Application Note: Screening and Identification of Potential Genotoxic Degradation Impurities using Q-TOF LC/MS with Advanced Software Solutions
6 June 2014
This Application Note demonstrates a quick and reliable software-assisted solution for screening and identifying trace-level potential genotoxic epoxide degradants from atorvastatin using MS/MS data. The method demonstrates mass-based fraction collection of a genotoxic impurity for further characterization. It is standard practice to study the stability profile of a drug substance under predetermined stress conditions. Oxidative degradation of some drugs during handling or storage can lead to the formation of genotoxic impurities. Pharmaceutical manufacturers
are required to monitor and identify genotoxic impurities at low levels.