Description

n-Desmethyl Edoxaban is a key pharmaceutical intermediate and metabolite of the direct oral anticoagulant Edoxaban. This compound is of critical importance for research and development in the pharmaceutical industry, particularly for analytical method development, pharmacokinetic studies, and impurity profiling. It is primarily utilized by pharmaceutical companies, contract research organizations (CROs), and academic research institutions focused on cardiovascular drug development and quality control.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantitative and qualitative analysis of Edoxaban and its related substances in drug substances and finished products.
• Metabolite Studies: Used in preclinical and clinical research to study the metabolism, pharmacokinetics, and pharmacodynamics of Edoxaban.
• Impurity Profiling & Control: Essential for identifying, characterizing, and controlling process-related impurities and degradation products in Edoxaban API manufacturing, ensuring compliance with ICH guidelines.
• Bioanalytical Method Development: A critical component in developing and validating sensitive HPLC, LC-MS, or LC-MS/MS methods for the detection of Edoxaban and its metabolites in biological matrices.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on drug metabolism and impurity qualification.
• Stability Testing: Employed as a marker in forced degradation and long-term stability studies of Edoxaban formulations.

Basic Information

Product Name	n-Desmethyl Edoxaban
CAS No.	778571-11-2
Molecular Formula	C23H28ClN7O4S
Molecular Weight	534.04 g/mol
Synonyms	Edoxaban Impurity; Edoxaban Metabolite M-4; Edoxaban Related Compound; N-Desmethyl Edoxaban; 1-(4-Carbamimidoylbenzyl)-5-chloro-N-((5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl)-1H-indole-3-carboxamide; DU-176b Metabolite; Lixiana Impurity
EINECS	Contact for details

Quality Control

Our n-Desmethyl Edoxaban is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, LC-MS for identity confirmation, and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical research and development. A detailed Certificate of Analysis (COA) with batch-specific data is provided with every shipment.

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 should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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