Rapid Analysis of Nitrosamines in Drug Product Using SIFT-MS

Introduction

The presence of nitrosamines in drug products is a continuing challenge for the pharmaceutical industry (EMA (2021); US FDA (2021)). Golob et al. (2022) have provided an excellent, up-to-date overview of the history. A method for quantitation of N-nitrosodimethylamine (NDMA) direct from drug products using headspace- selected ion flow tube mass spectrometry (SIFT-MS) was described in a recent application note (Perkins and Langford (2022a)). There, two ranitidine drug products were used as part of method development. Although these were not from a recalled batch to the best of our knowledge, NDMA concentrations of 68 and 328 ng g-1, respectively, were detected.