Product Overview

Product Features

• Oral Bioavailability: High oral absorption, convenient administration compared to injectable 5-FU.
• Tumor-Targeted Activation: Converted to 5-FU by thymidine phosphorylase (TP), overexpressed in many tumors.
• Controlled Toxicity: Lower systemic side effects (e.g., myelosuppression) than conventional 5-FU.
• High Purity: HPLC ≥98.0%, compliant with USP/EP pharmacopeia standards.
• Stable & Crystalline: Well-defined crystal form, good stability under recommended storage.

Physical & Chemical Properties

Physical Properties

1. Appearance: White to off-white crystalline powder.
2. Odor: Odorless.
3. Molecular Formula: C15H22FN3O6.
4. Molecular Weight: 359.35 Da.
5. Melting Point: 110–121 °C.
6. Density: 1.49 ± 0.1 g/cm3 (predicted).
7. Flash Point: 87 °C.
8. Solubility:
   • Water: ~6 mg/mL (16.69 mM, clear when warmed).
   • Ethanol/DMSO: ~72 mg/mL (freely soluble).
   • Insoluble in non-polar solvents (hexane, ether).
9. pKa: 5.41 ± 0.40 (predicted).
10. Storage Temperature: 2–8 °C (refrigerated).

Chemical Properties

1. Prodrug Structure: Carbamate ester derivative of 5-fluorocytidine; no direct cytotoxicity until activated.
2. Metabolic Activation: Sequential enzymatic hydrolysis → 5'-deoxy-5-fluorocytidine → 5'-deoxy-5-fluorouridine → 5-FU (active).
3. Chemical Stability: Stable in solid state; hydrolyzes under strong acid/alkali.
4. Incompatibility: Avoid strong oxidants, extreme pH, and high temperature (>60 °C).

Applications

1. Pharmaceutical API (Primary Use)
   • Metastatic colorectal cancer: First-line monotherapy or combination therapy.
   • Breast cancer: Metastatic or adjuvant treatment (HER2-negative).
   • Gastric cancer: Advanced/metastatic disease.
   • Pancreatic cancer: Palliative treatment.
2. Mechanism of Action: 5-FU inhibits thymidylate synthase (TS), blocking DNA synthesis and inducing tumor cell apoptosis.
3. Research Use: In vitro/in vivo oncology models; drug metabolism and prodrug design studies.
4. Formulation: Oral tablets (150 mg, 500 mg); film-coated for stability.

Storage & Transportation

Storage Conditions

• Temperature: 2–8 °C (refrigerated, long-term); avoid freezing.
• Environment: Dry, dark, airtight container; protect from moisture and light.
• Shelf Life: 3 years (unopened, 2–8 °C); 6 months (opened, 2–8 °C).

Transportation

• UN Number: Not classified as dangerous goods (non-hazardous).
• Packaging: Sealed HDPE bottles or aluminum foil bags; outer carton with desiccant.
• Temperature: Ambient (≤25 °C) for short transit; cold chain preferred for bulk shipments.

Safety & Regulatory

GHS Classification

• Hazard Statements: H302 (Acute toxicity, oral), H315 (Skin irritation), H319 (Eye irritation), H335 (Respiratory irritation).
• PPE: Nitrile gloves, safety goggles, dust mask; handle in fume hood.

Regulatory

• CAS: 154361-50-9.
• EINECS: 604-948-1.
• HS Code: 2937190090 (antineoplastic API).
• Standards: USP, EP, cGMP; COA, MSDS, DMF available.
• Restrictions: For pharmaceutical manufacturing and research only; not for human consumption directly.

Full Specification Table