| 摘要 |
<P>PROBLEM TO BE SOLVED: To provide a novel crystallization method for efficiently producing a bicalutamide crystal suitable for an active pharmaceutical ingredient, a bicalutamide crystal having a particle size distribution and a specific surface area suitable as an active pharmaceutical ingredient, i.e. a bicalutamide crystal whose form is prescribed, by simply crushing the bicalutamide crystal obtained in the crystallization method, and a method for crystallizing bicalutamide, which is economical and excellent in the quality stability, and can be carried out industrially practically. <P>SOLUTION: The method for crystallizing bicalutamide is provided, which includes adding an acetone solution containing biculutamide to water. The bicalutamide crystal is provide which has a particle size distribution of: Dp<SB POS="POST">10</SB>=1 to 10 μm, Dp<SB POS="POST">50</SB>=10 to 25 μm, and Dp<SB POS="POST">90</SB>=25 to 100 μm, and is obtained by the crystallization method. Further, the bicalutamide crystal is provide which has a distribution of: Dp<SB POS="POST">10</SB>=1 to 3 μm, Dp<SB POS="POST">50</SB>=2 to 5 μm, and Dp<SB POS="POST">90</SB>=5 to 15 μm. <P>COPYRIGHT: (C)2012,JPO&INPIT |
