Description

Edoxaban Impurity 16 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the analytical characterization and quality control of the anticoagulant drug Edoxaban, ensuring product safety and regulatory compliance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, impurity profiling, and stability studies. Supplied with comprehensive analytical data, it supports the stringent requirements of modern pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantification and identification of Edoxaban Impurity 16 in active pharmaceutical ingredient (API) and finished drug product batches.
• Analytical Method Development and Validation: Used to develop, optimize, and validate sensitive HPLC, UPLC, or LC-MS methods for impurity detection in compliance with ICH Q2(R1) and Q3A/B guidelines.
• Quality Control and Assurance (QC/QA): Essential for routine quality control testing to monitor impurity levels and ensure the final drug product meets specified purity criteria.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to track the formation of this specific impurity under various stress conditions.
• Regulatory Submissions: Provides necessary impurity data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the drug substance's impurity profile.
• Research and Development: Used in synthetic chemistry R&D to study degradation pathways and to develop purification processes that minimize this impurity.

Basic Information

Product Name	Edoxaban Impurity 16
CAS No.	480450-69-9
Molecular Formula	C24H30ClN7O4
Molecular Weight	516.00 g/mol
Synonyms	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; Edoxaban Related Compound 16; Edoxaban EP Impurity G; Edoxaban USP Impurity 16; UNII-6W7Q4W6A1I; 6W7Q4W6A1I; Edoxaban Degradant; Edoxaban Process Impurity.
EINECS	Contact for details

Quality Control

Every batch of Edoxaban Impurity 16 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques (HPLC, LC-MS, NMR) to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

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. The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment.

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)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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