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The revised Oxytetracycline hydrochloride (0198) monograph to be published in the Ph. Eur. 10.0

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European Pharmacopoeia
Monograph
News
25 January 2019
Strasbourg, France

A revised version of the monograph on Oxytetracycline hydrochloride (0198) has been adopted by the European Pharmacopoeia Commission and will be published in the upcoming 10th Edition. This revised version will include impurity F as a specified impurity and will introduce a limit of maximum 1.0% for the sum of impurities D, E and F, changes seen as a temporary solution that would alleviate the issues faced by some users with the current version of the monograph. The revised monograph will become effective on 1 January 2020.

In the meantime, work on the monograph will continue and a revised draft will be published for public consultation in Pharmeuropa at a later date. Public consultation is a crucial stage in the monograph elaboration process and one in which manufacturers and other interested parties play a vital role: it is their comments on the draft which help ensure that the Ph. Eur. reflects accurately the quality of pharmaceutical substances available in Europe. The EDQM therefore strongly encourages all stakeholders to use this opportunity to review and provide their comments on the draft monographs published in Pharmeuropa.

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