Fludarabine Phosphate for Injection, USP contains fludarabine phosphate, USP, a fluorinated nucleotide analog of the antiviral agent vidarabine, 9-β-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 fludarabine phosphate, USP, 50 mg of mannitol, and sodium hydroxide to adjust pH to 7.7. The pH range for the final product is 7.2 to 8.2. Reconstitution with 2 mL of Sterile Water for Injection, USP results in a solution containing 25 mg/mL of fludarabine phosphate, USP intended for intravenous administration.
The chemical name for fludarabine phosphate, USP is 9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono- β - D-arabinofuranosyl)(2-fluoro-ara-AMP). The molecular formula of fludarabine phosphate, USP is C10H13FN5O7P (MW 365.2) and the structure is: