Detection and analysis of N-nitrosodimethylamine in ranitidine by using Q Exactive Focus High Resolution Mass Spectrometry

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…

APPLICATION NOTE 000235 Simultaneous quantitation of nine nitrosamines using a highly sensitive and LC-HRAM mass spectrometry method in multiple drug products Authors: Krishna Mane, Pratip Saha, Venkatesh Chanukuppa, Biswajayee Patra, Saravanan Kumar Thermo Fisher Scientific, Bengaluru, India Keywords: Nitrosamine quantitation,…

APPLICATION NOTE 73472 High-resolution accurate-mass liquid chromatography mass spectrometry (HRAM LC-MS) methodology for the determination and quantitation of nitrosamine impurities in drug products Authors: Olaf Scheibner, Thermo Fisher Scientific, Dreieich, Germany Teng Guo, Thermo Fisher Scientific, Beijing, China Angela Merrett,…

CASE STUDY 73263 Overcoming the challenges of nitrosamine impurities in drugs What pharmaceutical QA/QC laboratories need to know: Advanced GC-MS capabilities for cGMP nitrosamine testing Why we need to analyze nitrosamine impurities in drugs Unacceptable levels of nitrosamine impurities were…