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Generated: October 23, 2017

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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), Senanayaka; Chris H. (Shrewsbury, MA), Kessler; Donald W. (Groton, MA)
Assignee: Sepracor Inc. (Marlborough, MA)
Filing Date:Jan 14, 2008
Application Number:12/013,848
Claims:1. A solvent system for conversion of (R,R)-formoterol L-tartrate polymorph B to (R,R)-formoterol L-tartrate polymorph C comprising (R,R)-formoterol L-tartrate polymorph B, isopropyl alcohol, water, and at least 13% toluene, wherein the solvent is maintained at from 45.degree. C. to 50.degree. C.

2. A solvent system for conversion of (R,R)-formoterol L-tartrate polymorph B to (R,R)-formoterol L-tartrate polymorph C according claim 1, wherein toluene is present in the solvent system at from 13 weight % to 75 weight %.

3. A solvent system for conversion of (R,R)-formoterol L-tartrate polymorph B to (R,R)-formoterol L-tartrate polymorph C according to claim 1, wherein the solvent system is a 3.7:1.0:2.0 (w/w/w) isopropyl alcohol:toluene:water mixture.

4. A system for conversion of R,R)-formoterol L-tartrate polymorph B to (R,R)-formoterol L-tartrate polymorph C according to claim 1, wherein the (R,R)-formoterol L-tartrate polymorph B is present at 17 weight % of the system.
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