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FLUDARA FOR INJECTION contains fludara (fludarabine) bine phosphate, a fluorinated nucleotide analog of the antiviral agent vidarabine, 9-p-D-arabinofuranosyladenine (ara-A) that is relatively resistant to deamination by adenosine deaminase. Each vial of sterile lyophilized solid cake contains 50 mg of the active ingredient fludara (fludarabine) bine phosphate, 50 mg of mannitol, and sodium hydroxide to adjust pH to 7.7. The pH range for the final product is 7.2-8.2. Reconstitution with 2 mL of Sterile Water for Injection, USP, results in a solution containing 25 mg/mL of fludara (fludarabine) bine phosphate intended for intravenous administration.
The chemical name for fludara (fludarabine) bine phosphate is 9H-Purin-6-amine, 2-fluoro-9-(5-0-phosphono- 0-D-arabino-furanosyl) (2-fluoro-ara-AMP). The molecular formula of fludara (fludarabine) bine phosphate is C10H13FN5O7P (MW 365.2) and the structure is:
Fludara® (fludara (fludarabine) bine phosphate) Structural Formula Illustration