Kotoni, Dorina, Zelesky, Todd, Huang, Zongyon, Baertschi, Steve, Adams, Neal, Marden, Stacey, Campbell, John, Foti, Chris, Laue, Christian, Marillier, Pascal, Ultramari, Maria, Ribeira Franca, Jucara, Van Cleempoel, An, Santos, Ana Claudia, Wang, Chloe, Meng, Liping and Hicks, Simon (2024) Peak Purity Assessments in Forced Degradation Studies - an Industry Perspective. LC-GC europe : Solutions for Separation Scientists., 1 (1). pp. 22-31.

Abstract

This review article discusses scientific rationales and current best practices in pharmaceutical industry for performing chromatographic peak purity assessment (PPA) activities associated with the stability indicating analytical methods applicable to a regulatory submission. The discussion includes a comprehensive overview of PPA related regulatory landscape and common approaches to obtain PPA results, as well as strength and weakness of UV and mass spectrometry facilitated spectral PPA. The article also summarizes industry’s current best practice to assess and mitigate the risk of impure peak and is concluded with science-based recommendations to guide peak purity assessment.

Item Type:	Article
Keywords:	Peak purity, UV, MS, HPLC, analytical method, forced degradation studies
Date Deposited:	10 Apr 2024 00:46
Last Modified:	10 Apr 2024 00:46
URI:	https://oak.novartis.com/id/eprint/50726