Description

Edoxaban Impurity 39 is a high-purity chemical reference standard specifically identified as a process-related impurity of the anticoagulant drug Edoxaban. This compound is critical for pharmaceutical research, development, and quality control, ensuring the safety and efficacy of the final drug product. It is primarily used by analytical chemists and quality assurance professionals in pharmaceutical companies and contract research organizations (CROs) for method development, validation, and routine batch testing.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material to identify and quantify this specific impurity in Edoxaban active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating stability-indicating HPLC or UPLC methods in compliance with ICH guidelines.
• Quality Control and Batch Release Testing: Essential for establishing impurity limits and conducting routine quality control to ensure drug substance and product meet stringent pharmacopeial specifications.
• Stability Studies: Employed to monitor the formation of this impurity over time under various stress conditions (e.g., heat, humidity, light) as part of drug stability programs.
• Regulatory Submissions: Provides necessary data on impurity identity and levels for regulatory filings (e.g., FDA, EMA) to support drug approval.
• Process Chemistry Research: Aids chemists in understanding and optimizing the Edoxaban synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Edoxaban Impurity 39
CAS No.	2081883-55-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Edoxaban Related Compound 39; Edoxaban EP Impurity G; Edoxaban USP Impurity; N-[5-Chloro-2-(2H-tetrazol-5-yl)phenyl]-4-(ethoxymethyl)-5-methyl-2-oxo-1-[4-(trifluoromethyl)phenyl]-1,2-dihydropyridine-3-carboxamide; Edoxaban Process Impurity; Lixiana Impurity; Savaysa Impurity
EINECS	Contact for details

Quality Control

Every batch of Edoxaban Impurity 39 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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