Stress studies Decomposition/Degradation

Ojha T, Bakshi M, Chakraborti AK, Singh S. The ICH guidance in practice stress decomposition studies on three piperazinyl quinazoline adrenergic receptor-blocking agents and comparison of their degradation behavior. J Pharm Biomed Anal 2003 31 775-783. 

The choice of stress conditions should be consistent with product decomposition under normal manufacturing, storage, and use conditions. Recommended stress factors include high and low pH, elevated temperature, photolysis, and oxidation. The extent of the stress applied in forced degradation studies should ensure formation of the desired amount (usually 10-20%) of degradation. 

The forced degradation experiments do not necessarily result in product decomposition. The study can be stopped if no degradation is observed after DS or DP has been exposed to a stress that exceeds conditions of accelerated stability protocol. Protocols for generation of product-related degradation may differ for DS and DP due to differences in matrices and concentrations. For example, sugar additives often present in DP are known to stabilize proteins vis-a-vis denaturing conditions. 

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