AN OVERVIEW: STABILITY STUDY OF PHARMACEUTICAL PRODUCTS AND SHELF LIFE PREDICTION
*Md. Habib Ullah Bhuyian, Dr. Harun Ar Rashid, Md. Mohsin, Khadija Tut Tahera
ABSTRACT
Stability studies 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. These 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 presented in a concise manner in the present review. Stability is the extent to which a product retains, within the specified limits, throughout its period of storage and use, the same properties and characteristics possessed at the time of its packaging. Stability testing thus evaluates the effect of environmental factors on the quality of a drug substance or a formulated product which is utilized for prediction of its shelf life, determine proper storage conditions and suggest labeling instructions. Current trends in stability testing also described.
Keywords: Stability, Stability studies, Stability testing, Shelf Life.
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