VARENICLINE STANDARD AND IMPURITY CONTROL

PROBLEM TO BE SOLVED: To provide a composition comprising varenicline or a pharmaceutically acceptable salt thereof and controlling the amount of impurities thereof. SOLUTION: The varenicline composition comprises one or more of several mononitro, monoamino, mixed aminonitro, diamino or dinitro inte...

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Bibliographic Details
Main Authors BRONK KAREN S, SINAY TERRY G, WITHBROE GREGORY JOHN, FRANK ROBERT BUSCH
Format Patent
LanguageEnglish
Published 11.10.2007
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Summary:PROBLEM TO BE SOLVED: To provide a composition comprising varenicline or a pharmaceutically acceptable salt thereof and controlling the amount of impurities thereof. SOLUTION: The varenicline composition comprises one or more of several mononitro, monoamino, mixed aminonitro, diamino or dinitro intermediates which are synthetic intermediates therefor at >0 to ≤about 500 ppm, ≤about 100 or ≤about 10 ppm concentration in the composition comprising the varenicline. COPYRIGHT: (C)2008,JPO&INPIT
Bibliography:Application Number: JP20070078240