Review on Stability Indicating Assay Method or Forced Degradation Study: Strategy and Regulatory Consideration
Author:
Affiliation:
1. B. K. Mody Government Pharmacy College, Rajkot - 360003, Gujarat, India.
2. Government Pharmacy College, Gandhinagar - 382027, Gujarat, India.
3. L.M. College of Pharmacy, Ahmedabad - 380009, Gujarat, India.
Abstract
Publisher
A and V Publications
Subject
General Medicine
Reference38 articles.
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3. Vyas AJ, Visana NM, Patel AI, Patel AB, Patel NK, Shah SR. Analytical quality by design in stress testing or stability-indicating method. Asian J Pharm Anal. 2021; 11(2):170–8.
4. Patel AB, Asnani AH, Vyas AJ, Patel NK, Patel AI, Lumbhani AN. A Brief Review on Genotoxic impurities in Pharmaceuticals. Asian J Pharm Res. 2021 [cited 2023 Feb 16]; 11(3):187–93
5. B. Patel A, K. Jinja B, Kumar J. Vyas A, K. Patel N, I. Patel A, B. Sheth D, et al. A Retrospective Study of Warning letters Issued by US FDA Over 2019-2021. Asian J Pharm Res. 2022; (483):295–301.
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