Description

Edoxaban is a highly selective, direct-acting oral anticoagulant (DOAC) that specifically inhibits Factor Xa, a key enzyme in the blood coagulation cascade. This targeted mechanism of action makes it a critical active pharmaceutical ingredient (API) for the formulation of modern antithrombotic medications. It is primarily required by global pharmaceutical manufacturers for the production of finished dosage forms used in the prevention and treatment of conditions such as stroke and systemic embolism in patients with non-valvular atrial fibrillation, and for the treatment of venous thromboembolism.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of oral anticoagulant tablets (e.g., Savaysa/Lixiana).
• Stroke Prevention: Formulation into medications for reducing the risk of stroke and systemic embolism in patients with atrial fibrillation.
• Venous Thromboembolism (VTE) Treatment: Used in drugs for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
• Post-Surgical Prophylaxis: Potential application in formulations for preventing blood clots after orthopedic surgeries like hip or knee replacement.
• Research & Development: Serves as a reference standard and key intermediate in pharmacological research for new anticoagulant therapies.
• Generic Drug Manufacturing: Essential for companies developing bioequivalent generic versions of branded edoxaban products.

Basic Information

Product Name	Edoxaban
CAS No.	912273-65-5
Molecular Formula	C24H30ClN7O4S
Molecular Weight	548.06 g/mol
Synonyms	DU-176b; Lixiana (Trade Name); Savaysa (Trade Name); Edoxaban Tosylate; N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-[(dimethylamino)carbonyl]-2-[[(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridin-2-yl)carbonyl]amino]cyclohexyl]ethanediamide; Factor Xa Inhibitor DU-176b; 1-(N-((5-Chloropyridin-2-yl)carbamoyl)-2-((5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridin-2-yl)formamido)cyclohex-3-enecarboxamido)cyclopropanecarboxylic acid
EINECS	Contact for details

Quality Control

Our Edoxaban is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH guidelines. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with agreed-upon specifications for pharmaceutical use.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Loss on Drying	≤ 1.0%
Specific Rotation	Contact for details

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.