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Title:
AN ISOLATED ATOMOXETINE IMPURITY, PROCESSES FOR THE PREPARATION OF ATOMOXETINE IMPURITIES AND THEIR USE AS REFERENCE STANDARDS
Document Type and Number:
WIPO Patent Application WO2006004979
Kind Code:
A3
Abstract:
The present invention provides isolated N-methyl-3-(3-methylphenoxy)-3-phenylpropylamine hydrochloride, and preparation thereof as well as of N-methyl-3-(4-methylphenoxy)-3-phenylpropylamine hydrochloride and of N-methyl-3-phenoxy-3-phenylpropylamine hydrochloride. The invention further provides the use of the above compounds as reference markers and/or reference standards during the synthesis of Atomoxetine. Also provided is a method of limiting the amounts of the impurities 3FT (3-fluorotoluene), 4FT (4-fluorotoluene), and FB (fluorobenzene) in the 2-fluorotoluene starting material used in the synthesis of Atomoxetine Hydrochloride. The purity of the Atomoxetine Hydrochloride product is ensured by determining the amounts of 3FT, 4FT, and FB in the 2-fluorotoluene starting material with the marker 3-ATM HC1.

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Inventors:
CASTELLI EUGENIO (IT)
VAILATI ALESSANDRA (IT)
Application Number:
PCT/US2005/023423
Publication Date:
April 13, 2006
Filing Date:
June 28, 2005
Export Citation:
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Assignee:
TEVA PHARM FINE CHEMICALS SRL (IT)
TEVA PHARMA (US)
CASTELLI EUGENIO (IT)
VAILATI ALESSANDRA (IT)
International Classes:
C07C217/48
Foreign References:
EP0052492A11982-05-26
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