欧洲药典-凡例(中英文对照)

欧洲药典-凡例

1.1. GENERAL STATEMENTS

The General Notices apply to all monographs and other texts of the European Pharmacopoeia. 总论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，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 the light of experimental results of stability studies.

药品在有效期内必须性质稳定，明确的有效期或说明应由权力机构批准。专论的题目在使用时必须一致。任何药品的有效期和有效期的起始时间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.

除总论和各论中另有说明，各论中的说明为法定要求；除为了提供特定信息，如果各论引用总论中内容时，总论为法定要求。

The active ingredients (medicinal substances), excipients (auxiliary substances), 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. The tests and assays described are the official methods upon which the standards of the Pharmacoooeia 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 各论中描述的有效成分（药用物质），赋形剂（辅料），药物制剂和其它成分用于人和兽的使用（除非明确限制不可使用）。一种药品只有在符合各论中各项要求时，才算药典中的药品。但并不要求药品上市前，供应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，和过程控制，自检药品是否符合药典要求。权力机构认为充分的环境条件应符合药典要求。检测和试验方法应基于药典的标准.经权利机构允许可采用其它的分析方法以达到控制目的，若出现争论或异议，应以药典方法为准。

Certain materials that are the subject of a pharmacopoeia1 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 important for 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。 General monographs. Substances and preparations that are the subject of an individual monograph are also required to comply with relevant, applicable general monographs.

总论：各论中介绍的药物和制剂也应符合总论中的相关要求。

Cross-references to applicable general monographs are not normally given in individual monographs. 参照总论中的一些内容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，总论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.

总论中介绍的剂量形式适用于典型定义的所有制剂。对于一特定制剂不必要对所有特性进行限定，一些要求可由相关的机构补充。

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、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.

“除另有批准”是指一些要求修改后，经权利机构允许的。

Statements containing the word "should" are informative or advisory.

一段话中出现“可以”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。

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.

可供选择的方法：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。

1.2. OTHER PROVISIONS APPLYING

TO GENERAL CHAPTERS AND MONOGRAPHS

为总论和各论提供的信息

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 in the same conditions, the stated quantity is taken for examination. Reagents are used in the prescribed amounts.

用量：用于试验的量有具体限度时，规定用于检测的量为一大约值。实际用量不得超过规定量的10%，由实际用量计算结果。对于限度无规定值的试验，限度依赖于相同条件下与对照品测试结果相比较，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），体积由吸液管、量瓶或滴定管测量 ；否则，用量筒或刻度吸量管测定。使用微量吸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。

Unless otherwise prescribed, analytical procedures are carried out at a temperature between 15 "C and 25 "C.

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）。相同量的溶液以白色或黑色为背景水平方向进行对照试验，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 "C 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 second 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，残渣两次连续称重偏差小于0.5mg。干燥或炽灼的第二次称重分别根据残渣的性质和量继续干燥或炽灼一定时间后进行。

Where drying is prescribed using one of the expressions "in a desiccator" or "in uacuo", it is carried out using the conditions described under 2.2.32. Loss on drying.

干燥是在干燥器或真空中进行，操作条件参见干燥失重（2.2.32）中所示。

REAGENTS 试剂

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.

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。一些情况下，试剂要求分析纯；对于其它一些试剂，适用性有其它规定。

SOLVENTS 溶剂

Where the name of the solvent is not stated, the term "solution" implies a solution in water.

溶剂如无特殊说明，溶液是指水溶液。

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 on Purified water (0008) is used, except that for many purposes the requirements for

bacterial endotoxins (Purified water in bulk) and microbial 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（批量的纯化水）或微生物污染（容器中的纯化水）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 (C2H5O) required.

除另有特殊说明，"ethanol"是指无水乙醇，"alcohol"是指96%的乙醇。其它的乙醇稀溶液浓可用"ethanol"或"alcohol"表示，浓度用百分比表示（ml/ml）.

EXPRESSION OF CONTENT 内容的说明

In defining content, the expression "per cent" is used according to circumstances with one of two meanings:

- per cent m/m (percentage, mass in mass) expresses the number of grams of substance in 100 grams of final product,

- per cent V f l (percentage, volume in volume) expresses the number of millilitres of substance in 100 millilitres of final product.

The expression "parts per million (ppm)" refers to mass in mass, unless otherwise specified.

在定义的内容中，百分比有以下两个含义：

%（g/g） 表示100g溶液中含有溶质若干克；

%（ml/ml） 表示100ml溶液中含有溶质若干毫升；

ppm 表示溶质的含量为百万分之几。

TEMPERATURE 温度

Where an analytical procedure describes temperature without a figure, the general terms used have the following meaning:

- in a deep-freeze : below - 15 "C,

- in a refrigerator: 2 "C to 8 "C,

- cold or cool: 8 "C to 15 "C,

- room temperature: 15 "C to 25 "C.

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：

-低温冷冻：-15℃以下

-冷藏柜中：2-8℃

-冷却：8-15℃

-室温：15-25℃

1.3. GENERAL CHAPTERS CONTAINERS

1.3.总论内容

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.

用于制作包材的原料在总论3.1中有描述。原料的统称，特别是塑料材质，每种都包含一系列性质和添加物不同的产品。原料的测试方法和限度依赖于它的组成成分，所以只适用于组成成分明确的原料检测。组成成分不同的原料检测方法不同，具体的检测方法由权力机构决定。

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，在标题规定/产品下可能规定使用的包材规格；有些各论中会在标题贮藏下指出建议使用的包材规格。