Detection and Quantitation of NDMA Impurity in Ranitidine Drug Substances and Products by LC-HRMS on LCMS-9030

User Benefits

- Determination of NDMA in ranitidine API and drug products by an orthogonal LC-HRMS method on LCMS-9030. - NDMA was found in all the six samples and their levels increased significantly in comparison with the results measured in 10 months ago by LC-MS/MS (TQ) method.

Introduction

Among the nitrosamines listed by US FDA and EMA, NDMA is the most-frequently found one in sartans, ranitidine and metformin drug products. Dedicated LC-MS/MS and LCHRMS methods [1,2] were developed and used for monitoring of NDMA in metformin and ranitidine APIs and drug products. In Apr. 2020, US FDA requested removal of all ranitidine products from the US market, which have been used as for 30 years. In Sep. 2020, EMA recommended to suspend all ranitidine medicines in the Europe [3]. This is because investigation reveals that the level of NDMA increases significantly with time of storage even under normal conditions, which may lead to the level of NDMA in the ranitidine product above the acceptable daily intake limit. In this Application News, an LC-HRMS method is introduced as an orthogonal method to the LC-MS/MS method [4] for the determination of NDMA in ranitidine products.

September 24, 2021 GMT