Description

Dronedarone CAS NO 141626-36-0 is a non-iodinated benzofuran derivative belonging to the class III antiarrhythmic agents. This compound is of critical importance as a key pharmaceutical intermediate and active pharmaceutical ingredient (API) used in the development and manufacture of cardiac rhythm management medications. It is primarily required by pharmaceutical manufacturers, research institutions, and fine chemical suppliers engaged in the production of cardiovascular therapeutics and advanced pharmacological research.

Application

• Active Pharmaceutical Ingredient (API) for the formulation of antiarrhythmic medications.
• Pharmaceutical Intermediate in the synthesis of complex cardiovascular drugs.
• Reference Standard for quality control and analytical method development in pharmaceutical laboratories.
• Research & Development of novel cardiac therapies and pharmacological studies.
• Contract Manufacturing for companies outsourcing API production under cGMP guidelines.
• Clinical Trial Material supply for investigational new drug (IND) applications.

Basic Information

Product Name	Dronedarone
CAS No.	141626-36-0
Molecular Formula	C31H44N2O5S
Molecular Weight	556.76 g/mol
Synonyms	Dronedarone Hydrochloride; SR 33589; N-[2-Butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-1-benzofuran-5-yl]methanesulfonamide; Multaq (Brand Name); 1-Benzofuran-5-methanesulfonamide, N-[2-butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-]; SR-33589; UNII-8G7126E5ZY
EINECS	Contact for details

Quality Control

Our Dronedarone is manufactured under strict quality management systems to ensure it meets the rigorous standards required for pharmaceutical applications. Each batch is subjected to comprehensive analytical testing, including identity confirmation, purity assay, and impurity profiling via advanced techniques like HPLC and GC. Certificates of Analysis (COA) are provided, detailing compliance with in-house specifications aligned with ICH guidelines. We support audits and can supply materials suitable for use under cGMP conditions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after opening to prevent degradation from atmospheric moisture. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Loss on Drying	≤ 0.5%
Heavy Metals	≤ 20 ppm

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