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Good Quality Human API - Rivaroxaban 366789-02-8 Blood system protect Antithrombosis – Neore

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Good Quality Human API - Rivaroxaban 366789-02-8 Blood system protect Antithrombosis – Neore Detail:

Payment: T/T, L/C
Product Origin: China
Shipping Port: Beijing/Shanghai/Hangzhou
Production capacity: 200kg/month
Order(MOQ): 25kg
Lead Time: 3 Working Days
Storage condition: Stored in cool, dry place, room temperature.
Package material: drum
Package size: 25kg/drum
Safety information:  Not dangerous goods

Rivaroxaban

Introduction

Rivaroxaban, is an anticoagulant medication (blood thinner). It use in adults with nonvalvular atrial fibrillation (except atrial fibrillation due to rheumatic valvular heart disease, and atrial fibrillation after heart valve replacement) to reduce the risk of stroke and systemic embolism.
Rivaroxaban, is used to treat and prevent blood clots.
Rivaroxaban, is used f for adult patients undergoing elective hip or knee replacement surgery to prevent venous thrombosis.

Specification (EP)

Item

Specification

Appearance

White or yellowish powder

Solubility

Practically insoluble in water, freely soluble in DMSO, practically insoluble in anhydrous ethanol and in heptanes.

Identification

IR: Spectrum should comply with the WS

 

HPLC-RT of sample under enantiometric purity test should comply with that of WS.

Water ≤0.5%

Sulphate ash

≤0.1%

Loss on drying

≤0.5%
Heavy metals ≤20ppm

Enantionmer

Impurity A: ≤0.4%

Residual solvent

Ethanol: ≤5000ppm

Ethyl acetate: ≤5000ppm

Acetone: ≤5000ppm

N,N-Dimethylformamide: ≤880ppm

Methylene chloride: ≤600ppm

Benzene: ≤2ppm

Related substance

Impurity B: ≤0.10%

Impurity D: ≤0.10%

Impurity E: ≤0.10%

Impurity F: ≤0.10%

Impurity G: ≤0.10%

Impurity H: ≤0.10%

Impurity I: ≤0.10%

Impurity J: ≤0.10%

RVB-4-NJSH: ≤0.10%

RVB-ZA: ≤0.10%

RVB-BAM: ≤0.10%

RVB-ZC: ≤0.10%

RVB-HBY: ≤75ppm

Any other unknown impurity: ≤0.10%

Total impurity: ≤0.3%

Particle size distribution

D10:/

D50:/

D90:/

Assay

(anhydrous substance)

98.0-102.0

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Good Quality Human API - Rivaroxaban 366789-02-8 Blood system protect Antithrombosis – Neore detail pictures


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