Methods and Protocols for Drug Stability Studies

Abstract

Stability is a significant quality attribute for drug molecules and pharmaceutical preparations. Investigation of drug stability is essential to improve quality, safety and efficacy. The drug toxicity and adverse effects prevented by proper evaluation of parameters are related to stability. The toxic effects could be due to degraded impurities, drug metabolites or functional groups of drug molecules. Therefore, stability studies are planned to identify and maintain the product quality, throughout the shelf life. The major role of such studies is to predict shelf life, determine the suitable storage condition and suggest the label instructions. Stability studies are deemed as prerequisite for the recognition and endorsement of pharmaceuticals. Stability studies should comply the guidelines of the ICH, the WHO or other agencies deemed fit. These guidelines postulate the outline for the execution of stability studies on both drug and dosage form. The aim of these guidelines is not to constrain the experimentation but to execute the proper and meaningful experiments. The scope of these guidelines is limited to pharmaceutical dosage forms and any feed impregnated with medicinal product. Stability studies are necessary for the development and registration of newer drug.