The five monographs on sartans with a tetrazole ring, namely Valsartan (2423), Losartan potassium (2232), Irbesartan (2465), Candesartan cilexetil (2573) and Olmesartan medoxomil (2600) have been revised to align them with the latest regulatory recommendations issued by the CHMP that were published on 13 November 2020 on the EMA’s website. The revision concerns a rewording of the “Production” section and deletion of the N-nitrosamines test section.
These revised monographs were not published in Pharmeuropa for public enquiry as the changes made are in line with the CHMP recommendations. In addition, to ensure that the implementation date for the Ph. Eur. requirements is aligned with regulatory decisions as much as possible, the Ph. Eur. Commission has decided to publish the monographs under the rapid-revision procedure. The implementation date for the five revised monographs has therefore been set as 1 April 2021. The PDF versions of these monographs can be downloaded from the EDQM website. The revised monographs have been added to the online and downloadable versions of Supplements 10.4 and 10.5. They will be included in the printed version from Supplement 10.6.
NB: users are reminded that according to the Ph. Eur. General Notices, statements containing the word “should” are informative or advisory.
More information in the press release: Control of N-nitrosamine impurities in sartans: revision and rapid implementation of five Ph. Eur. Monographs.