Evolution of regulatory aspects of genotoxic impurities in pharmaceuticals: Survival of the fittest

The genotoxic impurities (GIs) are carcinogenic hence its management during synthesis of pharmaceuticals is very important to be detected even in trace level for the safe use of the drugs. The presence of drug substance/drug product DNA-reactive impurities poses a significant problem for drug regulators as well as industry. There are several regulatory guidelines and position papers focused on controlling the amount of impurities within the specified limits. The present compilation gives an account of updated information about GIs and reviews the regulatory aspects for GIs in active pharmaceutical ingredients/drug formulations. A detailed discussion about control strategies in the context of GIs is also described precisely. The analysis of GIs is a challenging and complex aspect of the drug development process. Control and determination of these impurities at ppm or ppb levels are significant challenges for analysts, therefore the approaches for the analysis of GIs have also been discussed. [GRAPHICS]