Edoxaban Tosylate is the tosylate monohydrate salt of edoxaban, an orally active, direct and selective factor Xa inhibitor. It is an anticoagulant that inhibits factor Xa, an important enzyme in the coagulation cascade, thereby reducing thrombin generation and blood-clot formation. (pubchem.ncbi.nlm.nih.gov)
Edoxaban Tosylate is used as the active pharmaceutical ingredient in edoxaban-containing medicinal products. It is associated with prevention and treatment of thromboembolic disorders, including prevention of stroke and systemic embolism in certain patients with non-valvular atrial fibrillation and treatment of venous thromboembolism. (accessdata.fda.gov)
Swapnroop Drugs and Pharmaceuticals provides Edoxaban Tosylate API for pharmaceutical development and manufacturing applications, subject to applicable quality specifications and regulatory requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |
| Melting Point | 150°C – 154°C |