Stability:- Basic Concepts and Objectives

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stability :- Basic Concepts and Objectives ESSENTIAL DEFINITIONS ACCORDING TO ICH stability stability is officially defined as the time lapse(period) during which drug substance (API) or drug product (FPP) to retains the same properties and characteristics( Physical, Chemical, Microbiological, Therapeutic and Toxicological specifications to maintain its identity, strength, quality, and purity ) that it possessed at the time of manufacture. ACCELERATED stability TESTING These are the studies designed to increase the rate of chemical degradation and physical change of a drug by using exaggerated storage conditions as part of the formal stability testing programmes. The data thus obtained, in addition to those derived from real time stability studies , may be used to assess longer term chemical effects under non-accelerated conditions and to evaluate the impact of short-term excursions outside the label storage conditions, as might occur during shipping.

STRESS TESTING–FORCED DEGRADATION (API) Studies undertaken to elucidate the intrinsic stability of the API. Such testing is part of the development strategy and is normally carried out under more severe conditions than those used for accelerated testing. To identify potential degradants (degradation pathways) of the API and assess if they can

  Stability, Studies, Forced, Degradation, Forced degradation