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化学药物残留溶剂研究的技术指导原则中国医学科学院基础医学研究所
指导原则编号： 【H 】 G P H 7 - 1
化学药物残留溶剂研究的技术指导原则
二 OO 五年三月
1
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·············································································································8
(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 ·································
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