Pending completion of the review of the related substances test published in Ph. Eur. 9.0 by the Ph. Eur. group of experts, and to ensure a continuing supply of erythromycin ethylsuccinate active substance to the European markets, a revised monograph has been prepared as an interim measure and will be effective from 01 May 2017. The monograph has been revised to replace the test for related substances published in Ph. Eur. 9.0 with the test in the monograph published in Ph. Eur. 8.0, and the impurities section has therefore been adapted accordingly; the rest of the monograph remains unchanged.
This revised monograph will be available online as of Supplement 9.1 and in the other formats, i.e. print and downloadable, as of Supplement 9.3.
This change has been endorsed and carried out in the form of a Resolution of the European Committee on Pharmaceuticals and Pharmaceutical Care, with a view to its rapid implementation outside the normal publication cycle of the European Pharmacopoeia.
Any future changes or revisions of this monograph would be published in Pharmeuropa for public consultation and comment according to the normal procedure. The EDQM encourages all interested parties to provide input at that time.