Nitrosamines alert: extended deadline to submit data on NDMA and other impurities in products containing azithromycin

Between the end of 2021 and the beginning of 2022, the Competent Authorities has testing on a representative batches number of azithromycin-containing finished products for the detection of NDMA and other impurities (e.g. NDBA). The deadline has been set at 1 March 2022 for presenting the results.

Following a specific request from EFPIA (European Federation of Pharmaceutical Industries and Associations), the CDMh (Co-ordination Group for Mutual Recognition and Decentralised procedures – Human) has decided to postponed the deadline to 1 May 2022, maintaining the original mandatory request concerning the testing of a representative number of batches.

MÉRIEUX NUTRISCIENCES’ GMP PHARMACEUTICAL LABS ARE READY TO RECEIVE YOUR PRODUCTS.

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 NDMA determination for azithromycin-containing finished products with LOQ not higher than 10% of the limit of specification applicable to the most common drug products. In order to quickly respond to our customers, dedicated lines were implemented to offer targeted analytical services for nitrosamine analysis.