Fondaparinux Sodium API is a synthetic sulfated pentasaccharide anticoagulant based on the antithrombin-binding sequence of heparin. It is a selective inhibitor of activated Factor X (Xa). Fondaparinux Sodium has CAS Number 114870-03-0, molecular formula C₃₁H₄₃N₃Na₁₀O₄₉S₈, and molecular weight 1728.08 g/mol. The current USP monograph defines Fondaparinux Sodium as a white to off-white powder and specifies 95.0%–103.0% content on an anhydrous and solvent-free basis.
Fondaparinux Sodium is a highly sulfated synthetic pentasaccharide containing ten sodium ions. It is freely soluble in water, sodium chloride solution and sodium hydroxide solution, and is practically insoluble in ethanol.
Fondaparinux Sodium has the molecular formula C₃₁H₄₃N₃Na₁₀O₄₉S₈ and molecular weight 1728.08 g/mol. Its CAS Registry Number is 114870-03-0.
USP specifies 95.0%–103.0% Fondaparinux Sodium on the anhydrous and solvent-free basis. Published USP-compliant CoA data also provide numerical limits for related substances, residual chloride, residual solvents, pH, water, heavy metals, endotoxins and microbial enumeration.
Fondaparinux Sodium is an anticoagulant API and a selective inhibitor of activated Factor X (Xa). It is used in pharmaceutical formulations for anticoagulant therapy.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 95.0% – 103.0% |
| Loss on Drying | NMT 20.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 6.0 – 8.0 |
| Individual Impurity | NMT 0.8% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |