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angie_lee

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karl2100: 金币+1, 谢谢发言! 2012-11-26 22:37:06
应该要做毒理试验,确定杂质的安全性。
2楼2012-11-26 21:21:54
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douniw

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xiaoxiao270: 金币+1 2012-11-30 19:07:29
1,参考ICH,根据每日最大剂量确定:>2g,质控限度0.15%;10mg~2g,0.2%;1mg~10mg,0.5%; <10mg,0.5%;如果想定更高的限度需要做毒理试验支撑。
2.《浅谈杂质限度制定的一般原则》张哲峰,(国家食品药品监督管理局药品审评中心,北京100038)
3楼2012-11-30 12:58:27
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Malisa

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xiaoxiao270: 金币+1 2012-11-30 19:07:33
如果是杂质含有致癌性基团(比如亚硝基、偶氮基之类的),限度要求更低。一般要求是小于1.5微克/天。
4楼2012-11-30 13:55:07
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