INTERNATIONAL JOURNAL OF SCIENTIFIC DEVELOPMENT AND RESEARCH International Peer Reviewed & Refereed Journals, Open Access Journal ISSN Approved Journal No: 2455-2631 | Impact factor: 8.15 | ESTD Year: 2016
open access , Peer-reviewed, and Refereed Journals, Impact factor 8.15
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.
Keywords:
Forced degradation, Stability indicating methods, ICH guidelines
Cite Article:
"Degradation and Stability Profiling in Pharmaceutical Analysis: Review", International Journal of Science & Engineering Development Research (www.ijsdr.org), ISSN:2455-2631, Vol.7, Issue 9, page no.403 - 408, September-2022, Available :http://www.ijsdr.org/papers/IJSDR2209067.pdf
Downloads:
000337215
Publication Details:
Published Paper ID: IJSDR2209067
Registration ID:201651
Published In: Volume 7 Issue 9, September-2022
DOI (Digital Object Identifier):
Page No: 403 - 408
Publisher: IJSDR | www.ijsdr.org
ISSN Number: 2455-2631
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