An isolated atomoxetine impurity, processes for the...

Details An isolated atomoxetine impurity, processes for the... An isolated atomoxetine impurity, processes for the...

C - Chemistry, Metallurgy

07

C

C07C 217/48 (2006.01)

Patent

CA 2561387

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.

La présente un N-méthyl-3-(3-méthylphénoxy)-3-phénylpropylamine hydrochlorure isolé et sa fabrication ainsi qu'un N-méthyl-3-(4-méthylphénoxy)-3-phénylpropylamine hydrochlorure et un N-méthyl-3-phénoxy-3-phénylpropylamine hydrochlorure. L'invention concerne également l'utilisation des composés ci-dessus comme marqueurs de référence et/ou normes de référence pendant la synthèse de l'atomoxétine. Est en outre décrit un procédé permettant de limiter les quantités d'impuretés de 3FT (3-fluorotoluène), de 4FT (4-fluorotoluène), et de FB (fluorobenzène) dans le matériau de départ 2-fluorotoluène utilisé dans la synthèse dhydrochlorure d'atomoxetine. Pour garantir la pureté de l'hydrochlorure d'atomoxétine, on détermine les quantités de 3FT, 4FT, et de FB dans le matériau de départ 2-fluorotoluène au moyen du marqueur 3-ATM HC1.

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