Review: Development of forced degradation studies of drugs

Authors

  • R. D Chakole Government College of Pharmacy, Amravati
  • M. S. Charde Government College of Pharmacy, Amravati
  • Jitendra Kumar Government College of Pharmacy Amravati, MS
  • A. S. Welankiwar Government College of Pharmacy Amravati, MS

DOI:

https://doi.org/10.7439/ijap.v2i3.1407

Abstract

Forced degradation studies show the chemical behavior of the molecule which in turn helps in the development of formulation and package. A forced degradation study is an essential step in the design of a regulatory compliant stability program for both drug substances and products, and formalized as a regulatory requirement in ICH Guideline Q1A in 1993. Forced degradation is a degradation of new drug substance and drug product at conditions more severe than accelerated conditions. It is required to demonstrate specificity of stability indicating methods and also provides an insight into degradation pathways and degradation products of the drug substance and helps in elucidation of the structure of the degradation products. Thus, this review discusses the current trends in performance of forced degradation studies by providing a strategy for conducting studies on degradation mechanisms.

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Published

2013-06-30

Issue

Vol. 2 No. 3 (2013): May-Jun

Section

Review Article

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How to Cite

1.
Review: Development of forced degradation studies of drugs. Int J Adv Pharm [Internet]. 2013 Jun. 30 [cited 2024 Sep. 8];2(3):34-9. Available from: https://ssjournals.co.in/index.php/ijap/article/view/1407

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