Residential impurities resulting from manufacturing and formulation, or from degradation of the active pharmaceutical ingredient may be present in synthetic pharmaceutical products.A subset of these impurities may present a potential for genotoxicity and therefore pose an additional safety concern to clinical subjects and patients.The ICH guidance on impurity evaluation (Q3A/B) provides guidance on how to identify genotoxic impurities but give no guidance on the acceptable level.The EMEA and FDA currently have available guidance on genotoxic impurities in pharmaceuticals.