Description

Edoxaban Impurity 11 (1R,2R,4S) is a specific stereoisomeric impurity associated with the anticoagulant active pharmaceutical ingredient (API) Edoxaban. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method development, validation, and quality control. It is essential for manufacturers, analytical laboratories, and regulatory bodies focused on ensuring the purity, safety, and efficacy of Edoxaban-based drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a high-purity certified reference material (CRM) for the identification and quantification of impurities in Edoxaban API and finished dosage forms.
• Analytical Method Development: Critical for developing and optimizing chromatographic methods (e.g., HPLC, UPLC) to separate and accurately measure this specific stereoisomer.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity profiles and ensure compliance with strict pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation and levels of this impurity during forced degradation and long-term stability testing of Edoxaban formulations.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Edoxaban to minimize the formation of this impurity.

Basic Information

Product Name	Edoxaban Impurity 11 (1R,2R,4S)
CAS No.	480451-98-7
Molecular Formula	C24H30ClN7O4S
Molecular Weight	548.06 g/mol
Synonyms	Edoxaban Related Compound 11; (1R,2R,4S)-Isomer of Edoxaban Impurity; 5-Chloro-N-(((5S)-2-oxo-3-(4-(3-oxomorpholino)phenyl)-1,3-oxazolidin-5-yl)methyl)thiophene-2-carboxamide (1R,2R,4S)-Isomer; Lixiana Impurity 11; Savaysa Impurity 11; DU-176b Impurity 11; (1R,2R,4S)-Edoxaban Stereoisomer
EINECS	Contact for details

Quality Control

Our Edoxaban Impurity 11 (1R,2R,4S) is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and strength. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques including HPLC, NMR, and MS. We support compliance with ICH guidelines and can provide materials suitable for use in regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

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 individual unknown 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.