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Fludarabine phosphate
1. Basic Information
Name: Fludarabine phosphate
Alias: 9-β-D-Arabinofuranosyl-2-fluoroadenine 5'-monophosphate
CAS No.: 75607-67-9
Molecular Formula: C10H13FN5O7P
Molecular Weight: 365.21
Category: Anti-tumor chemotherapy API, purine nucleoside antimetabolite, hematological malignancy therapeutic raw material, pharmacopoeia reference standard
2. Physical and Chemical Properties
Physical Properties
- Appearance: White to off-white crystalline powder
- Odor: Odorless
- Solubility: Soluble in dilute alkaline water; slightly soluble in water, methanol; insoluble in ethanol, acetone, ether, aliphatic hydrocarbons
- Melting Point: Decomposes above 230℃ without clear melting point
- Predicted Density: 1.82 g/cm3
- Hygroscopy: Moderately hygroscopic, easy to absorb moisture in high humidity environment
- Aqueous property: Weakly acidic aqueous solution; unstable under high temperature and alkaline conditions, prone to hydrolysis and dephosphorylation
Chemical Properties
- Molecular structure: Fluorinated arabinofuranosyl adenine monophosphate, contains fluorine substituted purine ring, furanose ring and phosphate group
- Anti-tumor mechanism: After intracellular phosphorylation, inhibits DNA polymerase and ribonucleotide reductase, blocks tumor cell DNA synthesis and induces lymphocyte apoptosis
- Hydrolysis characteristic: Phosphate ester bond hydrolyzes under heating/alkali to generate fludarabine free base; fluoropurine ring stable under weak acid
- Photostability: Highly light-sensitive; UV irradiation triggers degradation and discoloration, activity decreases sharply
- Thermal stability: Stable below 80℃; long-term heating above 120℃ decomposes, releases toxic fluoride and phosphorus-containing fumes
- Compatibility: Compatible with acidic buffer solutions; incompatible with strong alkali, heavy metal salts, strong oxidants
3. Main Application Fields
1. Anti-Lymphoma API Raw Material (Core Application)
Chemotherapy drug raw material for treating B-cell chronic lymphocytic leukemia, low-grade non-Hodgkin lymphoma; used for injection lyophilized powder formulations
2. Anti-Tumor Compound Preparation Intermediate
Combined with cyclophosphamide, rituximab for combined chemotherapy regimens
3. Pharmacopoeia Quality Control Reference Standard
HPLC reference substance for related substance detection of fludarabine phosphate injections and bulk drugs
4. Biomedical Laboratory Research Reagent
Model nucleoside inhibitor for tumor cell proliferation and immune cell metabolism research
4. Quality Specification Table
| Test Item | Standard Specification |
| CAS Number | 75607-67-9 |
| Molecular Formula | C10H13FN5O7P |
| Appearance | Uniform off-white crystalline powder without yellow discoloration |
| HPLC Assay | Pharma API Grade 98.0%–102.0%, Reference Standard ≥99.5% |
| Water Content (KF) | ≤0.50% |
| Single Unknown Related Substance | ≤0.10% |
| Total Related Substances | ≤0.50% |
| Heavy Metals (Pb) | ≤10 ppm |
| Endotoxin | ≤0.1 EU/mg (Injection Grade) |
| Packaging | Light-proof nitrogen-filled aluminum foil vacuum bag; bulk 25kg PE lined sealed fiber drum |
| Storage Condition | Hermetically sealed low-temperature warehouse 2–8℃, full light shielding, isolated from humid air, alkaline and oxidizing chemicals |
| Transportation Requirement | Cytotoxic anti-tumor pharmaceutical powder, controlled hazardous chemical transport, separate from food and daily chemicals |
| Shelf Life | 36 months under intact nitrogen sealed packaging |
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