Predicting the photostability characteristics of active pharmaceutical ingredients using electron paramagnetic resonance spectroscopy

Abstract

The EPR methods were shown to have the potential to predict the ICH level of photodegradation for an API in the solid state using only a small amount of sample and after just 10 minutes exposed to light. This testing can be performed in a shorter time frame than ICH compliant testing and can potentially be used early in development to predict the photostability characteristics of an API.