Method for producing alpha form crystals of sapropterin...

Organic compounds -- part of the class 532-570 series – Organic compounds – Four or more ring nitrogens in the bicyclo ring system

Reexamination Certificate

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Reexamination Certificate

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08039617

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.

REFERENCES:
patent: 4595752 (1986-06-01), Azuma et al.
patent: 4713454 (1987-12-01), Sakai et al.
patent: 60-178887 (1985-09-01), None
patent: 09 157270 (1997-06-01), None
patent: WO 2005065018 (2005-07-01), None
Schircks, et al., “A New Regiospecific Synthesis of L-Biopterin2)”, Helvetica Chimica Acta, vol. 68, No. 6, pp. 1639-1643, XP009063871, 1985.
Schircks, et al., “Herstellung von (6 R, S)-5,6,7,8-Tetrahydro-L-biopterin, 7,8-Dihydro-L-biopterin, L-Sepiapterin, Deoxysepiapterin, (6 R, S)-5,6-Dihydrodeoxysepiapterin und 2′-Deoxybiopterin1)”, Helvetica Chimica Acta, vol. 61, No. 7, pp. 2731-2738, XP-002391645, 1978.

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