欧洲药典8.0-凡例双语版.pdf

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 mand