Process of preparing a crystalline azithromycin monohydrate
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United States of America Patent
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Mar 23, 2010
Grant Date -
Mar 23, 2006
app pub date -
Aug 24, 2005
filing date -
Aug 30, 2004
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Abstract
The present invention provides a process of preparing a crystalline azithromycin monohydrate. The process involves dissolving azithromycin in a solution containing ethanol, adding the dissolved azithromycin into water to precipitate the crystals, isolating and drying the precipitate to a water content of about 5% (w/w) to about 7% (w/w). The resulting azithromycin monohydrate is stable, exhibiting less than 2% degradation, and non-hydroscopic.
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