C - Chemistry – Metallurgy – 07 – C
Patent
C - Chemistry, Metallurgy
07
C
C07C 381/12 (2006.01) A61K 31/167 (2006.01) A61P 37/08 (2006.01) G01N 21/21 (2006.01) G01N 23/20 (2006.01)
Patent
CA 2573481
A method of evaluating the evenness of suplatast tosilate crystals; and stable crystals having evenness in optical purity. The method of evaluating the evenness of suplatast tosilate crystals is characterized by comprising (a) a step in which a solvent is added to the suplatast tosilate crystals to dissolve up to 3% of the crystals and part of the supernatant of the resultant suspension is taken out and examined for optical purity and (b) a step in which a solvent is then added to the remaining suspension to dissolve the whole crystals and part of the solution is taken out and examined for optical purity, and by comparing the optical purity obtained in the step (a) with that obtained in the step (b). Suplatast tosilate crystals excellent in evenness and thermal stability are provided.
Procédé d~évaluation de la régularité de cristaux de tosilate suplatast; et cristaux stables d~une pureté optique régulière. Le procédé d~évaluation de la régularité de cristaux de tosilate suplatast est caractérisé en ce qu~il contient (a) une phase dans laquelle on ajoute un solvant aux cristaux de tosilate suplatast pour dissoudre jusqu~à 3% des cristaux et l~on prélève une partie du produit surnageant de la suspension résultante et l~on étudie la pureté optique de celle-ci et (b) une phase dans laquelle on ajoute ensuite un solvant au reste de la suspension pour dissoudre les cristaux tout entiers et l~on prélève une partie de la solution et l~on étudie la pureté optique de celle-ci, et en ce que l~on compare la pureté optique obtenue lors de la phase (a) à celle obtenue dans la phase (b). L~invention porte également sur des cristaux de tosilate suplatast d~excellentes régularité et stabilité thermique.
Nagai Keiko
Ushio Takanori
Gowling Lafleur Henderson Llp
Taiho Pharmaceutical Co. Ltd.
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