STABILITY TESTING GUIDELINES OF PHARMACEUTICAL PRODUCTS

Abstract

Stability studies of pharmaceutical products ensuring the maintenance of product quality, safety and efficacy throughout the shelf life are considered as pre-requisite for the acceptance and approval of any pharmaceutical product. Stability of a pharmaceutical product may be defined as the capability of a particular formulation in a specific container/closure system to remain within its physical, chemical, microbiological, toxicological, protective and informational specifications. Stability studies are required to be conducted in a planned way following the guidelines issued by ICH, who and or other agencies. Importance of various methods followed for stability testing of pharmaceutical products, guidelines issued for stability testing and other aspects related to stability of pharmaceutical products have been included in the present review Keywords: stability testing, stability studies, stability, pharmaceutical products, international council for harmonisationÂ