欧洲药典7.4索引(现行版)
美国药典、欧洲药典、日本药典最新介绍
内容简介
共5卷，第1、2卷主要为药品各论，第3卷为膳食 补充剂各论，第4、5卷主要为通则（包括测试方 法及通用原则等）。共有各种测试方法178项和通 用信息168项（如离子色谱、拉曼等），其中测试 方法依次分为微生物方法6项（如无菌）、生物方 法25项（如活性和效价测定等）、化学方法69项 （一般鉴别试验1项、有机生物碱色谱鉴定以及限 度和含量测定等68项）、物理方法78项（如灰分、 pH、泄露率等）；
内容简介
美国药典正文药品名录分别按法定药名字母顺序 排列，各药品条目大都列有药名、结构式、分子 式、CAS登记号、成分和含量说明、包装和贮藏 规格、鉴定方法、有关物质、含量测定等项目。
可根据书后所附的USP和NF的联合索引查阅本书。
欧洲药典
历史沿革
1977年出版第一版《欧洲药典》
从1980年到1996年期间，每年将增修订的项目与 新增品种出一本活页本，汇集为第二版《欧洲药 典》各分册，未经修订的仍按照第一版执行。
美国药典、欧洲药典、日本药 典最新介绍
一土三石 20200520
主要内容
➢药典简介 ➢美国药典（历史沿革、内容简介） ➢欧洲药典（历史沿革、内容简介） ➢日本药典（历史沿革、标准来保证人类和牲畜使用的药物的质量、 剂量和药物纯度和浓度标准的权威性出版物。它是在专业的，通常 是政府的权威人士的监督下进行编辑，并且是所有药物的制造、分 配和药物治疗所必须遵照的标准 。
年7月1日开始实施。
自1971年第8版起每五年更新一版，期
间会出版增补本。
内容简介
《日本药典》现行版为第17版，于2016年3月7日 颁布，目前共1卷和1增补本。
主要内容为凡例、生药通则、制剂通则、通用测 试处理及设备、各论、生药及成药、红外对照图 谱、紫外对照图谱、通用信息等，增补本主要为 增修订内容，类似中国药典。
如何使用欧洲药典
有单独的有关物质检查项目，它可以控制杂质部分 中包含的所有杂质，或者需要几个检验项目来分别 控制所有已知杂质概况 。与药典的符合性也可通过 检验与该物质来源有关的已知杂质来达到。” (第
– 符合专论 = 专论中所有强制部分 – 各药物成分在使用时符合 – 制剂在其有效期内符合
Claude Coune
注意事项 (4)
• 备选方法
– 是可供参考的试验方法，在有争议时也是基 本实验方法 – 如果能得到相同结果（合格或不合格），可 以使用备选方法 – 使用者的责任 (在很多情况下需要批准)
Claude Coune
总则 5.2.8
• “6-6 牛奶及牛奶衍生物: 根据目前的科 牛奶及牛奶衍生物: 学发展水平，不管其地理来源是哪里， 牛奶是不可能带来任何TSE污染风险的。” • 但是…
Claude Coune
总则 5.2.8
• “按照下列条件生产的牛奶衍生物是不可能带来 任何TSE风险的，所以应该认为与本章相符。
更多案例研究
• 多种合成途径，
– 例如：吡罗昔康 Piroxicam
• 特定杂质
– 例如：法莫替丁 Famotidine
Claude Coune
吡罗昔康
• 其杂质列表表明其有三种合成途径，分 别使用了甲醇、乙醇和异丙醇。应该检 查所列的所有杂质吗？
– “如果专论中包含的物质具有不同杂质概况，可能会
Claude Coune
注意事项 (5)
• 检验项目的缺省
– 在某些情况下某些检验项目不需要进行，因 为经过验证或有其他合理解释证明可以不做 该项检验 – 如果与工艺相关的杂质在实际工艺中不会产 生，可以不进行该杂质的检验
Claude Coune
国外药典介绍
欧洲药典增补版
• 欧洲药典第8版包括两个基本卷，于2013年7月出版发行，以后在每次欧洲
药典委员会全会做出决定后，通过非累积增补本更新，每年出3个增补本。第 8版累计共有8个非累积增补本（8.1～8.8）。 各增补版的出版日期及执行的日期。·
欧洲各册内容介绍
第一卷
各论举例、前言、介绍、总目录、第8版内容简介（包括新增内容、 修订内容和更正内容）
欧洲各册内容介绍第一卷各论举例前言介绍总目录第8版内容简介包括新增内容修订内容和更正内容版内容简介包括新增内容修订内容和更正内容genaralnotice凡例分析方法通论包装材料及包装试剂genaraltext通则各论通则剂型各论人用疫苗各论兽用疫苗各论人用免疫血通则各论通则剂型各论人用疫苗各论兽用疫苗各论人用免疫血清各论兽用免疫血清各论放射制剂及放射制剂起始物各论人20151215清各论兽用免疫血清各论放射制剂及放射制剂起始物各论人用手术缝合线各论兽用手术缝合线各论草药及草药制剂各论顺势疗法制剂各论用手术缝合线各论兽用手术缝合线各论草药及草药制剂各论顺势疗法制剂各论第二卷各论举例各论按字母的索引页总索引每卷均有侧面黑色索引标示各论举例各论按字母的索引页总索引每卷均有侧面黑色索引标示欧洲各册内容介绍增补举例
USP–NF 的不断 修订
修订公告 IRA拟议的修订 说明
勘误表
2019/12/16
美国药典的修订
USP–NF 不断进行修订。 修订包括 USP–NF 年度修订和每年两 次增补，以及 USP 网站上的加速修订。 USP 使用加速修订过程 加快修订美国药典–国家处方集 (USP–NF)。加速修订包括修订公 告、临时修订声明 (IRA) 和勘误表。 是 USP 最快的修订途径，可取代在 USP–NF 及其增补（印刷版 和在线版）中发布的标准。 在 USP 网站上发布的修订公告指示 其正式日期和纳入正式出版物中的日期。 IRA 在 PF 中发布，征求公众意见期为 90 天。 在意见（如果有） 通过审查并且 IRA 得到相关专家委员会的批准后，最终 IRA 将发 布在 USP 网站上。 与修订公告一样，IRA 可取代在印刷版和在线 版的 USP–NF 及其增补中发布的标准。 IRA 被纳入下一个可用的 USP–NF 或增补中。 是指在 USP–NF 或其增补中发布的文字有误，不能准确地反映专 家委员会批准的预期要求。 勘误表发布在网站上，并立即成为正 式版本。 勘误表被纳入下一个可用的正式出版物中。
欧洲药典附录中文版
欧洲药典附录中文版第二部分、附录附录1 溶液的澄清度 (3)附录2 溶液颜色检查 (4)附录3 旋光度 (9)附录4 铵盐检查法 (11)附录5 氯化物检查法 (13)附录6 硫酸盐灰分 (14)附录7 铁 (16)附录8 重金属 (18)附录9 干燥失重 (23)附录10 硫酸盐检查法 (24)附录11 红外吸收分光光度法 (26)附录12 pH测定 (31)附录13 滴定 (37)附录14 氯化物鉴别反应 (40)附录15 指示剂颜色与溶液pH 的关系 (41)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1.0g硫酸肼溶于水，加水稀释至100.0ml，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。
药物分析第二章药品质量标准()
现以在《中国药典》2010年版正文中收载的 阿司匹林为例说明。
现在是5页\一共有38页\编辑于星期二
阿司匹林
Asipilin
Aspirin
C9H8O4 180.16 本品为2-（乙酰氧基）苯甲酸。含C9H8O4不得少于 99.5%。
现在是6页\一共有38页\编辑于星期二
C. 50 ml滴定管
D. 50 ml量瓶
E. 100 ml量筒
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例4. 中国药典中规定，称取“2.00 g”系指
A. 称取重量可为1.5～2.5 g
B. 称取重量可为1.95～2.05 g
C. 称取重量可为1.995～2.005 g D. 称取重量可为1.9995～2.0005g
二部收载化学药品、抗生素、生化药品、 放射性药品及各类制剂，还有药用辅料等；
第三部收载生物药品。
同时配套出版了《中国药典》2010年版英文版。
现在是18页\一共有38页\编辑于星期二
1．收载品种
本版药典共收载4567个品种,其中新增1386种，修订 2237种。
一部收载品种2165种,其中新增1019种，修订634种； 二部收载品种2271种，新增330种，修订1500种；
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小结
二、《中国药典》的内容
（二）品名目次
（三）正文 （四）附录
（五）索引
三、现行中国药典 四、局（部）颁标准和地方标准 五、地方标准上升国家标准的概况 六、药品质量标准的制订原则
七、几部外国药典
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附：练习题
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欧洲药典引用格式示范
欧洲药典引用格式示范欧洲药典（EuropeanPharmacopoeia， EP）是欧洲医药学会的官方文献，主要提供药物检验、实验分析和药品加工过程中实施质量控制的标准和方法。
它有助于制定和维护适用于整个欧洲药品市场的质量标准，也可以帮助政府更好地管理和审查药品的质量，从而保障公众使用药品的安全性。
欧洲药典引用格式是一种给出对欧洲药典文献的引用方式，它不仅能让读者更清晰地理解引用内容，还能帮助检索文献，更加方便。
欧洲药典引用格式主要由以下五部分组成：（1）文献标题；（2）作者；（3）出版者；（4）出版日期；（5）文献编号。
文献标题（Title）又叫文献名称，是引用的文献的标题，它的格式可以是文本、表格或图片，其中文本须正确书写文献标题，应将文献标题中的关键词与介词一起放在括号中。
表格及图片格式中，要将关键词以及表格（图）所代表的意思放在大括号中。
作者（Author）又叫撰写者，指引用文献的撰写者，作者的格式可以是文本，也可以是表格，文本格式要求把作者的姓名、机构及国家（若有）按照姓名、机构、国家的排列顺序放在括号中。
表格格式要求将作者的姓名及机构放在大括号中。
出版者（Publisher）指引用文献的出版商，其中文本格式要求将出版社名与出版年份放在括号中。
出版日期（Publication Date）是指引用文献的出版日期，格式要求将出版日期放在括号中，出版日期是以日期及月份的形式书写，月份用大写英文字母表示，日期用三位数表示。
文献编号（Document Number）指文献的编号，也叫文献号，其中文本格式要求将文献编号放在括号中，文献编号一般以出版商的文献编号为准，有些文献还有ISBN（国际标准书号）编号，也要放在括号中。
以上为欧洲药典引用格式的示范，引用格式的正确性对于读者了解文献、检索文献非常重要，同时也为学生们从中引用有效地材料提供了重要的参考。
引用格式的掌握也是学术性文章写作的基本素养之一。
欧洲药典附录定稿版
欧洲药典附录精编W O R D版IBM system office room 【A0816H-A0912AAAHH-GX8Q8-GNTHHJ8】第二部分、附录附录1 溶液的澄清度............................................附录2 溶液颜色检查............................................附录3 旋光度..................................................附录4 铵盐检查法..............................................附录5 氯化物检查法............................................附录6 硫酸盐灰分..............................................附录7 铁......................................................附录8 重金属..................................................附录9 干燥失重................................................附录10 硫酸盐检查法 (16)附录11 红外吸收分光光度法......................................附录12 pH测定.................................................附录13 滴定....................................................附录14 氯化物鉴别反应..........................................附录15 指示剂颜色与溶液pH 的关系..............................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。
药物分析第七版题库
药物分析1.药物分析主要是采用物理学、化学、物理化学或生物化学等方法和技术，研究化学结构已知的合成药物和天然药物及其制剂的组成、理化性质、真伪鉴别、纯度检查以及有效成分的含量测定等。
所以，药物分析是一门研究与发展药品质量控制的方法性学科。
2.药物分析的基本任务是检验药品质量，保障人民用药安全、合理、有效的重要方面。
3.目前公认的全面控制药品质量的法规有GLP 、GMP 、GSP 、GCP 、GAP。
4.《药品生产质量管理规范》可用( D )表示。
(A)USP (B)GLP (C)BP (D)GMP (E)GCP5.《药品临床试验质量管理规范》可用( E )表示。
(A)GMP (B)GSP (C)GLP (D)TLC (E)GCP一、1.中国药典的主要内容由凡例、正文、附录和索引四部分组成。
2.目前，《中华人民共和国药典》的最新版为(2015版)3.英国药典的缩写符号为( B )。
(A)GMP (B)BP (C)GLP (D)RP－HPLC (E)TLC4.GMP是指( B )(A)药品非临床研究质量管理规范(B)药品生产质量管理规范(C)药品经营质量管理规范(D)药品临床试验质量管理规范(E)分析质量管理5.根据药品质量标准规定，评价一个药品的质量采用( A )(A)鉴别，检查，质量测定(B)生物利用度(C)物理性质(D)药理作用6.中国药典和国外常用药典的现行版本及英文缩写分别是什么？答: 中华人民共和国药典：Ch.P 日本药局方:JP 英国药典:BP 美国药典:USP欧洲药典:Ph.Eur(EP) 国际药典：Ph.Int(IP)二、填空题1．药物鉴别方法要求专属性强，再现性好，灵敏度高、操作简便、快速。
2．常用的鉴别方法有化学鉴别法、光谱鉴别法、色谱鉴别法和生物学法。
三、1. 药物纯度合格是指EA. 含量符合药典规定B. 符合分析纯的规定C. 绝对不含杂质D. 对病人无害E. 不超过该药物杂质限量的规定2. 在氯化物检查中，需在暗处放置5min后再比较浊度，其目的是DA. 避免氯化银沉淀生成B. 使生成的氯化银沉淀溶解C. 避免碳酸银沉淀生成D. 避免单质银析出E. 避免氯化银沉淀析出3. 在氯化物检查中，供试品溶液如不澄清，可经滤纸滤过后检查。
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)。
欧洲药典索引
┃ ┃ ┃ ┣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
药典基本知识
第二节 中国药典
中国药典（英文缩写：Ch.P）的沿革
我国建国后先后出版了八版药典： 1953、1963、1977、1985、1990、1995、2000、2005
年版 现行中国药典为2005年版，2005.7.1开始实施 1953年版：共一部，收载药品531种 1963-2000年版：分一、二两部
取样精密度与准确度 称定：指所称取重量的百分之一 精密称定：指所称取重量的千分之一 精密量取：指量体积移液管的精密度 “约”若干：指不超过规定量的±10%
精确度
恒重
除另有规定外，系指供试品连续两次干燥或炽灼后的重量差 异在0.3mg以下的重量；干燥至恒重的第二次及以后各次称重均在 规定条件下继续干燥1小时后进行；炽灼至恒重的第二次称重应在 继续炽灼30分钟后进行。
量 的比例，此外，根据需要可采用下列符号：
%（g/g） 表示溶液100g中含有溶质若干克； %（ml/ml） 表示溶液100ml中含有溶质若干毫升； %（ml/g） 表示溶液100g中含有溶质若干毫升； %（g/ml） 表示溶液100ml中含有溶质若干克； 液体的滴 系指在20℃时，以1.0ml水为20滴进行换算。
最新版本为USP(30)-NF（25）
《英国药典》 （BP）
始于1618年，近现代世界上最早的药典，是英 国制药标准的重要来源。英国药典不仅提供了药 用和成药配方标准以及公式配药标准，而且也展 示了许多明确分类并可参照的欧洲药典专著。
英国药典出版周期不定，最新版本BP（2007）
《日本药局方》（JP）
《国际药典》（Ph.Int)
由联合国世界卫生组织WHO主持编订。 第一版于1951和1955年分两卷出版。 第二版于1967年出版。 第三版目前有5卷 国际药典更多关注发展中国家的需要，并且只推
欧洲药典HPLC规定
可以减少进样量，但不得增加。
可以减少，不得增加
当仪器配置改变时，会影响分辨率和保留 时间，可能需要增加延迟体积，因此可以 改变梯度开始时等度运行的时间。
当柱尺寸改变时，必要时可以按下式改变流速：
式中： F1为药典正文中的流速；F2为改变后的流速；L1为药典正文中的柱 长;L2为改变后的柱长；d1为药典正文中柱的内径；d2为改变后柱的内 径。
进行有关物质检查时，定量限（以信噪比为10计算）应 小于或等于忽略限。
系统适用性试验
进行原料药的含量测定时，采用对照品溶液进样数次，按下式计算最 大允许相对标准偏差（Ｓｒ（％）ｍａｘ）：
式中，Ｋ为常数0.349，从表达式
推导得出 表示Ｂ=1.0时，６次进样后获得的百分相对标准偏差。Ｂ为药典正文中各个品 种含量限度的上限与100%之差。ｎ为对照品溶液的重复进样次数（３<=ｎ<= ６）。Ｔ90%,ｎ－１为当自由度为ｎ－１,概率水平为90%,（双侧）时的ｔ检验值。 除另有规定外，最大允许相对标准偏差不得超过下表相应的数值。
（2）流动相pH值：±0.2，pH7.6可以在7.4-7.8 之间调整
对仪器的一般要求和色谱条件
3.缓冲盐浓度：±10%，例如：20mM磷酸钾可 以在18-22mM范围内，只要pH值符合要求就行
4.流速：±50%，例如：1mL/min流速可以在 0.5至1.5mL/min范围内变化
对仪器的一般要求和色谱条件
欧洲药典对HPLC的规定
对仪器的一般要求和色谱条件
1.色谱柱
(1)色谱柱长度：±70%，150*4.6mm规格的色谱柱， 柱长可以改变±105mm (2)色谱柱内径：±25%，150*4.6mm规格的色谱柱， 内径可以改变±1.15mm (3)粒径大小：可以降至50%，10um的粒径可以调整 为5um
欧洲药典总体结构(中).pdf
Claude Coune
FRCs的地位 (2)
• “以下检验项目不是强制性的要求，但
考虑到达到药品生产、质量和功效的一 致性是十分重要的，建议生产商确证这 些特性，并将所用的分析方法和结果提 供给使用者。以下方法已经证明是适用 的，但也可以使用其它方法。”
Claude 多案例研究
• 多种合成途径，
– 例如：吡罗昔康 Piroxicam
• 特定杂质
– 例如：法莫替丁 Famotidine
Claude Coune
吡罗昔康
• 其杂质列表表明其有三种合成途径，分 别使用了甲醇、乙醇和异丙醇。应该检 查所列的所有杂质吗？
– “如果专论中包含的物质具有不同杂质概况，可能会
Claude Coune
药用物质
• 生产方面的考虑
– – – – – – – – 重组蛋白 TSE风险 发酵 特殊的性质 多晶形 有关物质 残留溶剂 与功能相关的性质
Claude Coune
• 详细说明专论中不同部分的地位
TSE风险物质
• 该物质可能由牛奶制得
– 所以 有传递TSE风险的产品（＃1483）也适 用 – 该专论主要是提供了参阅总文5.2.8的途径， 它与欧盟关于TSE风险产品的指南注释（第2 版，2003年）内容一致
–第5版药典中所有专论均重新编号，无论是 新的、修订的或是未作改动的。 –修订：要考虑药典总的实施日期[见目录] –更正：要考虑出版日期[见内封]
Claude Coune
返回到各论
• 标题: 乳糖，无水物和一水合物 – “在专论标题中有关水化物的描述有所改 变。在药典第4版或在随后版本中第一次出 现的所有专论，其水化程度，只要可以， 均在标题中标明。但在以前的版本中，只 有存在几种水化物时才标明水化程度。” [ 见介绍]
各国药典最新版及出版周期
中国药典（ChP）：最新版2015版自家药典，每五年更新一次，很了解，不用多说。
官方网站：/美国药典（USP）：最新版USP39-NF34美国药典-国家处方集第39版于2015年12月份出版，2016年5月1日生效，是由美国政府所属的美国药典委员会编辑出版的关于药典标准的公开出版物。
它包含关于药物、剂型、原料药、辅料、医疗器械和食物补充剂的标准。
美国药典-国家处方集每年出版一次。
2016版《美国药典》包含4卷及2个增补版。
官方网站：/英国药典（BP）：最新版BP2016英国药典是英国药品委员会（British Pharmacopoeia Commission）的正式出版物，是英国制药标准的重要来源。
英国药典不仅为读者提供了药用和成药配方标准以及公式配药标准，而且也向读者展示了许多明确分类并可参照的欧洲药典专著。
英国药典出版周期不定，最新的版本为2016版，英国药典2016版共6卷。
官方网站：https:///欧洲药典（EP）：最新版EP8.8欧洲药典(EP)：每3年1版，中间有8次增补版，如：8.1~8.8。
欧洲药典8为欧洲药典最新版本(2013年7月出版，2014年1月生效)，欧洲药典第8版包括两个基本卷，于2013年7月出版发行，以后在每次欧洲药典委员会全会做出决定后，通过非累积增补本更新，每年出3个增补本。
第8版累计共有8个非累积增补本（8.1～8.8）。
各增补版的出版日期及执行的日期。
官方网站：http://online.edqm.eu/EN/entry.htm日本药典（JP）：最新版JP16日本药局方：（The Japanese Pharmacopoeia）由日本药局方编集委员会编篡，由厚生省颁布执行。
分两部出版，第一部收载原料药及其基础制剂，第二部主要收载生药，家庭药制剂和制剂原料，日本药典最新版是第十六改正版，每五年出版一次。
JP14，2001年3月31号公布，4月1号使用；JP15，2006年3月31号公布，4月1号使用；JP16，2011年4月1号使用。
欧洲药典7.0-凡例(全)
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。
各论中描述的活性物质，赋形剂，药物制剂和其它项目都是人用和兽用的（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，特别是赋形剂，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。
欧洲药典附录中文版.
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 (7)附录4 铵盐检查法 (9)附录5 氯化物检查法 (11)附录6 硫酸盐灰分 (13)附录7 铁 (14)附录8 重金属 (16)附录9 干燥失重 (21)附录10 硫酸盐检查法 (23)附录11 红外吸收分光光度法 (25)附录12 pH测定 (29)附录13 滴定 (34)附录14 氯化物鉴别反应 (37)附录15 指示剂颜色与溶液pH 的关系 (38)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1.0g硫酸肼溶于水，加水稀释至100.0ml，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。
欧洲药典附录中文版
欧洲药典附录中文版————————————————————————————————作者：————————————————————————————————日期：第二部分、附录附录1 溶液的澄清度 (1)附录2 溶液颜色检查 (2)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 (24)附录15 指示剂颜色与溶液pH 的关系 (25)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1.0g硫酸肼溶于水，加水稀释至100.0ml，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1-1ⅠⅡⅢⅣ浊度标准液 5.0ml 10.0ml 30.0ml 50.0ml水95.0ml 90.0ml 70.0ml 50.0ml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。
绪论
一、 药物分析的性质和任务
运用化学、 药物分析 运用化学、物理化学或生 物化学的方法和技术来研究化学结构已经 明确的合成药物或天然药物及其制剂的质 量控制方法, 量控制方法,也研究有代表性的中药材及 中药制剂和生化药物及制剂的质量控制方 法. 药物分析是一门研究和发展药品全面 质量控制的“方法学科” 质量控制的“方法学科”.
二、 国家药品标准
药 典 主 要 内 容
一、凡例 二、正文 三、附录 四、索引
二、 国家药品标准
2. 国外药典概况
美国药典 USP (The United States Pharmacopoeia ) 现行版2006 29版 2006年 现行版2006年29版 美国国家处方集 NF (The National Formulary) 现行版为2006 24版 2006年 现行版为2006年24版
一、 药物分析的性质和任务
2）为新药开发提供质量控制方法
① 新药质量标准及稳定性研究 天然产物活性成分化学结构确证. ② 天然产物活性成分化学结构确证. ③ 现代生物技术所研制的生化药物和基 因工程药物质量标准研究. 因工程药物质量标准研究.
一、 药物分析的性质和任务
3）分析新技术的应用 分析新技术的应用
二、 国家药品标准
中华人民共和国药典
药典是一个国家关于药品标准的 药典是一个国家关于药品标准的 法典, 法典,是国家管理药品生产与质量 依据。 的依据。
与中国药典配套使用的相关书籍 临床用药须知》 ①《临床用药须知》 药品红外光谱集》 ② 《药品红外光谱集》 中药彩色图集》 ③ 《中药彩色图集》 中药薄层彩色图集》 ④ 《中药薄层彩色图集》 中国药品通用名》 ⑤ 《中国药品通用名》
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EUROPEAN PHARMACOPOEIA7.4INDEXTo 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...............................................7.1-3377means 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 .................................................................................4433/forum.php?mod=viewthread&tid=21456&fromuid=1023/forum.php?mod=viewthread&tid=21456&fromuid=1023EUROPEAN PHARMACOPOEIA7.4EUROPEAN PHARMACOPOEIA 7.4Index Numerics 1.General 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 -Rotatingviscometer 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.Meltingpoint -instantaneous method (32)2.2.17.Drop point..............................................................................322.2.18.Freezing point.......................................................................342.2.19.Amperometrictitration (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.Liquidchromatography......................................................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 acidanalysis (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..........................................................................7.2-35312.2.6.Refractiveindex......................................................................262.2.7.Optical rotation.......................................................................262.2.8.Viscosity (27)2.2.9.Capillaryviscometer method (27)2.2.Physical and physicochemical methods.................................212.3.1.Identification reactions of ions and functional groups..1072.3.2.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)2.4.13.Sulfates........................................................................7.3-37812.4.14.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 bythin-layer chromato-position of fatty acids by gas chromatography (119)2.4.23.Sterols in fatty oils....................................................7.2-35352.4.24.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)position of fatty acids in oils rich in omega-3acids..................................................................................................1302.4.2.Arsenic (113)2.4.30.Ethylene glycol and diethylene glycol inethoxylatedsubstances.......................................................................................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-flaskmethod (139)plexometric titrations................................................1402.5.12.Water:semi-micro determination.. (140)2.5.13.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 -Acetylin 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.Carbondioxide in gases (143)2.5.25.Carbon monoxide in gases...............................................1442.5.26.Nitrogen monoxide and nitrogen dioxide in gases.. (145)2.5.27.Oxygeningases..................................................................1452.5.28.Water in gases.....................................................................1452.5.29.Sulfur dioxide.....................................................................1452.5.2.Ester value.............................................................................1372.5.30.Oxidising substances (146)/forum.php?mod=viewthread&tid=21456&fromuid=1023Index EUROPEAN PHARMACOPOEIA7.42.5.31.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 B1in 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)/forum.php?mod=viewthread&tid=21456&fromuid=1023EUROPEAN PHARMACOPOEIA 7.4Index2.9.32.Porosity and pore-size distribution of solids by mercury porosimetry.....................................................................................2992.9.33.Characterisation of crystalline and partially crystallinesolids 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......................................7.4-41012.9.41.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.................................2533.1.10.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)3.1.14.Materials based on plasticised poly(vinyl chloride)for containers for aqueous solutions for intravenous infusion..3553.1.15.Polyethylene terephthalate for containers forpreparations 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 parenteralpreparationsand 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 parenteralpreparations and ophthalmic preparations..............................3423.1.7.Poly(ethylene -vinyl acetate)for containers and tubing for totalparenteralnutritionpreparations (345)3.1.8.Silicone oil used as a lubricant.........................................3473.1.9.Silicone elastomer for closures and tubing....................3473.1.Materials used forthe 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 andblood 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 parenteralpreparations,for powders and for freeze-dried powders (374)3.2.Containers.................................................................................3633-O -Desacyl-4′-monophosphoryl lipid A.............................7.2-36394.1.1.Reagents........................................................................7.4-41094.1.2.Standard solutions for limit tests.............................7.4-42164.1.3.Buffersolutions...........................................................7.4-42204.1.Reagents,standard solutions,buffer solutions........7.4-41094.2.1.Primary standards for volumetric solutions..........7.4-42254.2.2.Volumetric solutions...................................................7.4-42254.2.Volumetric analysis.........................................................7.4-42254-Aminobenzoic acid.....................................................................13714.Reagents...............................................................................7.4-41095.10.Control of impurities in substances for pharmaceutical use............................................................................................7.4-42475.1.10.Guidelines for using the test forbacterial endotoxins..5205.11.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.Genetransfer medicinalproducts for human use (647)5.1.4.Microbiological quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use...........5075.1.4.Microbiological quality ofnon-sterile pharmaceutical preparations and substances for pharmaceutical use (5.8.).........................................................................................7.1-33475.1.5.Application of the F 0concept to steamsterilisation ofaqueous preparations...................................................................5085.15.Functionality-related characteristics of excipients.........6615.1.6.Alternative methods for control ofmicrobiologicalquality...............................................................................................5085.16.Crystallinity....................................................................7.4-42535.17.1.Recommendations on dissolution testing.....................6655.17.Recommendations on methods for dosage forms testing...............................................................................................6655.1.7.Viralsafety (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 biologicalproducts (527)5.2.2.Chicken flocks free from specified pathogens for theproduction and quality control of vaccines.............................5275.2.3.Cell substrates for the production of vaccines for humanuse.....................................................................................................5305.2.4.Cell cultures for the production of veterinaryvaccines (533)5.2.5.Substances of animal origin for the production ofimmunological veterinary medicinal products........................5355.2.6.Evaluation of safety of veterinary vaccines andimmunosera ...................................................................................5365.2.7.Evaluation of efficacy of veterinary vaccines andimmunosera (538)5.2.8.Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinalproducts..................................................................................7.4-42335.2.9.Evaluation of safety of each batch of veterinary vaccines and immunosera............................................................................5475.2.Generaltexts 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 radionuclidesmentionedin the European Pharmacopoeia (611)5.8.Pharmacopoeial harmonisation..................................7.1-33455.9.Polymorphism...........................................................................627/forum.php?mod=viewthread&tid=21456&fromuid=1023。