Abstract: ASAP Assumptions and the Impact on Predictions:
Case Study on controlling Mutagenic Degradation

ASAP Assumptions and the Impact on Predictions: Case Study on controlling Mutagenic Degradation

Accelerated stability programs have become an integral part of pharmaceutical development. An understanding of the assumptions that go into those projections are critical to the accuracy.  For example, the activation energy, humidity correction, the time of the projection, and even the response factor of the degradants can dramatically impact the accuracy of the projections.   With regard to genotoxic impurity control, these parameters need to be accounted for prior to making shelf life projections in order to minimize the risk since an inaccurate projection can drastically impact the long-term control strategy.  Based upon variables within the humidity-modified Arrhenius equation, a recommended approach for the control of genotoxic impurities will be presented.