Description

Dronedarone n-Oxide CAS NO 1638586-56-7 is a key pharmaceutical intermediate and metabolite of the antiarrhythmic drug Dronedarone. This compound is of significant interest for research and development in the pharmaceutical industry, particularly in the study of drug metabolism, pharmacokinetics, and the synthesis of related active pharmaceutical ingredients (APIs). It is primarily utilized by pharmaceutical R&D laboratories, analytical service providers, and manufacturers engaged in the development and quality control of cardiovascular medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the qualitative and quantitative analysis of Dronedarone and its metabolites in drug substance and finished product testing.
• Metabolite Research: Critical for in-vitro and in-vivo studies investigating the metabolic pathways, bioavailability, and excretion profile of Dronedarone.
• Process Impurity Profiling: Used to identify, monitor, and control the n-Oxide derivative as a potential impurity during the synthesis and purification of Dronedarone API.
• Analytical Method Development: Essential for developing and validating sensitive HPLC, LC-MS, or GC-MS methods for pharmacokinetic studies and bioanalytical assays.
• Chemical Synthesis Intermediate: Acts as a building block or precursor in the research-scale synthesis of novel Dronedarone analogs or derivatives for new drug discovery programs.

Basic Information

Product Name	Dronedarone n-Oxide
CAS No.	1638586-56-7
Molecular Formula	C31H44N2O6S
Molecular Weight	572.76 g/mol
Synonyms	Dronedarone N-Oxide; Dronedarone Metabolite; N-Desbutyl Dronedarone N-Oxide; SR 33589 N-Oxide; 2-Butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-5-methylsulfonylbenzofuran N-Oxide; Benzofuran, 2-butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-5-(methylsulfonyl)-, N-oxide; Dronedarone Impurity (N-Oxide)
EINECS	Contact for details

Quality Control

Our Dronedarone n-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity assay by HPLC, and control of related substances and residual solvents. A Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment to ensure traceability and compliance with your research or quality standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

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)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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