根据亚硝胺类杂质致癌机理,吲哚亚硝胺杂质不会产生碳正离子进而与DNA碱基反应产生致癌作用。吲哚亚硝胺杂质不适用于CPCA分类,无法计算AI值。亚硝胺类杂质也不适用于ICH M7指导原则。
请问各位朋友,对于吲哚亚硝胺杂质应该怎么计算AI值呢?
Are you reffering to some impurity related to duloxetine?
In general nitrosoindole should not be concidered CoC as you mentioned, but it should be concidered as nitrosating agent. SO if you have any secondary amines downstream your process you should include it in your RA.