Peripheral opioid receptor antagonists and uses thereof
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...
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Main Authors | , , , , , , , , , , , , |
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Format | Patent |
Language | English |
Published |
30.04.2014
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Subjects | |
Online Access | Get full text |
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Summary: | 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). |
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Bibliography: | Application Number: NZ20090602667 |