HRAM LC-MS method for the determination of nitrosamine impurities in drugs

In this application note we discuss a fast, highly sensitive quantitation of nine nitrosamines with a Thermo Scientific™ Orbitrap Exploris™ 120 mass spectrometer.

We will demonstrate the quantitation of nitrosamine impurities in ranitidine drug substance and product below the daily acceptable intake level, that meets the requirements of FDA regulatory guidelines. Use of Thermo Scientific™ Chromeleon™ Chromatography Data System (CDS) software for both data collection and processing in a 21 CFR 11 compliant environment with full data integrity and security capabilities for cGMP facilities will also be detailed.