An Update for Pharmaceutical Stress Testing Enabled by Modern Informatics Technologies

Stress testing or forced degradation is a fundamental part of drug development, specifically related to purity through control of stability. Control strategies for stability require stability-indicating methods (SIMs), built on the foundation of well-designed and conducted stress testing studies. Conditions for stressing include elevated heat and humidity, susceptibility to hydrolysis across a wide pH range, and susceptibility to oxidative and photolytic degradation. The primary goal is to comprehensively induce pharmaceutically-relevant degradation pathways, at levels that facilitate SIM development and validation, such that all realistic degradation products are formed and can be analytically detected.

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