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99% up by HPLC Edoxaban Tosylate Monohydrate 1229194-11-9 CAS NO.1229194-11-9
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- Product Details
Keywords
- Edoxaban Tosylate Monohydrate
- Edoxaban Tosylate
- 1229194-11-9
Quick Details
- ProName: 99% up by HPLC Edoxaban Tosylate Monoh...
- CasNo: 1229194-11-9
- Molecular Formula: C31H40ClN7O8S2
- Application: API
- ProductionCapacity: Metric Ton/Day
- Purity: 99% up by HPLC
- LimitNum: 0 Metric Ton
Superiority
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1) Specialized in pharmaceutical and healthcare industrial since 1987
2) ISO 9001:2015 & SGS audited supplier .
3) Accept various payment terms : T.T 30-60 days.
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Details
|
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 |
|
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 |
|
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.
