null Fast track revision of monograph Dipotassium clorazepate monohydrate (0898)

EDQM Strasbourg, France 01/04/2019

It has been brought to our attention that the conversion factor of 13.63 prescribed in the assay is inappropriate and leads to an overestimation of the content. Therefore, it has to be replaced by a factor of 13.03. In order to ensure the continuous supply of dipotassium clorazepate API to the European market, the monograph has been revised with an implementation date of 1 April 2019.

The updated text of the monograph is available on the EDQM website. This revised monograph has already been added to the online version of the Ph. Eur., Supplement 9.7, and will be included in the print and downloadable versions of the 10th Edition of the Ph. Eur.