Crystal form of neptinib di-p-methylbenzenesulfonate, preparation method thereof, and pharmaceutical composition containing same
AssigneeShenzhen Neptunus Pharmaceutical Research Institute Co., Ltd.
InventorsTian Tang, Feng Jin, Yanqing Wang, Jing Wu, Xiarou Liu, Jing'an Yang, Hanlin Feng, Lin Yu
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Abstract
Provided is a composition of N-[4-[(3-chloro-4-fluorophenyl)amino]-7-[3-(ethoxy)-6-quinazolinyl]-4-(dimethylamino)-2-butenamide p-toluene sulfonate 1.5 hydrate α-polymorph. The α-polymorph has a stable form, a defined melting point, a good chemical stability, and a good endurance to high temperature and light irradiation, and is suitable for pharmaceutical use.
Claims8
A crystal form α of (E)-N-(4-((3-chloro-4-fluorophenyl)amino)-7-ethoxyquinazolin-6-yl)-4-(dimethylamino)but-2-enamide di-p-methylbenzenesulfonate represented by Formula (1), said crystal form α is (E)-N-(4-((3-chloro-4-fluorophenyl)amino)-7-ethoxyquinazolin-6-yl)-4-(dimethylamino)but-2-enamide di-p-methylbenzenesulfonate 1.5 hydrate, having an X-ray powder diffraction pattern with characteristic peaks at 2θ° of 5.0±0.2, 12.1±0.2, 14.5±0.2, 15.6±0.2, 17.6±0.2, 18.7±0.2, 20.1±0.2, 22.0±0.2, 25.4±0.2, 26.0±0.2 and 26.3±0.2,
Dependencies are inferred from the claim text.