化学药物稳定性的研究技术指导原则.docVIP

PAGE 【 H 】 G P H 6 - 1 指导原则编号： 化学药物稳定性研究 技术指导原则 二○○四年十一月 目 录 一、概述··················································1 二、稳定性研究设计的要点··································1 （一）样品的批次和规模·······························1 （二）包装及放置条件·································2 （三）考察时间点·····································2 （四）考察项目·······································2 （五）分析方法·······································3 三、稳定性研究的试验方法·································3 （一）影响因素试验···································3 1.1高温试验··································