Analysis of Genotoxic Nitrosamines in Losartan and Ranitidine Active Pharmaceutical Ingredients

Rapid Analysis of Genotoxic Nitrosamines by HPLC-MS/MS Sensitive, Robust Assay Using a SCIEX Triple Quad™ 4500 System and the ExionLC™ System Lihai Guo, Zhimin Long, Xiangyang Leng APAC Applications Support Center, China Introduction Genotoxic impurities (GTI’s) are intermediate, reactive products…

Highly Selective and Sensitive Method for Quantification of Nitrosamines in Valsartan Drug Substances Quantification using SCIEX Triple Quad™ 5500+ LC-MS/MS System − QTRAP® Ready with an ExionLC™ AD System Aman Sharma1, Sandeep Choudhary1, M Chandrasekar1, Manoj Pillai1 SCIEX, India Valsartan…

Quantify NDMA using the SCIEX QTRAP® 4500 LC-MS/MS System N-Nitrosodimethylamine (NDMA) Analysis in Ranitidine Active Pharmaceutical Ingredient and Drug Product Using QTRAP® 4500 System The presence of nitrosamines, especially NDMA, has been identified in ranitidine drug products by the United…

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…