Stress Testing / Forced Degradation Studies and Experimental Approach for Stress Studies in Analytical Chemistry

Abstract

Stress testing is defined as the stability testing of drug substances and drug products under conditions exceeding those used for accelerated testing. The ICH defined accelerated testing as “studies designed to increase the rate of chemical degradation or physical change of an active drug substance or drug product using exaggerated storage conditions as part of the formal, definitive, storage program, Forced degradation studies should be performed on each unique formulation before formal stability studies begin. Oxidative drug degradation reactions are typically auto oxidative, which is radical initiated. Radical-initiated reactions start with an initiation phase involving the formation of radicals, followed by a propagation phase and eventually a termination phase. Thermolytic degradation is usually thought of as degradation caused by exposure to temperatures high enough to induce bond breakage, that is, pyrolysis. Photolytic degradation is the degradation that results from exposure to ultraviolet or visible light in the wavelength range of approximately 300–800 nm.