| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
|
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The convergent synthesis of edoxiban tosilate (XI) involves the union of three key structural subunits, diamino cycloh exane intermediate 127, pyridyl amino oxoacetate 128, and thiazole acid 129 (Scheme 1) and the discovery synthesis and related compounds were disclosed in several publications. Several patents on the improved synthesis of the diamino and thiazole intermediates have been disclosed, including an improved synthesis of edoxaban. Because the synthesis described in the latest patents do not involve any chromatographic purification, this is the most likely processscale route, and will be highlighted (Scheme 1-3).
Edoxaban (tosylate Monohydrate) is an oral anticoagulant drug which acts as a direct factor Xa inhibitor. Edoxaban (tosylate Monohydrate) was developed by Daiichi Sankyo and approved in July 2011 in Japan for prevention of venous thromboembolisms (VTE) following lower-limb orthopedic surgery. Edoxaban (tosylate Monohydrate) was also approved by the FDA in January 2015 for the prevention of stroke and non-central-nervous-system systemic embolism.
| Item | Test Standard | Testing Result | |
| Assay | 99% | Complies | |
| Apperence | White Powder | Complies | |
| Particle Size | 100% pass 80 mesh | Complies | |
| Oder | Characteristic | Complies | |
| Taste | Characteristic | Complies | |
| Loss on Drying | ≤5.0% | 2.20% | |
| Residue on Ignition | ≤0.1% | 0.05% | |
| Residual | ≤0.1% | Complies | |
| Residual Ethanol | ≤0.5% | Complies | |
| Heave Mentals | ≤10ppm | Complies | |
| Na | ≤0.1% | <0.1% | |
| Pb | ≤3 ppm | Complies | |
| Total Plate | <1000CFU/g | Complies | |
| Yeast & Mold | <100 CFU /g | Complies | |
| E. Coli | Negative | Complies | |
| Salmonella | Negative | Complies | |
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