Analytical Insights into Forced Degradation Studies: A Systematic Review of Methodologies, Applications, and Regulatory Implications

Authors

  • Ashwini Tayde Department of Quality Assurance, Shri D.D Vispute College of Pharmacy and Research Center, Devad, New Panvel

DOI:

https://doi.org/10.61920/jddb.v1i03.133

Keywords:

Forced degradation, Accelerated conditions, Analytical techniques, Stability indicating methodologies, Formulation, Packaging

Abstract

Forced degradation, as a method to induce the breakdown of novel drug substances and products under harsher conditions than accelerated conditions, plays a critical role in demonstrating the specificity of stability indicating techniques. This process not only elucidates the degradation pathways and products of drug substances but also facilitates the elucidation of structural details of degradation products. Additionally, forced degradation studies provide valuable insights into the chemical behavior of molecules, aiding in formulation and packaging development. Despite its importance, existing regulatory guidelines often lack detailed explanations on the execution of forced degradation experiments, resulting in generic directives. This review aims to bridge this gap by delineating study methodologies, elucidating degradation mechanisms, and summarizing analytical techniques essential for the development of stability indicating methodologies. By addressing current trends in forced degradation research, this review contributes to the advancement of analytical methodologies in pharmaceutical development.

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Published

2024-08-25

How to Cite

Tayde, A. (2024). Analytical Insights into Forced Degradation Studies: A Systematic Review of Methodologies, Applications, and Regulatory Implications. Journal of Drug Delivery and Biotherapeutics, 1(03), 13–23. https://doi.org/10.61920/jddb.v1i03.133