Trace Level Quantification of Potential Mutagenic Impurities in Pharmaceuticals

Application Note Pharmaceutical Determination of Nitrosamines in Active Pharmaceutical Ingredients High flexibility and performance at lowest cost using the Agilent 1260 Infinity II Prime LC with the Agilent Ultivo LC/TQ for LC/MS analysis Author Edgar Naegele Agilent Technologies, Inc. Abstract…

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 Pharmaceuticals Highly Sensitive LC/MS/MS Method for the Simultaneous Quantification of Mutagenic Azido Impurity Analogues in Five Different Sartan APIs and Formulations Detection of regulated genotoxic impurities from the drug manufacturing process Authors Kartheek Srinivas Chidella, Saikat Banerjee, and…

Application Note Pharmaceuticals Quantitation of N-Nitroso Sitagliptin Impurity (NTTP) in Sitagliptin and Metformin Combination Drug Product Using the Agilent 6475 LC/TQ Authors Preeti Bharatiya, Prasanth Joseph, Vivek Dhyani, Saikat Banerjee, and Kannan Balakrishnan Agilent Technologies, Inc. Abstract Nitrosamine impurities are…