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Edoxaban Tosylate Monohydrate 1229194-11-9

Edoxaban Tosylate Monohydrate 1229194-11-9

98% up by HPLC, DMF, WC
  • 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.

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Send A Message
Send A Message
If you are interested in our products and want to know more details,please leave a message here,we will reply you as soon as we can.

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