化学药物残留溶剂研究的技术指导原则

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化学药物残留溶剂研究的技术指导原则
目录
一、概述································································································································……1
二、基本内容·……2
（一）残留溶剂研究的基本原则·……2
1、确定残留溶剂的研究对象·……2
2、确定残留溶剂时需要考虑的问题·……2
3、残留溶剂分类及研究原则·……4
（二）研究方法的建立及方法学验证·········································……6
1、研究方法的建立·····························································································……6
2、方法学验证·…… g
（三）研究结果的分析及质量标准的制定·……9
1、残留溶剂表示方法·……9
2、质量标准制定的一般原则及阶段性要求·……10
（四）需要关注的几个问题·……12
1、附录中无限度规定和未收载的有机溶剂·……12
2、未知有机挥发物·……12
3、多种有机溶剂综合影响·……13
4、中间体的残留溶剂·……13
5、制剂工艺对制剂残留溶剂的影响·……14
6、辅料残留溶剂的研究及对制剂的影响·……14
三、参考文献·……14
四、附录······························································································································……16
五、著者·……17

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