What is Fludarabine phosphate?
Fludarabine phosphate, chemical name 9-beta-arabinofuranosyl-2-fluoroadenine-5'-phosphate, is used to treat chronic lymphocytic leukemia. Fludarabine phosphate USP appears as a white powder. Ranked in the World Health Organization standard list.
| Product name | Fludarabine phosphate USP |
| CAS | 75607-67-9 |
| structural formula | C10H13FN5O7P |
| molecular weight | 365.21 |
| EINECS | 616-242-0 |
| melting point | 203°C(dec.)(lit.) |
| boiling point | 864.2±75.0 °C(Predicted) |
| Acidity coefficient (pKa) | 1.86±0.10(Predicted) |
| density | 2.39±0.1 g/cm3(Predicted) |
| Storage condition | 2-8°C |
What is the pharmacological action of Fludarabine phosphate ?
Fludarabine phosphate USP is a purine nucleoside anti-tumor product, which can inhibit adenosine deaminase. Mainly used for chronic lymphocytic leukemia, including chronic lymphocytic leukemia, non-Hodgkin's lymphoma, acute myeloid leukemia and acute lymphoblastic leukemia.
It has been observed in early clinical studies that it can limit bone marrow toxicity, nausea and vomiting, and the increase of liver enzymes.
It can improve the remission rate of diseases by promoting tumor cell apoptosis. The ways of promoting apoptosis are mainly achieved by regulating the following ways: death receptor pathway, mitochondrial pathway, P53, ceramide, Bcl-2 family and some apoptosis promoters and inhibitors.
Fludarabine phosphate USP is a fluorinated nucleotide analogue of arabinoside, an antiviral drug, which can relatively resist the deamination of adenosine deaminase. It is rapidly dephosphorylated into Fludarabine, which can be taken up by cells and then phosphorylated by intracellular deoxycytidine kinase to become active triphosphate. The metabolite can inhibit DNA synthesis by inhibiting nucleotide reductase, DNA polymerase α, δ and σ, DNA primer enzyme and DNA ligase. In addition, RNA polymerase II can be partially inhibited to reduce protein synthesis. The mechanism of action may be various and is still under study.
Product Specification
| Items | Specifications | Results | ||
| Appearance | White or white-like powder | Complies | ||
| Assay | 98%-101% | 99.96% | ||
| Identification | By IR | Complies | ||
| By HPLC | Complies | |||
| Residue on Ignition | ≤ 0.20% | 0.09% | ||
| Related Substance | Any single impurity: ≤0.10% | 0.06% | ||
| Total Impurities: ≤1.00% | 0.16% | |||
| Particle Size | D90: ≤100µm | Complies | ||
| Heavy metals | ≤20ppm | 3.95ppm | ||
| As | ≤1ppm | ≤1ppm | ||
| Pb | ≤1ppm | ≤1ppm | ||
| Cd | ≤1ppm | ≤1ppm | ||
| Hg | ≤0.1ppm | ≤0.1ppm | ||
| Total Plate count | ≤1000CFU/g | <10CFU/g | ||
| Yeast &Mould | ≤100CFU/g | <10CFU/g | ||
| Escherichia Coli | Negative | Negative | ||
| P.aeruginosa | Negative | Negative | ||
| S.aureus | Negative | Negative | ||
| Salmonella | Negative | Negative | ||
| Conclusion: The test results are conformed to the in-house specification | ||||
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Attention: It should be noted that this product is not intended for the diagnosis, treatment, cure, or prevention of any disease. Please consult your doctor and learn about available research before use. Please do not use without authorization. This compound can only be used for research purposes. The US Food and Drug Administration has not evaluated these claims.
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