A review on stability studies an overview

Abstract

World Health Organization states that, the stability of finished pharmaceutical products depends, on the one hand, on environmental factors such as ambient temperature, humidity and light, and, on the other, on product- related factors. The objective of stability study is to determine the shelf life, namely the time period of storage at a specified condition within which the drug product still meets its established specifications, and also to assure the stability of a drug product, namely maintenance of the drug product packed in it specified packaging material and stored in the established storage condition within the determined time period. Any physical, chemical or microbi- ological change in the product potentially impacts the efficiency and integrity of the final product and may there- fore directly or indirectly impact patients’ health. So physio-chemical, chemical, microbial, container closure sys- tem properties should be evaluated for all dosage forms, as well as preservative and antioxidant content. The four major climate zones and the associated storage conditions stipulated in current stability guidelines are summa- rized by their characteristic prevalent annual climatic conditions. The ICH guideline indicates that stress testing is designed to determine the intrinsic stability of the molecule by establishing degradation pathway in order to iden- tify the likely degradation products. Through this review a successful stability study will establish the shelf-life date of the drug product.