Analytical challenges in stability testing for genotoxic impurities

• Selective genotoxic degradants are discussed to highlight the analytical challenges.
• Analytical methods for genotoxic impurities are generally applicable to degradants.
• Guidance needed on predicting risk of genotoxic degradants early and controlling it.
• Literature on genotoxic degradants is scarce but publications should increase.

This review presents selective case studies in the literature and in the authors’ laboratories highlighting common degradation pathways that could lead to the formation of genotoxic degradants. It is the intention of this review to spark further discussions in this field, which is apparently still at a juvenile stage, with a goal to provide general guidance that can benefit drug developers and regulatory agencies in the long run.