Description

Edoxaban Impurity 20 (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 involved in 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 qualitative and quantitative analysis.
• Analytical Method Development: Used to develop and optimize chromatographic methods (e.g., HPLC, UPLC) for impurity profiling of Edoxaban API.
• Quality Control & Assurance: Critical for routine batch testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Employed to identify and quantify degradation products in forced degradation and long-term stability studies of Edoxaban formulations.
• Pharmacopoeial Testing: Used in testing to meet monograph specifications for Edoxaban in pharmacopoeias such as USP or EP.

Basic Information

Product Name	Edoxaban Impurity 20 (1R,2R,4S)
CAS No.	1928729-31-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Edoxaban Related Compound 20; (1R,2R,4S)-Isomer of Edoxaban Impurity; Edoxaban Stereoisomer Impurity; Lixiana Impurity 20; DU-176b Impurity 20; (1R,2R,4S)-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
EINECS	Contact for details

Quality Control

Our Edoxaban Impurity 20 (1R,2R,4S) is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure high purity and accurate characterization. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profile is provided with every shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept in a desiccated environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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