化学药物稳定性研究技术指导原则-中国医学科学院基础医学研究所.PDFVIP

指导原则编号： 【H 】G P H 6 - 1 化学药物稳定性研究技术指导原则 二○○五年三月 目 录 一、概述···················································································································································1 二、稳定性研究设计的要点········································································································1 ·············································································································1 （一）样品的批次和规模 ··················································································································2 （二）包装及放置条件 ·····························································································································2 （三）考察时间点 ··································································································································2 （四）考察项目 ··································································································································3 （五）分析方法 三、稳定性研究的试验方法········································································································3 （一）影响因素试验·················