Edoxaban Tosylate Monohydrate is the monohydrate tosylate salt form of edoxaban, an orally active, direct and selective inhibitor of coagulation factor Xa. By selectively inhibiting factor Xa, edoxaban reduces thrombin generation and limits blood-clot formation.
Edoxaban Tosylate Monohydrate is used as the active pharmaceutical ingredient in pharmaceutical formulations containing edoxaban. It belongs to the direct oral anticoagulant (DOAC) class and is associated with the prevention and treatment of thromboembolic conditions.
Swapnroop Drugs and Pharmaceuticals provides Edoxaban Tosylate Monohydrate 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 | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |
| Melting Point | 150°C – 154°C |