THE CHALLENGE OF NITROSAMINES IN DRUG PRODUCTS AND API: HOW AUTOMATION CAN HELP (INITIAL RESULTS)

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 74059 Highly sensitive and robust LC-MS/MS solution for quantitation of nitrosamine impurities in metformin drug products Authors: Hao Yang1, Edmund Moy1, Michael Volny1, Claudia Martins1, Min Du2, Wael Elmasri3, Tanya Tadey4 Thermo Fisher Scientific, San Jose, CA; Thermo…

Application note | 001657 Pharma Highly sensitive and robust LC-HRAM-MS method for simultaneous quantitation of sixteen nitrosamines in multiple drug products Goal Authors Krishna Mane , Venkatesh Chanukuppa , The aim of this study was to evaluate and report on…

Nitrosamine impurities in drug substances / LCMSTM-9030 Application News Detection and Quantitation of Nitrosamine Impurities in Drug Substances by LC-HRMS on LCMS-9030 Zhaoqi Zhan1, Zhe Sun1, Deepti Bhandarkar2, Shailendra Rane2, Pratap Rasam2, Jitendra Kelkar2 (Asia Pacific) Pte Ltd, 2 Shimadzu…