Degradation and Stability Profiling in Pharmaceutical Analysis: Review

Kanchan Dhanappa Nagrale , Pooja Lenin Kumbhar , Manoj.S.Charde , Ritu .D.Chakole

Forced degradation, Stability indicating methods, ICH guidelines

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 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 about the current trends in performance of forced degradation studies by providing strategy for the conduct of studies, degradation mechanisms and also describes the regulatory aspects of force degradation and the study of stability and also the analytical methods helpful for development of stability indicating method.

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"Degradation and Stability Profiling in Pharmaceutical Analysis: Review", IJSDR - International Journal of Scientific Development and Research (www.IJSDR.org), ISSN:2455-2631, Vol.7, Issue 9, page no.403 - 408, September-2022, Available :https://ijsdr.org/papers/IJSDR2209067.pdf

Volume 7 Issue 9, September-2022

Pages : 403 - 408

Paper Reg. ID: IJSDR_201651

Published Paper Id: IJSDR2209067

Downloads: 000347210

Research Area: Pharmacy

Country: Solapur, Maharashtra, India

Published Paper PDF: https://ijsdr.org/papers/IJSDR2209067

Published Paper URL: https://ijsdr.org/viewpaperforall?paper=IJSDR2209067

ISSN: 2455-2631 | IMPACT FACTOR: 9.15 Calculated By Google Scholar | ESTD YEAR: 2016

An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 9.15 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator

Publisher: IJSDR(IJ Publication) Janvi Wave

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