Online ISSN: 2515-8260

STABILITY INDICATING METHOD USING FORCED DEGRADATION STUDY: A REVIEW

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Rohan S. Ahire, Dhirendra B. Sanghai

Abstract

Forced degradation studies play a crucial role in assessing the chemical stability of pharmaceuticals and identifying potential degradation pathways. These studies involve subjecting drug substances or drug products to various stress conditions, including temperature, humidity, light, oxidation, and acid/base hydrolysis, to accelerate degradation and evaluate the inherent stability of the compounds. In this review, we present a comprehensive analysis of forced degradation studies conducted in the pharmaceutical industry, highlighting their importance in the development and quality control of drugs. The primary objective of forced degradation studies is to simulate and predict the degradation pathways and degradation products that may arise during the drug's shelf-life or under specific storage conditions. By subjecting the drug molecules to stress conditions, potential degradation impurities can be identified and characterized using sophisticated analytical techniques. This review covers the fundamental aspects of forced degradation studies, including the selection of appropriate stress conditions, sample preparation techniques, and analytical methodologies for impurity profiling. We discuss the factors influencing degradation, such as pH, temperature, humidity, and light exposure, and their impact on the stability of drugs. Furthermore, we delve into the regulatory requirements and guidelines governing forced degradation studies, ensuring that pharmaceutical companies comply with the established standards and produce safe and effective drugs. The significance of forced degradation studies extends beyond stability assessment, as they aid in elucidating the chemical mechanisms involved in degradation processes and provide insights into formulation development and packaging design. Additionally, the identification and quantification of degradation impurities facilitate the establishment of impurity acceptance criteria, ensuring product quality and patient safety.

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