Detection and Quantitation of Nitrosamine Impurities in Drug Substances by LC-HRMS on LCMS-9030

Gas Chromatograph Mass Spectrometer GCMS-TQTM8050 NX, AOC-20i+s Plus Application News Quantitation of 6 N-Nitrosamines in Metformin and 5 Sartan APIs as per the EDQM method Procedure C Nitish Suryawanshi, Dheeraj Handique, Prashant Hase, Sanket Chiplunkar, Durvesh Sawant, Aseem Wagle, Rahul…

Gas Chromatograph Mass Spectrometer GCMS-TQTM8050 NX, HS-20 Application News Quantitation of 7 Nitrosamines in API by HSGC-MS/MS as per proposed USP General Chapter <1469> Nitish Suryawanshi, Dheeraj Handique, Prashant Hase, Sanket Chiplunkar, Durvesh Sawant, Aseem Wagle, Rahul Dwivedi, Jitendra Kelkar…

Application Note Pharmaceutical Small Molecules Simultaneous Determination of Eight Nitrosamine Impurities in Metformin Using the Agilent 6470 Triple Quadrupole LC/MS Detection of regulated genotoxic impurities from the drug manufacturing process Authors Kartheek Srinivas Chidella, Chander Mani, Saikat Banerjee, and Dr.…

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…