Description

Edoxaban Impurity 26 (1R,2S,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 key reference standard for analytical method development, validation, and quality control. It is primarily used by analytical chemists, quality assurance professionals, and regulatory affairs specialists in the pharmaceutical industry to ensure the purity, safety, and efficacy of Edoxaban-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Edoxaban API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure compliance with strict pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., FDA, EMA) to support drug approval.
• 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 26 (1R,2S,4R)
CAS No.	1255529-33-9
Molecular Formula	C24H30ClN7O4S
Molecular Weight	548.06 g/mol
Synonyms	(1R,2S,4R)-4-[(5-Chloro-2-pyridinyl)amino]-2-[[(5S)-6,7-dihydro-5H-thieno[3,2-c]pyridin-5-yl]carbonyl]-1-(2-hydroxyethyl)-N-(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridin-2-yl)-1H-imidazole-5-carboxamide; Edoxaban Related Compound 26; Edoxaban Stereoisomer Impurity; Lixiana Impurity 26; Savaysa Impurity 26; DU-176b Impurity 26; (1R,2S,4R)-Isomer of Edoxaban Impurity
EINECS	Contact for details

Quality Control

Our Edoxaban Impurity 26 (1R,2S,4R) is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity, chiral purity, and structural confirmation (NMR, MS) to ensure identity and potency. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary reference standards. Our quality commitment aligns with ICH Q3A/B, USP General Chapter <1086>, and cGMP guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, in a dry environment. This material is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC, Area %)	≥ 98.0%
Chiral Purity (Chiral HPLC)	≥ 99.0% (1R,2S,4R isomer)
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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