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Generated: January 17, 2018

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Title:Formoterol tartrate process and polymorph
Abstract: A method of preparation of a highly pure salt of R,R-formoterol L-tartrate is disclosed. The process provides the most thermodynamically stable polymorph by recrystallization of a novel polymorph.
Inventor(s): Tanoury; Gerald J. (Hudson, MA), Senanayake; Chris H. (Brookfield, CT), Kessler; Donald W. (Groton, MA)
Assignee: Sunovion Pharmaceuticals Inc. (Marlborough, MA)
Filing Date:Jun 07, 2010
Application Number:12/794,991
Claims:1. A process for preparing (R,R)-formoterol L-tartrate polymorph A comprising: converting (R,R)-formoterol L-tartrate polymorph B to (R,R)-formoterol L-tartrate polymorph C in a solvent system comprising isopropyl alcohol, water, and at least 13% toluene, wherein the solvent system is maintained at between 40.degree. C. and 55.degree. C., and preparing (R,R)-formoterol L-tartrate polymorph A from (R,R)-formoterol L-tartrate polymorph C through crystallization.

2. A process according to claim 1, wherein the solvent system is maintained at between 40.degree. C. and 45.degree. C.

3. A process according to claim 1, wherein the solvent system is maintained at between 45.degree. C. and 50.degree. C.
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