Accurate Determination of Trace Nitrosamines in Sartan, Ranitidine and Metformin Based Drugs
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.
Key Learning Objectives
- Understand what mutagenic impurities are and why it's important to characterize and quantify them, even when present in trace amounts
- Understand the current regulatory guidelines for nitrosamines analysis in drug substance and product in Angiotensin II Receptor Blockers (sartan), ranitidine and metformin drugs
- Learn about approaches for the confident identification and quantification of nitrosamines in APIs and drugs
Who Should Attend
- Laboratory managers
- Chromatographers
- Analytical chemists and scientists
- New product developers
- Pharma quality control manager
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)
