Stress Degradation-A Review

Abstract

Stress degradation or stress degradation is a key approach in pharmaceutical research and development for predicting longer period of stability. The change in the quality of the drug substance and drug product over the long run owing to various aspects of the environment such as temperature, light and humidity to figure out a resample period or a drug products shelf life, as well as suggested storage conditions is detected with the help of stability testing. Furthermore, the regulatory guidance is highly generic and does not clarify how stress degradation tests are conducted. This review discusses the various conditions involved in stress degradation study.