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

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17 March 2021
Strasbourg, France

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.

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