Nitrosamine alerts: EMA defined acceptance limit for N-nitrosomorpholine in pharmaceutical products

29 June 2021 – EMA/409815/2020 Rev.4

EMA has updated the document “Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products” with the acceptance limit applicable for N-nitrosomorpholine, in addition to those listed previously for other 8 nitrosamines.

OUR CAPABILITIES

Thanks to the long-standing experience in nitrosamines analyses, Mérieux NutriSciences’ Pharmaceutical and R&D Divisions have developed and validated suitable high sensitive LC-MS/MS methods for NMOR limit determination in pharmaceutical products and packaging, and in the other listed nitrosamines. In order to quickly respond to our customers, dedicated lines have been implemented to offer rapid and targeted analytical services for nitrosamine analysis.

Please refer to the Questions & Answers document for complete information.