Description

Edoxaban Tosylate Monohydrate is the tosylate salt monohydrate form of Edoxaban, a highly selective, direct, and reversible inhibitor of Factor Xa. This active pharmaceutical ingredient (API) is critical for the formulation of anticoagulant medications used to prevent and treat thromboembolic disorders. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of novel oral anticoagulants (NOACs) and generic drugs.

Application

• Pharmaceutical API: Primary use as the active ingredient in the commercial production of anticoagulant tablets (e.g., Savaysa/Lixiana).
• Generic Drug Formulation: Serves as a key component for generic pharmaceutical companies developing bioequivalent versions of Edoxaban-based medications.
• Research & Development: Utilized in preclinical and clinical studies for investigating new therapeutic applications of Factor Xa inhibition.
• Dosage Form Development: Employed in the R&D of various solid oral dosage forms, including stability studies and excipient compatibility testing.
• Reference Standard: Can be used as a high-purity chemical reference standard in analytical laboratories for quality control and method validation.

Basic Information

Product Name	Edoxaban Tosylate Monohydrate
CAS No.	1229194-11-9
Molecular Formula	C₂₉H₃₃ClN₇O₇S
Molecular Weight	667.13 g/mol
Synonyms	Edoxaban p-Toluenesulfonate Monohydrate; 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 Monohydrate; DU-176b Tosylate Monohydrate; Lixiana Tosylate Monohydrate; Savaysa Tosylate Monohydrate; Edoxaban Tosylate Hydrate; Edoxaban Monotosylate Monohydrate
EINECS	Contact for details

Quality Control

Our Edoxaban Tosylate Monohydrate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for pharmaceutical use, including identity, purity, and impurity profile. Certificates of Analysis (COA) detailing results from tests such as HPLC assay, chiral purity, residual solvents, and water content (KF) are provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	2.0% - 4.0%
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	NMT 20 ppm
Specific Rotation	Contact for details

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