Abstract

FORCED DEGRADATION STUDIES FOR DRUG SUBSTANCES AND DRUG PRODUCTS -OVERVIEW OF REGULATORY GUIDANCE

Yogesh Wankhede* and Darekar A. B.

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Abstract

When developing stability-indicating methods, especially when there is minimal data about probable degradation products, forced degradation or stress testing is intended to control specificity. Several guidelines currently provide information and direction on forced degradation tests. Forced degradation studies are used to determine the degradation pathway of drug substance during the development, manufacturing, packing and storage of pharmaceutical products. According to ICH regulations, some factors might cause degradation, such as light, oxidation, dry heat, acidic or basic environments, hydrolysis, etc. The forced degradation experiments are best exemplified by ICH Q1A, Q1B, Q1C, Q1D, Q1E, Q1F, Q2(R1), Q3A(R2), Q3B, Q5C,Q6A, QSE, and Q7A. This review provides the new trends in forced degradation studies, procedure to carry out the studies according to ICH Guidelines and other regulatory bodies such as The United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Japanese Pharmacopeia (JP), and the Agencia Nacional de Vigilancia Sanitaria (ANVISA).

Keywords: Forced degradation, ICH, Hydrolysis, Oxidation, Photolytic, Stability.