M7第四类杂质如何判定?ICH M7(R1)第4类 杂质 定义:Alerting structure, same alert in drug substance or compounds related to the drug substance (e.g., process intermediates) which have been tested and are non-mutagenic. 后面详细解释如下:An impurity with a structural alert that is shared (e.g., same structural alert in the same position and chemical environment) with the drug substance or related compounds can be considered as non-mutagenic (Class 4 in Table 1) if the testing of such material in the bacterial mutagenicity assay was negative. 也就是说,如果一个杂质与API或者 中间体 具有相同的警示结构(位点相同化学环境也相同),同时相应的API或者中间体经细菌致突变性实验证实为阴性的,可以被认为第四类杂质,当作非致突变杂质控制。这里就有一个问题,警示结构位置相同很好判断,相同的化学环境怎么认定?取代基不同比如API是某警示结构中带了某个取代基,杂质是另一种取代基,取代基不同肯定化学环境有差异吧,能认为化学环境还相同吗?有没有哪位老师肯不吝赐教解我疑惑?不胜感激!查看更多1个回答 . 12人已关注