H-化学药物杂质研究技术指导原则 20070823.docVIP

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H-化学药物杂质研究技术指导原则 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 3 - 1 化学药物杂质研究的技术指导原则二○○五年三月目录一、概述·····················································································································································1 二、杂质的分类····································································································································2 三、分析方法·········································································································································3 (一)分析方法的选择···························································································································3 1、有机杂质的分析方法············································································································3 2、无机杂质的分析方法············································································································3 (二)分析方法的验证···························································································································5 (三)有机杂质的定量方法················································································································6 四、杂质检测数据的积累··············································································································7 五、杂质限度的制订····························································································································9 (一)有机杂质的限度确定·············································································································10 1、创新药物······································································································································10 2、仿制已有国家标准的药品································································································12 3、其它新药·········

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H-化学药物杂质研究技术指导原则 20070823.docVIP