Description

Betrixaban is a highly selective, direct-acting oral anticoagulant (DOAC) that functions as a potent and reversible inhibitor of Factor Xa. This targeted mechanism of action makes it a critical active pharmaceutical ingredient (API) for the development of next-generation antithrombotic therapies. It is primarily utilized by pharmaceutical manufacturers and research institutions engaged in the formulation of novel anticoagulant medications for the prevention and treatment of thromboembolic disorders.

Application

• Pharmaceutical API: Primary use as the active ingredient in the commercial production of finished dosage forms, specifically oral anticoagulant tablets or capsules.
• Clinical Research: Serves as a reference standard and key material in preclinical and clinical studies investigating new anticoagulant protocols and combination therapies.
• Formulation Development: Used in R&D laboratories for developing and optimizing solid dosage formulations, including stability testing and bioavailability enhancement.
• Generic Drug Manufacturing: Essential for companies producing generic versions of betrixaban-based medications upon patent expiry, ensuring therapeutic equivalence.
• Analytical Standard: Employed as a high-purity standard in quality control laboratories for HPLC, LC-MS, and other analytical methods to assay drug products and raw materials.

Basic Information

Product Name	Betrixaban
CAS No.	330942-05-7
Molecular Formula	C23H22ClN5O3
Molecular Weight	451.90 g/mol
Synonyms	PRT054021; BMS-562247; N-(5-Chloropyridin-2-yl)-2-[4-(N,N-dimethylcarbamimidoyl)benzamido]-5-methoxybenzamide; Betrixabanum; UNII-7K5K3L0T8I
EINECS	Contact for details

Quality Control

Our Betrixaban is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, suitable for pharmaceutical applications. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting results for assay, related substances, residual solvents, and other critical parameters.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with 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.