杂质研究指导原则.pdf

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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······················

4、······················································································3(二)分析方法的验证···························································································································5(三)有机杂质的定量方法······················

5、··························································································6四、杂质检测数据的积累··············································································································7五、杂质限度的制订·································

6、···························································································9(一)有机杂质的限度确定·············································································································101、创新药物··································

7、····································································································102、仿制已有国家标准的药品································································································123、其它新药····································

8、·································································································12(二)无机杂质的限度确定········································································································