Bazhina Nataliya,Donato George Joseph,Fabian Steven R.,Lokhnauth John,Megati Sreenivasulu,Melucci Charles,Ofslager Christian,Patel Niketa,Radebaugh Galen,Shah Syed M.,Szeliga Jan,Zhang Huyi,Zhu Tianmi
申请号:
NZ71008509
公开号:
NZ710085A
申请日:
2009.09.30
申请国别(地区):
NZ
年份:
2017
代理人:
摘要:
Disclosed is a composition comprising a unit dosage form of (R)-N-methylnaltrexone bromide of formula III wherein the compound of formula III is present at 7%-75% based on the total weight of the composition; wherein A- is an anion of a Brønsted acid; wherein the composition is substantially free of tungsten and is contained in a package that is substantially free of tungsten; and wherein the composition comprises less than 190 ppm of an impurity compound of formula II, wherein X- is an anion of a Brønsted acid.