Description

Edoxaban Impurity 23 is a high-purity chemical reference standard used in the analytical profiling and quality control of the anticoagulant active pharmaceutical ingredient (API), Edoxaban. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is primarily utilized in research and development, method validation, and routine quality testing within the pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific process-related impurities in Edoxaban API.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing of Edoxaban drug substances and finished products to meet ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing impurity characterization data for health authorities like the FDA and EMA.
• Stability Studies: Employed to monitor the formation and levels of this impurity under various stress conditions and throughout the drug product's shelf life.
• Chemical Research: Used in academic and industrial research to study the degradation pathways and synthesis by-products of Edoxaban.

Basic Information

Product Name	Edoxaban Impurity 23
CAS No.	1700085-03-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Edoxaban Related Compound 23; Edoxaban Impurity K; Edoxaban EP Impurity K; Edoxaban USP Impurity; 1-(4-(Aminomethyl)phenyl)-N-(5-chloro-2-pyridinyl)-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide impurity; Lixiana Impurity; Savaysa Impurity; DU-176b Impurity
EINECS	Contact for details

Quality Control

Our Edoxaban Impurity 23 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques like HPLC, LC-MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, impurity profile, and analytical results. We support compliance with ICH Q3A/B, USP, and EP guidelines.

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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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