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New monograph on Sulfobutylbetadex sodium (2804)

European Pharmacopoeia
10 July 2018
Strasbourg, France

The new monograph on Sulfobutylbetadex sodium (2804) was published in Supplement 9.6.

Variability in the molecular mass related to the range of degree of substitution covered by this monograph has justified the immediate revision of the text to enlarge the content limits from 98.0-102.0% to 95.0-105.0%, in order to avoid undue batch rejection. In addition the percentage content will be expressed in terms of “sulfobutylbetadex sodium” instead of “C42H70-nO35(C4H8SO3Na)n”.

The revised monograph will be published in Supplement 9.8 (implementation date: 1st July 2019).

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