| 摘要 |
Disclosed herein is a quick-release tablet formulation that comprises 1 to 100 mg of the active ingredient fludara at a purity of >99.19%, together with Lactose monohydrate, Colloidal silicon dioxide, Microcrystalline cellulose (avicel), Crosscaramellose-Na (sodium carboxymethyl cellulose), and magnesium stearate, characterized in that the contaminants in the fludara do not exceed a percentage as follows: 0.02% 2-Fluoro-9-([beta]-D-arabinofurarnosyl)-9H-purine-6-amine, 0.12% 6-Amino-9(5-O-phosphono-[beta]-D-arabinofuranosyl)-9H-purin-2-ol, 0.02% 2-Fluoro-9H-purine-6-amine, 0.02% 6-Amino-9H-purin-2-ol, 0.05% 2-Fluoro-9-(5-O-phosphono-[beta]-D-ribofuranosyl)-9H-purine-6-amine, 0.1% 9-(3,5-O-diphosphono-[beta]-D-arabinofuranosyl)-2-fluoro-9H-purine-6-amine, 0.1% 9-(2,5-O-diphosphono-[beta]-D-arabinofuranosyl)-2-fluoro-9H-purine-6-amine, 0.02% 2-Fluoro-9-(5-O-phosphono-[beta]-D-arabinofuranosyl)-9H-purine-6-amine, 0.06% 2-Ethoxy-9-(5-O-phosphono-[beta]-D-arabinofuranosyl)-9H-purine-6-amine, 0.02% 2-(6-Amino-9H-purin-2-yl)-9-(5-O-phosphono-[beta]-D-arabinofuranosyl)-9H-purine-6-amine and O,O'-bis[2-(6-amino-2-fluoro-9H-purin-9-yl)-5-deoxy-[alpha]-D-arabinofuranos-5-yl]-phosphate, 0.1% 9-(2-Chloro-2-deoxy-5-phosphono-[beta]-D-arabinofuranosyl)-2-fluoro-9H-purine-6-amine, and 0.1% 9-(2,5-Anhydro-[beta]-D-arabinofuranosyl)-2-fluoro-9H-purine-6-amine.
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