欧洲药典-凡例(中英文对照)

欧洲药典-凡例1.1. GENERAL STATEMENTSThe 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 whethercompliance 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 applyto 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。