Description

Edoxaban Impurity 1 is a designated reference standard used in the analytical profiling and quality control of the anticoagulant active pharmaceutical ingredient (API), Edoxaban. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in the development and validation of chromatographic methods for impurity identification and quantification.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Edoxaban API and its finished dosage forms.
• Method Development & Validation: Essential for developing, validating, and transferring robust HPLC/UPLC methods in quality control laboratories.
• Stability Studies: Used to monitor the formation of this specific impurity during forced degradation and long-term stability studies of Edoxaban.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Research & Development: Employed in synthetic route optimization and impurity fate mapping during the process development of Edoxaban.
• Quality Assurance/Control (QA/QC): Used as a system suitability and identification marker in the routine batch release testing of Edoxaban.

Basic Information

Product Name	Edoxaban Impurity 1
CAS No.	41374-72-5
Molecular Formula	C24H30ClN7O4
Molecular Weight	515.99 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 A; Edoxaban EP Impurity A; Edoxaban USP Impurity A; DU-176b Impurity; Lixiana Impurity; Savaysa Impurity
EINECS	Contact for details

Quality Control

Every batch of Edoxaban Impurity 1 is manufactured and handled under strict quality management systems. The material undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

Specification

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

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