指导原则编号【h】gph6-1

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1、指导原则编号：【H】GPH6-1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························································································

2、················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·····················

3、········································································································2（四）考察项目··································································································································2（五）分析方法··········································

4、························································································3三、稳定性研究的试验方法········································································································3（一）影响因素试验·············································································

5、··········································41.1高温试验·························································································································41.2高湿试验·················································································································

6、···············41.3光照试验·······························································································································5（二）加速试验··································································································································5（三）

7、长期试验··································································································································6（四）药品上市后的稳定性研究·····························································································6四、稳定性