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In order to perform a toxicological evaluation of the mutagenicity/genotoxicity potential of an organic impurity, its chemical structure should be provided.
Furthermore, when the evaluation is focused on all the mutagenic impurities related to a drug substance/product, information on its route of synthesis (ROS) should be provided, as well as the information obtained from its stability data.
Please note that this information is necessary for performing an accurate and reliable risk assessment. The purpose of this questionnaire is to compile and interpret the results on the actual and potential impurities to evaluate their mutagenicity/genotoxicity potential. In this way, the conclusions extracted in the subsequent risk analysis will be reliable for regulatory purposes.
ICH M7 assessment comprises mutagenicity/genotoxicity revision of both actual and potential impurities which could arise from the synthesis or degradation of the drug product.
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