Patent ID: 7148207

Claim:
A quick-release tablet formulation that comprises 1 to 100 mg of the active ingredient fludarabine phosphate having a purity of >99.19%, lactose monohydrate, colloidal silicon dioxide, microcrystalline cellulose, sodium carboxymethyl cellulose, and magnesium stearate, wherein said formulation releases fludarabine phosphate with a quick release profile, and wherein the contaminants in the fludarabine-phosphate do not exceed: 0.02% 2-fluoro-9-(β-D-arabinofuranosyl)-9H-purine-6-amine, 0.12% 6-amino-9(5-O-phosphono-β-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-β-D-ribofuranosyl)-9H-purine-6-amine, 0.1% 9-(3,5-O-diphosphono-β-D-arabinofuranosyl)-2-fluoro-9H-purine-6-amine, 0.1% 9-(2,5-O-diphosphono-β-D-arabinofuranosyl)-2-fluoro-9H-purine-6-amine, 0.02% 2-fluoro-9-(5-O-phosphono-β-D-arabinofuranosyl)-9H-purine-6-amine, 0.06% 2-ethoxy-9-(5-O-phosphono-β-D-arabinofuranosyl)-9H-purine-6-amine, 0.02% 2-(6-amino-9H-purin-2-yl)-9-(5-O-phosphono-β-D-arabinofuranosyl)- 9H-purine-6-amine and O,O′-bis[2-(6-amino-2-fluoro-9H-purin-9-yl)-5-deoxy-α-D- arabinofuranos-5-yl]-phosphate, 0.1% 9-(2-chloro-2-deoxy-5-phosphono-β-D-arabinofuranosyl)-2-fluoro-9H-purine- 6-amine, and 0.1% 9-(2,5-anhydro-β-D-arabinofuranosyl)-2-fluoro-9H-purine-6-amine.