Rivaroxaban 99% Purity Factor Xa Inhibitor CAS 366789-02-8 Anticoagulant API Pharmaceutical Grade

Product Overview

Rivaroxaban is an orally active, direct Factor Xa inhibitor used for the prevention and treatment of thromboembolic disorders. Marketed under the brand name Xarelto, rivaroxaban was the first oral direct Factor Xa inhibitor approved by the FDA in July 2011, representing a major advancement in anticoagulation therapy. By selectively inhibiting Factor Xa, a key enzyme in the blood coagulation cascade, rivaroxaban effectively prevents thrombin generation and clot formation. It offers significant advantages over traditional vitamin K antagonists, including predictable pharmacokinetics, rapid onset of action, and no need for routine coagulation monitoring.

Chemically, rivaroxaban is 5-chloro-N-({(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene-2-carboxamide with the molecular formula C₁₉H₁₈ClN₃O₅S and a molecular weight of 435.88 g/mol. It is a white to off-white crystalline powder with solubility in DMSO and DMF. The compound exhibits high selectivity for Factor Xa over other serine proteases and excellent oral bioavailability.

Mechanism of Action

Rivaroxaban exerts its anticoagulant effect through targeted inhibition of Factor Xa:

• Factor Xa Inhibition: Potently and selectively inhibits free and clot-bound Factor Xa, a critical enzyme at the convergence point of the intrinsic and extrinsic coagulation pathways

• Dose-dependent Anticoagulation: Produces predictable, dose-dependent prolongation of prothrombin time (PT) and activated partial thromboplastin time (aPTT)

• Rapid Onset: Peak plasma concentrations achieved within 2-4 hours of oral administration, providing fast anticoagulant effect

• Predictable Pharmacokinetics: High oral bioavailability (80-100%) with predictable absorption and elimination

• No Routine Monitoring: Unlike warfarin, no regular coagulation monitoring required due to predictable dose-response relationship

Research Applications & Market Significance

Rivaroxaban has revolutionized anticoagulation therapy across multiple indications:

• Deep Vein Thrombosis (DVT): Treatment and secondary prevention of deep vein thrombosis

• Pulmonary Embolism (PE): Treatment and secondary prevention of pulmonary embolism

• Atrial Fibrillation: Stroke prevention in non-valvular atrial fibrillation

• Orthopedic Surgery: Thromboprophylaxis following elective hip or knee replacement surgery

• Coronary Artery Disease: Secondary prevention in combination with antiplatelet therapy

• Peripheral Artery Disease: Emerging indications in peripheral artery disease

The global NOAC (Novel Oral Anticoagulant) market is expected to exceed $40 billion by 2028, driven by growing prevalence of atrial fibrillation and venous thromboembolism, and the shift away from warfarin. Rivaroxaban continues to be a market leader with one of the broadest indication portfolios among NOACs.

Quality Specifications

Our rivaroxaban is manufactured under strict GMP conditions and meets international pharmacopeia standards:

• Purity: ≥99.0% determined by HPLC

• Identity confirmed by NMR, mass spectrometry, and infrared spectroscopy

• Water content: ≤0.5%

• Residual solvents: Meet ICH Q3C guidelines

• Heavy metals: ≤10 ppm

• Related substances: Each impurity ≤0.1%, total impurities ≤0.5%

• Enantiomeric purity: ≥99.8% ee

• Residue on ignition: ≤0.1%

• Each batch accompanied by comprehensive Certificate of Analysis (COA)

• Stable for 36 months when stored at room temperature in sealed containers

Packaging & Shipping

We offer flexible packaging options to meet diverse customer needs:

• Small quantities: 1kg, 5kg aluminum foil bags

• Bulk quantities: 25kg fiber drums with PE liners

• Custom packaging available upon request

• GMP-grade packaging available for pharmaceutical customers

• Shipped at ambient temperature

• International shipping with proper documentation

• MSDS and COA provided with each shipment