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：
NZ60266709
公开号：
NZ602667A
申请日:
2009.09.30
申请国别(地区):
NZ
年份:
2014
代理人:
摘要：
602667 Disclosed is an isolated compound of formula I which is an oxidative impurity found in samples such as (R)-N-methylnaltrexone bromide, wherein: R1 and R2 are each independently aliphatic； and X- is a suitable anion. Also disclosed is a crystalline form of the compound II-1. Further disclosed is a method of determining the amount of a compound of formula II-1 in a sample of (R)-N-methylnaltrexone when the compound of formula II-1 is present, comprising the steps of: (a) providing a sample of (R)-N-methylnaltrexone bromide； (b) performing LC/MS or HPLC analysis of the sample of (R)-N-methylnaltrexone bromide； and (c) determining the amount of the compound of formula II-1 in the sample of (R)-N-methylnaltrexone bromide. Additionally disclosed is a kit comprising a compound of formula I or II-1； and the kit further comprises one or more reference standards of (R)-N-methylnaltrexone bromide, and/or Impurity B, Impurity C, Impurity D, Impurity E, Impurity F, Impurity G, Impurity H, and Impurity I (as defined herein).
