February 2020

LGC’s NDMA reference standard and tailored analytical testing solution provides answers to nitrosamines question

Following the discovery of N-Nitrosodimethylamine (NDMA) in Ranitidine products, late in 2019, the European Medicines Agency (EMA) requires all Marketing Authorisation Holders (MAHs) to review their medicines for the possible presence of nitrosamines and assess potential need to provide test data for all drug products at risk.

LGC’s NDMA reference standard is available as a high-quality analytical solution, within its Mikromol range. As Mike Ludlow, Science Lead of LGC’s Drug Development Solutions Division, explains, “Our Mikromol range has more than 5,000 pharmaceutical API, impurity and excipient reference standards. Each comes with a comprehensive Certificate of Analysis detailing the characterisation process for the material, and ensuring its suitability for both qualitative and quantitative analysis. In addition, unlike the neat reference substance, the new solution allows for easier handling in your laboratory and has no shipment restrictions.”

He continued, “LGC also has validated robust LC-MS/MS methodology to analyse drug substance and drug products (including Ranitidine) for the presence of N-Nitrosodimethlyamine (NDMA) and N-Nitrosodiethanolamine (NDELA). This methodology can also be applied to other related impurities, such as N-Nitrosodibutylamine, N-Nitrosodiphenylamine, and Nitrosomorpholine, among others.      

“Our approach is to work with our clients to determine an individually-tailored course of action for their products. For example, for most formulation types a limit test at an agreed Target Analytical Level - ideally set lower than the limits suggested by FDA and EMA - is generally considered to be the best approach, but, where required, fully validated quantitative methods can be developed.”

LGC will be showcasing their tailored solutions at the Nitrosamine Impurities Conference in Frankfurt, Germany on 18 Feb and 19 March, as well as at the BOS Basel event, 1-2 July 2020, booth #29

If you would like more information please contact us.