Apixaban 99% Purity Anticoagulant API Factor Xa Inhibitor CAS 503612-47-3 Pharmaceutical Grade EP USP Standard

Product Overview

Apixaban is a highly selective, reversible, direct inhibitor of blood coagulation factor Xa. It is an oral anticoagulant used for the prevention and treatment of various thromboembolic disorders. Unlike warfarin, which inhibits multiple coagulation factors and requires regular INR monitoring, apixaban selectively targets factor Xa, providing predictable anticoagulation with a lower risk of bleeding and fewer drug interactions.

Chemically, apixaban is 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide. It has a molecular formula of C₂₅H₂₅N₅O₄ and a molecular weight of 459.50 g/mol. Apixaban is a white to pale-yellow powder with very low aqueous solubility (approximately 0.04 mg/mL at physiological pH) but good bioavailability when administered orally.

Mechanism of Action

Apixaban exerts its anticoagulant effect through highly selective factor Xa inhibition:

• Direct Factor Xa Inhibition: Binds directly and reversibly to the active site of factor Xa, inhibiting both free and clot-bound factor Xa

• Thrombin Generation Inhibition: By inhibiting factor Xa, the key enzyme in the coagulation cascade that converts prothrombin to thrombin, apixaban reduces thrombin generation and subsequent fibrin formation

• No Effect on Platelets: Does not directly affect platelet aggregation, reducing the risk of bleeding complications

• Predictable Pharmacokinetics: Rapid oral absorption with peak plasma concentrations at 3-4 hours, approximately 50% absolute bioavailability, and a half-life of approximately 12 hours

Clinical Indications & Market Position

Apixaban is indicated for multiple therapeutic areas:

• Non-valvular Atrial Fibrillation: Reduction of risk of stroke and systemic embolism

• Deep Vein Thrombosis (DVT): Treatment and secondary prevention

• Pulmonary Embolism (PE): Treatment and prevention of recurrence

• Post-surgical Thromboprophylaxis: Prevention of DVT and PE following hip or knee replacement surgery

As one of the most widely prescribed oral anticoagulants globally, apixaban has gained significant market share due to its favorable efficacy and safety profile. The global apixaban market continues to grow driven by the increasing prevalence of atrial fibrillation and venous thromboembolism worldwide.

Quality Specifications

Our apixaban API meets strict pharmacopoeial standards:

• Complies with EP and USP monograph requirements

• Purity: ≥99.0% by HPLC

• Related substances: Total impurities ≤1.0%, single impurity ≤0.1%

• Residual solvents: Meet ICH Q3C guidelines

• Heavy metals: ≤10 ppm

• Loss on drying: ≤0.5%

• Residue on ignition: ≤0.1%

• Particle size: Customizable (D90 ≤ 50μm standard)

• Each batch released with full Certificate of Analysis (COA)

• GMP manufacturing with complete regulatory documentation

Packaging & Storage

• Packaging options: 25kg fiber drums with double PE liners, 5kg aluminum tins, 1kg aluminum foil bags

• Custom packaging: Available upon request for special requirements

• Storage conditions: Store in tightly sealed containers in a cool, dry place, protected from light

• Shelf life: 36 months under proper storage conditions

• Supply capacity: Tons per month, ensuring reliable supply for both large and small customers

• Regulatory support: DMF, CEP, and other regulatory filings available to support customer registrations