General chapter 2.5.42. N-Nitrosamines in active substances and revised sartan monographs

In February 2021, the European Pharmacopoeia revised 5 monographs on sartans containing a tetrazole ring [(Valsartan (2423), Losartan potassium (2232), Irbesartan (2465), Candesartan cilexetil (2573) and Olmesartan medoxomil (2600)]. The rapid revision process concerned a new wording of the “Production” section and the deletion of the N-nitrosamines test section. The 5 revised monographs will become legally binding on 1 April 2021.
_{March 26, 2021}