Analysis of Five Nitrosamine Impurities in Drug Products and Drug Substances Using Agilent GC/MS/MS Instrumentation

Application Note Pharma and Biopharma Quantification of Nitrosamine Impurities in Metformin Using Agilent GC/MS/MS Instrumentation Authors Soma Dasgupta, Vivek Dhyani, Samir Vyas, and Melissa Churley, Agilent Technologies, Inc. Abstract Since June 2018, several drugs were recalled due to the presence…

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…

Application Note Pharma & Biopharma Quantification of Nine Nitrosamine Impurities in Sartan Drugs Using an Agilent GC-TQ Authors Soma Dasgupta, Vivek Dhyani, and Melissa Churley Agilent Technologies, Inc. Abstract In this application note, a method for the analysis of nine…

Application Note Pharmaceuticals Simultaneous Estimation of Eleven Nitrosamine Impurities in Metformin Drug Product Using an Agilent 6495D LC/TQ Authors Abstract Preeti Bharatiya, Prasanth Joseph, Vivek Dhyani, and Saikat Banerjee Agilent Technologies, Inc. This application note presents a comprehensive analytical method…