Description

Edoxaban Impurity 28 (1R,2R,4R) 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 material for analytical method development, validation, and quality control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Edoxaban-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Edoxaban Impurity 28 in API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Critical for routine batch testing to ensure compliance with ICH Q3A/B guidelines and regulatory specifications.
• Stability Studies: Employed to track the formation of this impurity under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Used to study and optimize synthetic pathways to minimize the formation of this stereoisomeric impurity.

Basic Information

Product Name	Edoxaban Impurity 28 (1R,2R,4R)
CAS No.	1255529-38-4
Molecular Formula	C24H30ClN7O4S
Molecular Weight	548.06 g/mol
Synonyms	Edoxaban Related Compound 28; (1R,2R,4R)-Isomer of Edoxaban Impurity; N-(5-Chloropyridin-2-yl)-N'-[(1R,2R,4R)-4-[[(5-chlorothiophen-2-yl)carbonyl]amino]-2-(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl]oxamide; Lixiana Impurity 28; Savaysa Impurity 28; DU-176b Impurity 28; (1R,2R,4R)-Edoxaban Impurity
EINECS	Contact for details

Quality Control

This high-purity reference material is manufactured under strict quality control conditions. Each batch is characterized and qualified using advanced analytical techniques including HPLC, LC-MS, NMR, and chiral analysis to confirm identity, purity, and stereochemical integrity. Our quality system is designed to support GMP/GLP-compliant applications. Comprehensive Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under inert atmosphere.

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, Area %)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Chiral Purity (Chiral HPLC)	≥ 99.0% (1R,2R,4R isomer)
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.