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The Role of Expert Assessment and In Silico Predictions in Determining Genotoxic Risk of N-Nitrosamine Impurities

pdf fileTennant RE; Oliveira A;

N-nitrosamine compounds are generally considered highly potent genotoxic carcinogens, whereby even an intake below the conservative threshold of toxicological concern (TTC) for impurities in pharmaceutical products under the ICH M7 guideline has the potential to be of risk to patients. The N-nitrosamine class is therefore included in the ‘cohort of concern’ within ICH M7 and such compounds must be controlled to a significantly lower acceptable limit.

The aim of this study is to demonstrate that a combination of in vitro data, in vivo data and in silico tools may aid expert review for ICH M7 impurity assessment of N-nitrosamine compounds.


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