Description

Edoxaban Tosylate CAS NO 480449-71-6 is the tosylate salt form of Edoxaban, a highly selective, direct, and reversible inhibitor of coagulation factor Xa (FXa). This active pharmaceutical ingredient (API) is critical for the development and manufacturing of oral anticoagulant medications. It is primarily required by pharmaceutical companies and research institutions engaged in the production of novel anticoagulant therapies for the prevention and treatment of thromboembolic disorders.

Application

• Pharmaceutical API: Primary raw material for the formulation of finished dosage forms, specifically oral anticoagulant tablets.
• Anticoagulant Drug Development: Key intermediate in R&D for next-generation Factor Xa inhibitor drugs.
• Clinical Research: Used as a reference standard in pharmacokinetic, pharmacodynamic, and bioequivalence studies.
• Generic Drug Manufacturing: Serves as the core API for producing generic versions of Edoxaban-based medications post-patent expiry.
• Analytical Testing: Employed as a high-purity standard in quality control laboratories for HPLC and other chromatographic assays.

Basic Information

Product Name	Edoxaban Tosylate
CAS No.	480449-71-6
Molecular Formula	C₂₄H₃₀ClN₇O₄S • C₇H₈O₃S
Molecular Weight	738.26 g/mol
Synonyms	Edoxaban p-Toluenesulfonate; Edoxaban Tosylate Monohydrate; DU-176b Tosylate; Lixiana Tosylate; Savaysa 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 p-Toluenesulfonate; 1-(5-Chloro-2-pyridinyl)-N-[(1S,2R,4S)-4-[(dimethylamino)carbonyl]-2-[[[(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridin-2-yl)carbonyl]amino]methyl]cyclohexyl]-1H-pyrazole-5-carboxamide 4-Methylbenzenesulfonate
EINECS	Contact for details

Quality Control

Our Edoxaban Tosylate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity pharmaceutical grade specifications, including identity, potency, and impurity profile verification. A Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and other critical parameters is provided with every shipment to ensure full traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a low-humidity environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Heavy Metals	≤ 20 ppm

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