Crystalline chemotherapeutic

摘要

N-[4-(3-Amino-1H-indazol-4-yl)phenyl]-N′-(2-fluoro-5-methylphenyl)urea Hydrate Crystalline Form 1, ways to make it, formulations comprising it and made with it and methods of treating patients having disease using it are disclosed.

主权项

1. A process for making N-[4-(3-Amino-1H-indazol-4-yl)phenyl]-N′-(2-fluoro-5-methylphenyl)urea Hydrate Crystalline Form 1 comprising:
providing a mixture comprising N-[4-(3-amino-1H-indazol-4-yl)phenyl]-N′-(2-fluoro-5-methylphenyl)urea and solvent, wherein the N-[4-(3-amino-1H-indazol-4-yl)phenyl]-N′-(2-fluoro-5-methylphenyl)urea is completely dissolved in the solvent; and causing N-[4-(3-Amino-1H-indazol-4-yl)phenyl]-N′-(2-fluoro-5-methylphenyl)urea Hydrate Crystalline Form 1 to exist in the mixture, which N-[4-(3-Amino-1H-indazol-4-yl)phenyl]-N′-(2-fluoro-5-methylphenyl)urea Hydrate Crystalline Form 1, when measured at about 25° C. with radiation at 1.54178 Å, is characterized by a powder diffraction pattern having respective 2θ values of about 6.2°, 12.0°, 12.4°, 12.8°, 13.4°, 14.2°, 15.2°, 15.6°, 16.2° and 19.7°.