Several sartan, ranitidine and metformin-based drug products were recently recalled due to the presence of unacceptable amounts of mutagenic nitrosamine impurities. The USFDA and other regulatory agencies have provided analytical testing guidance for the evaluation of trace nitrosamine impurities in these drug substances and drug products. Consequently, API and drug product manufacturers are under increased pressure to accurately identify and quantify mutagenic impurities in APIs and drug products.
In this presentation, we will present the relevant GC/MS and LC/MS based analytical strategies to accurately detect and quantify nitrosamines in sartan, ranitidine, and metformin-based drugs.
Presenter: Soma Dasgupta, Ph.D. (Application Engineer, GC/GCMS, Agilent Technologies)
Presenter: Chander Mani (Application Engineer, Agilent Technologies)
Presenter: Kartheek Srinivas Chidella (Application Engineer, Agilent Technologies)
Presenter: Kelly McSweeney (Contributing Editor, C&EN Media Group)