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H-化学药物残留溶剂 20070823.doc

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精品资料精品资料 PAGE / NUMPAGES 精品资料指导原则编号：【 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··············································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········································