Edoxaban Tosylate Monohydrate 1229194-11-9

98% up by HPLC, DMF, WC

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Product Details

Product Information

Product name	Edoxaban Tosylate Monohydrate
CAS No.	1229194-11-9
Molecular Formula	C31H40ClN7O8S2
Molecular Weight	738.2744
Quality Standard	98% up by HPLC
Appearance	White to almost white powder

COA of Edoxaban Tosylate Monohydrate

ITEMS	SPECIFICATION	RESULT
Appearance	White powder	Conforms
Identity	The IR spectrum corresponds to reference standard	Conforms
	The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay.	Conforms
	X-ray diffraction: the X-ray diffraction pattern of the sample matches the characteristic pattern of Edoxaban tosylate Form I	Conforms
Water	2.2%-3.0%	2.6%
Residue on ignition	NMT 0.1%	0.01%
P-toluenesulfonic acid	NLT 22.9% & NMT 24.9% (on anhydrous basis)	24.1%
Enantiomeric purity	EXB RC01: NMT 0.15%	Not detected
Related substances	EXB RC06: NMT 0.15%	Not detected
	EXB RC10: NMT 0.15%	Not detected
	EXB RC11: NMT 0.15%	Not detected
	Any individual unspecified impurity: NMT 0.10%	0.03%
	Total impurities: NMT 0.15%	0.03%
Residual solvents	Ethanol: NMT 5000ppm	Not detected
	Acetonitrile: NMT 410ppm	Not detected
	Methylene chloride: NMT 600ppm	Not detected
	Triethylamine: NMT 5000ppm	Not detected
Particle size		D₁₀: 2.61 μm D₅₀: 6.43 μm D₉₀: 21.5 μm
Assay	NLT 98.0% & NMT 102.0% (on anhydrous basis)	99.8%
Conclusion	The products complies with the specification of in-house standard

Usage

Function of Edoxaban

Edoxaban is primarily used to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation not due to valvular heart disease.

In people with atrial fibrillation, anticoagulant drugs prevent blood from forming clots in the heart to reduce the risk of stroke. It is important that a variety of these types of drugs provide more choices for patients. The researchers compared the safety and efficacy of edoxaban and warfarin in patients with atrial fibrillation requiring oral anticoagulants, observing a composite of adverse clinical events including all-cause death, thromboembolic events, and major bleeding. From the comprehensive evaluation point of view, the efficacy of edoxaban is no worse than that of warfarin. At the same time, edoxaban resulted in some higher bleeding complications (mainly gastrointestinal) compared to warfarin (or analogues available in countries). Based on these results, the trial met its primary endpoint of non-inferiority, and edoxaban may be a reasonable alternative to warfarin, although the drug was noted to increase bleeding in the study population.

*Products under the patent are only for R&D use