Highly Sensitive and Robust UPLC-MS/MS Quantification of Nitrosamine Impurities in Sartan and Ranitidine Drug Substances

[ 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,…

[ TECHNOLOGY BRIEF ] Reliable HPLC/UV Quantification of Nitrosamine Impurities in Valsartan and Ranitidine Drug Substances Margaret Maziarz and Paul Rainville Waters Corporation, Milford, MA, USA The ACQUITY Arc System with PDA Detector, integrated with an ACQUITY QDa Mass Detector…

Nitrosamine Impurities Application Guide Confidently Detect and Quantify Mutagenic Impurities in APIs and Drug Products Sartan-Based Losartan Valsartan Candesartan Telmisartan Metformin Ranitidine Nitrosamines are formed by chemical reactions that occur during API manufacturing whether from starting materials, intermediates, reactants, reuse…