Development of forced degradation and stability indicating studies of drugs-A review

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 subs...

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Bibliographic Details
Published in:Journal of pharmaceutical analysis 2014-06, Vol.4 (3), p.159-165
Main Authors: Blessy, M, Patel, Ruchi D., Prajapati, Prajesh N., Agrawal, Y.K.
Format: Article
Language:English
Subjects:
Degradation conditions
Degradation product
Forced degradation
Review
Stability indicating method
Stress testing
制剂产品
化学行为
审查
毒品
稳定性
降解产物
降解机理
降解途径
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Summary: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.
ISSN:2095-1779
2214-0883
DOI:10.1016/j.jpha.2013.09.003