 2.2.39.Molecular mass distribution in dextrans (57)2.2.3.Potentiometric determination of pH (26)2.2.40.Near-infrared spectrophotometry (59)2.2.41.Circular dichroism (63)2.2.42.Density of solids (64)2.2.43.Mass spectrometry (65)2.2.44.Total organic carbon in water for pharmaceutical use (68)2.2.45.Supercritical fluid chromatography (68)2.2.46.Chromatographic separation techniques (69)2.2.47.Capillary electrophoresis (74)2.2.48.Raman spectrometry (79)2.2.49.Falling ball viscometer method (80)2.2.4.Relationship between reaction of solution, approximate pH and colour of certain indicators (27)2.2.54.Isoelectric focusing (81)2.2.55.Peptide mapping (82)2.2.56.Amino acid analysis.......................................................862.2.5.Relative density.. (27)2.2.6.Refractive index (28)2.2.7.Optical rotation......................................................5.4-3695 2.2.8.Viscosity (29)2.2.9.Capillary viscometer method (29)2.2.Physical and physicochemical methods (23)2.3.1.Identification reactions of ions and functional groups...............................................................................5.5-4101 2.3.2.Identification of fatty oils by thin-layer chromatography. (98)2.3.3.Identification of phenothiazines by thin-layer chromatography (99)2.3.4.Odour (99)2.3.Identification (95)2.4.10.Lead in sugars (107)2.4.11.Phosphates (108)2.4.12.Potassium (108)2.4.13.Sulphates (108)2.4.14.Sulphated ash......................................................5.3-3341 2.4.15.Nickel in polyols.. (108)2.4.16.Total ash (108)2.4.17.Aluminium (108)2.4.18.Free formaldehyde (109)2.4.19.Alkaline impurities in fatty oils (109)2.4.1.Ammonium (103)2.4.21.Foreign oils in fatty oils by thin-layer chromatography (109)position of fatty acids by gas chroma-tography (110)2.4.23.Sterols in fatty oils..............................................5.1-2787 2.4.24.Identification and control of residual solvents (113)2.4.25.Ethylene oxide and dioxan (118)2.4.26.N,N-Dimethylaniline (119)2.4.27.Heavy metals in herbal drugs and fatty oils (119)2.4.28.2-Ethylhexanoic acid (120)position of fatty acids in oils rich inomega-3-acids...................................................................5.5-4107 2.4.2.Arsenic (103)2.4.30.Ethylene glycol and diethylene glycol in ethoxylated substances........................................................................5.2-3095 2.4.3.Calcium.. (103)2.4.4.Chlorides (104)2.4.5.Fluorides (104)2.4.6.Magnesium (104)2.4.7.Magnesium and alkaline-earth metals (104)2.4.8.Heavy metals (104)2.4.9.Iron (107)2.4.Limit tests (103)2.5.10.Oxygen-flask method (130)plexometric titrations (130)2.5.12.Water:semi-micro determination (130)2.5.13.Aluminium in adsorbed vaccines (131)2.5.14.Calcium in adsorbed vaccines (131)2.5.15.Phenol in immunosera and vaccines (131)2.5.16.Protein in polysaccharide vaccines (131)2.5.17.Nucleic acids in polysaccharide vaccines (132)2.5.18.Phosphorus in polysaccharide vaccines (132)2.5.19.O-Acetyl in polysaccharide vaccines (132)2.5.1.Acid value................................................................5.2-3099 2.5.20.Hexosamines in polysaccharide vaccines. (132)2.5.21.Methylpentoses in polysaccharide vaccines (133)2.5.22.Uronic acids in polysaccharide vaccines (133)2.5.23.Sialic acid in polysaccharide vaccines (133)2.5.24.Carbon dioxide in gases (134)2.5.25.Carbon monoxide in gases (134)2.5.26.Nitrogen monoxide and nitrogen dioxide in gases (135)2.5.27.Oxygen in gases (136)2.5.28.Water in gases (136)2.5.29.Sulphur dioxide (136)2.5.2.Ester value (127)2.5.30.Oxidising substances (137)2.5.31.Ribose in polysaccharide vaccines (137)2.5.32.Water:micro determination (137)2.5.33.Total protein (138)2.5.34.Acetic acid in synthetic peptides (141)2.5.35.Nitrous oxide in gases (141)2.5.36.Anisidine value (142)2.5.3.Hydroxyl value (127)2.5.4.Iodine value (127)2.5.5.Peroxide value (128)2.5.6.Saponification value (129)2.5.7.Unsaponifiable matter (129)2.5.8.Determination of primary aromaticamino-nitrogen (129)2.5.9.Determination of nitrogen by sulphuric acid digestion (129)2.5.Assays (127)2.6.10.Histamine (153)2.6.11.Depressor substances (153)2.6.12.Microbiological examination of non-sterile products (total viable aerobic count) (154)2.6.13.Microbiological examination of non-sterile products (test for specified micro-organisms) (156)2.6.14.Bacterial endotoxins (161)2.6.15.Prekallikrein activator........................................5.5-4111 2.6.16.Tests for extraneous agents in viral vaccines for human use (169)2.6.17.Test for anticomplementary activity of immunoglobulin (170)2.6.18.Test for neurovirulence of live virus vaccines (172)2.6.19.Test for neurovirulence of poliomyelitis vaccine (oral) (172)2.6.1.Sterility (145)2.6.20.Anti-A and anti-B haemagglutinins(indirect method) (174)2.6.21.Nucleic acid amplification techniques............5.5-4111 2.6.22.Activated coagulation factors...........................5.5-4115 2.6.24.Avian viral vaccines:tests for extraneous agents in seed lots............................................................................5.4-3699 2.6.25.Avian live virus vaccines:tests for extraneous agents in batches of finished product.....................................5.3-3345 2.6.26.Test for anti-D antibodies in human immunoglobulin for intravenous administration....................................5.3-3348 2.6.2.Mycobacteria. (149)2.6.7.Mycoplasmas (149)2.6.8.Pyrogens (152)2.6.9.Abnormal toxicity (153)2.6.Biological tests (145)2.7.10.Assay of human coagulation factor VII (203)2.7.11.Assay of human coagulation factor IX............5.5-4120 2.7.12.Assay of heparin in coagulation factors (204)2.7.13.Assay of human anti-D immunoglobulin (205)2.7.14.Assay of hepatitis A vaccine..............................5.1-2795 2.7.15.Assay of hepatitis B vaccine(rDNA). (207)2.7.16.Assay of pertussis vaccine(acellular) (208)2.7.17.Assay of human antithrombin III (209)2.7.18.Assay of human coagulation factor II (209)2.7.19.Assay of human coagulation factor X (210)2.7.1.Immunochemical methods (187)2.7.20.In vivo assay of poliomyelitis vaccine (inactivated) (210)2.7.21.Assay of human von Willebrand factor...........5.5-4120 2.7.22.Assay of human coagulation factor XI............5.5-4121 2.7.2.Microbiological assay of antibiotics. (188)2.7.4.Assay of human coagulation factor VIII...........5.5-4119 2.7.5.Assay of heparin.. (195)2.7.6.Assay of diphtheria vaccine(adsorbed).....................1962.7.7.Assay of pertussis vaccine (197)2.7.8.Assay of tetanus vaccine(adsorbed)..................5.1-2791 2.7.9.Test for Fc function of immunoglobulin. (202)2.7.Biological assays (187)2.8.10.Solubility in alcohol of essential oils (216)2.8.11.Assay of1,8-cineole in essential oils (216)2.8.12.Determination of essential oils in vegetable drugs (217)2.8.13.Pesticide residues (218)2.8.14.Determination of tannins in herbal drugs (221)2.8.15.Bitterness value (221)2.8.16.Dry residue of extracts (222)2.8.17.Loss on drying of extracts (222)2.8.1.Ash insoluble in hydrochloric acid (215)2.8.2.Foreign matter (215)2.8.3.Stomata and stomatal index (215)2.8.4.Swelling index (215)2.8.5.Water in essential oils (216)2.8.6.Foreign esters in essential oils (216)2.8.7.Fatty oils and resinified essential oils in essential oils (216)2.8.8.Odour and taste of essential oils (216)2.8.9.Residue on evaporation of essential oils (216)2.8.Methods in pharmacognosy (215)2.9.10.Ethanol content and alcoholimetric tables (237)2.9.11.Test for methanol and2-propanol...................5.3-3362 2.9.12.Sieve test (239)2.9.13.Limit test of particle size by microscopy (239)2.9.14.Specific surface area by air permeability (239)2.9.15.Apparent volume (241)2.9.16.Flowability (242)2.9.17.Test for extractable volume of parenteral preparations.....................................................................5.3-3363 2.9.18.Preparations for inhalation:aerodynamic assessment of fine particles...............................................................5.2-3103 2.9.19.Particulate contamination:sub-visible particles (253)2.9.1.Disintegration of tablets and capsules..............5.3-3351 2.9.20.Particulate contamination:visible particles. (255)2.9.22.Softening time determination of lipophilic suppositories (256)2.9.23.Pycnometric density of solids (257)2.9.24.Resistance to rupture of suppositories and pessaries (258)2.9.25.Dissolution test for medicated chewing gums..................................................................................5.2-3116 2.9.26.Specific surface area by gas adsorption.........5.1-2811 2.9.27.Uniformity of mass of delivered doses from multidose containers. (263)2.9.28.Test for deliverable mass or volume of liquid and semi-solid preparations (263)2.9.29.Intrinsic dissolution............................................5.4-3705 2.9.2.Disintegration of suppositories and pessaries (227)2.9.36.Powder flow..........................................................5.3-3363 2.9.37.Optical microscopy..............................................5.3-3366 2.9.38.Particle-size distribution estimation by analytical sieving...............................................................................5.3-3368 2.9.3.Dissolution test for solid dosage forms............5.3-3353 2.9.40.Uniformity of dosage units................................5.3-3370 2.9.42.Dissolution test for lipophilic solid dosage forms..................................................................................5.3-3373 2.9.4.Dissolution test for transdermal patches (231)2.9.5.Uniformity of mass of single-dose preparations (233)2.9.6.Uniformity of content of single-dose preparations..234 2.9.7.Friability of uncoated tablets..............................5.2-3103 2.9.8.Resistance to crushing of tablets.. (235)2.9.9.Measurement of consistency by penetrometry (235)2.9.Pharmaceutical technical procedures (225)3.1.10.Materials based on non-plasticised poly(vinyl chloride) for containers for non-injectable,aqueous solutions (289)3.1.11.Materials based on non-plasticised poly(vinyl chloride)for containers for dry dosage forms for oral administration..........................................................................2913.1.1.1.Materials based on plasticised poly(vinyl chloride)for containers for human blood and blood components. (269)3.1.1.2.Materials based on plasticised poly(vinyl chloride)for tubing used in sets for the transfusion of blood andblood components (272)3.1.13.Plastic additives (293)3.1.14.Materials based on plasticised poly(vinyl chloride)for containers for aqueous solutions for intravenous infusion......................................................................................2963.1.15.Polyethyleneterephthalatefor containers forpreparations not for parenteral use.....................................2983.1.1.Materials for containers for human blood and blood components. (269)3.1.3.Polyolefines (274)3.1.4.Polyethylene without additives for containers for parenteral preparations and for ophthalmic preparations..............................................................................2783.1.5.Polyethylene with additives for containers for parenteral preparations and for ophthalmicpreparations..............................................................................2793.1.6.Polypropylene for containers and closures for parenteral preparationsand ophthalmic preparations (282)3.1.7.Poly(ethylene -vinyl acetate)for containers and tubing for total parenteral nutrition preparations........................2853.1.8.Silicone oilused as a lubricant (287)3.1.9.Silicone elastomer for closures and tubing..............2883.1.Materials used for the manufacture of containers.....2693.2.1.Glass containers for pharmaceutical use..................3033.2.2.1.Plastic containers for aqueous solutions for parenteral infusion..................................................................3093.2.2.Plastic containers and closures for pharmaceuticaluse...............................................................................................3083.2.3.Sterile plastic containers for human blood and bloodcomponents...............................................................................3093.2.4.Empty sterile containers of plasticised poly(vinylchloride)forhuman blood and blood components...........3113.2.5.Sterile containers of plasticisedpoly (vinylchloride)for human blood containing anticoagulant solution.......3123.2.6.Sets for the transfusion of blood and blood components................................................................................3133.2.8.Sterile single-use plastic syringes................................3143.2.9.Rubber closures for containers for aqueous parenteral preparations,for powders and for freeze-dried powders..3163.2.Containers...........................................................................3034.1.1.Reagents..................................................................5.4-37094.1.1.Reagents..................................................................5.5-41254.1.2.Standard solutions for limit tests.......................5.4-38174.1.2.Standard solutions for limit tests.......................5.5-41264.1.3.Buffer solutions.....................................................5.4-38214.1.3.Buffer solutions.....................................................5.5-41264.1.Reagents,standard solutions,buffer solutions..5.4-37094.2.1.Primary standards for volumetric solutions....5.4-38274.2.2.Volumetric solutions.............................................5.4-38274.2.2.Volumetric solutions.............................................5.5-41274.2.Volumetric analysis...................................................5.4-38274.Reagents.........................................................................5.4-37095.10.Control of impurities in substances for pharmaceuticaluse......................................................................................5.5-41455.11.Characters section in monographs (565)5.1.1.Methods of preparation of sterile products..............4455.1.2.Biological indicators of sterilisation (447)5.1.3.Efficacy of antimicrobial preservation.......................4475.1.4.Microbiological quality of pharmaceuticalpreparations (449)5.1.5.Application of the F 0concept to steam sterilisation of aqueous preparations....................................................5.1-2821 5.1.6.Alternative methods for control of microbiological quality................................................................................5.5-41315.1.Generaltexts onsterility..................................................4455.2.1.Terminology used in monographs on vaccines (453)5.2.2.Chicken flocks free from specified pathogens for the production and quality control of vaccines...............5.1-28255.2.3.Cell substrates for the production of vaccines for human use.................................................................................4555.2.4.Cell cultures for the production of veterinaryvaccines (458)5.2.5.Substances of animal origin for the production ofveterinary vaccines (460)5.2.6.Evaluation of safety of veterinary vaccines andimmunosera ....................................................................5.1-28275.2.7.Evaluation of efficacy of veterinary vaccines and immunosera.....................................................................5.1-28295.2.8.Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (463)5.2.9.Evaluation of safety of each batch of veterinary vaccines and immunosera.............................................5.1-28305.2.General texts on vaccines (453)5.3.Statistical analysis of results of biological assays andtests (475)5.4.Residual solvents...............................................................5075.5.Alcoholimetric tables.........................................................5195.6.Assay of interferons..................................................5.3-33815.7.Table of physical characteristics of radionuclidesmentioned in the European Pharmacopoeia.....................5395.8.Pharmacopoeial harmonisation.....................................5515.9.Polymorphism (555)AAbbreviationsand symbols (1.5.) (9)Abnormal toxicity (2.6.9.) (153)Absinthiiherba ........................................................................2710Absorption spectrophotometry,infrared (2.2.24.). (37)Absorption spectrophotometry,ultraviolet and visible (2.2.25.).............................................................................5.2-3089Acacia (905)Acaciae gummi (905)Acaciae gummi dispersione desiccatum .............................905Acacia,spray-dried (905)Acamprosate calcium................................................................906Acamprosatum calcicum (906)Acarbose..............................................................................5.1-2873Acarbosum .........................................................................5.1-2873Acebutololhydrochloride................................................5.4-3889Acebutololi hydrochloridum .........................................5.4-3889Aceclofenac (909)Aceclofenacum (909)Acesulfame potassium.....................................................5.4-3890Acesulfamum kalicum ....................................................5.4-3890Acetazolamide (912)Acetazolamidum (912)Acetic acid,glacial (913)Acetic acid in synthetic peptides (2.5.34.) (141)Acetone................................................................................5.1-2875Acetonum ...........................................................................5.1-2875Acetylcholine chloride...............................................................914Acetylcholini chloridum .. (914)Acetylcysteine..............................................................................915Acetylcysteinum (915)β-Acetyldigoxin..................................................................5.5-4185β-Acetyldigoxinum ...........................................................5.5-4185Acetylsalicylic acid (917)Acetyltryptophan,N - (918)Acetyltyrosine,N - (920)Aciclovir..............................................................................5.3-3436Aciclovirum.......................................................................5.3-3436 Acidum4-aminobenzoicum (973)Acidum aceticum glaciale (913)Acidum acetylsalicylicum (917)Acidum adipicum (926)Acidum alginicum (942)Acidum amidotrizoicum dihydricum (967)Acidum aminocaproicum (974)Acidum ascorbicum (1025)Acidum asparticum (1029)Acidum benzoicum (1072)Acidum boricum (1117)Acidum caprylicum (1172)Acidum chenodeoxycholicum (1247)Acidum citricum anhydricum (1306)Acidum citricum monohydricum (1307)Acidum edeticum.............................................................5.4-3933 Acidum etacrynicum.. (1542)Acidum folicum (1630)Acidum fusidicum (1645)Acidum glutamicum (1670)Acidum hydrochloridum concentratum (1755)Acidum hydrochloridum dilutum (1756)Acidum iopanoicum (1824)Acidum iotalamicum (1825)Acidum ioxaglicum (1826)Acidum lacticum..............................................................5.2-3227 Acidum lactobionicum.. (1885)Acidum maleicum (1966)Acidum malicum (1966)Acidum mefenamicum (1984)Acidum methacrylicum et ethylis acrylas polymerisatum 1:1 (2005)Acidum methacrylicum et ethylis acrylas polymerisatum 1:1dispersio30per centum (2005)Acidum methacrylicum et methylis methacrylas polymerisatum1:1 (2006)Acidum methacrylicum et methylis methacrylas polymerisatum1:2 (2007)Acidum nalidixicum (2080)Acidum nicotinicum (2097)Acidum nitricum (2105)Acidum oleicum (2132)Acidum oxolinicum (2165)Acidum palmiticum (2179)Acidum phosphoricum concentratum (2237)Acidum phosphoricum dilutum (2238)Acidum pipemidicum trihydricum (2249)Acidum salicylicum.........................................................5.1-3007 Acidum(S)-lacticum........................................................5.2-3227 Acidum sorbicum.. (2467)Acidum stearicum (2490)Acidum sulfuricum (2520)Acidum tartaricum (2534)Acidum thiocticum...........................................................5.5-4312 Acidum tiaprofenicum.. (2578)Acidum tolfenamicum (2601)Acidum tranexamicum (2609)Acidum trichloraceticum (2620)Acidum undecylenicum (2658)Acidum ursodeoxycholicum (2662)Acidum valproicum (2669)Acid value(2.5.1.)..............................................................5.2-3099 Acitretin. (922)Acitretinum (922)Acriflavinii monochloridum (924)Acriflavinium monochloride (924)Actinobacillosis vaccine(inactivated),porcine (784)Activated charcoal....................................................................1246Activated coagulation factors(2.6.22.).........................5.5-4115 Additives,plastic(3.1.13.) (293)Adenine (924)Adeninum (924)Adenosine (925)Adenosinum (925)Adeps lanae.......................................................................5.2-3285 Adeps lanae cum aqua.. (2709)Adeps lanae hydrogenatus (2708)Adeps solidus (1711)Adipic acid (926)Adrenaline tartrate (927)Adrenalini tartras (927)Aer medicinalis (929)Aer medicinalis artificiosus (932)Aerodynamic assessment of fine particles in preparations for inhalation(2.9.18.).........................................................5.2-3103 Aether.. (1548)Aether anaestheticus (1549)Agar (928)Agni casti fructus.............................................................5.4-3892 Agnus castus fruit.............................................................5.4-3892 Agrimoniae herba (929)Agrimony (929)Air,medicinal (929)Air,synthetic medicinal (932)Alanine (933)Alaninum (933)Albendazole (934)Albendazolum (934)Albumini humani solutio...............................................5.3-3511 Albumin solution,human................................................5.3-3511 Alchemilla (935)Alchemillae herba (935)Alcohol benzylicus...........................................................5.5-4197 Alcohol cetylicus...............................................................5.3-3475 Alcohol cetylicus et stearylicus....................................5.3-3474 Alcohol cetylicus et stearylicus emulsificans A.. (1239)Alcohol cetylicus et stearylicus emulsificans B (1241)Alcoholes adipis lanae (2703)Alcoholimetric tables(2.9.10.) (237)Alcoholimetric tables(5.5.) (519)Alcohol isopropylicus (1841)Alcohol oleicus (2134)Alcohol stearylicus...........................................................5.3-3621 Alcuronii chloridum.. (935)Alcuronium chloride (935)Alexandrian senna pods (2404)Alfacalcidol (937)Alfacalcidolum (937)Alfadex (938)Alfadexum (938)Alfentanil hydrochloride (939)Alfentanili hydrochloridum (939)Alfuzosin hydrochloride (941)Alfuzosini hydrochloridum (941)Alginic acid (942)Alkaline-earth metals and magnesium(2.4.7.) (104)Alkaline impurities in fatty oils(2.4.19.) (109)Allantoin (942)Allantoinum (942)Allergen products (569)Allii sativi bulbi pulvis (1651)Allium sativum ad praeparationes homoeopathicas (897)Allopurinol (943)Allopurinolum (943)all-rac-α-Tocopherol..........................................................5.5-4313 all-rac-α-Tocopheryl acetate...........................................5.5-4314 Almagate.............................................................................5.2-3169Almagatum.........................................................................5.2-3169 Almond oil,refined...........................................................5.4-3893 Almond oil,virgin.............................................................5.3-3437 Aloe barbadensis.. (947)Aloe capensis (948)Aloes,barbados (947)Aloes,Cape (948)Aloes dry extract,standardised (949)Aloes extractum siccum normatum (949)Alphacyclodextrin (938)Alprazolam (950)Alprazolamum (950)Alprenolol hydrochloride (952)Alprenololi hydrochloridum (952)Alprostadil (953)Alprostadilum (953)Alteplase for injection (956)Alteplasum ad iniectabile (956)Alternative methods for control of microbiological quality (5.1.6.)................................................................................5.5-4131 Althaeae folium (1974)Althaeae radix...................................................................5.2-3232 Alum. (959)Alumen (959)Aluminii chloridum hexahydricum (960)Aluminii hydroxidum hydricum ad adsorptionem..5.5-4186 Aluminii magnesii silicas (961)Aluminii oxidum hydricum (962)Aluminii phosphas hydricus (963)Aluminii phosphatis liquamen.....................................5.3-3438 Aluminii sulfas (964)Aluminium(2.4.17.) (108)Aluminium chloride hexahydrate (960)Aluminium hydroxide,hydrated,for adsorption........5.5-4186 Aluminium in adsorbed vaccines(2.5.13.).. (131)Aluminium magnesium silicate (961)Aluminium oxide,hydrated (962)Aluminium phosphate gel...............................................5.3-3438 Aluminium phosphate,hydrated.. (963)Aluminium sulphate (964)Amantadine hydrochloride (964)Amantadini hydrochloridum (964)Ambroxol hydrochloride (965)Ambroxoli hydrochloridum (965)Amfetamine sulphate (966)Amfetamini sulfas (966)Amidotrizoic acid dihydrate (967)Amikacin (968)Amikacini sulfas...............................................................5.4-3894 Amikacin sulphate............................................................5.4-3894 Amikacinum. (968)Amiloride hydrochloride..................................................5.3-3439 Amiloridi hydrochloridum.............................................5.3-3439 Amino acid analysis(2.2.56.).. (86)Aminobenzoic acid,4- (973)Aminocaproic acid (974)Aminoglutethimide (975)Aminoglutethimidum (975)Amiodarone hydrochloride (977)Amiodaroni hydrochloridum (977)Amisulpride (978)Amisulpridum (978)Amitriptyline hydrochloride (980)Amitriptylini hydrochloridum (980)Amlodipine besilate (981)Amlodipini besilas (981)Ammonia(13N)injection (817)Ammoniae(13N)solutio iniectabilis (817)Ammoniae solutio concentrata.............................................983Ammonia solution,concentrated. (983)Ammonii bromidum (985)Ammonii chloridum (986)Ammonii glycyrrhizas....................................................5.1-2876 Ammonii hydrogenocarbonas.. (988)Ammonio methacrylate copolymer(type A) (983)Ammonio methacrylate copolymer(type B) (984)Ammonio methacrylatis copolymerum A (983)Ammonio methacrylatis copolymerum B (984)Ammonium(2.4.1.) (103)Ammonium bromide (985)Ammonium chloride (986)Ammonium glycyrrhizate................................................5.1-2876 Ammonium hydrogen carbonate.. (988)Amobarbital (988)Amobarbital sodium (989)Amobarbitalum (988)Amobarbitalum natricum (989)Amoxicillin sodium (990)Amoxicillin trihydrate......................................................5.3-3440 Amoxicillinum natricum (990)Amoxicillinum trihydricum...........................................5.3-3440 Amperometric titration(2.2.19.).. (34)Amphotericin B (995)Amphotericinum B (995)Ampicillin,anhydrous (996)Ampicillin sodium (998)Ampicillin trihydrate (1001)Ampicillinum anhydricum (996)Ampicillinum natricum (998)Ampicillinum trihydricum (1001)Amygdalae oleum raffinatum.......................................5.4-3893 Amygdalae oleum virginale..........................................5.3-3437 Amylum pregelificatum (2490)Anaesthetic ether (1549)Analysis,thermal(2.2.34.) (52)Analytical sieving,particle-size distribution estimation by (2.9.38.).............................................................................5.3-3368 Angelicae radix (1003)Angelica root (1003)Anhydrous silica,hydrophobic colloidal......................5.5-4297 Animal anti-T lymphocyte immunoglobulin for human use (1010)Animal spongiform encephalopathies,products with risk of transmitting agents of (577)Animal spongiform encephalopathy agents,minimising the risk of transmitting via human and veterinary medicinal products(5.2.8.) (463)Aniseed (1006)Anise oil (1004)Anisi aetheroleum (1004)Anisidine value(2.5.36.) (142)Anisi fructus (1006)Anisi stellati aetheroleum (2488)Anisi stellati fructus.........................................................5.5-4297 Antazoline hydrochloride. (1006)Antazolini hydrochloridum (1006)Anthrax spore vaccine(live)for veterinary use (715)Anti-A and anti-B haemagglutinins(indirect method)(2.6.20.) (174)Antibiotics,microbiological assay of(2.7.2.) (188)Anticoagulant and preservative solutions for human blood (1007)Anticomplementary activity of immunoglobulin(2.6.17.)..170 Anticorpora monoclonalia ad usum humanum......5.2-3127 Anti-D antibodies in human immunoglobulins for intravenous administration,test for(2.6.26.)..................................5.3-3348 Anti-D immunoglobulin,human. (1732)Anti-D immunoglobulin,human,assay of(2.7.13.) (205)。

欧洲EMEA COS 常见问题

Q：CEP和COS都是欧洲药典适用性证书的缩写吗？一旦原料药厂家拿到CEP证书，是否代表了上市授权，该证书可否作为药品自由销售的证明书？A：欧洲药典适用性证书英文名为：Certificate of Suitability to Monograph of European Pharmacopoeia，它可以简写成COS或者CEP。

从原则上来说，当一个原料药厂家获得COS证书，可以说它就已经获得了进入欧洲市场的“准入证”，该原料药在欧洲范围内的销售活动的确是被允许的；但事实上，药品最终是以制剂形式应用于人体的，其上市前制剂商要按相关法定药管机构递交申请资料，经该法定机构批准后才能上市。

而且只有当使用该原料药的制剂上市申请被批准之后，制剂商才会大量购买该原料药，原料药的自由销售环节才全部被打通，才是获得了真正意思上的自由销售。

所以，原料药的销售与其欧洲制剂商客户的上市申请密不可分，在此，建议原料药厂家在准备COS认证的同时，一定要加强与国外客户的联络，争取时间。

值得提出的是，在制剂的上市申请资料中，原料药部分资料只是作为其中的一部分的而提交的。

对于获得COS证书的原料药，制剂商在药品上市申请资料中的原料药部分可以由COS证书来替代，这对于原料药厂家来说，无论在成本还是技术保密方面，都是很有利、有竞争力的。

Q：EDMF与FDA的DMF能否互认？如不能，以后有无可能？南美、中东、东南亚等国家是否认同EDMF，即，编写了EDMF可不可以不作该地区的DMF？A：欧洲药品上市申请之一即为通过原料药厂家提供EDMF（European Drug Master File，欧洲药物主文件）；而原料药进行美国FDA认证的第一步就是该原料药已经向FDA递交DMF文件并获得DMF登记号。

二者都是用来证明原料药质量的文件，但是适用不同的地区。

药品注册技术要求和格式在全球的不统一一直是医药企业和药管部门关注的重大问题，这也就是ICH出现的原因，即便ICH成立以来，制定了一系列的技术指导原则和采纳了统一格式（CTD），但目前为止，实际上每个地区的申报资料要求并不完全相同，也没有达到绝对的互认。

欧洲药典索引

┃ ┃ ┃ ┣Acarbose
┃ ┃ ┃ ┣Acebutolol hydrochloride
┃ ┃ ┃ ┣Aceclofenac ┃ ┃ ┃ ┣A源自esulfame potassium
┃ ┃ ┃ ┣Acetazolamide
┃ ┃ ┃ ┣Acetic acid, glacial
┃ ┃ ┃ ┣Acetone
┃ ┃ ┃ ┣Amiodarone hydrochloride
┃ ┃ ┃ ┣Amisulpride
┃ ┃ ┃ ┣Amitriptyline hydrochloride
┃ ┃ ┃ ┣Amlodipine besilate
┃ ┃ ┃ ┣Ammonia solution, concentrated
┃ ┃ ┃ ┣Anti-T lymphocyte immunoglobulin for human use, animal
┃ ┃ ┃ ┣Anticoagulant and preservative solutions for human blood
┃ ┃ ┃ ┣Apomorphine hydrochloride
┃ ┃ ┃ ┣Bacampicillin hydrochloride
┃ ┃ ┃ ┣Bacitracin zinc
┃ ┃ ┃ ┣Bacitracin
┃ ┃ ┃ ┣Baclofen
┃ ┃ ┃ ┣Bambuterol hydrochloride
┃ ┃ ┃ ┣Barbital
┃ ┃ ┃ ┣Barium sulphate
┃ ┃ ┃ ┣Betahistine mesilate
┃ ┃ ┃ ┣Betamethas one dipropionate

欧洲药典校正因子

欧洲药典校正因子全文共四篇示例，供读者参考第一篇示例：欧洲药典校正因子（European Pharmacopoeia (EP) Reference Standard）是欧洲药典委员会（European Pharmacopoeia Commission）认可的一种可追溯性校准品，用于验证药典的准确性和可重复性。

欧洲药典校正因子的作用是确保药品质量标准的一致性和可信度，是药品生产和监管领域的重要参考标准。

欧洲药典校正因子通常是由欧洲药典委员会认可的专门机构或实验室生产，并按照国际药典标准进行验证和认证。

这些校正因子针对特定药品或化合物，通过精确的测量和分析来确定其质量、纯度和稳定性。

欧洲药典校正因子的使用可以帮助药品制造商确定其产品是否符合规定的药品质量标准，从而保证药品的有效性和安全性。

欧洲药典校正因子的使用范围涵盖了各种药品、化妆品和保健品领域，包括原料药、成品药、药用辅料等。

药品生产企业可以根据需要选择合适的校正因子进行验证和校准，确保其产品符合相关的法规和标准要求。

监管机构也可以通过对药品中校正因子含量的检测，评估和监督药品的质量和合规性。

欧洲药典校正因子的使用需要严格遵守相关的操作规程和实验方法，确保测量结果的准确性和可靠性。

在实际使用中，需要根据药品的特性和规格要求选择适当的校正因子，并进行定量测定和校准实验，确保产品符合预期的质量标准。

还需要对校正因子进行储存和管理，避免其受到外部环境因素的影响，确保其质量和稳定性。

欧洲药典校正因子是保证药品质量标准的重要工具，可以帮助药品制造商和监管机构确保药品的质量、安全性和有效性。

通过严格的质量控制和监督，可以提高药品市场的透明度和可信度，促进药品的科学发展和创新，保护消费者的健康和安全。

希望未来欧洲药典校正因子的使用能够得到进一步的规范和完善，为药品行业的发展和进步做出更大的贡献。

第二篇示例：欧洲药典校正因子是指用来纠正分析结果的因素，确保药品的质量及安全性。

欧洲药典适用性证书的申请

欧洲药典适用性证书(COS/CEP)的申请1 COS的由来欧盟成员国以外国家生产的原料药，最初要想获得许可进入欧洲市场，原料药生产商育先耍向欧洲用户捉供上市申请所需要的支持性文件，即''欧洲药物档案(European Drug Master File, EDMF),Z,供欧洲用户上市申请时使用。

EDMF程序决定了原料药生产商必须向每•个用户提供EDMF,而且欧盟药品管理部门也不向生产商颁发任何的证明性文件。

随着欧洲经济•体化，近几年欧洲的医药管理体制及法规发生了明显的变化。

对成员国以外的医药产品进入成员国市场的管制政策也做出了相应的调整。

成立于1964年的欧洲药典委员会(Euro—Dean Directorate fO rthe Ouality of Medicines, EDQM),至今已有英、法、德等31个成员国，并在世界各地有20个左右的观察员国。

中国药典委员会在1994年成为欧洲药典委员会的观察员之•。

欧洲药典委员会在与美国、日本等国药典委员会协调统•药典标准过程中也起着积极主导作用。

根据1999年12月22日生效的欧洲议会公共健康委员会(Public Health Committee)的决议，由当时欧洲药典委员会的27个成员国正式启动了•个新的证书程疗:，即''欧洲药典适用性证书"'(Certificate of Suitability to Monographs of the European Pharmacopoeia, COS.或称CEP),并被欧盟各成员国*认。

根据这•程序，原料药的生产商(或供应商)应该就他们原料药的化学纯度和微生物质虽方而做适用性评估。

或者做传播动物海绵状脑病(疯牛病，TSE)危险的评估。

这两个评估也可以同时进行。

COS的目的是为了方便和简化异国之间的交流，保证原料药质量符合最新的欧洲药典要求。

申请人只要获得了cos证书，原料药生产商就只需向欧洲客户出示并捉供证书复印件，欧洲客户即可凭此COS证书复印件向欧洲药管当局申请上市，并可在31个成员国中的任•国上市。

欧洲药品管理简介-DH

EMEA相关管理机构
EMEA：The European Medicines Agency
CHMP：Committee for Medicinal Products for Human Use
CVMP：Committee for Medicinal Products for Veterinary Use
EDQM
EDQM = European Directorate for the Quality of Medicines Council of Europe (Strasbourg) 欧洲药品质量理事会理事会位于法国斯拉斯堡市
EDQM-图
欧洲药品质量理事会
35个成员，包括欧盟、16个观察员（4个欧洲+阿尔及利亚、澳大利亚、加拿大、中国、马达加斯加、马来西亚、摩洛哥、塞内加尔、突尼斯、美国和叙利亚。WHO也是观察员。）
品放行责任人，在不受业主雇佣关系干扰的条件下，对以下各项负责（参见第52条）： (a) 如系相关成员国生产的药品，每批药品的生产和检查均符合成员国的法律、法规，符合上市许可证的规定。 (b) 如系第三国的进口药品，每批药品均在进口成员国完成全面的定性试验、至少所有有效成分的定量分析，以及为确保药品符合上市许可证要求的其它试验或检查。
Project management
Information technology
Personnel and budget Infrastruture services Accounting
欧洲药品管理局下属机构
常务理事 EMEA 总人数：约 470人
综合质量管理及审计
常务支持部法律处
人用药品人用药品注册
ICH 成员和观察员

药学英语词汇汇总

药学英语词汇目录注册、市场、法规、行政 (1)补充1—制药行业 (22)补充2-- FDA,GMP,ICH英语词汇 (32)试剂、化学结构 (43)工艺 (57)药剂 (62)补充1-药剂专业英语词汇 (66)补充2—药剂学英文词汇 (72)补充3—生物制药专业英语词汇 (80)MSDS（化学品安全技术说明书） (94)药物分析（含稳定性研究） (97)补充1—药物分析 (148)数理统计 (159)补充1—统计学 (160)包装、贮存 (165)药用拉丁文 (167)微生物检查 (168)免疫学 (172)药理毒理、临床研究（含中医和拉丁词汇） (186)补充1—药理学词汇 (210)补充2—七年制药理学专业词汇表 (233)补充3—药理学专业英语 (247)补充4—临床试验英语词汇 (297)缩写 (305)注册、市场、法规、行政1906 Pure Food and Drugs Act 美国的《1906年食品和药品法》Abbreviated New Drug Application (ANDA) 简化新药申请。

是FDA规定的仿制药申请程序Abstract 文摘acceptance notification 受理通知书accommodate remarks and explanations 补充注释Acquisition 收购active ingredient 主成分Active Pharmaceutical Ingredient (API)(or Drug Substance) 活性药用成分(原料药)active pharmaceutical ingredient (API), active ingredient (AI), drug substance, bulk drugs 原料药Active Pharmaceutical Ingredients (API) 活性药物成分研发机构APIAcute Toxicity 急性毒性试验additional sheets 附页administrative protection 行政保护adulterated 伪劣的adverse drug reaction reporting 药品不良反应报告affix the official seal 加盖公章after examination 经审查aging country 老龄化国家Aktiengesellschaft (A.G.) 德语，为”股份公司“。

欧洲药典EP列表之三

EP(欧洲药典委员会)是欧洲的一个关键的组织，参与协调与合作的标准化、监管和质量控制的药物、输血、器官移植、制药和医药保健.安全药物以及它们安全使用的质量标准。

我们的标准品已经被认可为全球性的科学基准。

欧洲药典在欧盟成员国内具有法律约束力。

同样,EDQM开发用于输血、器官移植和消费者的身体健康问题领域的标准品和指导发展。

我们的使命是保障人类获取良好的药物和医疗保健的基本权利和促进、保护人类和动物的健康。

我们重视的是，首先，公共健康、科学技能、正直、客观和对欧洲委员会基本原则的尊重。

我们致力于与地区、国家以及国际机构、政府、机构和行业协会之间的合作以获取更大的收益。

我们还致力于通过不断改进,获取最高质量的产品和服务,为我们的客户、合作伙伴和员工争取更大的利益。

广州优瓦仪器有限公司是从事提供实验室分析领域内产品的专业公司；目前公司已是集研发、生产与销售为一体的综合性企业；在行业内具有良好的声誉；主要产品包括色谱产品、化学试剂、标准品、实验室用品、分析仪器配件及耗材等,总部位于香港。

我们代理的品牌有：USP、EP、BP、TLC、TRC、Molcan、LGC、Wellington、Chiron、Witega、NRC、ERM、Irmm、MBH、Fluorochem、TCI、Chemservice、Accstandard、 GmbH 、CIL 、C/D/N ISOTopes 、Inorganic Ventures、ULTRA Scientific 、NSI 、KeyOrganics、LC-Laboratoies 、Wibby 、APSC 、SPEX CertiPrep 、NIST、ACROS、Fluka、Matrix、Sigma、TCI、Strem、BP、Cerilliant 、Chromadex、Frontier、Echelon 、Serva 、Medical Isotope 、ChemBridge 、AMRESCO、SGE Analytical Science 、Brand BRAND 、VITLAB 、ISO 、Hamilton 、ISOLAB我们专注进口标准品。

欧洲药典7.5版

欧洲药典75版欧洲药典80中文版欧洲药典中文版欧洲药典最新版欧洲药典中文版下载欧洲药典最新版本ep欧洲药典最新版本欧洲药典附录中文版最新版欧洲药典ep88现版欧洲药典2015
EUROPEAN PHARMACOPOEIA 7.5
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...............................................7.5-4579 means the monograph Amikacin sulfate can be found on page 4579 of Supplement 7.5. Note that where no reference to a supplement is made, the text can be found in the principal volume.
EUROPEAN PHARMACOPOEIA 7.5
Index
Numerics 1. General notices ................................................................... 7.5-4453 2.1.1. Droppers................................................................................... 15 2.1.2. Comparative table of porosity of sintered

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Code per vial Unit chargesNew Y0001414Human Hepatitis B immunoglobulin1100 mg155 IU/vial0722, 0338Yes-20°C c90 €Y0001484Medroxyprogesterone acetate for peak identification125 mg10673Yes+5°C a79 €Y0001523Ursolic acid125 mg194.0 % C–ÐH÷‡O–2439Yes+5°C a79 €Y0001532Norethisterone acetate for system suitability1 2.585 mg10850Yes+5°C a79 €Y0001562Doxylamine hydrogen succinate 160 mg11589+5°C a79 €Y0001565Recombinant Major Allergen rBet v 110.01025 mg110.25 micrograms of rBet v 11063Yes-20°C c90 €Y0001566Recombinant Major Allergen rPhl p 5a10.00856 mg18.56 micrograms of rPhl p 5a1063Yes-20°C c90 €Y0001567Docusate sodium110 mg11418+5°C a79 €Y0001570Nitrofural impurity B 130 mg194.8 % C…H…OŸN; (5-nitrofuran-2-yl)methylene diacetate1135Yes+5°C a79 €Y0001571Naloxone impurity D125 mg10729Yes+5°C a79 €Y0001572Atovaquone1270 mg199.3% CœœHŒ…ClO–2192Yes+5°C g79 €Y0001573Atovaquone for system suitability110 mg12192Yes+5°C g79 €Y0001574Mesalazine for system suitability110 mg11699Yes+5°C a79 €Y0001575Bupivacaine impurity F170 mg12,6-dimethylaniline0541+5°C g79 €Y0001577Isoprenaline impurity A115 mg11-(3,4-dihydroxyphenyl)-2-[(1-methylethyl)amino]ethanone1332+5°C a79 €Y0001580Rocuronium bromide110 mg11764-20°C g79 €New Y0001581Alimemazine for system suitability1 5 mg1Yes+5°C g79 €New Y0001583Alimemazine hemitartrate115 mg12650+5°C g79 €Y0001585Cellulose acetate butyrate 160 mg1+5°C a79 €New Y0001587Atomoxetine for impurity A identification110 mg1Yes79 €New Y0001588Atomoxetine impurity B 110 mg179 €New Y0001589Atomoxetine impurity D1 5 mg179 €New Y0001591Flutamide for system suitability110 mg11423Yes+5°C g79 €New Y0001592Ivy leaf dry extract HRS170 mg116% of C—…H…ÿOœÿ2148Yes-20°C c79 €New Y0001594Megestrol acetate impurity K10.01 mg1+5°C a79 €New Y0001596Diacerein impurity B120 mg194,4%2409Yes+5°C a79 €New Y0001597Diacerein impurity mixture10.014 mg12409Yes+5°C a79 €New Y0001598Dutasteride1150 mg12641Yes+5°C a79 €New Y0001599Wedelolactone115 mg12564Yes-20°C c79 €New Y0001603Dutasteride for system suitability110 mg12641Yes+5°C a79 €New Y0001604Finasteride for peak identification115 mg1Yes+5°C a79 €New Y0001605Eucommia bark HRS12100 mg1Yes79 €Y0001609Norflurane - reference spectrum1 1 mg1l79 €New Y0001612Esculin125 mg192,4% CŒ—HŒÿO…2452Yes+5°C a79 €New Y0001633Ethylcellulose1100 mg10822+5°C a79 €Y0001561Abacavir sulfate120 mg12589+5°C a79 €Code per vial Unit chargesY0001551Abacavir for system suitability110 mg12589Yes+5°C a79 €Y0001552Abacavir for peak identification110 mg12589Yes+5°C a79 €Y0000055Acamprosate calcium - reference spectrum1n/a11585l79 €Y0000116Acamprosate impurity A150 mg13-aminopropane-1-sulphonic acid1585+5°C a79 €Y0000500Acarbose294.7 mg194.7 mg Cœ—H÷–NOŒ‡2089+5°C a79 €Y0000354Acarbose for identification110 mg12089+5°C a79 €Y0000427Acarbose for peak identification220 mg1Batch 1 is valid until 1 May 2013 2089Yes+5°C a79 €A0040000Acebutolol hydrochloride150 mg10871+5°C a79 €0871+5°C a79 €Y0000359Acebutolol impurity B210 mg1-[3-acetyl-4-[(2RS)-2-hydroxy-3-[(1-methylethyl)amino] propoxy]phenyl]acetamide (diacetolol)Y0000127Acebutolol impurity C120 mg1N-(3-acetyl-4-hydroxyphenyl)butanamide0871+5°C a79 €0871+5°C a79 €Y0000128Acebutolol impurity I20.004 mg1N-[3-acetyl-4-[(2RS)-3-(ethylamino)-2-hydroxypropoxy]phenyl]butanamideY0000056Aceclofenac - reference spectrum1n/a11281l79 €Y0001094Aceclofenac for peak identification110 mg11281Yes+5°C g79 €Y0000085Aceclofenac impurity F120 mg1benzyl[[[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxy]acetate1281+5°C g79 €1281+5°C g79 €Y0000086Aceclofenac impurity H110 mg1[[[[[[[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxy]acetyl] oxy]acetyl]oxy]acetic acidY0000810Acemetacin1100 mg11686+5°C g79 €Y0000811Acemetacin impurity A110 mg14-chlorobenzoic acid1686+5°C a79 €Y0000842Acemetacine impurity mixture10.06 mg11686Yes+5°C g79 €A0070000Acesulfame potassium250 mg11282+5°C a79 €1282Yes+5°C a79 €A0070020Acesulfame potassium impurity B415 mg15-chloro-6-methyl-1,2,3-oxathiazin-4(3§)-one 2,2-dioxide ; Batch 3 is validuntil 31 August 2013A0100000Acetazolamide1100 mg10454+5°C a79 €Y0001084Acetazolamide for system suitability10.0068 mg10454Yes+5°C a79 €Y0000002Acetylcholine chloride150 mg11485,1971-20°C c79 €A0150000Acetylcysteine350 mg10967+5°C a79 €A0152000Acetylcysteine impurity C810 mg188.5% CŒÐHŒÿNœOÿSœ; N,N'-diacetyl-L-cystine0967Yes+5°C a79 €A0153000Acetylcysteine impurity D510 mg1N,£-diacetyl-L-cysteine0967+5°C a79 €Y0000565ß-Acetyldigoxin250 mg198.6% C÷–HÿÿOŒ—2168+5°C f79 €Y0000642ß-Acetyldigoxin for peak identification110 mg12168Yes+5°C f79 €A0200000Acetylsalicylic acid415 mg10309+5°C a79 €Y0001460Acetylsalicylic acid for peak identification110.26 mg10309Yes+5°C a79 €A0208000N-Acetyltryptophan2125 mg11383+5°C a79 €A0202000N-Acetyltyrosine1200 mg11384+5°C a79 €Y0001462Acetylsulfadiazine 10.002 mg10294+5°C a79 €Code per vial Unit charges Y0000693Acholeplasma laidlawii BRP1 1 ml120607Yes-80°C d120 €A0220000Aciclovir375 mg10968+5°C a79 €Y0001271Aciclovir for peak identification 120.303 mg1Batch 1 is valid until 31 August 2012 0968Yes+5°C a79 €Y0001269Aciclovir for peak identification 220.004 mg1Batch 1 is valid until 30 September 2012 0968Yes+5°C a79 €Y0001264Aciclovir for system suitability110 mg10968+5°C a79 €A0225000Acitretin2100 mg199.7% CœŒHœÿO–1385+5°C g(b)79 €Y0001464Actaea racemosa dry extract for system suitability HRS11200 mg12069Yes-20°C c79 €Y0001543Actaea racemosa for assay CRS1300 mg174.7% C÷œHÿ—NOŒÿ; Monoammonium glycyrrhizate2069Yes+5°C a79 €Y0001463Actaea racemosa HRS11200 mg12069Yes+5°C a79 €Y0001121Adapalene1100 mg199.9% Cœ‡Hœ‡O–2445+5°C a79 €Y0001120Adapalene impurity C2 6 mg11-[2-(methyloxy)phenyl]tricyclo[3.3.1.1]decane2245+5°C a79 €Y0001119Adapalene for peak identification1 2.022 mg12445Yes+5°C a79 €A0230000Adenine250 mg10800,1486+5°C g79 €A0230200Adenosine150 mg11486+5°C a79 €Y0000110Adipic acid150 mg11586+5°C a79 €Y0000882Adrenaline1 5 mg12303+5°C g79 €+5°C f79 €A0300000Adrenaline tartrate5100 mg10254, 0285,0732 Y0000740Adrenaline impurity mixture20.005 mg10254,2303Yes+5°C f79 €Y0000707Adrenaline tartrate with impurity A115 mg10254Yes+5°C f79 €Y0000883Adrenaline with impurity F110 mg12303Yes+5°C g79 €Y0000728Agnus castus fruit standardised dry extract1200 mg10.13% CŒ…HŒ‡O‡2147Yes-20°C c79 €A0325000Alanine360 mg10614,0752+5°C a79 €A0325100Albendazole150 mg11386+5°C g79 €A0325200Alcuronium chloride250 mg11285-20°C g(c)79 €A0325450Alfacalcidol8 5 mg199.8% CœŸH÷÷Oœ ; Batch 7 is valid until 31 December 2012 1286Yes-20°C e(d)300 €New Y0001601Alfacalcidol for system suitability1 2.5 mg11286Yes-20°C e(d)79 €A0325451Alfacalcidol - reference spectrum1n/a11286l79 €A1225000Alfadex3150 mg189.7% [CÿHŒÐ0—]ÿ1070,1487+5°C a79 €A0325500Alfentanil hydrochloride - reference spectrum1n/a11062l79 €A0325800Alfuzosin hydrochloride210 mg11287+5°C a79 €Y0000832Alfuzosin for system suitability110 mg11287Yes+5°C a79 €A0349000Allantoin160 mg11288+5°C a79 €A0350000Allopurinol2100 mg199.9% C—H÷N÷O0576Yes+5°C g79 €A0350010Allopurinol impurity A210 mg15-amino-1H-pyrazole-4-carboxamide 0576+5°C g79 €0576+5°C g79 €A0350020Allopurinol impurity B310 mg15-formylamino-1H-pyrazole-4-carboxamide ; Batch 2 is valid until 31December 2012Code per vial Unit charges0576+5°C g79 €A0350030Allopurinol impurity C310 mg15-(4H-1,2,4-triazol-4-yl)-1H-pyrazole-4-carboxamide ; Batch 2 is valid until 1May 2013A0350040Allopurinol impurity D315 mg1ethyl 5-amino-1H-pyrazole-4-carboxylate0576+5°C g79 €G0400000Glycerol (85 per cent) - reference spectrum1n/a10496,0497l79 €A0350050Allopurinol impurity E120 mg1ethyl 5-(formylamino)-1H-pyrazole-4-carboxylate0576+5°C g79 €A0351000Allylstrychnine bromide110 mg11285-20°C g(c)79 €Yes-20°C e(d)242 €H0215000Hepatitis C Virus RNA for NAT testing BRP140 mg5HCV-RNA content 500 IU per vial; For plasma pool testing by NAT See leaflet,20621Y0000235Almagate125 mg113.4% carbonic acid2010+5°C a79 €Y0000255Almagate - reference spectrum1n/a12010l79 €A0357000Alprazolam - * psy2100 mg11065+5°C j79 €A0360000Alprenolol hydrochloride1100 mg10628,0876+5°C a79 €Y0000054Alprostadil250 mg199.4% CœÐH–÷O— ; Batch 1 is valid until 31 January 2013 1488Yes-20°C g(c)79 €Y0000606Altizide2150 mg199.9% CŒŒHŒ÷ClN–O÷S–0370,2185+5°C a79 €Y0000843Altizide impurity B115 mg13-[(2,2-dimethoxyethyl)sulphanyl]prop-1-ene2185+5°C a79 €Y0000687Alverine citrate1 5 mg12156+5°C a79 €Y0000595Alverine for peak identification10.125 mg12156Yes-20°C c79 €Y0000607Alverine impurity D110 mg1N-(3-cyclohexylpropyl)-N-ethyl-3-phenylpropan-1-amine2156+5°C a79 €A0363000Amantadine hydrochloride1100 mg10463+5°C a79 €A0363700Ambroxol hydrochloride3125 mg11489+5°C a79 €A0900000Amfetamine sulfate - reference spectrum1n/a10368l79 €A0365000Amidotrizoic acid dihydrate1100 mg10873+5°C a79 €Y0001461Amidotrizoic acid for system suitability10.08 mg10873Yes+5°C a79 €A0368000Amikacin 3200 mg191.7 % CœœH÷–N—OŒ– ; Batch 2 is valid until 28 February 2013 1289,1290Yes+5°C a79 €Y0001467Amikacin impurity I120 mg1(2S)-4-amino-2-hydroxybutanoic acid1290+5°C a79 €A0365900Amikacin sulfate3200 mg1The batch 3 is not suitable for use in the assay in monograph 1290:07/2012.1290Yes+5°C a79 €Amikacin CRS A0368000 is also needed. See leaflet.1289,1290Yes+5°C a79 €Y0001117Amikacin for system suitability210 mg1amikacin for system suitability CRS 1 is suitable for 01/2010:1289 and01/2010:1290 only. Batch 2 is suitable for 07/2012:1289 and 07/2012:1290.A0370000Amiloride hydrochloride1100 mg10651+5°C g79 €0651+5°C g79 €Y0000020Amiloride impurity A320 mg1methyl-3,5-diamino-6-chloropyrazine-2-carboxylate ; Batch 2 is valid until 31August 2013Y00001734-Aminobenzoic acid260 mg11687+5°C a79 €A0420000Aminocaproic acid150 mg10874+5°C a79 €A04600007-Aminodesacetoxycephalosporanic acid220 mg1Cefadroxyl impurity B 0708,0813+5°C a79 €A0496000Aminoglutethimide1125 mg11291+5°C a79 €A0496005Aminoglutethimide impurity A 120 mg1(3¢£)-3-(3-aminophenyl)-3-ethylpiperidine-2,6-dione; (3-aminoglutethimide)1291+5°C a79 €Code per vial Unit charges A0496020Aminoglutethimide impurity D110 mg13,3'-[diazenediyldi(4,1-phenylene)]bis(3-ethylpiperidine-2,6-dione);1291+5°C a79 €(azoglutethimide)A0575000Amiodarone hydrochloride3100 mg10803+5°C g(b)79 €Y0000129Amiodarone impurity D320 mg1(2-butyl-benzofuran-3-yl)-(4-hydroxy-3,5-diiodophenyl)methanone0803+5°C g79 €Y0000130Amiodarone impurity E320 mg1(2-butylbenzofuran-3-yl)(4-hydroxyphenyl)methanone ; Batch 2 is valid until0803+5°C g79 €31 August 2012A0590000Amisulpride210 mg11490+5°C a79 €Y0001534Amisulpride for system suitability 1 1.0015 mg11490Yes+5°C a79 €1490+5°C a79 €A0590004Amisulpride impurity B110 mg14-amino-N-[[(2RS)-1-ethylpyrrolidin-2-yl]methyl]-5-(ethyl sulphonyl)-2-hydroxybenzamideY0000563Amitriptyline hydrochloride110 mg10464+5°C g79 €Y0000049Amlodipine besilate4150 mg199.7% CœÿH–ŒClNœO‡S1491Yes+5°C g79 €Y0001067Amlodipine for peak identification215 mg1Batch 1 is valid until 31 August 2013 1491Yes+5°C g79 €1491Yes+5°C g79 €Y0001068Amlodipine impurity A215 mg13-ethyl 5-methyl (4RS)-4-(2-chlorophenyl)-2-[[2-(1,3-dioxo-1,3-dihydro-2H-isoindol-2-yl)ethoxy]methyl]-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate ;Batch 1 is valid until 1 June 20131491+5°C g79 €Y0001069Amlodipine impurity B215 mg13-ethyl 5-methyl (4RS)-4-(2-chlorophenyl)-6-methyl-2-[[2-[[2-(methylcarbamoyl)benzoyl]amino]ethoxy]methyl]-1,4-dihydropyridine-3,5-dicarboxylate ; Batch 1 is valid until 30 November 20131491+5°C g79 €Y0001070Amlodipine impurity G215 mg1dimethyl 4-(2-chlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate ; Batch 1 is valid until 1 June 2013Y0000302Ammonio methacrylate copolymer(type A) - reference1n/a12081l79 €spectrum1n/a12082l79 €Y0000303Ammonio methacrylate copolymer(type B) - referencespectrumA0650000Amobarbital - * psy1500 mg10594+5°C j79 €A0700000Amobarbital sodium - * psy1500 mg10166+5°C j79 €+5°C a79 €A0800000Amoxicillin trihydrate5200 mg186.2% CŒÿHŒ…N–O—S0167,0168,0260,0577,0578,0813, 1140,1653 Y0000005Amphotericin B4100 mg1Batch 4 is not suitable for microbiological assay (see leaflet).1292Yes-20°C c79 €Y0001014Amphotericin B for peak identification210 mg1Batch 1 is valid until 1 June 2013 1292Yes-20°C c79 €Y0001361Amphotericin B for microbiological assay1100 mg1944 IU per mg20702Yes-20°C c79 €Yes+5°C a79 €New A1000000Ampicillin (anhydrous)5220 mg197.7% CŒÿHŒ…N–O÷S ; Batch 4 is valid until 31 December 2013 0167,0168,0578, 1168,1169 A1100000Ampicillin trihydrate2150 mg10168,0260,05+5°C a79 €77,0578,0808,2211, 2212 Y0001522Anastrozole1100 mg1100.0% CŒŸHŒ…N—2406Yes+5°C a79 €Code per vial Unit chargesY0001531Anastrozole impurity E110 mg12,2'-[5-(hydroxymethyl)benzene-1,3-diyl]bis(2-methylpropanenitrile)2406+5°C a79 €Y0001386Angelica dahuria root1160 mg12556Yes+5°C a79 €+5°C a79 €A1200000Anhydrotetracycline hydrochloride415 mg193.3% CœœHœœNœOŸ0210,0211,1654Y0001244Amylmetacresol1285 mg199.5% CŒœHŒ‡O2405Yes+5°C g79 €Y0001245Amylmetacresol for peak identification110 mg12405Yes+5°C g79 €Y0001466Anhydrous Docetaxel115 mg12593+5°C a79 €A1210000Antazoline hydrochloride150 mg10972+5°C a79 €A1220000Alpha-apo-oxytetracycline520 mg1Batch 4 is valid until 31 December 2013 0198Yes+5°C g79 €Y0001465Apomorphine hydrochloride hemihydrate115 mg10136+5°C a79 €Y0001471Apomorphine impurity B (morphine sulfate) * - narc140 mg188.2% C–÷H÷ÐNœOŒÐS,5HœO; morphine sulfate0136Yes+5°C k90 €A1230000Beta-apo-oxytetracycline520 mg188,0% CœœHœœNœO‡ ; Batch 4 is valid until 31 July 2012 0198Yes+5°C g79 €A1250000Aprotinin solution BRP30.5 ml122.3 Ph. Eur. Units per ml0579,0580Yes+5°C a79 €Y0001154Aprotinin for system suitability1 2.7 mg10580Yes+5°C a79 €A1269000L-Arabinitol110 mg11381+5°C a79 €Y0000806Arbutin1100 mg193.5% CŒœHŒÿOŸ1054+5°C a79 €A1270000Arginine350 mg199.8% CÿHŒ÷N÷O0806,0930,16Yes+5°C a79 €54, 2114,2566Y0000304Arginine aspartate120 mg12096+5°C a79 €+5°C a79 €A1271000Arginine hydrochloride250 mg10805,0885,0998Y0001323Aristolochia1140 mg120821Yes+5°C g79 €Y0001185Aristolochic acid I1 1 mg1 1.00 mg CŒŸHŒŒNOŸ20821Yes+5°C g79 €Y0001175Aristolocholic acid for system suitability 1 1 mg120821Yes+5°C g79 €Y0000079Articaine hydrochloride2100 mg11688+5°C a79 €Y0000080Articaine impurity A215 mg1methyl3-[[2-(propylamino)acetyl]amino]-4-methylthiophene-2- carboxylate1688+5°C a79 €Y0000081Articaine impurity E110 mg1methyl 4-methyl-3-[[(2RS)-2-[(1-methylethyl)amino]propanoyl]amino]1688+5°C a79 €thiophene-2-carboxylate+5°C a79 €A1300000Ascorbic acid4100 mg1Vitamin C ; Batch 3 is valid until 31 December 2012 0253,0958,1791Y0001024Ascorbic acid impurity C220 mg1D-xylo-hex-2-ulosonic acid (D-sorbosonic acid)0253,1791+5°C a79 €0253,1791+5°C a79 €Y0001170Ascorbic acid impurity D210 mg1methyl D-xylo-hex-2-ulosonate (methyl D-sorbosonate) ; Batch 1 is valid until31 December 2012Y0000800Ascorbyl palmitate110 mg10807+5°C a79 €Y0000305Asparagine monohydrate160 mg12086+5°C a79 €A1320000Aspartame240 mg10973+5°C a79 €A1321000Aspartame impurity A410 mg12-(5-benzyl-3,6-dioxopiperazin-2-yl) acetic acid (diketopiperazine)0973+5°C a79 €A1330000Aspartic acid250 mg10750,0797+5°C a79 €Code per vial Unit charges Y0001171Astragaloside IV140 mg197.8% C÷ŒHÿ‡OŒ÷2435-20°C c79 €A1340000Atenolol3100 mg10703+5°C a79 €Y0001089Atenolol for system suitability1 5 mg10703Yes+5°C a79 €New Y0001586Atomoxetine hydrochloride1110 mg199,9% CŒŸHœœClNO2640Yes+5°C g79 €Y0001327Atorvastatin calcium trihydrate2150 mg195.3% CÿÿHÿ‡CaFœN÷OŒÐ ; Batch 1 is valid until 30 November 2013 2191Yes+5°C a79 €Y0001328Atorvastatin impurity A110 mg1desfluoroatorvastatin2191+5°C a79 €Y0001329Atorvastatin impurity B210 mg13-epi-atorvastatin ; Batch 1 is valid until 30 November 2013 2191+5°C a79 €Y0001330Atorvastatin impurity C110 mg1fluoroatorvastatin2191+5°C a79 €Y0001331Atorvastatin impurity D210 mg13-[(4-fluorophenyl)carbonyl]-2-(2-methylpropanoyl)-N,3-diphenyloxirane-2-carboxamide ; Batch 1 is valid until 31 August 20132191+5°C a79 €Y0001332Atorvastatin impurity E210 mg1ent-atorvastatin ; Batch 1 is valid until 28 February 2013 2191+5°C a79 €Y0000424Atracurium besilate2120 mg198.5% Cÿ—H‡œNœOŒ‡Sœ1970Yes+5°C g(b)79 €Y0000105Rutoside trihydrate3100 mg187.6% CœŸH–ÐOŒÿ1795,1874,2184,2427,2639Yes+5°C a79 €Y0000503Atracurium for impurity F identification1 5 mg11970Yes+5°C g(b)79 €Y0000504Atracurium for peak identification1 5 mg11970Yes+5°C g(b)79 €Y0000878Atropine130 mg12056+5°C g79 €Y0000845Atropine for peak identification20.25 mg1Batch 1 is valid until 31 January 2013 0068,2056Yes+5°C g79 €Y0000816Atropine impurity B110 mg1(1R,3r,5S)-8-azabicyclo[3.2.1]oct-3-yl (2RS)-3-hydroxy-2-phenylpropanoate(noratropine)0068,2056+5°C g79 €A1400000Atropine sulfate420 mg1Batch 3 is valid until 31 August 2013 0068+5°C g79 €Y0000029Azaperone150 mg11708+5°C a79 €A1500000Azathioprine1100 mg10369+5°C a79 €Y0001240Azathioprine impurity A110 mg11-methyl-4-nitro-1H-imidazol-5-amine0369+5°C a79 €Y0001246Azathioprine impurity G2 5 mg16-[(1-methyl-4-nitro-1H-imidazol-5-yl)sulfanyl]-7H-purin-2-amine(thiamiprine)0369+5°C a79 €Y0000326Azelastine hydrochloride125 mg11633+5°C g79 €Y0000327Azelastine impurity B1 5 mg11-benzoyl-2-[(4RS)-1-methylhexahydro-1H-azepin-4-yl]diazane1633+5°C g79 €Y0000328Azelastine impurity D1 5 mg14-(4-chlorobenzyl)phthalazin-1(2H)-one1633+5°C g79 €Y0000329Azelastine impurity E1 5 mg13-(4-chlorobenzilidene)isobenzofuran-1(3H)-one1633+5°C g79 €New Y0000306Azithromycin4200 mg194.4% C–‡HŸœNœOŒœ ; Batch 3 is valid until 31 December 2013 1649Yes+5°C a79 €Y0000637Azithromycin for peak identification 215 mg11649Yes+5°C a79 €New Y0000641Azithromycin for system suitability60.05 mg1Batch 5 is valid until 31 October 2013 1649Yes+5°C a79 €Y0000307Azithromycin impurity A210 mg16-demethylazithromycin1649+5°C a79 €Y0000285B19 virus DNA for NAT testing BRP1150 mg5B19 virus DNA content logŒÐ 5.8 IU per ml for plasma pool testing by NAT See leaflet,0557,1527,1646Yes-20°C e(d)242 €B0070000Bacampicillin hydrochloride3120 mg192.9% CœŒHœ‡ClN–OŸS0808,0852+5°C a79 €Code per vial Unit charges B0100000Bacitracin zinc2150 mg162.9 IU per mg0465,0466,20-20°C b79 €702 B0200000Baclofen150 mg10653+5°C g79 €0653Yes+5°C g79 €B0200050Baclofen impurity A350 mg191.4% CŒÐHŒÐClNO; (¢£)-4-amino-3-(4-chlorophenyl)butyric acid lactam ;Batch 2 is valid until 31 January 2013Y0001273Baicalin110 mg188.5% CœŒHŒ‡OŒŒ2438Yes+5°C a79 €B0250000Bambuterol hydrochloride1100 mg11293+5°C a79 €B0300000Barbital - * psy1500 mg10170+5°C j79 €Y0001525Basic butylated methacrylate copolymer120 mg11975Yes+5°C a79 €Y0000295Basic butylated methacrylate copolymer -reference1n/a11975l79 €spectrumYes+5°C a79 €B0305000Beclometasone dipropionate anhydrous4150 mg199.2% Cœ‡H–ŸClOŸ ; Batch 3 is valid until 1 June 2013 0654,1449,1709 Y0000351Beclometasone dipropionate monohydrate110 mg11709+5°C a79 €Y0000352Beclometasone dipropionate for system suitability315 mg1Batch 2 is valid until 28 February 2013 0654,1709Yes+5°C a79 €Y0000469Beclometasone dipropionate for peak identification110 mg10654,1709Yes+5°C a79 €Y0001073Beclometasone dipropionate impurities F and N 10.052 mg10654,1709Yes+5°C a79 €New Y0001607Belamcanda chinensis rhizome HRS1110 mg12561Yes+5°C a79 €Y0001025Benazepril hydrochloride1160 mg199.5 % Cœ÷Hœ…ClNœO—2388+5°C a79 €Y0001038Benazepril for system suitability10.016 mg12388Yes+5°C a79 €Y0001026Benazepril impurity A110 mg1[(3R)-3-[[(1R)-1-(ethoxycarbonyl)-3-phenylpropyl]amino]-2-oxo-2,3,4,5-2388+5°C a79 €tetrahydro-1H-1-benzazepin-1-yl]acetic acidB0400000Bendroflumethiazide1100 mg10370+5°C a79 €Y0000564Bendroflumethiazide impurity A1 5 mg14-amino-6-(trifluoromethyl)benzene-1,3-disulphonamide0370+5°C a79 €Y0000044Benfluorex hydrochloride150 mg11601+5°C a79 €Y0000043Benfluorex hydrochloride for system suitability1360 mg11601+5°C a79 €+5°C a79 €B0470000Benperidol1100 mg11010,1172,1254, 1708 B0477000Benserazide hydrochloride150 mg11173+5°C a79 €B0477010Benserazide impurity A120 mg1(2RS)-2-amino-3-hydroxypropanohydrazide1173+5°C a79 €Y0001071Benserazide impurity C110 mg1(2RS)-2-amino-3-hydroxy-2'-[(1EZ)-(2,3,4-trihydroxybenzylidene)]1173+5°C a79 €propanohydrazideY0001079Benserazide for peak identification110 mg11173Yes+5°C a79 €Y0001064Benzaldehyde1150 mg10372,0371Yes+5°C g79 €Y0001060Benzalkonium chloride for system suitability 320 mg10371,0372Yes+5°C g79 €B0490000Benzarone110 mg1(2-ethylbenzofuran-3-yl)(4-hydroxyphenyl)methanone1393+5°C a79 €0373Yes+5°C a79 €B0500000Benzathine benzylpenicillin2200 mg190.7% C÷‡H—ÿNÿO‡Sœ24.1% CŒÿHœÐNœ (N,N'-dibenzylethylenediamine)Code per vial Unit chargesY0000775Benzbromarone110 mg11393+5°C g79 €B0550000Benzethonium chloride1100 mg10974+5°C g79 €B0600000Benzocaine150 mg10011,1088+5°C a79 €Y0001470Benzoic acid130 mg10934+5°C a79 €Y0000647Benzophenone140 mg11784+5°C g79 €Y0000167Benzyl alcohol250 mg1See leaflet0256,0371,03Yes+5°C a79 €72,1827B0670000Benzyl benzoate - reference spectrum1n/a10705l79 €B0680000S-Benzylmercaptoacetyltriglycin110 mg11372+5°C a79 €B0700000Benzylpenicillin potassium2100 mg10113,0148,01+5°C a79 €49Yes+5°C a79 €B0900000Benzylpenicillin sodium7200 mg199.4% CŒÿHŒŸNœNaO÷S; Penicillin G sodium0113,0114,0148, 0149Y0001149Berberine chloride120 mg184.3% CœÐHŒ‡ClNO÷1831,2500Yes+5°C a79 €+5°C a79 €B0950000Betadex4200 mg188.4% [CÿHŒÐO—]Ÿ1070,1487,1804Y0000391Betahistine dihydrochloride250 mg11665+5°C a79 €B0990000Betahistine mesilate1100 mg11071+5°C a79 €B1000000Betamethasone475 mg10312,0354,03+5°C g79 €88, 0561,0811B1030000Betamethasone acetate2100 mg10548,0975+5°C g79 €0809Yes+5°C g79 €B1040000Betamethasone dipropionate3150 mg199.5% Cœ‡H–ŸFOŸ; Betamethasone dipropionate CRS 2 is suitable formonograph 01/008:0809 only.Y0001416Betamethasone dipropionate for peak identification110 mg10809Yes+5°C g79 €Y0001418Betamethasone dipropionate for system suitability110 mg10809Yes+5°C g79 €B1045000Betamethasone sodium phosphate3100 mg10549,0810+5°C g79 €B1054000Betamethasone 17-valerate3100 mg10322,0811+5°C g79 €B1055000Betamethasone 21-valerate315 mg10811+5°C g79 €Y0001027Betamethasone valerate for system suitability125 mg10811Yes+5°C g79 €Y0001065Betamethasone valerate impurity mixture 20.018 mg1Batch 1 is valid until 31 December 2012 0811+5°C g79 €B1103000Betaxolol hydrochloride260 mg1Batch 1 is valid until 1 June 2013 1072+5°C a79 €B1103100Betaxolol impurity A210 mg1(2RS)-1-(4-ethylphenoxy)-3-[(1-methylethyl)amino]propan-2-ol1072+5°C a79 €Y0001354Betaxolol impurity C1 5 mg12-[[4-[2-(cyclopropylmethoxy)ethyl]phenoxy]methyl]oxirane1072-20°C c79 €Y0001360Betaxolol for peak identification115 mg11072Yes+5°C a79 €B1115000Bezafibrate1100 mg11394+5°C a79 €Y0001444Bicalutamide1100 mg199.8% CŒ‡HŒ÷F÷NœO÷S2196Yes+5°C g79 €Y0001448Bicalutamide for system suitability115 mg12196Yes+5°C g79 €Y0001078Bicisate labelling kit124 mg12123+5°C g79 €Code per vial Unit chargesB1110000Bifonazole 1100 mg11395+5°C a79 €B1110004Bifonazole impurity B310 mg14-[(RS)-(biphenyl-4-yl)phenylmethyl]-1H-imidazole trifluoroacetate1395+5°C a79 €Y0001421Bifonazole for system suitability110 mg11395Yes+5°C a79 €Y0001059Bilberry dry extract1250 mg1 3.44% of cyanidin 3-O-glucoside chloride (CœŒHœŒClOŒŒ)2394Yes-20°C c79 €B1116000Biotin220 mg1Vitamin H1073+5°C a79 €B1120000Biperiden hydrochloride160 mg11074+5°C g79 €B1121000Biperiden impurity A220 mg1(1RS)-1-[(1SR,2SR,4SR)-bicyclo[2.2.1]hept-5-en-2-yl]-1-phenyl- 3-(piperidin-1-yl)propan-1-ol (endo form)1074+5°C g79 €B1140000Bisacodyl350 mg10595+5°C a79 €Y0000608Bisacodyl for peak identification110 mg10595+5°C a79 €Y0000694Bisacodyl for system suitability1 5 mg10595Yes+5°C a79 €Y0000812Bisoprolol fumarate150 mg11710+5°C a79 €Y0000877Bisoprolol for peak identification2 1.007 mg1Bisoprolol for system suitability method A CRS has been renamed asBisoprolol for peak identification CRS. ; Batch 1 is valid until 31 August 20121710Yes+5°C a79 €Y0000813Bisoprolol for system suitability2 1.005 mg1Bisoprolol for system suitability method B CRS has been renamed asBisoprolol for system suitability CRS1710Yes+5°C a79 €B1141000Bleomycin sulfate17 mg18910 IU per vial; bleomycin Aœ : 67.0%; Bleomycin Bœ : 29.2%;demethylbleomycin Aœ : 2.6%0976,20702Yes-20°C a79 €Y0000434Boldine230 mg198.8% CŒ…HœŒNO÷1396, 1816Yes+5°C a79 €B1142000Bordetella pertussis mouse antiserum BRP10.5 mg1Anti-PT: 19.5 ELU/vial Anti-FHA: 69 ELU/vialAnti-69k: 17 ELU/vial Anti-Fim 2/3: 28 ELU/vial See leaflet,20716Yes-20°C c90 €B1143000Bromazepam - * psy360 mg10778,0879+5°C j79 €Y0000645Bromazepam for system suitability - * psy110 mg10879Yes+5°C j79 €B1145000Bromhexine hydrochloride3100 mg10706+5°C g79 €Y0000200Bromhexine impurity C315 mg1N-(2-aminobenzyl)-N-methylcyclohexanamine ; Batch 2 is valid until 1 June20130706+5°C a79 €B1150000Bromocriptine mesilate230 mg10596-20°C g(c)79 €Y0000677Bromocriptine mesilate for system suitability1 5 mg10596Yes-20°C g(c)79 €B1152000Bromperidol1100 mg10616,1178+5°C a79 €B1152050Bromperidol decanoate160 mg11397,1431+5°C a79 €B1153000Brompheniramine maleate1100 mg10977,1196+5°C a79 €Y0000468Brotizolam - * psy110 mg12197+5°C j79 €Y0000470Brotizolam impurity B110 mg12-bromo-4-(2-chlorophenyl)-6H-thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4]diazepine (demethylbrotizolam)2197+5°C a79 €B1155000Brucella melitensis Rev. 1 strain BRP - * MOT (Biotox)1 1 mg10793Yes+5°C e(b)79 €B1157300Budesonide4110 mg199.7% Cœ—H–÷Oÿ1075Yes+5°C a79 €Y0001148Budesonide for system suitability110 mg11075Yes+5°C a79 €B1156000Bufexamac1100 mg11179+5°C a79 €Code per vial Unit charges B1157400Buflomedil hydrochloride2100 mg11398+5°C a79 €Y0001529Buflomedil for peak identification10.45 mg11398Yes+5°C a79 €B1157410Buflomedil impurity B220 mg14-(pyrrolidin-1-yl)-1-(4-hydroxy-2,6-dimethoxyphenyl)butan-1-one1398+5°C a79 €B1158000Bumetanide1150 mg11076+5°C a79 €Y0000309Bumetanide impurity A1 5 mg13-nitro-4-phenoxy-5-sulphamoylbenzoic acid1076+5°C a79 €Y0000310Bumetanide impurity B1 5 mg13-amino-4-phenoxy-5-sulphamoylbenzoic acid1076+5°C a79 €B1160000Bupivacaine hydrochloride2100 mg10541+5°C g79 €Y0000088Bupivacaine impurity B220 mg1(2RS)-N-(2,6-dimethylphenyl)piperidine-2-carboxamide0541+5°C a79 €Y0000089Bupivacaine impurity E220 mg16-(butylamino)-N-(2,6-dimethylphenyl)hexanamide0541+5°C g79 €Y0001108Buprenorphine - * psy110 mg11180+5°C j79 €Y0001109Buprenorphine hydrochloride - * psy110 mg11181+5°C j79 €Y0001122Buprenorphine for system suitability - * psy110 mg11180,1181Yes+5°C j79 €B1168000Buserelin2 2 mg1 2.00 mg per vial of CÿÐH‡ÿNŒÿOŒ–1077-20°C c79 €B1168020D-His-Buserelin 10.5 mg11077-20°C c79 €Y0000131Buspirone hydrochloride1 5 mg11711+5°C g79 €Y0000471Buspirone for system suitability1 2 mg11711Yes+5°C g79 €B1170000Busulfan150 mg10542+5°C g79 €Y0001487Butyl methacrylate1100 mg11975+5°C g79 €Yes+5°C a79 €Y0001304Butyl methanesulfonate130 µL120537,20538,20539 B1217000Butyl parahydroxybenzoate2100 mg1See leaflet0881,1216Yes+5°C a79 €Y0001357Butyl parahydroxybenzoate impurity E115 mg12-methylpropyl 4-hydroxybenzoate (iso-butyl parahydroxybenzoate)0881+5°C a79 €B1212000Butylhydroxyanisole460 mg1Batch 3 is valid until 31 August 2013 0880+5°C g79 €+5°C g79 €B1215000Butylhydroxytoluene150 mg1Plastic additive 070581,30103,30105,30106,30107 Y0000472Cabergoline1100 mg199.8% CœÿH–ŸN—Oœ1773Yes-20°C c79 €Yes+5°C g79 €C0100000Caffeine470 mg1See leaflet0267,0268,1504New Y0000787Caffeine for system suitability310 mg1Batch 2 is valid until 30 November 2013 0267, 0268Yes+5°C g79 €C0166000Calcifediol4 5 mg195.3% CœŸH÷÷Oœ ; Batch 3 is valid until 28 February 2013 1295Yes-20°C e(d)150 €C0166001Calcifediol - reference spectrum1n/a11295l79 €Y0000499Calcipotriol (anhydrous) - reference spectrum1n/a12011l79 €Y0000473Calcipotriol monohydrate210 mg194.3% CœŸH÷ÐO– ; Batch 1 is valid until 31 August 2013 2011,2284Yes+5°C g79 €Y0000474Calcipotriol monohydrate - reference spectrum1n/a12284l79 €C0200000Calcitonin (salmon)9 1 mg2Batch 8 is valid until 1 June 2013 0471Yes-20°C c79 €Y0000632Calcitonin-Gly 2 1 ml1About 0.9 mg per ml0471-20°C c79 €。