Description

Desbutyl Dronedarone Hydrochloride is a key pharmaceutical intermediate and metabolite of the antiarrhythmic drug Dronedarone. This compound is of significant importance for research, development, and quality control processes within the pharmaceutical industry. It is primarily utilized by manufacturers and research institutions involved in the synthesis of active pharmaceutical ingredients (APIs), analytical method development, and metabolic studies.

Application

• Pharmaceutical Intermediate: A critical building block in the synthesis and manufacturing of Dronedarone API.
• Reference Standard: Used as a certified reference material (CRM) for analytical method validation and quality control testing in pharmaceutical laboratories.
• Metabolite Studies: Essential for pharmacokinetic and pharmacodynamic research to understand the drug's metabolism and biological activity.
• Impurity Profiling: Serves as a known impurity standard to monitor and control the purity of Dronedarone batches during production.
• Research & Development: Utilized in preclinical and clinical research for developing new cardiovascular therapies and formulations.

Basic Information

Product Name	Desbutyl Dronedarone Hydrochloride
CAS No.	141626-35-9
Molecular Formula	C29H38N2O4S • HCl
Molecular Weight	543.15 g/mol
Synonyms	N-[2-Butyl-3-[4-(3-dibutylaminopropoxy)benzoyl]-5-benzofuranyl]methanesulfonamide Hydrochloride (Desbutyl); Desbutyl Dronedarone HCl; Dronedarone Desbutyl Metabolite Hydrochloride; SR 35021 Hydrochloride (Desbutyl); Benzofuran-5-methanesulfonamide, N-[2-butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-, hydrochloride (1:1); UNII-1K5W6SGF6P
EINECS	Contact for details

Quality Control

Our Desbutyl Dronedarone Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, residual solvent analysis, and identification by spectroscopic methods, to ensure it meets the high standards required for pharmaceutical research and development. A detailed Certificate of Analysis (COA) is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, well-ventilated area. Keep the container sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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