Description

Betrixaban Impurity 1 CAS NO 1616693-59-4 is a high-purity chemical reference standard specifically identified as a process-related impurity of the anticoagulant drug Betrixaban. This compound is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of impurities to ensure drug safety and efficacy. It is an essential material for analytical laboratories, quality control departments, and regulatory affairs teams within the global pharmaceutical and biotechnology sectors.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of Betrixaban Impurity 1 during drug substance and drug product analysis.
• Method Development and Validation: Serves as a critical component in developing and validating robust analytical methods, such as HPLC and LC-MS, for impurity detection.
• Quality Control and Assurance: Essential for routine quality control testing in pharmaceutical manufacturing to monitor impurity levels and ensure batch-to-batch consistency.
• Regulatory Compliance and Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data required for drug approval.
• Stability Studies: Employed in forced degradation and long-term stability studies of Betrixaban to understand impurity formation pathways.
• Research and Development: Used in synthetic chemistry R&D to study the formation and fate of this impurity during the Betrixaban manufacturing process.

Basic Information

Product Name	Betrixaban Impurity 1
CAS No.	1616693-59-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Betrixaban Related Compound 1; Betrixaban Impurity; Betrixaban EP Impurity; Betrixaban USP Impurity; N-(5-Chloropyridin-2-yl)-2-(4-(N,N-dimethylcarbamimidoyl)benzamido)-5-methoxybenzamide (Tentative); 1616693-59-4; UNII-Contact for details
EINECS	Contact for details

Quality Control

Our Betrixaban Impurity 1 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assessment and structural confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and analytical methods is provided with every shipment to support your quality and regulatory requirements.

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 desiccated environment to maintain stability and purity. Handle and store under inert conditions if specified.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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