Fruzaqla

11. DESCRIPTION Fruquintinib is a kinase inhibitor with the chemical name 6-[(6,7-dimethoxyquinazolin-4-yl)oxy]- N ,2-dimethyl-1-benzofuran-3-carboxamide. Its molecular formula is C 21 H 19 N 3 O 5 , which corresponds to a molecular weight of 393.39 g/mol. Fruquintinib has the following chemical structure: Fruquintinib is a white to off-white powder with a dissociation constant (pK a ) of 2.78. The aqueous solubility of fruquintinib is pH-dependent with a solubility of 0.9 μg/mL at pH 6.8 that increases under acidic conditions to 129.9 μg/mL at pH 1. FRUZAQLA (fruquintinib) capsules for oral administration contain 1 mg or 5 mg of fruquintinib. The inactive ingredients are corn starch, microcrystalline cellulose, and talc. The 1 mg capsule shell contains FD&C Yellow No. 5 (tartrazine), FD&C Yellow No. 6 (sunset yellow FCF), gelatin, and titanium dioxide. The 5 mg capsule shell contains FD&C Blue No. 1 (brilliant blue FCF), FD&C Red No. 40 (allura red AC), gelatin, and titanium dioxide. The printing ink for 1 mg and 5 mg capsules contains butanol, dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution. Chemical Structure