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ISSN 2063-5346
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ADVANCED DEVELOPMENTS IN THE CONDUCT OF ACCELERATED STABILITY AND DRUG DEGRADATION STUDIES

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Gangadevi Nataraja1,2, Y. Ismail, M1 . Vijaya Vara Prasad1*
» doi: 10.48047/ecb/2023.12.9.224

Abstract

The deterioration of new drug materials and drug compounds in forced conditions is more intense than the deterioration observed in accelerated conditions. The specificity of stability indicating techniques must be demonstrated. Stability studies are a common practice to ensure that pharmaceutical products remain safe, of high quality, and effective throughout their shelf life. In pharmaceutical research, forced degradation is a powerful technique often employed to investigate how drug ingredients and products break down, and to develop stability testing procedures that generate reliable stability data. It is crucial to understand the impurities that arise when medicines are stored under different environmental conditions. Therefore, comprehending a drug's purity profile and its performance of various environmental conditions is vital. The goal is to gather evidence on how different environmental conditions, such as temperature, light, and humidity, affect the quality of a drug substance or product as it ages. By subjecting the drug material to stress testing, it is possible to identify the predictable degradation products, which helps in understanding the degradation pathways and inherent stability of the molecule. This also validates the effectiveness of the analytical techniques used to assess stability. The specific approach to stress testing will vary depending on the type of drug materials and product being evaluated. The results of forced degradation research shed valuable insights in the analytical field.

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