USP29-1086药典药品中的杂质(中+英 已校).docVIP

1086 IMPURITIES IN OFFICIAL ARTICLES 1086药典药品中的杂质 Concepts about purity change with time and are inseparable from developments in analytical chemistry. If a material previously considered to be pure can be resolved into more than one component, that material can be redefined into new terms of purity and impurity. Inorganic, organic, biochemical, isomeric, or polymeric components can all be considered impurities. Microbiological species or strains are sometimes described in similar terms of resolving into more than one component. 关于纯度的概念随时间的改变而改变，并且与分析化学的发展息息相关。如果之前被认为是纯净的物料可以被分解成不只一个组分，那么那个物料可重新定义为纯度和杂质的新术语。无机的、有机的、生物化学的、同质异构或聚合组分可以全部看作是杂质。微生物种类或菌种如果可以分解为不只一个组分时，用同样的术语来描述。 Communications about compendial articles may be improved by including in this Pharmacopeia the definitions of terms and the contexts in which these terms are used. (See Definitions below.) There has been much activity and discussion in recent years about term definition. Certain industry-wide concerns about terminology and context deserve widespread publication and ready retrievability and are included here. (See Industrial Concepts below.) See Foreign Substances and Impurities, in the section Tests and Assays, under General Notices and Requirements, as well as the recently adopted general chapter, Ordinary Impurities á466?. Some other general chapters added over the years have also addressed topics of purity or impurity as these have come into focus or as analytical methodology has become available. Analytical aspects are enlarged upon in the chapter Validation of Compendial Methods á1225?. 关于药典产品的交流，可以通过包括在该药典中的术语定义和使用这些术语的背景的方式（参见以下的定义）得到改进。近些年，关于术语的定义已经展开了很多的活动和讨论。某些行业范围内关于术语与背景的问题，值得广泛的发行并可以检索，而且被包括在此（参见下面的企业概念）。参见凡例的检查与分析部分中的外来物质和杂质，以及近期被采用的通用章节，一般杂质〈466〉。这几年里增加的其他的一些通用章节同样也论述过纯度和杂质的问题，因为这些问题已经成为了焦点性论题或是因为分析方法学已变得可以利用。药典方法的验证〈1225〉一章中进一步论述了分析问题。 Monographs on bulk pharmaceutical chemicals usually cite one of three types of purity tests: (1) a chromatographic purity test coupled with a nonsp