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

contributed by Thermo Fisher Scientific | 03/15/2021

Application benefits

Detection and quantification of nine nitrosamines with a single liquid chromatography-high resolution accurate mass (HRAM) mass spectrometry method
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

To demonstrate fast, highly sensitive quantitation of nine nitrosamines with a Thermo Scientific™ Orbitrap Exploris™ 120 mass spectrometer, and the use of the LC-MS method to measure nitrosamine impurities in commercially available ranitidine drug substances and products

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