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 signatory
States 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 article
complies with the requirements of the relevant monograph. Such references to monographs in the texts of the Pharmacopoeia are shown using the
monograph 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。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。
A preparation must comply throughout its period of validity; a distinct period of
validity and/or specifications for opened or broached containers may be
decided by the competent authority. The subject of any other monograph must comply throughout its period of use. The period of validity that is assigned to any given article and the time from which that period is to be calculated are
decided by the competent authority in light of experimental results of stability studies.
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。
Unless otherwise indicated in the General Notices or in the monographs,
statements in monographs constitute mandatory requirements. General
chapters become mandatory when referred to in a monograph, unless such
reference is made in a way that indicates that it is not the intention to make the text referred to mandatory but rather to cite it for information.
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。
The active substances, excipients, pharmaceutical preparations and other articles described in the monographs are intended for human and veterinary use (unless explicitly restricted to one of these uses). An article is not of Pharmacopoeia quality unless it complies with all the requirements stated in the monograph. This does not imply that performance of all the tests in a monograph is necessarily a prerequisite for a manufacturer in assessing compliance with the Pharmacopoeia before release of a product. The manufacturer may obtain assurance that a product is of Pharmacopoeia quality from data derived, for example, from validation studies of the manufacturing process and from in-process controls. Parametric release in circumstances deemed appropriate by the competent authority is thus not precluded by the need to comply with the Pharmacopoeia.
各论中描述的活性物质，辅料，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。
The tests and assays described are the official methods upon which the standards of the Pharmacopoeia are based. With the agreement of the competent authority, alternative methods of analysis may be used for control purposes, provided that the methods used enable an unequivocal decision to be made as to whether compliance with the standards of the monographs would be achieved if the official methods were used. In the event of doubt or dispute, the methods of analysis of the Pharmacopoeia are alone authoritative. 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。
Certain materials that are the subject of a pharmacopoeial monograph may exist in different grades suitable for different purposes. Unless otherwise indicated in the monograph, the requirements apply to all grades of the material. In some monographs, particularly those on excipients, a list of
functionality-related characteristics that are relevant to the use of the substance may be appended to the monograph for information. Test methods for determination of one or more of these characteristics may be given, also for information.
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。
Quality systems. The quality standards represented by monographs are valid only where the articles in question are produced within the framework of a suitable quality system.
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。
General monographs. Substances and preparations that are the subject of an individual monograph are also required to comply with relevant, applicable general monographs. Cross-references to applicable general monographs are not normally given in individualmonographs.
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。
General monographs apply to all substances and preparations within the scope of the Definition section of the general monograph, except where a preamble limits the application, for example to substances and preparations that are the subject of a monograph of the Pharmacopoeia
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。
General monographs on dosage forms apply to all preparations of the type defined. The requirements are not necessarily comprehensive for a given specific preparation and requirements additional to those prescribed in the general monograph may be imposed by the competent authority.
通则中介绍的剂量形式适用于典型定义的所有制剂。对于特殊给药制剂的规定并不全面，其在各论中有增加的要求，这些要求也是权力机构强制实施的。
General monographs and individual monographs are complementary. If the provisions of a general monograph do not apply to a particular product, this is expressly stated in the individual monograph.
通则和各论是互补的。如果通则不适合某些特殊产品，那么在各论中有特别规定。
Validation of pharmacopoeial methods. The testmethods given in monographs and general chapters have been validated in accordance with accepted scientific practice and current recommendations on analytical validation. Unless otherwise stated in the monograph or general chapter, validation of the test methods by the analyst is not required.
药典方法确认：各论和通则中的检测方法已经根据适宜的科学实验和通行的分析验证确认。除各论和通则中另有规定外，药典中的分析方法不需要验证。
Implementation of pharmacopoeial methods. When implementing a pharmacopoeial method, the user must assess whether and to what extent the suitability of the method under the actual conditions of use needs to be demonstrated according to relevant monographs, general chapters and quality systems.
药典方法的实施：当采用一种药典方法时，用户必须评估实际的使用条件，并且该方法应符合一般章节和质量体系的相关专著并得到证明。
Conventional terms. The term ‘competent authority’ means the national, supranational or international body or organisation vested with the authority for making decisions concerning the issue in question. It may, for example, be a national pharmacopoeia authority, a licensing authority or an official control laboratory.
惯用术语： “权力机构”是指对一些问题进行仲裁的国家、超国家的、国际机构或授权组织。例如，国家药典委员会等。
The expression ‘unless otherwise justified and authorised’ means that the requirements have to be met, unless the competent authority authorises a modification or an exemption where justified in a particular case.
“除证明和授权”是指该要求必须遵守，除非特殊情况下权力机构授权减免。
Statements containing the word ‘should’ are informative or advisory.
陈述中出现“应该（should）”是指此段描述作为信息提供或建议。
In certain monographs or other texts, the terms ‘suitable’ and ‘appropriate’ are used to describe a reagent, micro-organism, test method etc.; if criteria for suitability are not described in the monograph, suitability is demonstrated to the satisfaction of the competent authority.
在某些各论或文章中出现了“合适的”和“适当的”用于描述一种试剂、微生物、检测方法等；若各论中没有介绍适用性标准，适用性的论述应符合权力机构的要求。
Medicinal product. (a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings and/or animals; or (b) any substance or combination of substances that may be used in or administered to human beings and/or animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
药品：(a) 指用于人或动物，起治疗或预防作用的化合物或多组分化合物。(b) 指用于人或动物，通过发挥药理、免疫、代谢作用起恢复、纠正、调整生理机能的化合物或多组分化合物。或用于医疗诊断的物质。
Herbal medicinal product. Any medicinal product, exclusively containing as
active ingredients one or more herbal drugs or one or more herbal drug
preparations, or one or more such herbal drugs in combination with one or
more such herbal drug preparations.
中药：指以一种或多种草药或草药制剂为活性成分的药品。
Active substance. Any substance intended to be used in the manufacture of a medicinal product and that, when so used, becomes an active ingredient of the medicinal product. Such substances are intended to furnish a pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or
prevention of disease, or to affect the structure and function of the body.
活性成分：指具有活性用作治疗的药物产品。例如：提供药理活性或直接用于诊断或影响身体构造及功能的物质。
Excipient (auxiliary substance). Any constituent of a medicinal product that is not an active substance. Adjuvants, stabilisers, antimicrobial preservatives,
diluents, antioxidants, for example, are excipients.
辅料（辅料）：除活性成分外药物产品的其他构成成分。例如：辅助剂、稳定剂、防腐剂、稀释剂、抗氧化剂等均属于辅料。
Interchangeable methods. Certain general chapters contain a statement that the text in question is harmonised with the corresponding text of the Japanese Pharmacopoeia and/or the United States Pharmacopeia and that these texts are interchangeable. This implies that if a substance or preparation is found to comply with a requirement using an interchangeable method from one of these pharmacopoeias it complies with the requirements of the European
Pharmacopoeia. In the event of doubt or dispute, the text of the European
Pharmacopoeia is alone authoritative.
可互换的方法：一些章节中会出现这样的描述，此篇文章与JP或USP一致，这意味着一种药物或制剂采用JP或USP中的任意一种方法时，同样符合EP的要求。若出现争论或异议时，以EP为准。
References to regulatory documents. Monographs and general chapters may contain references to documents issued by regulatory authorities for medicines, for example directives and notes for guidance of the European Union. These references are provided for information for users for the Pharmacopoeia.
Inclusion of such a reference does not modify the status of the documents
referred to, which may be mandatory or for guidance.
法规参考：各论和通则可能包含有权威部门颁布的参考文献，例如，欧盟发行的指南。这些参考可以给药典使用者提供信息。这些参考并不会改变相关文件的法律效力。
1.2 OTHER PROVISIONS APPLYING TO GENERAL CHAPTERS AND
MONOGRAPHS
适用于通则和各论的其他规定取样量：
Quantities. In tests with numerical limits and assays, the quantity stated to be taken for examination is approximate. The amount actually used, which may deviate by not more than 10 per cent from that stated, is accurately weighed or measured and the result is calculated from this exact quantity. In tests where the limit is not numerical, but usually depends upon comparison with the behaviour of a reference substance in the same conditions, the stated quantity is taken for examination. Reagents are used in the prescribed amounts.
数量：检验方法中取样量有限度时，该规定值为一近似值。实际取样量不得超过规定量的±10%，由实际称量值计算结果。对于无限度规定值的试验，限度依据相同条件下与对照品测试结果相比较而定，取规定量用于试验。使用规定量的试剂。
Quantities are weighed or measured with an accuracy commensurate with the indicated degree of precision. For weighings, the precision corresponds to plus or minus 5 units after the last figure stated (for example, 0.25 g is to be interpreted as 0.245 g to 0.255 g). For the measurement of volumes, if the figure after the decimal point is a zero or ends in a zero (for example, 10.0 mL or 0.50 mL), the volume is measured using a pipette, a volumetric flask or a burette, as appropriate; otherwise, a graduated measuring cylinder or a graduated pipette may be used. Volumes stated in microlitres are measured using a micropipette or microsyringe.
用精密度和准确度相当的仪器量取一定量的被测物。称重时，精密度为末位数字的正负0.5个单位（例如，0.25g是指0.245-0.255g）。体积测量时，如果小数点后的数字为零或末位数字为零时（例如10.0ml或0.50ml），体积用移液管、容量瓶或滴定管测量；否则，用量筒或刻度吸量管测定。使用微量移液管和微量注射器测量可精确到微升。
It is recognised, however, that in certain cases the precision with which quantities are stated does not correspond to the number of significant figures stated in a specified numerical limit. The weighings and measurements are then carried out with a sufficiently improved accuracy.
在某些情况下，如果精确度不符合要求，称重或测量时可通过提高准确度来弥补。
Apparatus and procedures. Volumetric glassware complies with Class A requirements of the appropriate International Standard issued by the International Organisation for Standardisation.
仪器和程序：玻璃量具应符合国际标准组织制定的A级标准。
Unless otherwise prescribed, analytical procedures are carried
out at a temperature between 15℃ and 25℃.
除另有说明，分析过程在15-25℃条件下进行。
Unless otherwise prescribed, comparative tests are carried out using identical tubes of colourless, transparent, neutral glass with a flat base; the volumes of liquid prescribed are for use with tubes having an internal diameter of 16 mm, but tubes with a larger internal diameter may be used provided the volume of
liquid used is adjusted (2.1.5). Equal volumes of the liquids to be compared are examined down the vertical axis of the tubes against a white background, or if necessary against a black background. The examination is carried out in diffuse light.
除另有说明外，用中性、无色、透明的平底同质试管进行对照试验；用内径为16mm的试管取规定量的液体试剂，若液体用量有调整可选用内径为其它规格的试管（2.1.5）。相同体积的溶液以白色或黑色为背景垂直方向进行对照试验，试验在漫射光条件下进行。
Any solvent required in a test or assay in which an indicator is to be used is previously neutralised to the indicator, unless a blank test is prescribed.
除有空白试验的情况下，用于试验的所有溶剂使用前应加入指示剂中和。
Water-bath. The term ‘water-bath’ means a bath of boiling water unless water at another temperature is indicated. Other methods of heating may be substituted provided the temperature is near to but not higher than 100℃ or the indicated temperature.
水浴：除另有说明外，水浴是指在沸水中进行。若要求的温度在100℃以下或指定温度，可用其它的加热方法。
Drying and ignition to constant mass. The terms ‘dried to constant mass’ and ‘ignited to constant mass’ mean that 2 consecutive weighings do not differ by more than 0.5 mg, the 2nd weighing following an additional period of drying or of ignition respectively appropriate to the nature and quantity of the residue.
干燥或炽灼至恒重：干燥或炽灼至恒重是指烘干或炽灼后，连续两次称重差异不超过0.5mg。根据残渣的性质和数量再次干燥或炽灼一定时间后进行第二次称量。
Where drying is prescribed using one of the expressions ‘in a desiccator’ or ‘in vacuo’, it is carried out using the conditions described in chapter 2.2.32. Loss on drying.
干燥是在干燥器或真空中进行，操作方法参见干燥失重（2.2.32）中所示。
Reagents. The proper conduct of the analytical procedures described in the Pharmacopoeia and the reliability of the results depend, in part, upon the quality of the reagents used. The reagents are described in general chapter 4. It is assumed that reagents of analytical grade are used; for some reagents, tests to determine suitability are included in the specifications.
试剂：药典中规定的分析方法和测试结果的可靠性依赖于所使用试剂的性质。试剂在总论4中有描述。一般情况下，试剂要求分析纯；对于某些试剂，正文中另有说明。
Solvents. Where the name of the solvent is not stated, the term ‘solution’ implies a solution in water.
溶剂:溶剂如无特殊说明，“溶解”一般是指在水中溶解。
Where the use of water is specified or implied in the analytical procedures
described in the Pharmacopoeia or for the preparation of reagents, water complying with the requirements of the monograph Purified water (0008) is used, except that for many purposes the requirements for bacterial endotoxins (Purified water in bulk) andmicrobial contamination (Purified water in containers) are not relevant. The term ‘distilled water’ indicates purified water prepared by distillation.
药典中规定用于分析操作或制备试剂的水，应符合各论中纯化水（0008）的要求，被内毒素或微生物污染后不得使用。蒸馏水是指纯化水经蒸馏后制得。
The term ‘ethanol’ without qualification means anhydrous ethanol. The term
‘alcohol’without qualification means ethanol (96 per cent). Other dilutions of ethanol are indicated by the term ‘ethanol’ or ‘alcohol’ followed by a statement of the percentage by volume of ethanol (C2H6O) required.
除另有特殊说明，“乙醇”是指无水乙醇，“酒精”是指96%的乙醇。其它的“乙醇”或“酒精”的稀溶液用乙醇(C2H5O)的体积百分比表示。
Expression of content. In defining content, the expression ‘per cent’ is used according to circumstances with one of 2 meanings:
含量的表达：在定义的内容中，百分比有以下两个含义：
–per cent m/m (percentage, mass in mass) expresses the number of grams of substance in 100 g of final product;
%（ml/ml）：表示100ml溶液中含有溶质若干毫升；
–per cent V/V (percentage, volume in volume) expresses the number of millilitres of substance in 100 mL of final product.
%（g/g）：表示100g溶液中含有溶质若干克；
The expression ‘parts per million’(or ppm) refers to mass in mass, unless otherwise specified.
ppm :表示溶质的含量为百万分之几。
Temperature. Where an analytical procedure describes temperature without a figure, the general terms used have the following meaning:
温度:如分析操作中所规定的温度无具体描述，通常使用的术语的含义如下所示：
–in a deep-freeze: below?15℃;
-冷冻：-15℃以下
–ina refrigerator:2℃to 8℃;
-冷藏：2-8℃
–cold or cool: 8℃ to15℃;
-阴凉：8-15℃
–room temperature: 15 ℃ to 25 ℃.
-室温：15-25℃
1.3 GENERAL CHAPTERS
总论
Containers. Materials used for containers are described in general chapter 3.1.
General names used for materials, particularly plastic materials, each cover a range of products varying not only in the properties of the principal constituent but also in the additives used. The test methods and limits for materials depend on the formulation and are therefore applicable only for materials whose
formulation is covered by the preamble to the specification. The use of
materials with different formulations, and the test methods and limits applied to them, are subject to agreement by the competent authority.
容器：用于制作包材的原料在总论3.1中有描述。“原料”作为统称，特别是塑料材质，每种产品都包含一系列不同主要成分和添加物。原料的测试方法和限度依赖于它的配方，所以说明书的序言应包含适宜的原料配方。配方不同的原料检测方法不同，检测方法应符合权力机构的规定。
The specifications for containers in general chapter 3.2 have been developed for general application to containers of the stated category, but in view of the wide variety of containers available and possible new developments, the
publication of a specification does not exclude the use, in justified
circumstances, of containers that comply with other specifications, subject to agreement by the competent authority.
总论3.2中描述的包材规格适用于一般的分类，但考虑到包材规格的可变性，只要满足权力机构的要求，其它规格也可使用。
Reference may be made within the monographs of the Pharmacopoeia to the definitions and specifications for containers provided in chapter 3.2. Containers.
The general monographs for pharmaceutical dosage forms may, under the
heading Definition/Production, require the use of certain types of container ;
certain other monographs may, under the heading Storage, indicate the type of container that is recommended for use.
药典各论中使用的包材可选用总论3.2中介绍的类型。各论中药物剂量形式中，在“定义/产品”项下可能规定使用的包材规格；有些各论中会在“贮藏”项下指出建议使用的包材规格。
1.4 MONOGRAPHS
各论
TITLES
标题
Monograph titles are in English and French in the respective versions and there
is a Latin subtitle.
在各自版本中各论标题是用英语或法语写的，副标题是拉丁文。
RELATIVE ATOMIC AND MOLECULAR MASSES
相对原子质量和相对分子质量
The relative atomic mass (Ar) or the relative molecular mass (Mr) is shown, as andwhere appropriate, at the beginning of each monograph. The relative atomic and molecular masses and the molecular and graphic formulae do not constitute analytical standards for the substances described.
相对原子质量（Ar）或相对分子质量（Mr）在每篇各论开头的位置写出。相对原子质量、相对分子质量、分子结构式并不包括在物料的分析标准中。
CHEMICAL ABSTRACTS SERVICE (CAS) REGISTRY NUMBER
CAS登记号
CAS registry numbers are included for information in monographs, where applicable, to provide convenient access to useful information for users. CAS Registry NumberR is a registered trademark of the American Chemical Society. 各论中包含了CAS登记号这一信息。合适的情况下，为用户获得有效信息提供便捷途径。CAS 登记号是美国化学协会注册商标。
DEFINITION
定义
Statements under the heading Definition constitute an official definition of the substance, preparation or other article that is the subject of the monograph.
在“定义”项下的说明是物料、制剂、或各论其他部分文字的官方释义。
Limits of content. Where limits of content are prescribed, they are those determined by the method described under Assay.
含量：有含量规定时，由分析方法下的描述决定。
Herbal drugs. In monographs on herbal drugs, the definition indicates whether the subject of the monograph is, for example, the whole drug or the drug in powdered form. Where a monograph applies to the drug in several states, for example both to the whole drug and the drug in powdered form, the definition states this.
中药：中药的各论中，在“定义”部分而非正文部分，药物是以完整药材或粉末形式进行描述的，或是药材和粉末两种形式都有描述。
PRODUCTION
生产
Statements under the heading Production draw attention to particular aspects of themanufacturing process but are not necessarily comprehensive. They constitute mandatory requirements for manufacturers, unless otherwise stated. They may relate, for example, to source materials; to the manufacturing process itself and its validation and control; to in-process testing; or to testing that is to be carried out by the manufacturer on the final article, either on selected batches or on each batch prior to release. These statements cannot necessarily be verified on a sample of the final article by an independent analyst. The competent authority may establish that the instructions have been followed, for example, by examination of data received from the manufacturer, by inspection of manufacture or by testing appropriate samples.
在“生产”项下的描述中，对生产过程中有特殊要求的有提出注意，但不包括必要的普遍要求。除非另有规定，对于生产商来说这些描述是强制性的规定。例如，涉及到原料、生产过程、验证和控制、中间体测试、由生产者参与的最终实验、以及批次的选择或优先放行批次的选择。这些描述不需要通过单独的分析最终产物样品来证实。主管部门会建立相应的规定，比如检查生产商提供的数据，审查生产商或检测相应的样品。
The absence of a Production section does not imply that attention to features such as those referred to above is not required.
“生产”项下未描述的部分并不意味着对相关特性不做要求。如上面提到的那些是必须的。
Choice of vaccine strain, Choice of vaccine composition. The Production section of a monograph may define the characteristics of a vaccine strain or vaccine composition. Unless otherwise stated, test methods given for verification of these characteristics are provided for information as examples of suitable methods. Subject to approval by the competent authority, other test methods may be used without validation against the method shown in the monograph.
疫苗株和疫苗成分的选择：各论中“生产”项下的说明也适用于疫苗株和疫苗成分的特性。除另有规定外，验证这些特性的检验方法需要提供适合的参考信息。通过主管部门批准后，其他检测方法就不需要验证，和各论中的方法进行比对即可。
POTENTIAL ADULTERATION
潜在掺假
Due to the increasing number of fraudulent activities and cases of adulteration, information may be made available to Ph. Eur. users to help detect adulterated materials (i.e. active substances, excipients, intermediate products, bulk products and finished products).
由于欺骗事件和掺假的情况越来越多，用户可以帮助检测掺假的物料（即活性物质，辅料，中间产品，散装产品和成品）并把信息提供给EP。
To this purpose, a method for the detection of potential adulterants and relevant limits, together with a reminder that all stages of production and sourcing are
subjected to a suitable quality system, may be included in this section of monographs on substances for which an incident has occurred or that present a risk of deliberate contamination. The frequency of testing by manufacturers or by users (e.g. manufacturers of intermediate products, bulk products and finished products, where relevant) depends on a risk assessment, taking into account the level of knowledge of the whole supply chain and national requirements.
为了达到这个目的，用一个检测潜在参杂物和相关限度的方法提醒与整个生产阶段和采购接受合适的质量系统，可能包括专著中已经发生或存在故意污染的物质。制造商或使用者（例如中间产品、散装产品和成品的制造商，在相关处）测试的频率取决于评估风险，同时考虑到整个供应链的知识水平和国家需求。
This section constitutes requirements for the whole supply chain, from manufacturers to users (e.g. manufacturers of intermediate products, bulk products and finished products, where relevant). The absence of this section does not imply that attention to features such as those referred to above is not required.
这章节整个供应链的要求从生产商到用户（如制造商中间产品，散装产品和成品，相关情况）构成。没有描述的部分的并不意味着对相关特征不要求，如上面提到的那些是必需的。
CHARACTERS
性质
The statements under the heading Characters are not to be interpreted in a strict sense and are not requirements.
在“性质”项下的描述无严格意义上的解释和要求。
Solubility. In statements of solubility in the Characters section, the terms used have the following significance, referred to a temperature between 15 ℃and 25 ℃.
溶解度：“性质“项下对于溶解度的描述包括以下几种定义，且温度要控制在15℃~25℃。
The term ‘partly soluble’ is used to describe a mixture where only some of the components dissolve. The term ‘miscible’ is used to describe a liquid that is miscible in all proportions with the stated solvent.
“部分溶解”是指混合物中部分成分溶解。“混溶”是指液体与指定溶剂可以任意比例互溶。
IDENTIFICATION
鉴别
Scope. The tests given in the Identification section are not designed to give a full confirmation of the chemical structure or composition of the product; they are intended to give confirmation, with an acceptable degree of assurance, that the article conforms to the description on the label.
范围：鉴别项下的试验不能完全确认化学结构或药品成分；在确保认可的情况下，这些试验可用来确认标签的描述。
First and second identifications. Certain monographs have subdivisions entitled ‘First identification’ and ‘Second identification’. The test or tests that constitute the ‘First identification’ may be used in all circumstances. The test or tests that constitute the ‘Second identification’ may be used in pharmacies provided it can be demonstrated that the substance or preparation is fully traceable to a batch certified to comply with all the other requirements of the monograph.
第一和第二鉴别：某些各论中细分出了“第一鉴别”和”“第二鉴别”。“第一鉴别”的试验在任何情况下都可采用。若该产品完全可以追溯，且可以证明该产品完全符合各论中其它的规定，则可以采用第二鉴别。
Certain monographs give two or more sets of tests for the purpose of the first identification, which are equivalent and may be used independently. One or more of these sets usually contain a cross-reference to a test prescribed in the Tests section of the monograph. It may be used to simplify the work of the analyst carrying out the identification and the prescribed tests. For example, one identification set cross-refers to a test for enantiomeric purity while the other set gives a test for specific optical rotation: the intended purpose of the two is the same, that is, verification that the correct enantiomer is present.
各论第一鉴别项下中给出的两个或多个鉴别试验，它们是等效的并且各自独立不相关联。在各论的“检查“项下通常包含一个或多个交叉引用，用来简化鉴别或检查项下的检验工作。例如：对映异构体的检查，在鉴别项下引用了旋光度检查项下的内容，以此证明是否有对映异构体存在。
Powdered herbal drugs. Monographs on herbal drugs may contain schematic
drawings of the powdered drug. These drawings complement the description given in the relevant identification test.
中药粉末:中药的各论中包含粉末特征图，这些图的完整描述在相关鉴别项下。
TESTS AND ASSAYS
检查
Scope. The requirements are not framed to take account of all possible impurities. It is not to be presumed, for example, that an impurity that is not detectable by means of the prescribed tests is tolerated if common sense and good pharmaceutical practice require that it be absent. See also below under Impurities.
范围：该要求并未对所有杂质进行记述。例如：未进行规定检查的未知杂质通常情况下和良好的药学实践要求下都是允许存在的，这些也可参见在“杂质”项。
Calculation. Where the result of a test or assay is required to be calculated with reference to the dried or anhydrous substance or on some other specified basis, the determination of loss on drying, water content or other property is carried out by the method prescribed in the relevant test in the monograph. The words ‘dried substance’ or ‘anhydrous substance’ etc. appear in parentheses after the result.
计算：当测试结果需要以干燥品或无水物计算时，或用其他特定指标计算时，干燥失重、水分或其他指标的测试方法参见相关各论中的叙述。干燥物或无水物等是在结果后用圆括号附加说明。
Where a quantitative determination of a residual solvent is carried out and a test for loss on drying is not carried out, the content of residual solvent is taken into account for the calculation of the assay content of the substance, the specific optical rotation and the specific absorbance. No further indication is given in the specific monograph.
对残留溶剂进行定量测定，和对干燥过程中的损失进行了测试，并将残留溶剂的含量考虑进去，测定了该物质的含量、特定的旋光度和特定的吸光度。在具体的专著中没有给出进一步的指示。
Limits. The limits prescribed are based on data obtained in normal analytical practice; they take account of normal analytical errors, of acceptable variations in manufacture and compounding and of deterioration to an extent considered acceptable. No further tolerances are to be applied to the limits prescribed to determine whether the article being examined complies with the requirements of the monograph.
限量：限量规定是基于常规分析实验数据之上；还要考虑常规分析的误差，生产工艺和产品的波动，可接受的变坏的程度。各论中要求的“限量”项必须检查。
In determining compliance with a numerical limit, the calculated result of a test
or assay is first rounded to the number of significant figures stated, unless otherwise prescribed. The limits, regardless of whether the values are expressed as percentages or as absolute values, are considered significant to the last digit shown (for example 140 indicates 3 significant figures). The last figure of the result is increased by one when the part rejected is equal to or exceeds one half-unit, whereas it is not modified when the part rejected is less than a half-unit.
对于有数值的限量，除非另有规定，检测结果首先是对重要数字进行四舍五入的处理。限量无论是用百分比还是绝对值表示，数值的最后一位为有效位（例如140表示3位有效数值）。要舍弃的数字如果等于或超过了一个半单位就增加一位，如果少于一个半单位则不改变。
Indication of permitted limit of impurities. The acceptance criteria for related substances are expressed in monographs either in terms of comparison of peak areas (comparative tests) or as numerical values. For comparative tests, the approximate content of impurity tolerated, or the sum of impurities, may be indicated in brackets for information only. Acceptance or rejection is determined on the basis of compliance or non-compliance with the stated test. If the use of a reference substance for the named impurity is not prescribed, this content may be expressed as a nominal concentration of the substance used to prepare the reference solution specified in the monograph, unless otherwise described. 杂质限度的表示：有关物质的接受标准在专著中有规定，无论是对比的峰值区域（对比测试）或作为数值计算。对于比较试验，所含杂质的近似含量，或杂质的总和，可在括号内表示，仅供参考。接受与否的标准取决于结果符不符合该实验。除非另有规定，如果该处未对已知杂质对照品进行叙述，该内容在各论的对照品溶液准备项下集中详述。
Herbal drugs. For herbal drugs, the sulfated ash, total ash, water-soluble matter, alcohol-soluble matter, water content, content of essential oil and content of active principle are calculated with reference to the drug that has not been specially dried, unless otherwise prescribed in the monograph.
中药：对于中药而言，计算酸不溶性灰分，总灰分，浸出物，醇溶性浸出物，水分，挥发油和含量测定无需特别进行干燥，除非各论中另有说明。
Equivalents. Where an equivalent is given, for the purposes of the Pharmacopoeia only the figures shown are to be used in applying the requirements of the monograph.
当量：药典给出“当量”只是为了在各论中要求时用于计算。
Culture media. The culture media described in monographs and general chapters have been found to be satisfactory for the intended purpose. However, the components of media, particularly those of biological origin, are of variable quality, and it may be necessary for optimal performance to modulate the concentration of some ingredients, notably:
培养基：各论和通则中记载的培养基应满足其使用目的。然而培养基的组成，特别是生物来源都不相同，因而为了达到最佳的使用效果有必要调整一些配比，常见的有：
–peptones and meat or yeast extracts, with respect to their nutritive properties;
-蛋白胨和肉或酵母膏，需要注明其营养特性
–bufferingsubstances;
-缓冲物质
–bile salts, bile extract, deoxycholate, and colouring matter, depending on their selective properties;
-胆盐，胆汁提取物，脱氧物和有色物质，取决于其选择性成分
–antibiotics, with respect to their activity.
-抗体，取决于其活性
STORAGE
储存
The information and recommendations given under the heading Storage do not constitute a pharmacopoeial requirement but the competent authority may specify particular storage conditions that must be met.
“储存”项下的信息和建议并不是药典的要求，但权力机构可能会对特殊储存条件做出规定。
The articles described in the Pharmacopoeia are stored in such a way as to prevent contamination and, as far as possible, deterioration. Where special conditions of storage are recommended, including the type of container (see section 1.3. General chapters) and limits of temperature, they are stated in the monograph.
药典中记述的储存方式是用来预防污染和变质的。当需要某种特殊储存条件时，应该包括“容器类型(参照通则1.3部分)”和“温度限制”，并记载在各论中。
The following expressions are used in monographs under Storage with the meaning shown.
以下是各论中对储存条件表述的解释。
In an airtight container means that the product is stored in an airtight container
(3.2). Care is to be taken when the container is opened in a damp atmosphere.
A low moisture content may be maintained, if necessary, by the use of a desiccant in the container provided that direct contact with the product is avoided.
“密闭”是指产品储存在一个密闭的容器中(3.2)。当容器敞放在潮湿的环境中时需要注意。如有必要保持低水分时可在容器中直接放入干燥剂，但要避免与产品直接接触。
Protected from light means that the product is stored either in a container made
of a material that absorbs actinic light sufficiently to protect the contents from change induced by such light, or in a container enclosed in an outer cover that provides such protection, or is stored in a place from which all such light is excluded.
“避光”保存是指产品既可以储存在由能足够吸收光线的材料容器中来保证产品在光的影响下不变质，也可以储存在外部富有遮盖物的容器中，或可以储存在一个完全不透光的地方。
LABELLING
标签
In general, labelling of medicines is subject to supranational and national regulation and to international agreements. The statements under the heading Labelling are not therefore comprehensive and, moreover, for the purposes of the Pharmacopoeia only those statements that are necessary to demonstrate compliance or non-compliance with the monograph are mandatory. Any other labelling statements are included as recommendations. When the term ‘label’ is used in the Pharmacopoeia, the labelling statements may appear on the container, the package, a leaflet accompanying the package, or a certificate of analysis accompanying the article, as decided by the competent authority.
通常情况下，药品的标签应获得国家和国际组织的批准。“标签”项下的说明并不一定很全面，而且药典规定这些说明中必须注明是否符合各论的标准。其他要求也可写在标签中。当“标签”在药典中使用时，这些标签就可能会在容器，包装，随包装的传单和检验结果报告单中出现，决定权归主管部门。
WARNINGS
警告
Materials described in monographs and reagents specified for use in the Pharmacopoeia may be injurious to health unless adequate precautions are taken. The principles of good quality control laboratory practice and the provisions of any appropriate regulations are to be observed at all times. Attention is drawn to particular hazards in certain monographs by means of a warning statement; absence of such a statement is not to be taken to mean that no hazard exists.
如不采取适当的保护措施，各论中记载的物料和药典中某些特殊的试剂可能会对身体造成伤害。良好质量控制实验室的相应规则条款随时都应引起注意。各论中提出注意特殊危险意味着警告，没有出现该种警告就意味着没有危险存在。
IMPURITIES
杂质
A list of all known and potential impurities that have been shown to be detected by the tests in a monograph may be given. See also chapter 5.10. Control of impurities in substances for pharmaceutical use. The impurities are designated
by a letter or letters of the alphabet. Where a letter appears to be missing, the impurity designated by this letter has been deleted from the list during
monograph development prior to publication or during monograph revision.
各论中可能给出了已知杂质或未知的可能存在杂质的检查方法（参照章节5.10：药用物料杂质的控制）。杂质是用一个字母或字母表的形式表示。当缺失了某个字母时，代表以该字母表示的杂质在各论的更新和修订中已被删除。
FUNCTIONALITY-RELATED CHARACTERISTICS OF EXCIPIENTS
辅料的功能特性
Monographs on excipients may have a section on functionality-related
characteristics. The characteristics, any test methods for determination and any tolerances are not mandatory requirements; they may nevertheless be relevant for use of the excipient and are given for information (see also section 1.1.
General statements).
各论中有关于辅料的功能特性的章节。关于用来测定这些特性和耐受性的检查都不是强制性要求，而是给出有关辅料使用的信息(参见凡例1.1部分)。
REFERENCE STANDARDS
对照品
Certain monographs require the use of reference standards (chemical
reference substances, herbal reference standards, biological reference
preparations, reference spectra). See also chapter 5.12. Reference standards.
某些各论中对对照品(化学对照品，生物标准品和标准图谱)的使用有要求（参照章节5.12：对照品）。
The European Pharmacopoeia Commission establishes the official reference standards, which are alone authoritative in case of arbitration. These reference standards are available from the European Directorate for the Quality of
Medicines & HealthCare (EDQM). Information on the available reference
standards and a batch validity statement can be obtained via the EDQM
website.
欧洲药典委员会建立了官方的对照品，检验时可单独授权使用。这些对照品来自欧洲医学与保健质量局(EDQM)。有关对照品的信息和有效期可以在EDQM的网站上查得。
1.5 ABBREVIATIONS AND SYMBOLS
缩写和符号
Abbreviations used in the monographs on immunoglobulins, immunosera and vaccines
各论中免疫球蛋白，免疫血清和疫苗使用的缩写
2.6.1. STERILITY 2.6.1 无菌检查法 The test is applied to substances, preparations or articles which, according to the Pharmacopoeia, are required to be sterile. However, a satisfactory result only indicates that no contaminating micro-organism has been found in the sample examined in the conditions of the test. 本检查方法适用于按照药典要求应当无菌的原料、制剂或其他物质。但是，如果按照本无菌检查法的结果符合要求，仅表明在该检查条件下未发现微生物污染。 PRECAUTIONS AGAINST MICROBIAL CONTAMINATION 微生物污染防范 The test for sterility is carried out under aseptic conditions. In order to achieve such conditions, the test environment has to be adapted to the way in which the sterility test is performed. The precautions taken to avoid contamination are such that they do not affect any micro-organisms which are to be revealed in the test. The working conditions in which the tests are performed are monitored regularly by appropriate sampling of the working area and by carrying out appropriate controls. 无菌检测试验应在无菌的条件下进行。为了达到这样的条件，检测环境应当与无菌检测的操作要求相适应。避免污染的防范措施应当不对本检查方法进行检测的微生物造成影响（应并不影响用本检查法检测的微生物）。通过对工作区域的适当取样以及进行适当的控制来对无菌检查的工作环境进行例行监测。 CULTURE MEDIA AND INCUBATION TEMPERATURES 培养基和培养温度 Media for the test may be prepared as described below, or equivalent commercial media may be used provided that they comply with the growth promotion test. 应按下面描述的方法制备无菌检查的培养介质，如果满足生长促进试验要求，与本处所述培养基相当的商业化培养基也可以采用（也可采用与本处……）。 The following culture media have been found to be suitable for the test for sterility. Fluid thioglycollate medium is primarily intended for the culture of
01/2008:2139 修订：7.3 长春西汀 Vinpocetine 欧洲药典10.0 Ph.Eur. 10.0 EP 10.0 C22H26N2O2Mr 350.5 [42971-09-5] 定义 乙基(13as,13bs)13α-乙基-2, 3 ,5 ,6-13α 13b六氢-1H-吲哚3, 2, 1-d吡啶3, 2, 1-ij,l, 5-二痰杂萘-12-羧酸。（Ethyl (13aS,13bS)-13a-ethyl-2,3,5,6,13a,13b-hexahydro- 1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate.） 含量：98.5%- 101.5%（干品）。 特征 外观：白色或微黄色结晶性粉末。 溶解性：几乎不溶于水，可溶于二氯甲烷，微溶于无水乙醇。 鉴别 A.比旋度（见检测项）。 B.红外吸收光谱（2.2.24）。 对比：长春西汀CRS。
检测 比旋光度(2.2.7):+127到+134（干品）。 取0.25 g溶于二甲基甲酰胺R，并用相同的溶剂稀释至25.0 ml。 有关物质。液相色谱（2.2.29）. 供试溶液。取50.0mg供试品溶于流动相并用流动相稀释至50.0ml。 对照溶液(a).取1.0ml 供试品溶液用流动相稀释至50.0ml。 对照溶液(b).取5.0mg 长春西汀杂质B CRS，6.0mg长春西汀杂质A CRS，5.0mg 长春西汀杂质C CRS 5.0mg长春西汀杂质D CRS，溶于流动相，并用流动相稀释至50.0ml。 对照溶液(c).取1.0ml 对照溶液(a)和1.0 ml对照溶液(b)用流动相稀释至20.0ml。 色谱柱: －尺寸：l = 0.25m, ? = 4.6mm －固定相：色谱用末端封尾的十八烷基硅烷键和硅胶R(5μm)。 流动相：15.4g/l 的醋酸铵R溶液，乙腈R（45:55 V/V）。 流速：1.0ml/min。 检测器：分光光度计，280nm。 进样量：15 μl 运行时间：长春西汀保留时间的3倍。 相对保留时间，以长春西汀（保留时间=约16min）为参照：杂质A= 约0.4；杂质D=约0.68；杂质B= 约0.75；杂质C=约0.83。 系统适应性：对照品溶液(c): －分离度：杂质Ｂ和Ｄ之间的分离度不得少于为2.0。 限度： －杂质A：不得超过对照品溶液(c)色谱图中相应峰的峰面积（0.6%）； －杂质B, D：每种杂质不得超过对照品溶液(c)色谱图中相应峰的峰面积（0.5%）； －杂质C：不得超过对照品溶液(c)色谱图中相应峰的峰面积的0.6倍（0.3%）；
系统适应性——美国药典 系统适应性是气相和液相色谱分析方法的重要组成部分，用于证明色谱系统的分离度和重现性能满足样品的分析要求。 测试基于这样的原理：仪器、电路、方法和样品组成一个整体系统，我们可以对这个系统进行测试评估。 影响色谱系统的因素包括： ●流动相的组成、离子强度、温度和pH 值 ●柱子大小、流速、柱温和压力 ●固定相特点，包括填料类型，载体形状、 粒径、孔径、表面积等。 ●常用固定相为反相硅胶，以十八碳烷基 健合硅胶最常用，其它经过化学修饰的 硅胶也有使用。 分离度R s是理论塔板数n的函数（也叫柱效），α是分离因子，k是容量因子（所有符号的意义见前文“色谱定义和说明”部分）。在规定的色谱条件下，n表示洗脱物中相邻化合物的分离程度，可作为衡量色谱系统柱效能的指标，但是不如直接测试的结果可靠。峰的尖锐程度部分反映柱效，这个参数对检查微量物质至关重要。 标准品或者标准溶液需要重复进样以确保精密度。除非个论中有规定, 系统适用性五针的数据的相对标准偏差不超过2.0%, 如果超过2.0%的话, 需要进样六针。 在含量测定中，如果纯品含量100%，则相对标准偏差没有最大值限制，这个值可根据多次进样对照溶液来计算： %RSD=KB/t90%，n-1 K为常数0.349，由公式k=(0.6/)×(t90%,5/)计算得来，表示B=1.0时六次进样的相对标准偏差。B是个案中规定的上限。n是对照溶液的进样次数（3≤n≤6），t90%,n-1是自由度为n-1、置信水平为90%，双侧检验时的t值。 除非另有规定，RSD不能超过下表中的值。此规定不适用于相关物质检测。 对称因子AS，用于衡量峰的对称性，完全对称时值为1。拖尾越严重，AS的值越大（见图4）。偶尔也会有值小于1的情况。如果对称因子与1的差值越大，则积分的精密度越差。 信噪比（S/N）是系统适应性的一个重要参数，计算公式如下（图5）： S/N = 2H/h H是峰高，即峰最高点到基线的距离；h是噪音最大值和最小值之间的差值。 系统适应性测试的数据通过重复进样标准品或者特定文件中规定的对照溶液而得到， 此文件中对相关参数的定义同样适用于其它操作条件，以下情况可做相应调整：●标准品（包括参考物质）对适应性测试 中的所有化合物均适用 ●在系统适应性测试中为改进色谱系统性能 而作适当调整 对色谱系统的调整不能弥补柱子和系统本 身的缺陷。 为满足系统适应性要求而对分析方法调整
3.1.3. 聚烯烃 定义 聚烯烃是通过乙烯或丙烯的聚合而成，或是通过这些不超过25%的高同系物的物质或羧酸或酯的共聚作用获得。某些材料可能是聚烯烃的混合物。 成品 添加一定数量的添加剂到聚合物中是为了优化它们的化学性质，物理性质和机械性能，为了使它们适用于预定用途。所有的这些添加剂都是选自附件列表，并指出了每一种产品中的最大允许含量。产品中最多包含有三种抗氧化剂，一种或几种润滑剂或抗粘连剂以及当材料必须提供光照保护时，还要添加二氧化钛作为遮光剂。 – 二叔丁基对甲酚（增塑剂07）：限量：0.125% –四钛季戊四醇松香酸酯[3-(3,5-二叔丁基-4-羟苯基)丙酸酯]（增塑剂09）：限量：0.3%–1,3,5-三羟甲基氨基甲烷(3,5-二叔丁基-4-邻羟苄基)- 三嗪-2,4,6(1H,3H,5H)-三酮, (增塑剂 13): 限量： 0.3% – 二乙烯[3,3-二[3-(1,1-dimethylethyl)-4-羟苯基]丁酸甲酯] (增塑剂08)：限量：0.3%– 二（十八烷基）二硫化物（增塑剂15）限量：0.3% 4,4′,4″-(2,4,6-三甲基苯-1,3,5-triyltrismethylene) –三羟甲基氨基甲烷[2,6-二(1,1-dimethylethyl)苯酚]（增塑剂10）限量：0.3% 2,2′-二(octadecyloxy)-5,5′-spirobi[1,3,2-dioxaphosphinane](增塑剂 14): 限量：0.3 %; – didodecyl 3,3′-硫代二丙酸（增塑剂16): 限量： 0.3 %; – dioctadecyl3,3′-硫代二丙酸(增塑剂 17): 限量：0.3 %; – 三羟甲基氨基甲烷[2,4-二(1,1-dimethylethyl)苯基] 亚磷酸盐 (增塑剂 12): 限量：0.3 %; – 增塑剂 18: 限量： 0.1%; –琥珀酸二甲酯和 (4-hydroxy-2,2,6,6-tetramethylpiperidin-1-yl)乙醇的共聚物 (增塑剂 22): 限量：0.3% 上面列出的抗氧化添加剂总含量不超过0.3%。 –铝碳酸镁：限量：0.5%； –烷基酰胺：限量：0.5%； –烯烃酰胺：限量：0.5%； –硅铝酸钠：限量：0.5%；
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
ICH领域专业术语表（质量、安全性） 序号英文中文 1 absorption 吸收 2 acceptable daily intake 可接受的日摄入量 3 accelerated test 加速试验 4 acceptance criteia 认可标准 5 accuracy 准确性 6 accelerated/stress stability studies 加速/强力破坏稳定性研究 7 action limits 内控限值 8 active ingredient 活性组分 9 active metabolite 活性代谢产物 10 additional test 附加实验 11 additions 添加剂 12 adduct 加合物 13 adequate exposure 充分暴露 14 adjuvant 佐剂 15 administration period 给药期 16 adventitious agents 外源性因子 17 adventitious contaminants 外来污染物 18 adventitious viruses 外源病毒 19 adverse reaction 不良反应 20 aerobic microorganisms 需氧微生物 21 affinity 亲和力 22 affinity chromatography 亲和层析 23 affinity column 亲和柱 24 agar and broth 琼脂和肉汤 25 aggregation 聚集 26 altered growth 生长改变 27 ambient condition 自然条件 28 amino acid sequence 氨基酸顺序 29 amino acids 氨基酸 30 amino sugars 氨基糖 31 analytical method 分析方法 32 antibiotics 抗生素 33 antibody 抗体 34 antibody production tests 抗体产生试验 35 antigenic specificity 抗原特异性 36 applicant 申报者 37 art and ethical standards 技术和伦理标准 38 assessment of genotoxicity 遗传毒性评价 39 attainment of full sexual function 达到性成熟 40 avidity 亲和性 41 background 背景 42 bacteria 细菌 43 base pairs 碱基对
2.2.32. LOSS ON DRYING 干燥失重 Loss on drying is the loss of mass expressed as per cent m/m. 干燥失重指重量损失，表述为% 重量/重量 Method. Place the prescribed quantity of the substance to be examined in a weighing bottle previously dried under the conditions prescribed for the substance to be examined. Dry the substance to constant mass or for the prescribed time by one of the following procedures. Where the drying temperature is indicated by a single value rather than a range, drying is carried out at the prescribed temperature +/- 2?C. 方法：将要求数量的待检样品放置于预先干燥的称量瓶中，按要求条件进行干燥，直至样品干至恒重或下述程序指定的时长。如果干燥温度给定的是一个值而不是一个范围，则在指定温度+/- 2?C进行干燥。 a) “in a desiccator”: the drying is carried out over diphosphorus pentoxide R at atmospheric atmostpheric pressure and at room temperature; “在干燥器中”：指在室温常压下，用五氧化二磷试剂，进行干燥 b) “in vacuo”: the drying is carried out over diphosphorus pentoxide R, at a pressure of 1.5 kPa at room temperature; “真空”：在室温下，真空1.5kPa下，用五氧化二磷试剂进行干燥 c) “in vacuo within a specified temperature range”: the drying is carried out over diphosphorus pentoxide R, at a pressure of 1.5kPa to 2.5kPa within the temperature range prescribed in the monograph; “在指定温度范围内真空下”：真空1.5kPa至2.5kPa下，各论要求的温度范围内，用五氧化二磷进行干燥 d) “in an oven within a specified temperature range”: the drying is carrie d out in an oven within the temperature range prescribed in the monograph; “在烘箱里指定温度下”：在各论要求的温度范围内，用烘箱进行干燥 e) “under high vacuum”: the drying is carried out over diphosphorus pentoxide R at a pressure not exceeding 0.1kPa, at the temperature prescribed in the monograph. “在高真空下”：在各论要求的温度下，不超过0.1kPa的真空下用五氧化二磷进行干燥 If other conditions are prescribed, the procedure to be used is described in full in the monograph. 如果需要采用其它条件，则在各论中应进行详细描述。
欧洲药典附录 Prepared on 22 November 2020
第二部分、附录 附录1 溶液的澄清度 在内径15～25mm，平底，无色、透明、中性玻璃管中，加入等量的供试溶液与浊度标准液，使液位的深度都为40mm，按如下所述方法进行比较。浊度标准液制备5分钟后，以色散自然光照射浊度标准溶液和供试溶液，在黑色背景下从垂直方向观察、比较澄清度或浑浊程度。色散自然光必须较容易区分浊度标准溶液Ⅰ与水，浊度标准溶液Ⅱ与浊度标准溶液Ⅰ。 如果供试溶液的澄清、透明程度与水相同，或者与所用溶剂相同，或者其澄清度不超过Ⅰ号浊度标准溶液，那么可判定该溶液为澄清。 试剂： 硫酸肼溶液：取硫酸肼溶于水，加水稀释至，静置4～6小时。 乌洛托品（六亚甲基四胺）溶液：在100ml容量平中，以水溶解乌洛托品。 浊度标准贮备液：在存放乌洛托品溶液的100ml容量瓶中，加的硫酸肼溶液。混合，静置24小时，贮存在无表面要求的玻璃容器中，可在2个月内使用。该浊度液不得黏附玻璃，用前必须充分摇匀。 浊度标准原液：取浊度标准贮备液15ml，加水稀释、定容至1000ml。该液临用前制备，至多保存24小时。 浊度标准液：由浊度标准原液与水按表1-1配制,即得。本液应临用前配制。
附录2 溶液颜色检查 按本药典规定，用下面两种方法之一可以检出溶液在棕色-黄色-红色范围内的颜色。 如果溶液A的外观与水或所用溶剂相同，或者颜色浅于标准比色液B 9 ，则可判定溶液A为无色。 方法I 用外径为12mm的无色、透明中性玻璃管取2ml的供试溶液，与相同玻璃管中的2ml的水，或2ml本文所规定的标准比色液（见标准比色液表）进行比较。在散射自然光，白色的背景下，水平观察比较颜色。 方法Ⅱ 用同样平底、内径为15～25mm的无色透明中性玻璃管，液位的深度为40mm，将供试溶液与水或溶剂或本文中规定的标准比色液（见标准比色液表）对比。在散射自然光，白色的背景下，垂直地观察比较颜色。 贮备液 黄色液称取46克氯化铁，加大约900ml盐酸溶液（25ml浓盐酸和975ml水混和）溶解，继续添加，并定容。 滴定并以上述盐酸溶液调整，使黄色液每毫升含 FeCl 3﹒6H 2 O。避光保存。 滴定在一个配有磨口塞的250ml锥形瓶内，加入黄色液，15ml 水，5ml浓盐酸和4g碘化钾，塞上瓶塞，在暗处放置15分钟，再加100ml 水。用的硫代硫酸钠标准溶液滴定游离的碘，在滴定接近终点时加淀粉试液作指示剂。 1ml 的硫代硫酸钠标准溶液相当于 FeCl 3﹒6H 2 O。 红色液称取60克氯化钴，加大约900ml盐酸溶液（25ml浓盐酸和975ml水混和）溶解，继续添加，并定容。 滴定并以上述盐酸溶液调整，使红色液每毫升含 CoCl 2﹒6H 2 O。 滴定在一个配有磨口塞的250ml锥形瓶内，加入红色液，5ml稀过氧化氢溶液和10ml 300g/l的氢氧化钠溶液，缓慢煮沸10分钟，冷却后，加60ml稀硫酸和2g碘化钾，塞上瓶塞，缓慢摇动锥形瓶，使沉淀溶解完全。用的硫代硫酸钠标准溶液滴定游离的碘，在滴定接近终点时加入淀粉试液作为指示剂。溶液变成粉红色时到达滴定终点。 的硫代硫酸钠标准溶液相当于 CoCl 2﹒6H 2 O。 蓝色液称取63克硫酸铜加大约900ml盐酸溶液（25ml浓盐酸和975ml水混和）溶解，继续添加，并定容。 滴定并以上述盐酸溶液调整，使蓝色液每毫升含 CuSO 4﹒5H 2 O。
附录1溶液的澄清度 在内径15～25mm，平底，无色、透明、中性玻璃管中，加入等量的供试溶液与浊度标准液，使液位的深度都为40mm，按如下所述方法进行比较。浊度标准液制备5分钟后，以色散自然光照射浊度标准溶液和供试溶液，在黑色背景下从垂直方向观察、比较澄清度或浑浊程度。色散自然光必须较容易区分浊度标准溶液Ⅰ与水，浊度标准溶液Ⅱ与浊度标准溶液Ⅰ。 如果供试溶液的澄清、透明程度与水相同，或者与所用溶剂相同，或者其澄清度不超过Ⅰ号浊度标准溶液，那么可判定该溶液为澄清。 试剂： 硫酸肼溶液：取硫酸肼溶于水，加水稀释至，静置4～6小时。 乌洛托品（六亚甲基四胺）溶液：在100ml容量平中，以水溶解乌洛托品。 浊度标准贮备液：在存放乌洛托品溶液的100ml容量瓶中，加的硫酸肼溶液。混合，静置24小时，贮存在无表面要求的玻璃容器中，可在2个月内使用。该浊度液不得黏附玻璃，用前必须充分摇匀。 浊度标准原液：取浊度标准贮备液15ml，加水稀释、定容至1000ml。该液临用前制备，至多保存24小时。 浊度标准液：由浊度标准原液与水按表1-1配制,即得。本液应临用前配制。 表1-1
附录2 溶液颜色检查 按本药典规定，用下面两种方法之一可以检出溶液在棕色-黄色-红色范围内的颜色。 如果溶液A的外观与水或所用溶剂相同，或者颜色浅于标准比色液B9，则可判定溶液A为无色。 方法I
用外径为12mm的无色、透明中性玻璃管取2ml的供试溶液，与相同玻璃管中的2ml的水，或2ml本文所规定的标准比色液（见标准比色液表）进行比较。在散射自然光，白色的背景下，水平观察比较颜色。 方法Ⅱ 用同样平底、内径为15～25mm的无色透明中性玻璃管，液位的深度为40mm，将供试溶液与水或溶剂或本文中规定的标准比色液（见标准比色液表）对比。在散射自然光，白色的背景下，垂直地观察比较颜色。 贮备液 黄色液称取46克氯化铁，加大约900ml盐酸溶液（25ml浓盐酸和975ml水混和）溶解，继续添加，并定容。 滴定并以上述盐酸溶液调整，使黄色液每毫升含 FeCl3﹒6H2O。避光保存。 滴定在一个配有磨口塞的250ml锥形瓶内，加入黄色液，15ml 水，5ml浓盐酸和4g碘化钾，塞上瓶塞，在暗处放置15分钟，再加100ml 水。用的硫代硫酸钠标准溶液滴定游离的碘，在滴定接近终点时加淀粉试液作指示剂。 1ml 的硫代硫酸钠标准溶液相当于 FeCl3﹒6H2O。 红色液称取60克氯化钴，加大约900ml盐酸溶液（25ml浓盐酸和975ml水混和）溶解，继续添加，并定容。 滴定并以上述盐酸溶液调整，使红色液每毫升含 CoCl2﹒6H2O。
第二部分、附录 附录1 溶液的澄清度 (2) 附录2 溶液颜色检查 (3) 附录3 旋光度 (6) 附录4 铵盐检查法 (8) 附录5 氯化物检查法 (9) 附录6 硫酸盐灰分 (10) 附录7 铁 (11) 附录8 重金属 (12) 附录9 干燥失重 (15) 附录10 硫酸盐检查法 (16) 附录11 红外吸收分光光度法 (17) 附录12 pH测定 (20) 附录13 滴定 (22) 附录14 氯化物鉴别反应 (23) 附录15 指示剂颜色与溶液pH 的关系 (24)
在内径15～25mm，平底，无色、透明、中性玻璃管中，加入等量的供试溶液与浊度标准液，使液位的深度都为40mm，按如下所述方法进行比较。浊度标准液制备5分钟后，以色散自然光照射浊度标准溶液和供试溶液，在黑色背景下从垂直方向观察、比较澄清度或浑浊程度。色散自然光必须较容易区分浊度标准溶液Ⅰ与水，浊度标准溶液Ⅱ与浊度标准溶液Ⅰ。 如果供试溶液的澄清、透明程度与水相同，或者与所用溶剂相同，或者其澄清度不超过Ⅰ号浊度标准溶液，那么可判定该溶液为澄清。 试剂： 硫酸肼溶液：取1.0g硫酸肼溶于水，加水稀释至100.0ml，静臵4～6小时。 乌洛托品（六亚甲基四胺）溶液：在100ml容量平中，以25.0ml水溶解2.5g乌洛托品。 浊度标准贮备液：在存放乌洛托品溶液的100ml容量瓶中，加25.0ml的硫酸肼溶液。混合，静臵24小时，贮存在无表面要求的玻璃容器中，可在2个月内使用。该浊度液不得黏附玻璃，用前必须充分摇匀。 浊度标准原液：取浊度标准贮备液15ml，加水稀释、定容至1000ml。该液临用前制备，至多保存24小时。 浊度标准液：由浊度标准原液与水按表1-1配制,即得。本液应临用前配制。
Date of implementation: 1 March 2010 Introduction: The holder of a Certificate of suitability shall inform the EDQM of any change to the information in the certification dossier by sending an application form and all necessary documents demonstrating that the conditions laid down in the present guideline are met. Classification of changes The changes have been classified in three categories (notification/minor/major) depending on the potential impact of the change on the quality of the final substance. These three categories are based on those (IA-IAIN/IB/II) of the Commission Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisation for medicinal products for human use and veterinary medicinal products. Any change not classified as a notification or a major change should be classified as a minor change except in the following cases where a new application should be submitted: - addition of a new route of synthesis and/or a new manufacturing site where the specifications of the final substance are different from the one already approved - transfer to a new holder that is not the same legal entity as the approved one, where the transfer does not occur because of a merger or because the company is sold, and where the manufacturer does not take out the Certificate of suitability in their own name. The changes related to Ph. Eur. monograph revisions or any other regulatory requirements are treated separately and generally initiated by the EDQM. 执行日期：2010年3月1日 介绍： 欧洲药典适用性证书持有人必须向EDQM报告所有与申报文件有关的变更，申报时应填写申请表格和所有必要的资料，证明变更符合现行指南的规定。 变更分类 根据变更对最终产品可能产生的影响程度，变更分为三类（通知/微小/重大）。 分类原则是根据EC法规1234/2008 (IA-IAIN/IB/II)：EC成员国审核人用和兽用制剂销售许可证变更规定 所有未划为通知或者重大变更的变更都是微小变更，但以下情形必须按新证书申请办理： - 增加新合成途径或新生产场地，而且成品质量标准发生变化。 - 持有人转让，新持有人与现行法人不同，这种转让不是公司合并、出售的结果，生产厂也没有以自己名义获取原有证书。
5.4 残留溶剂 在活性物质、辅料和医药产品中限定残留溶剂水平 ICH采取了关于残留溶剂杂质指导原则，这个指导原则描述了在活性物质、辅料和医药产品中的溶剂浓度限定。指导原则排除了已存在的市场产品。EP采用了和这项指导原则同样的原则，不管存在的活性物质、辅料和医药产品是否是药典专论的内容。所有的物质和产品都要测定它们中可能出现的溶剂浓度。 其中限额适用遵从以下的，溶剂残留量测试在特定专论一般不提及，因为从一个制造商到另一个采用的溶剂可能会有所不同，这一总章的要求通过制药用物质（2034）适用。在产品生产过程中所采用的溶剂应告知主管，该信息也列于为EP专论的合格证而递交的卷宗，在证书中也提及。 其中只有使用第三类溶剂时，采用干燥损失测定或者进行溶剂的具体测定。如果采用了一种被确认可行的、权威的第三类溶剂，但高于限度0.5%，溶剂的具体测定是需要的。 当使用第一类或第二类溶剂（或第三类溶剂超过限度0.5%）时，用在一般方法中描述的方法，否则采用经证实的合适的方法。 当进行残留溶剂的定量测定时，在计算物质含量时，这个结果被考虑进去，除了干燥检验。 杂质：残留溶剂的指导原则 1.前言 该指导原则的目的是建议为了病人安全在药物中可允许的残留溶剂的量。该指导原则建议少使用有毒溶剂，描述了一些残留溶剂的毒性允许水平。 在这医药产品中的残留溶剂被定义为在活性物质或辅料的制造或医药产品的制剂中使用的或产生的有机挥发性物质。这些溶剂没有通过实用生产技术完全清除，在活性物质合成中合适地选择溶剂会提高产量，决定一些晶体的结构、纯度、溶解性等特征，因此有时溶剂会成为合成过程中的重要参数，该指导原则并没有指出辅料中使用的溶剂和溶剂化物，但是，这些产品中的溶剂含量应该评估并说明理由。 由于残留溶剂没有疗效，所有残留溶剂的去除都应该达到产品的标准或药品生产和管理规范或其他质量要求，医药产品不应包含比安全系数更高的水平的残留溶剂，一些溶剂会造成不允许的毒性，应该在生产中避免，除非他们的使用在风险效益评估中有强烈的理由。为了防止病人的副作用，一些低严重毒性的溶剂应该被限制。理论上，在生产中不应该使用有毒溶剂，所有在该指导原则中出现的溶剂列表在附录1中，该列表并不是详尽无漏的，其他溶剂可以使用可加到表中，其中第一类和第二类的限度或者溶剂的分类也可以随着新的安全数据而改变，含有新溶剂的新产品在市场上许可的安全数据的支持是以这个指导原则中的杂质限度概念为基础的。 2.指导原则的范围 活性物质、辅料和医药产品中的残留溶剂都在该范围内，因此当知道生产或纯化过程会导致这些溶剂的出现时，必须进行检测，只须检测在活性物质、辅料和医药产品生产纯化中的残留溶剂。虽然制造商会选择检测医药产品，但也可以从生产医药产品的组分水平用一种累积方法来计算医药产品中的残留溶剂水平。如果计算结果等于或小于该指导原则中规定的，就不需要考虑医药产品的检测了，但是如果高于这个水平，就需要检测医药产品来确定合成过程中是否要减少相关溶剂的水平到可允许的量，如果在制造中使用了一种溶剂医药产品也应检测。
EN 868-5：1999 待灭菌医疗器械包装材料和系统 第5部分：纸与塑料膜组合的热封和自封袋和卷要求和试验方法 引言 本系列欧洲标准的第1部分规定了预期用作医疗器械包装的包装材料和系统的通用要求和试验方法。这些医疗器械最终在其包装内灭菌。 1 范围 EN 868的本部分规定了用符合EN 868-3规定的纸和符合本部分第4章规定的塑料膜制造的热封和自封袋的专用要求和试验方法。 4.2至4.7中的专用要求可用以证实符合第1部分的一项或多项要求，但不是其全部要求。 本标准规定的热封和自封袋和卷适用于包装最终灭菌的医疗器械。热封和自封袋和卷用作初包装能使使用者用前方便地无菌观察内装物，这一点非常重要。 2 规范性引用文件 EN 285 灭菌蒸汽灭菌大型灭菌器 EN 867-2 灭菌器中使用的非生物学系统第2部分：过程批示物（A级） EN 868-1待灭菌医疗器械包装材料和系统第1部分：通用要求和试验方法 EN 868-3待灭菌医疗器械包装材料和系统第3部分：袋（EN868-4所规定的）袋和卷（EN868-5所规定的）生产用纸要求和试验方法 EN 1422 医用灭菌器环氧乙烷灭菌器要求和试验方法 EN 28601数据元和交换格式信息交换日期和时间表示法（ISO 8601：1988和技术修改单1：1991） GB/T 7408-1994数据元和交换格式信息交换日期和时间表示法EQV ISO 8601-88 EQV ISO 8601-88 ASTM D 882：1995 塑料膜抗张性能试验方法 3定义 EN868-1的定义适用于本部分。 4 要求 4.1 总则 EN868-1的要求适用。 注：下列专用要求和试验方法可用于证实EN868-1的一项或多项要求，但不是全部要求。 4.2 材料 4.2.1 纸 纸应符合EN 868-3的要求。 4.2.2 塑料膜 4.4.2.1 塑料膜应是由两层或多层复合而成。按附录A试验时，塑料结合层（interplybond）应不发生分离或发白。 4.4.2.2 塑料膜和粘合区，都不应有已知足以引起健康危害的有毒物质释出。 在相应的欧洲标准或国际标准发布前，可执行相关的国家法规。 4.2.2.3 按附录B试验时，塑料膜应无针孔。 4.2.2.4在发射光下（日光或良好的人工照明）用正常视力或矫正视力检验时，塑料膜应无
头孢曲松钠（非无菌粉）标准操作规程(EUR) 6.1 性状：本品为类白色或淡黄色结晶性粉末，略吸湿。 6.2 鉴别： 6.2.1 本品的红外光图谱应与对照品的图谱一致。 6.2.2取本品0.1g置于试管中，加水2ml溶解，加150g/L碳酸钾溶液2ml，加热至沸，不得有沉淀生 成；加焦锑酸钾试液4ml，加热至沸；置冰水中冷却，必要时，用玻璃棒擦试管内壁，有致密的白色沉淀生成。 焦锑酸钾试液：取焦锑酸钾2g，在95ml热水中溶解，迅速冷却，加入氢氧化钾溶液（2.5g→50ml）和1ml稀氢氧化钠溶液（8.5g→100ml）。放置24小时，过滤加水稀释至150ml。 6.3 pH值：取本品2.40g，加无二氧化碳的水溶解并稀释至20.0ml，用pH仪测定，pH值应为6.0～ 8.0。 6.4 水分：取本品0.100g，用水分仪测定，含水分应为8.0%～11.0%。 6.5 溶液的澄清度与颜色：取本品2.40g，加无二氧化碳的水溶解并稀释至20.0ml，量取2ml该溶液 加水稀释至20ml，溶液应澄清无色；如显色，与黄色、黄绿色5号标准比色液比较，均不得更深。 6.6 比旋度：取本品0.250g加水稀释至25.0ml，依法测定，比旋度为-155°— -170°。 6.7 相关物质： 6.7.1色谱系统：色谱柱：Thermo ODS-2 HYPERSIL十八烷基硅烷键合硅胶柱（31605-254630）， 250mm×4.6mm 5μm，检测波长：254nm 流速：1.5ml/min 进样量：20μl 6.7.2 溶液配制： 供试品溶液：称取本品30.0mg，加流动相溶解并稀释至100.0ml。 对照溶液(a)：称取头孢曲松对照品30.0mg，加流动相溶解并稀释至100.0ml。 对照溶液(b)：称取头孢曲松对照品5.0mg和头孢曲松杂质A对照品5.0mg，加流动相溶解并稀释至100.0ml。 对照溶液(c)：量取1.0ml的供试品溶液，加流动相溶解并稀释至100.0ml。 0.067M 磷酸盐缓冲液pH7.0：称取0.908g磷酸二氢钾加水稀释至100.0ml，作为溶液A；称取 2.38g磷酸氢二钠加水稀释至100.0ml，作为溶液B，分别取38.9ml溶液A和61.1ml溶液B混合 均匀，如有必要调整pH至7.0。 pH5.0柠檬酸缓冲液：称取20.17g柠檬酸加水稀释至800ml。
第二部分、附录 附录1 溶液的澄清度 在内径15～25mm，平底，无色、透明、中性玻璃管中，加入等量的供试溶液与浊度标准液，使液位的深度都为40mm，按如下所述方法进行比较。浊度标准液制备5分钟后，以色散自然光照射浊度标准溶液和供试溶液，在黑色背景下从垂直方向观察、比较澄清度或浑浊程度。色散自然光必须较容易区分浊度标准溶液Ⅰ与水，浊度标准溶液Ⅱ与浊度标准溶液Ⅰ。 如果供试溶液的澄清、透明程度与水相同，或者与所用溶剂相同，或者其澄清度不超过Ⅰ号浊度标准溶液，那么可判定该溶液为澄清。 试剂： 硫酸肼溶液：取硫酸肼溶于水，加水稀释至，静置4～6小时。 乌洛托品（六亚甲基四胺）溶液?：在100ml容量平中，以水溶解乌洛托品。 浊度标准贮备液：在存放乌洛托品溶液的100ml容量瓶中，加的硫酸肼溶液。混合，静置24小时，贮存在无表面要求的玻璃容器中，可在2个月内使用。该浊度液不得黏附玻璃，用前必须充分摇匀。 浊度标准原液：取浊度标准贮备液15ml，加水稀释、定容至1000ml。该液临用前制备，至多保存24小时。 浊度标准液：由浊度标准原液与水按表1-1配制,即得。本液应临用前配制。 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B 9 ，则可判定溶液A为无色。 方法I 用外径为12mm的无色、透明中性玻璃管取2ml的供试溶液，与相同玻璃管中的2ml的水，或2ml本文所规定的标准比色液（见标准比色液表）进行比较。在散射自然光，白色的背景下，水平观察比较颜色。 方法Ⅱ 用同样平底、内径为15～25mm的无色透明中性玻璃管，液位的深度为40mm，将供试溶液与水或溶剂或本文中规定的标准比色液（见标准比色液表）对比。在散射自然光，白色的背景下，垂直地观察比较颜色。 贮备液 黄色液称取46克氯化铁，加大约900ml盐酸溶液（25ml浓盐酸和975ml 水混和）溶解，继续添加，并定容。 滴定并以上述盐酸溶液调整，使黄色液每毫升含 FeCl 3﹒6H 2 O。避光保存。 滴定在一个配有磨口塞的250ml锥形瓶内，加入黄色液，15ml 水，5ml 浓盐酸和4g碘化钾，塞上瓶塞，在暗处放置15分钟，再加100ml 水。用的硫代硫酸钠标准溶液滴定游离的碘，在滴定接近终点时加淀粉试液作指示剂。 1ml 的硫代硫酸钠标准溶液相当于 FeCl 3﹒6H 2 O。 红色液称取60克氯化钴，加大约900ml盐酸溶液（25ml浓盐酸和975ml 水混和）溶解，继续添加，并定容。 滴定并以上述盐酸溶液调整，使红色液每毫升含 CoCl 2﹒6H 2 O。 滴定在一个配有磨口塞的250ml锥形瓶内，加入红色液，5ml稀过氧化氢溶液和10ml 300g/l的氢氧化钠溶液，缓慢煮沸10分钟，冷却后，加60ml稀硫酸和2g碘化钾，塞上瓶塞，缓慢摇动锥形瓶，使沉淀溶解完全。用的硫代硫酸钠标准溶液滴定游离的碘，在滴定接近终点时加入淀粉试液作为指示剂。溶液变成粉红色时到达滴定终点。