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时间:2020-04-29
《杂质研究指导原则.pdf》由会员上传分享,免费在线阅读,更多相关内容在学术论文-天天文库。
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········································································································
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