欧洲药典（凡例）中英对照

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 test methods 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 s

ubstance. 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：

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。 P

RODUCTION 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 deion 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 deion 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

1.6 UNITS OF THE INTERNATIONAL SYSTEM (SI) USED IN THE PHARMACOPOEIA AND EQUIVALENCE WITH OTHER UNITS

药典中使用的国际制度单位（SI）和其他等价单位

INTERNATIONAL SYSTEM OF UNITS (SI)

国际制度单位

The International System of Units comprises 3 classes of units, namely base units, derived units and supplementary units(1). The base units and their definitions are set out in Table 1.6-1.

国际制度单位由3种单位组成，分别是基本单位，导出单位和辅助单位。基本单位及其定义参照表1.6-1。

The derived units may be formed by combining the base units according to the algebraic relationships linking the corresponding quantities. Some of these derived units have special names and symbols. The SI units used in the Pharmacopoeia are shown in Table 1.6-2.

根据相应数量的代数关系导出单位一般和基本单位联合使用。其中一些导出单位有特殊的名称和符号。欧洲药典中使用的国际制度单位参照表1.6-2。

Some important and widely used units outside the International System are shown in Table 1.6-3. 国际制度以外的一些重要的和广泛使用的单位参照表1.6-3。

The prefixes shown in Table 1.6-4 are used to form the names and symbols of the decimal multiples and submultiples of SI units.

表1.6-4表示的是国际制度单位中十进制倍数和约数名称和符号的前缀。

NOTES

备注

1. In the Pharmacopoeia, the Celsius temperature is used (symbol t). This is defined by the following equation:

药典中，摄氏温度是用符号t表示。定义式为： t=T-T 0 , T 0=273.15K。

The Celsius or centigrade temperature is expressed in degrees Celsius (symbol ℃). The unit ‘degree Celsius’ is equal to the unit ‘kelvin’.

摄氏温度或摄氏度都是用符号℃表示。摄氏度和开尔文的单位是一样的。

2. The practical expressions of concentrations used in the Pharmacopoeia are defined in the General Notices.

药典中使用的浓度或含量表示在通则中有表述。

3. The radian is the plane angle between two radii of a circle that cut off on the circumference an arc equal in length to the radius.

弧长等于半径的弧，其所对的圆心角为1弧度。

4. In the Pharmacopoeia, conditions of centrifugation are defined by reference to the acceleration due to gravity (g):

药典中，离心条件下可产生相应的重力加速度：g=9.80665m·s-2

5. Certain quantities without dimensions are used in the Pharmacopoeia: relative density (2.2.5), absorbance (2.2.25), specific absorbance (2.2.25) and refractive index (2.2.6).

药典中有一些符号式没有单位的，如相对密度(2.2.5),吸光度(2.2.25),百分吸光度(2.2.25)和折射率(2.2.6)

6. The microkatal is defined as the enzymic activity that, under defined conditions, produces the transformation (e.g. hydrolysis) of 1 micromole of the substrate per second.

酶活性用微卡他定义，在指定的条件下，每秒钟转化1微摩尔的底物的酶量（例如水解）(如水解作用)。

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