Mariah Ultramari

Mariah Ultramari is with Spektra Soluções Científico-Regulatórias Ltda, in São Paulo, Brazil.

Articles

Performing chromatographic peak purity assessments (PPA) in the pharmaceutical industry | Image Credit: © Vladimir Polikarpov - stock.adobe.com

Liquid Chromatographic Peak Purity Assessments in Forced Degradation Studies: An Industry Perspective

Pascal Marillier;Neal Adams;Steven W. Baertschi;John M. Campbell;Chris Foti;Juçara Ribeiro Franca;Simon Hicks;Dorina Kotoni;Christian Laue;Stacey Marden;Liping Meng;Ana Claudia de Oliveira Santos;Mariah Ultramari;An Van Cleempoe;Chloe Wang;Todd Zelesky;Zongyun Huang

January 1st 2024

This review article discusses scientific rationales and current best practices in the pharmaceutical industry for performing chromatographic peak purity assessments (PPA). These activities are associated with the development and validation of liquid chromatographic (LC) stability-indicating analytical methods applicable to regulatory submissions of small-molecule drug candidates. The discussion includes a comprehensive overview of the PPA-related regulatory and scientific landscape and common industry approaches to obtain PPA results, as well as the strengths and weaknesses of PDA-facilitated ultraviolet (UV) PPA and other PPA techniques.