世界卫生组织关于化学对照品的指导原则介绍___

化学对照品是药品标准中规定需要使用的标准物质，是药品标准的组成部分，也是药品检验不可缺少的物质。2006年欧洲药典委员会公布了欧洲药典标准物质指导原则，本指导原则为世界卫生组织公布的关于化学对照品的最新指导原则，现将主要内容翻译如下，供国内药品监督、检验、新药审评、研发机构人员参考。

This updated WHO guideline on chemical reference substances was established and issued by the WHO Expert Committee on Specifications for Pharmaceutical Preparations in 2007.The very first edition of WHO guideline was published in 1975,and then reviewed and modified in 1982 and subsequently revised in 1999.The purpose of establishing chemical reference substances guideline is aimed at fostering greater collaboration and harmonization among various national and regional authorities responsible for collections of chemical reference substances,furthermore,the context of this guideline describe the general principles for the establishment of primary and secondary chemical reference substances,provide the technical guidance on the source of candidate,evaluation,assignment of content,maintenance,distribution and all the relevant aspects of chemical reference substances.The final goal of this guideline is to achieve accuracy and reproducibility of the analytical results required by pharmacopoeia testing and pharmaceutical control in general.