Review on identification and quantification of genotoxic impurities

Genotoxic impurities can be broadly defined as those that have been demonstrated to cause harmful changes in genetic material regardless of the mechanism. Globally people suffer from various health complications due genotoxic impurities. Recent recommendations European and United States (USA) drug regulatory bodies mandate management possibly contaminants pharmaceutical ingredients at per million levels. The purpose this review is make a critical analysis techniques used comply with prevailing rules regulations very strict limits on Possible strategies further expand scope currently available technologies are also discussed. These include redesigning synthesis substance avoid introducing problematic impurities; modifying relevant process parameters eliminate or reduce such negligible levels; Using understanding demonstrate particular impurity cannot formed removed efficiently by conducting toxicity studies suspected not it low