Journal of Pharmaceutical Analysis· 2013Q1· Review
Development of forced degradation and stability indicating studies of drugs—A review
- 1,000citations
- Q1SCImago
- 2013year
Short summary
This review outlines strategies for conducting forced degradation studies and analytical methods for developing stability-indicating methods for drug substances and products.
AI-generated from the title and abstract; the full text is not read.
Key points
- Forced degradation studies use conditions more severe than accelerated testing.
- These studies are essential for demonstrating analytical method specificity and understanding drug degradation pathways.
- The findings aid in drug formulation and packaging development.
- The review provides strategies for conducting degradation mechanism studies and lists relevant analytical methods.
AI-generated from the title and abstract; the full text is not read.
Abstract
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. Forced degradation studies show the chemical behavior of the molecule which in turn helps in the development of formulation and package. In addition, the regulatory guidance is very general and does not explain about the performance of forced degradation studies. Thus, this review discusses the current trends in performance of forced degradation studies by providing a strategy for conducting studies on degradation mechanisms and also describes the analytical methods helpful for development of stability indicating method.
The authors' abstract, as published at the source. Journal of Pharmaceutical Analysis, 2013 · DOI ↗
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Field: Analytical Chemistry
Analytical ChemistryChemistry