UPLC-MS/MS Analysis of the N-Nitrosamine NDMA in Ranitidine

[ APPLICATION NOTE ] High Sensitivity Quantitation of Nitrosamine Genotoxic Impurities: LC-MS Analysis of Ranitidine Drug Product using the Waters ACQUITY UPLC I-Class/Xevo TQ-XS Tandem Quadrupole Mass Spectrometer Mary Trudeau Lame and Lindsay Hatch Waters Corporation, Milford, MA, USA APPLICATION…

[ TECHNOLOGY BRIEF ] Highly Sensitive and Robust UPLC-MS/MS Quantification of Nitrosamine Impurities in Sartan and Ranitidine Drug Substances Lindsay Hatch, Mary Lame, Dave Higton, Paul Rainville, and Gordon Fujimoto Waters Corporation, Milford, MA, USA The Xevo TQ-XS Mass Spectrometer,…

[ BROCHURE ] SUPPORTING THE CHALLENGE OF NITROSAMINE DRUG SUBSTANCE RELATED IMPURITIES ANALYSIS N-Nitrosamines are potentially mutagenic impurities that may pose a risk of cancer to humans when exposed over a prolonged period. Since 2018, global regulatory bodies have required…

Application Note Selective and Specific Quantitation of NDMA in Ranitidine with the Xevo G2-XS QTof Viviane Nascimento, Michael Murgu, Lauren Mullin Waters Corporation Abstract N-nitrosodimethlyamine (NDMA) is a compound of high interest for monitoring in various matrices, due to their…