Description

Edoxaban Impurity 24 (1S,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 processes. 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 reference material (CRM) for the identification and quantification of impurities in Edoxaban API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to separate and detect process-related impurities.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity profiles and ensure compliance with ICH Q3A/B guidelines and regulatory specifications.
• Stability Studies: Used to track the formation of degradation products under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary 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 specific stereoisomer.

Basic Information

Product Name	Edoxaban Impurity 24 (1S,2S,4R)
CAS No.	2024614-21-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(1S,2S,4R)-4-[(5-Chloro-2-pyridinyl)amino]-2-[(5-methyl-2-oxo-1,3-dioxol-4-yl)methyl]-1-piperidinecarboxylic acid, 1,1-Dimethylethyl ester; Edoxaban Related Compound 24; Edoxaban Stereoisomer Impurity; Edoxaban EP Impurity G; Edoxaban USP Impurity; Lixiana Impurity; DU-176b Impurity; Contact for additional synonyms.
EINECS	Contact for details

Quality Control

Every batch of Edoxaban Impurity 24 (1S,2S,4R) is manufactured and handled under strict quality management systems. The product undergoes comprehensive analytical testing, including advanced chromatographic and spectroscopic techniques, to confirm identity, purity, and strength. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results against stringent in-house specifications aligned with ICH guidelines. Our quality commitment ensures material suitable for GMP-regulated pharmaceutical analysis.

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) and must be kept under inert conditions or in a desiccator after opening to maintain stability and purity.

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 unspecified impurity ≤ 0.5%
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.