欧洲药典8.0-凡例双语版

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 signatoryStates 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 articlecomplies with the requirements of the relevant monograph. Such references to monographs in the texts of the Pharmacopoeia are shown using themonograph 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 ofvalidity and/or specifications for opened or broached containers may bedecided 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 aredecided 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. Generalchapters become mandatory when referred to in a monograph, unless suchreference 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 offunctionality-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。