Details for Patent: 7,732,641
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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. (Shrewsbury, MA), Kessler; Donald W. (Groton, MA) |
Assignee: | Sepracor Inc. (Marlborough, MA) |
Filing Date: | Dec 05, 2008 |
Application Number: | 12/329,196 |
Claims: | 1. (R,R)-formoterol L-tartrate in the form of a crystalline solid consisting of greater than 99.6% by weight of formoterol L-tartrate at least 95% in the polymorphic form of a thermodynamically stable third polymorph (A) of (R,R)-formoterol L-tartrate, said polymorph (A) having peaks at the diffraction degrees with the intensity shown below in an X-ray powder diffraction pattern: TABLE-US-00007 peak number 2-Theta Intensity 1 8.8 33.1 2 9.3 33.4 3 12.1 58.1 4 12.4 60.6 5 14.2 30.9 6 15.2 87.4 7 15.5 82.8 8 16.8 69.8 9 18.9 39.6 10 19.7 41.1 11 20.8 40.6 12 22.5 38.8 13 23.0 59.9 14 23.7 100.0 15 25.6 55.9 16 26.8 37.2 17 28.6 25.6 18 30.9 37.2 19 36.1 28.0 20 38.1 25.0 21 39.1 22.7 22 41.5 21.3 23 43.3 20.9 |