Description

Edoxaban Impurity 41 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the anticoagulant drug Edoxaban. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification, quantification, and control of process-related impurities. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing, particularly for those working on novel oral anticoagulants (NOACs).

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the qualitative and quantitative analysis of Edoxaban and its related substances.
• Method Development and Validation: Critical for developing and validating robust analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control (QC) Testing: Used in routine QC laboratories to monitor and control impurity levels in Edoxaban active pharmaceutical ingredient (API) and finished dosage forms to meet ICH guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive characterization data for specified impurities.
• Stability Studies: Employed to track the formation of degradation products in Edoxaban formulations under various stress conditions.
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthesis pathway of Edoxaban to minimize the formation of this specific impurity.

Basic Information

Product Name	Edoxaban Impurity 41
CAS No.	1353893-25-0
Molecular Formula	C24H30ClN7O4
Molecular Weight	515.99 g/mol
Synonyms	Edoxaban Related Compound 41; N-[(1S,2R,4S)-4-[(Dimethylamino)carbonyl]-2-[[5-(4,5-dihydro-2-oxazolyl)-2-methoxyphenyl]amino]cyclohexyl]-N5-(pyrimidin-2-yl)-2,5-thiophenedicarboxamide; Edoxaban Impurity; LCI-14741; UNII-5J6VY6I8Q4; Edoxaban EP Impurity I; Edoxaban USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Edoxaban Impurity 41 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profiles.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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