Nitrosamines impurities and ICH M7

Hello everyone, I am about harmonisation nitrosamines impurities and ICHM7. Classification ICH M7 is with the degree of mutagenicity, but the mutagenicity of most nitrosamines is unknown, which way that can classificated? What about TD50 and what about Nitrosamine drug substances related impurities?

Hi Hermine, welcome!

Nitrosamines are part of cohort of concern and hence, are currently outside the scope of ICH M7.
The only simple way at the moment to categorize nitrosamines is using Carcinogenicity Potency Categorization Approach (CPCA) as published by FDA, EMA and other main regulatory bodies.
The amount of carcinogenicity data available for nitrosamines is very limited, and normally you won’t be able to find TD50

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