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.
Authors:
Hao Yang, Thermo Fisher Scientific, San Jose, CA, US
Jon Bardsley, Thermo Fisher Scientific, Hemel Hempstead, UK
Min Du, Thermo Fisher Scientific, Boston, MA, US
Olaf Scheibner, Thermo Fisher Scientific, Dreieich, Germany
Keywords: Nitrosamines, NDMA, APCI, high resolution accurate mass, mass spectrometry, Orbitrap Exploris 120, Chromatography Data System, compliance-ready, generic drugs, impurities, genotoxic impurities, ranitidine, excipient, tSIM, tMS2
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
>> Download the Full Application Note as a PDF
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