Rivaroxaban API

CAS No: 366789-02-8
Appearance: White or off-white powder
Standard: in-house
Supply Ability: 500kg per month
Shelf Life: Two years
Payment: T/T, LC or DA
Delivery Time: Ready Stock
Origin: China
Shipping: DHL, FedEx, TNT, EMS, By Sea, By Air
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Product Introduction

We supply Rivaroxaban API

Our company is proud to offer the loftiest quality Rivaroxaban API. Our product is precisely manufactured to meet and exceed assiduity norms, icing its outstanding efficacity and safety for use in a variety of remedial operations. it is a well- known and largely effective oral anticoagulant, and our API is trusted by healthcare professionals worldwide. With our fidelity to delivering only the stylish products and support, you can always trust us to give dependable and harmonious results. communicate us moment to learn further about our products and how it can profit your operations.

 

What is Rivaroxaban API

Rivaroxaban is a new oral anticoagulant active pharmaceutical component, and it's a direct asset of Factor Xa. In cell-free trials, Ki and IC50 were0.4 nM and0.7 nM, independently. it has high selectivity towards mortal factor Xa, which is further than 10000 times further picky than other biologically affiliated serine proteases. Used for adult cases with non valvular atrial fibrillation( banning atrial fibrillation caused by rheumatic heart stopcock complaint and atrial fibrillation after heart stopcock relief surgery) to reduce the threat of stroke and systemic embolism.

 

Basic Information

Product Name: Rivaroxaban

CAS NO.: 366789-02-8

MF: C19H18ClN3O5S

MW: 435.88

EINECS No.: 685-132-2

MDL No.:MFCD11974010

Structural formula:

product-1-1

Purity: 99%+

Origin: China

Application: Anticoagulant drugs

Delivery Time: stock

Melting point: 228-229 ° C

Boiling point: 732.6 ± 60.0 ° C (Predicted)

Density: 1.460 ± 0.06g/cm3 (Predicted)

Solubility: insoluble in water; Insoluble in ethanol; ≥ 13.9mg/mL in DMSO under mild heating

 

Technical Specification:

Tests

Specifications

Results

Appearance

White to off-white powder

Complies

Identification

IR:Similar to reference substance

Complies

Retention time:Similar to reference substance

Complies

Polymorphic

XRD

Form I

Loss on drying

≤0.5%

0.17%

Residue on ignition

<0.1%

0.06%

Heavy Metals

≤0.002%

Complies

Impurity (by HPLC)

RV-3≤0.15%

0.02%

IM5≤0.15%

0.01%

IM4≤0.15%

Undetected

Des-Chloro-RV≤0.15%

0.01%

De-Carbonyl-RV≤0.15%

Undetected

3-Chloro-RV<0.15%

0.01%

RVM-3-1≤0.15%

0.01%

2,3-Dichloro-RV≤0.15%

Undetected

IM1≤0.15%

Undetected

Single impurity≤0.10%

0.06%

Total impurities≤1.0%

0.24%

Enantiomer

≤0.15%

200ppm

Residual solvents

Ethanol<5000ppm

Undetected

Diethyl ether≤5000ppm

720ppm

Ethyl acetate≤5000ppm

Undetected

Dichloromethane≤600ppm

Undetected

Tetrahydrofuran≤720ppm

Undetected

Toluene≤890ppm

Undetected

Triethylamine≤5000ppm

240ppm

DMF≤3000ppm

Undetected

Assay

98.0%~102.0%

99.8%

Particle size

D90≤20μm

Complies

The results above meet all requirements under Rivaroxaban in In-House Standard

Package: 100g;1kg; 25kg

Storage conditions: keep tightly closed, store in a cool dry place.

 

Drug action

Rivaroxaban API highly selectively and competitively inhibits free and bound Xa factors as well as prothrombin activity, prolonging activated partial thromboplastin time (PT) and prothrombin time (aPTT) in a dose-dependent manner. The essential difference between rivaroxaban and sulfamethoxazole/heparin is that it does not require the involvement of antithrombin III. can directly antagonize free and bound Xa factors, reduce the activation of thrombin, and thus prolong clotting time. It not only has a blocking effect on the formation of blood clots, but also can break the formed blood clots. During hip or knee replacement surgery, poor reflux of venous blood from the legs to the heart can easily lead to the formation of blood clots. it can help prevent the formation and further development of this blood clot.

 

what is the application of Rivaroxaban API

New anticoagulants were first used for thrombosis prevention after orthopedic surgeries, including total hip and knee replacement surgeries, and studies have reported that their effectiveness and safety are not inferior to those of low molecular weight heparin. Nowadays, new anticoagulants are gradually being widely used in the treatment of lower limb venous thrombosis and pulmonary embolism. In the latest diagnostic and treatment guidelines for acute pulmonary embolism developed by ESC in 2014, it was mentioned that new anticoagulants can replace traditional anticoagulant treatment methods as an emerging anticoagulant drug, and will gradually be promoted in high-risk cardiovascular diseases such as atrial fibrillation and acute coronary syndrome.

 

Purpose

Used for adult patients undergoing elective hip or knee replacement surgery to prevent venous thrombosis (VTE)

 

Indications

It has been approved for use in adult patients undergoing hip or knee replacement surgery to prevent venous thrombosis (VTE); And treat adult deep vein thrombosis (DVT) to reduce the risk of DVT recurrence and pulmonary embolism (PE) after acute DVT. Atrial fibrillation is a common arrhythmia in the , with a prevalence rate of up to 10% among people aged 75 and above. Patients with atrial fibrillation are prone to blood stasis in the atrium, leading to the formation of blood clots. The detachment of blood clots can lead to stroke. It has been approved and recommended for use in adult patients with non valvular atrial fibrillation to reduce the risk of stroke and systemic embolism.

 

Antithrombotic drugs

Rivaroxaban and dabigatran ester are currently the two most promising antithrombotic drugs. The essential difference between them and traditional antithrombotic drug heparin is that they do not require the involvement of antithrombin III and can directly antagonize free and bound Xa factors. Heparin, on the other hand, requires the presence of antithrombin III to function, and the Xa factor in the prothrombin complex is ineffective. These two new types of oral anticoagulants are hailed by the medical community as a significant advancement in the fields of anticoagulant therapy and potential lethal thrombus prevention, and will become a new milestone in the development history of cardiovascular drugs. Rivaroxaban was jointly developed by Bayer Pharmaceuticals in Germany and Johnson&Johnson in the United States. In October 2008, it was approved for sale in Canada and the European Union under the trade name Xarelto. It is the world's first oral direct Xa factor inhibitor, which can selectively and competitively inhibit free and bound Xa factors as well as prothrombin activity. It prolongs the activated partial thromboplastin time plate (PT) and prothrombin time (aPTT) in a dose-dependent manner, thereby prolonging clotting time and reducing thrombin formation. It has the characteristics of high bioavailability, wide spectrum of disease treatment, stable dose-response relationship, oral formula stool, and low risk of bleeding. it is also a medication for preventing and treating venous thrombosis. Clinically, it is mainly used to prevent the formation of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients after hip and knee joint replacement surgery. It can also be used to prevent stroke and non central nervous system embolism in patients with non valvular atrial fibrillation, reduce the risk of recurrence of coronary syndrome, and so on. Dabigatran is a novel anticoagulant drug with various characteristics developed by the German company Boehringer Ingelheim. In April 2008, it was first launched in Germany and the United Kingdom under the trade name Pradaxa. This is the first anticoagulant oral new drug to be launched in 50 years after warfarin, marking another milestone in the field of anticoagulant therapy and potential lethal thromboprophylaxis. Dabigatran ester is a novel synthetic direct thrombin inhibitor, which is a precursor drug for oral administration and belongs to non peptide thrombin inhibitors. After oral absorption through the gastrointestinal tract, it is converted into dabigatran ester with direct anticoagulant activity in the body. The drug binds to the fibrin specific binding site of thrombin, preventing fibrinogen from breaking down into fibrin, thereby blocking the final step of the coagulation cascade network and thrombus formation.

 

In conclusion

To sum up, Xi 'an Yihui Company as a professional manufacturer of Rivaroxaban API, with high-quality products, high level of research and development capabilities, advanced production equipment and technology, perfect after-sales service and other advantages, is the customer choice of the ideal partner.

if you need it, pls feel free to contact us any time. we will reply you ASAP.

Our contact information:

E-mail: sales@yihuipharm.com
Tel: 0086-29-89695240
WeChat or WhatsApp: 0086-17792415937

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