Description

Dronedarone Hydrochloride CAS NO 141625-93-6 is a high-purity pharmaceutical active ingredient, a benzofuran derivative developed as an antiarrhythmic agent. It is a critical intermediate and reference standard for the research, development, and quality control of cardiovascular medications. This compound is primarily utilized by pharmaceutical manufacturers, research institutions, and analytical laboratories engaged in the production and study of novel antiarrhythmic therapies.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the active pharmaceutical ingredient in the formulation of antiarrhythmic drugs for the treatment of atrial fibrillation and atrial flutter.
• Reference Standard: Serves as a certified reference material (CRM) for analytical method development, validation, and quality control testing in pharmaceutical laboratories.
• Research & Development: Used in preclinical and clinical research to study its pharmacokinetics, pharmacodynamics, and mechanism of action as a multi-channel blocker.
• Process Development: Employed as a key intermediate in the development and optimization of synthetic routes for large-scale API manufacturing.
• Impurity Profiling: Utilized to identify, quantify, and control related substances and degradation products during drug substance and drug product stability studies.

Basic Information

Product Name	Dronedarone Hydrochloride
CAS No.	141625-93-6
Molecular Formula	C31H44N2O5S · HCl
Molecular Weight	593.22 g/mol (as hydrochloride salt)
Synonyms	Dronedarone HCl; SR 33589; N-Butyl-N-[3-[4-(2,3-dihydroxypropoxy)benzoyl]benzofuran-2-ylmethyl]amine Hydrochloride; 1-[2-Butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-1-benzofuran-5-yl]methanesulfonamide Hydrochloride; Multaq (Brand Name) API; Atrial Fibrillation Drug Substance
EINECS	Contact for details

Quality Control

Our Dronedarone Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH guidelines. A detailed Certificate of Analysis (COA) providing results for assay, related substances, residual solvents, and other critical parameters is supplied with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities: NMT 1.0% Any individual impurity: NMT 0.5%
Water Content (KF)	NMT 1.0%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm
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.