Description

Edoxaban impurity 9/N1-(5-Chloro-2-pyridinyl)-N2-[(1S,2R,4S)-4-[(methylamino)carbonyl]-2-[[(4,5,6,7-tetrahydro-5-methylthiazolo[5,4-c]pyridin-2-yl)carbonyl]amino]cyclohexyl]ethanediamide is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity in the quality control and regulatory compliance of the anticoagulant active pharmaceutical ingredient (API), Edoxaban. It is essential for analytical method development, validation, and ensuring batch-to-batch consistency in API manufacturing. Pharmaceutical companies, contract research organizations (CROs), and quality control laboratories require this standard to meet stringent pharmacopeial and ICH guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Edoxaban-related substances.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles in Edoxaban API.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing of Edoxaban to ensure compliance with ICH Q3A(R2) and pharmacopeial limits for impurities.
• Regulatory Submissions: Supports the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory filings (e.g., FDA, EMA).
• Stability Studies: Employed to track the formation of degradation products in Edoxaban formulations under various stress conditions.
• Process Chemistry Research: Used to study and optimize synthetic pathways for Edoxaban, helping to minimize the formation of this specific impurity.

Basic Information

Product Name	Edoxaban impurity 9/N1-(5-Chloro-2-pyridinyl)-N2-[(1S,2R,4S)-4-[(methylamino)carbonyl]-2-[[(4,5,6,7-tetrahydro-5-methylthiazolo[5,4-c]pyridin-2-yl)carbonyl]amino]cyclohexyl]ethanediamide
CAS No.	740794-83-6
Molecular Formula	C25H30ClN7O4S
Molecular Weight	560.07 g/mol
Synonyms	Edoxaban Related Compound 9; Edoxaban Impurity 9; Lixiana Impurity 9; Savaysa Impurity 9; DU-176b Impurity; (1S,2R,4S)-4-(Methylcarbamoyl)-2-({[5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridine-2-carbonyl]}amino)cyclohexyl 2-[(5-chloropyridin-2-yl)amino]-2-oxoacetate; N1-(5-Chloro-2-pyridinyl)-N2-[(1S,2R,4S)-4-[(methylamino)carbonyl]-2-[[(4,5,6,7-tetrahydro-5-methylthiazolo[5,4-c]pyridin-2-yl)carbonyl]amino]cyclohexyl]ethanediamide
EINECS	Contact for details

Quality Control

Our Edoxaban impurity 9 is manufactured under GMP-compliant conditions and undergoes rigorous analytical characterization to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from multiple orthogonal techniques, including HPLC, LC-MS, NMR, and IR. The quality system is designed to meet the stringent requirements for pharmaceutical reference standards, supporting compliance with ICH guidelines and global regulatory expectations.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature of 15-25°C. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccation.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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