Ph. Eur. Supplement 10.4 is now available online and to download

The European Pharmacopoeia (Ph. Eur.) Supplement 10.4 is now available as part of the British Pharmacopoeia (BP) 2021 online edition. Users with a BP 2021 online licence will automatically have access to this in-year update. 

Customers who bought the BP 2021 complete package and wish to access Supplement 10.4 via the download version should complete the download form using the Product ID printed on the inside front cover of Volume I. Customers who only purchased the BP 2021 download will have been sent access instructions on their purchase confirmation email.  

Users should note that all Ph. Eur. Supplement 10.4 texts are marked with orange banners as the entirety of this Supplement has been incorporated into the BP 2021. 

The amended contents of the supplement can be viewed here

Rapid implementation of the revised sartan monographs on 1 April 2021
Valsartan, Losartan potassium, Irbesartan, Candesartan cilexetil, and Olmesartan medoxomil have been revised to align them with the latest regulatory recommendations issued by the Committee for Medicinal Products for Human Use (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. The implementation date for the five revised monographs has been set as 1 April 2021. The monographs will be published on pharmacopoeia.com on 1st April alongside the Ph. Eur. 10.4 update.