Stability indicating study by using different analytical techniques

Ms.Trupti Deepak Supekar , Ms.Mahima Sharma , Ms.Prachi Kharat , Ms.Sakshi Tilekar

Stability Indicating assay method, Regulatory guidelines, stress testing

This write up provides a review on the development of validated stability-indicating assay methods (SIAMs) for drug products. The imperfections of described methods concerning to regulatory requirements are highlighted. A systematic approach for the development of stability-indicating methods is demonstrated in this review article. The main current goal of stability-indicating assay methods (SIAMs) is to gives information about the conditions for stress testing so as to demonstrate the stability of drug substances and drug products. This paper reviews the regulatory aspects for development of stability-indicating methods. SIAMs are used to discriminate the active pharmaceutical ingredient (API) from its potential decomposition products and substances. Regulatory guidelines in ICH Q1AR2, Q3BR2, Q6A and FDA 21 CFR Section 211 requires validated stability-indicating methods. Forced degradation is required to establish specificity when developing SIAMs and for this reason, it should be performed prior to accomplishment of stability studies. Forced degradation of the drug standard and excipients is carried out under various conditions to determine whether the analytical method is stability-indicating. The approaches for the development of stability-indicating methods are discussed.

Published Paper   E-Certificate

"Stability indicating study by using different analytical techniques", IJSDR - International Journal of Scientific Development and Research (www.IJSDR.org), ISSN:2455-2631, Vol.8, Issue 12, page no.353 - 361, December-2023, Available :https://ijsdr.org/papers/IJSDR2312049.pdf

Volume 8 Issue 12, December-2023

Pages : 353 - 361

Paper Reg. ID: IJSDR_209558

Published Paper Id: IJSDR2312049

Downloads: 000347361

Research Area: Pharmacy

Country: -, -, India

Published Paper PDF: https://ijsdr.org/papers/IJSDR2312049

Published Paper URL: https://ijsdr.org/viewpaperforall?paper=IJSDR2312049

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

This work is licensed under a Creative Commons Attribution 4.0 International License and The Open Definition