ICH M7
The ICH guideline on assessment and control of DNA-reactive, potentially mutagenic impurities in pharmaceuticals. It uses structure-based assessment and Ames testing to classify impurities into five classes, and sets acceptable intakes based on a threshold of toxicological concern, commonly 1.5 µg per day for lifetime exposure. Nitrosamines belong to a cohort of concern that requires compound-specific limits.
Related terms
Genotoxic Impurity
An impurity that can damage DNA and potentially cause mutations or cancer, even at very low levels. Such impu…
ICH Q3A and Q3B
Two International Council for Harmonisation guidelines on impurities in new drug substances (Q3A) and new dru…
Nitrosamine
An organic compound containing the N-N=O group, formed when a secondary or tertiary amine reacts with a nitro…
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