Highly pure varenicline or a pharmaceutically acceptable salt thereof substantially free of methylvarenicline impurity

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专利权人:

Actavis Group PTC EHF

发明人:

Pradhan, Nitin Sharadchandra,Kumar, Arvapally Seshu,Trivedi, Nikhil,Sharma, Krishnadatt

申请号：

AU2011225747

公开号：

AU2011225747A1

申请日:

2011.03.08

申请国别(地区):

AU

年份:

2012

代理人:

摘要：

Provided herein is an impurity of varenicline, 6-methyl-5,8,14-triazatetracyclo[l 0.3.1.02n,049]hexadeca-2(l l),3,5,7,9-pentaene (methylvarenicline) impurity, and a process for the preparation and isolation thereof. Provided further herein is a highly pure varenicline or a pharmaceutically acceptable salt thereof substantially free of methylvarenicline impurity, a process for the preparation thereof, and pharmaceutical compositions comprising highly pure varenicline or a pharmaceutically acceptable salt thereof substantially free of methylvarenicline impurity.

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