Description

Edoxaban-D6 is a deuterium-labeled isotopologue of the direct oral anticoagulant Edoxaban, serving as a critical internal standard for precise bioanalytical quantification. Its primary value lies in enabling accurate and reliable pharmacokinetic and metabolic studies through mass spectrometry, ensuring data integrity in drug development and clinical research. This high-purity reference material is essential for pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory agencies involved in the analysis of Edoxaban.

Application

• Internal Standard for LC-MS/MS: Used as a stable, non-interfering internal standard for the quantitative bioanalysis of Edoxaban in biological matrices (plasma, serum, urine).
• Pharmacokinetic (PK) Studies: Enables precise measurement of drug concentration-time profiles to determine absorption, distribution, metabolism, and excretion (ADME) parameters.
• Metabolite Identification and Profiling: Assists in the identification and quantification of Edoxaban metabolites in in vitro and in vivo studies.
• Method Development and Validation: Critical for developing, optimizing, and validating robust analytical methods in compliance with GLP and GCP guidelines.
• Clinical Trial Support: Provides reliable quantification for therapeutic drug monitoring and efficacy/safety assessments during clinical trials.
• Quality Control in Manufacturing: Can be utilized in quality control laboratories to ensure the specificity and accuracy of analytical procedures for the active pharmaceutical ingredient (API).

Basic Information

Item	Detail
Product Name	Edoxaban-D6
CAS No.	1304701-57-2
Molecular Formula	C24H24D6ClN7O4
Molecular Weight	Approx. 516.0 g/mol
Synonyms	Edoxaban-d6; Lixiana-d6; Savaysa-d6; DU-176b-d6; N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-[(dimethylamino-d6)carbonyl]-2-[[(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridin-2-yl)carbonyl]amino]cyclohexyl]ethanediamide; (1S,2R,4S)-4-[(Dimethyl-d6-amino)carbonyl]-N-(5-chloro-2-pyridinyl)-N2-[(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridin-2-yl)carbonyl]-1,2-cyclohexanedicarboxamide
EINECS	Contact for details

Quality Control

Our Edoxaban-D6 is manufactured under strict quality systems to ensure the highest standards of purity and isotopic enrichment, suitable for sensitive analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for identity, purity (by HPLC), chemical purity, isotopic purity (D-enrichment), and residual solvents. We support compliance with cGMP and ISO 9001 standards, and specifications can be tailored to meet specific pharmacopeial or client requirements.

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); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98.0 atom % D
Chemical Purity (HPLC)	≥ 99.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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