Overcoming the challenges of nitrosamine impurities in drugs

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…

Routine, Ultra-Trace Analysis of Nitrosamines in Drugs using Gas-Chromatography – Orbitrap Mass Spectrometry Dominic Roberts, Giulia Riccardino, Aaron Lamb, and Cristian I. Cojocariu Thermo Fisher Scientific, Runcorn, UK ABSTRACT RESULTS The Orbitrap technology was coupled with static headspace sampling to…

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 | 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…