文档介绍:中药、天然药物稳定性研究技术指导原则
目录
一、概述··················································1
二、稳定性研究实验设计····································2
(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··········································3
三、稳定性研究实验方法···································3
(一)影响因素试验······································3
1、高温试验·············································3
2、高湿试验·············································4
3、光照试验········&#