Description

Edoxaban Impurity 40 is a high-purity chemical reference standard used in the analytical profiling of the anticoagulant drug Edoxaban. This compound is critical for pharmaceutical research and development, enabling the identification, quantification, and control of specific impurities during drug substance manufacturing. It is an essential material for quality assurance laboratories, regulatory compliance, and method validation within the global pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for impurity identification and quantification in Edoxaban API and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate stability-indicating HPLC/UPLC methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for setting impurity acceptance criteria in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Employed to monitor the formation and levels of this specific impurity under various forced degradation and long-term storage conditions.
• Pharmacopoeial Testing: Supports testing to meet the standards of pharmacopoeias such as USP, EP, or JP where applicable.

Basic Information

Product Name	Edoxaban Impurity 40
CAS No.	2081883-52-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Edoxaban Related Compound 40; Edoxaban Impurity J; Edoxaban EP Impurity J; Edoxaban USP Impurity; N-(5-Chloropyridin-2-yl)-2-((4-(N-((5-chloropyridin-2-yl)carbamoyl)carbamimidoyl)benzyl)oxy)benzamide (possible structural descriptor); Lixiana Impurity 40; Savaysa Impurity 40; DU-176b Impurity.
EINECS	Contact for details

Quality Control

Every batch of Edoxaban Impurity 40 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and must be handled in a dry environment to maintain stability and purity. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
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.