Varenicline standards and impurity controls

Details Varenicline standards and impurity controls Varenicline standards and impurity controls

A - Human Necessities

61

K

A61K 31/439 (2006.01) A61K 31/498 (2006.01) A61P 1/00 (2006.01) A61P 3/00 (2006.01) A61P 9/00 (2006.01) A61P 25/00 (2006.01) A61P 25/34 (2006.01)

Patent

CA 2644448

The subject invention provides a varenicline composition that comprises varenicline, or a pharmaceutically acceptable salt thereof, and an amount of a compound selected from one or more of several mononitro, monoamine mixed aminonitro, diamino or dinitro intermediates, and the concentration of said compound is greater than 0 ppm and not greater than about 500 ppm, not greater than about 100 ppm or not greater than about 10 ppm. Methods for synthesizing and using such varenicline compositions are also provided.

La présente invention concerne une composition de varénicline qui comprend de la varénicline ou un de ses sels pharmaceutiquement acceptable et une quantité d'un composé choisi parmi un ou plusieurs intermédiaires mononitro, aminonitro mélangé à une monoamine, diamino ou dinitro, la concentration dudit composé étant supérieure à O ppm et non supérieure à environ 500 ppm, non supérieure à environ 100 ppm ou non supérieure à environ 10 ppm. L'invention concerne également des procédés de synthèse et d'utilisation de telles compositions de varénicline.

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