化学药物杂质研究技术指导原则.doc

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1、指导原则编号：【H】GPH3-1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、·········································2三、分析方法·········································································································································3(一)分析方法的选择·································································································

3、··························31、有机杂质的分析方法············································································································32、无机杂质的分析方法············································································································3(二)分析方法的验证················

4、···········································································································5(三)有机杂质的定量方法················································································································6四、杂质检测数据的积累·················································

5、·····························································7五、杂质限度的制订····························································································································9(一)有机杂质的限度确定·····················································································

6、························101、创新药物······································································································································102、仿制已有国家标准的药品································································································123、其它新药········

7、·····························································································································12(二)无机杂质的限度确定·······································································································