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FLUDARINE PHOSPHATE USP
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DOSAGE FORM: Liquid/Lyophilized Injection, 50mg/vial

BIOLOGICAL SIGNIFICANCE

Fludarabine phosphate is a chemotherapy drug used in the treatment of hematological malignancies.

CLINICAL USE

Fludarabine is highly effective in the treatment of chronic lymphocytic leukemia, producing higher response rates than alkylating agents such as chlorambucil alone. Fludarabine is used in various combinations with other drugs in the treatment of indolent non-Hodgkins lymphomas. As part of the FLAG regimen, fludarabine is used together with cytarabine and granulocyte colony-stimulating factor in the treatment of acute myeloid leukaemia. Because of its immunosuppressive effects, fludarabine is also used in some conditioning regimens prior to non myeloablative allogeneic stem cell transplant.

MODE OF ACTION

Fludarabine is a purine analog, and is given intravenously. Fludarabine inhibits DNA synthesis by interfering with ribonucleotide reductase and DNA polymerase. It is active against both dividing and resting cells.

STRUCTURE:

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SPECIFICATIONS
COMPLIES TO USP
Assay NLT 95% - NMT 105 % of labeled claim
Identification Complies to USP
Water content NMT 5.0%
PH 7.2 – 8.2
BET NMT 7.7 USP EU per mg of Fludarbine phosphate
Sterility Complies to USP
   
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