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 “C₄₂H_70-nO₃₅(C₄H₈SO₃Na)_n”.

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