C - Chemistry – Metallurgy – 07 – D
Patent
C - Chemistry, Metallurgy
07
D
C07D 475/04 (2006.01)
Patent
CA 2604818
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 70degrees C; adding heated ethanol to the solution; and cooling the solution at a cooling rate of not faster than 3degrees C/min to a temperature of 40 to 55degrees C to precipitate the crystals.
L'invention décrit un procédé de production sélective de cristaux de chlorhydrate de saproptérine de forme alpha. Selon ledit procédé, le cristal de chlorhydrate de saproptérine de forme alpha est produit par les étapes de : dissolution de chlorhydrate de saproptérine dans de l~acide chlorhydrique à une concentration au moins égale à 4 mol/L à au moins 70 °C ; ajout d~éthanol chauffé à la solution ; et refroidissement de la solution à une vitesse de refroidissement d~au plus 3 °C/min jusqu~à une température de 40 °C à 55 °C afin de précipiter les cristaux.
Hotoda Katsumi
Kiyono Hiroomi
Tazawa Shinnosuke
Asubio Pharma Co. Ltd.
Daiichi Sankyo Company Limited
Gowling Lafleur Henderson Llp
Shiratori Pharmaceutical Co. Ltd.
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