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

In February 2021, the Ph. Eur. Commission revised the five monographs on sartans with a tetrazole ring, namely Valsartan (2423)Losartan potassium (2232)Irbesartan (2465)Candesartan cilexetil (2573) and Olmesartan medoxomil (2600), using the rapid revision process. The Production section was reworded and the N-nitrosamines test section was deleted. A reference to general chapter 2.5.42. N-Nitrosamines in active substances was introduced in the Production section to assist manufacturers. The five revised monographs become legally binding on 1 April 2021…