Description

Edoxaban Impurity A is a specified impurity of the anticoagulant drug Edoxaban, a direct Factor Xa inhibitor. This compound is critical for pharmaceutical research and development, serving as a key reference standard for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API). It is primarily required by analytical laboratories, quality control departments, and regulatory affairs teams within the pharmaceutical and biotechnology industries for method development, validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Edoxaban.
• Method Development & Validation: Essential for developing and validating analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control & Assurance: A critical tool for monitoring and controlling impurity levels during API synthesis and final drug product manufacturing to meet ICH guidelines.
• Regulatory Compliance & Submission: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity identification and quantification.
• Stability Studies: Employed in forced degradation and long-term stability studies to track impurity formation over time.
• Process Chemistry Research: Used by R&D scientists to understand and optimize synthesis pathways to minimize this specific impurity.

Basic Information

Product Name	Edoxaban Impurity A
CAS No.	1093351-29-1
Molecular Formula	C24H30ClN7O4S
Molecular Weight	548.06 g/mol
Synonyms	Edoxaban Related Compound A; Lixiana Impurity A; DU-176b Impurity A; N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-[(dimethylamino)carbonyl]-2-[[(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridin-2-yl)carbonyl]amino]cyclohexyl]ethanediamide; (1S,2R,4S)-4-(Dimethylcarbamoyl)-2-({[5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridin-2-yl]carbonyl}amino)-N-(5-chloropyridin-2-yl)cyclohexanecarboxamide; Edoxaban EP Impurity A; Edoxaban USP Impurity A
EINECS	Contact for details

Quality Control

Every batch of Edoxaban Impurity A is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Our quality commitment aligns with cGMP principles for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including identification (HPLC, MS), assay (HPLC), and impurity profile. Specifications are designed to meet or exceed the requirements of major pharmacopoeias (USP, EP).

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccant use.

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)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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