Method for producing alpha form crystals of sapropterin hydrochloride
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United States of America Patent
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Oct 18, 2011
Grant Date -
Oct 29, 2009
app pub date -
Apr 13, 2006
filing date -
Apr 14, 2005
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Abstract
A method for selectively producing stable alpha form crystals of sapropterin hydrochloride is provided. In this method, the alpha form crystal of sapropterin hydrochloride is produced by dissolving sapropterin hydrochloride with hydrochloric acid at a concentration of not less than 4 mol/L at not less than 70 degrees C.; adding heated ethanol to the solution; and cooling the solution at a cooling rate of not faster than 3 degrees C./min to a temperature of 40 to 55 degrees C. to precipitate the crystals.
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