Description

Dronedarone-D6 Hydrochloride is a deuterium-labeled internal standard of the antiarrhythmic agent dronedarone, specifically designed for use in quantitative analytical methods. This high-purity reference material is essential for ensuring accuracy and reliability in pharmacokinetic and bioanalytical studies. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and quality control departments for method development, validation, and regulatory compliance testing.

Application

• Quantitative Bioanalysis: Serves as a critical internal standard in LC-MS/MS and HPLC methods for the precise quantification of dronedarone and its metabolites in biological matrices (e.g., plasma, serum).
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion in preclinical and clinical research.
• Drug Metabolism and Disposition (DMPK): Used in metabolite profiling and stability studies to understand the metabolic pathways of dronedarone.
• Quality Control & Method Validation: Essential for validating analytical procedures in pharmaceutical quality control laboratories to meet ICH, FDA, and EMA guidelines.
• Clinical Trial Support: Provides reliable data for bioequivalence and therapeutic drug monitoring studies during clinical development phases.
• Forensic and Anti-Doping Analysis: Can be employed as a reference standard in specialized testing for drug identification and quantification.

Basic Information

Item	Detail
Product Name	Dronedarone-D6 Hydrochloride
CAS No.	1329809-23-5
Molecular Formula	C31H38D6N2O5S • HCl
Molecular Weight	606.26 g/mol (approx.)
Synonyms	Dronedarone-d6 HCl; N-[2-Butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-5-benzofuranyl]methanesulfonamide-d6 Hydrochloride; SR 33589-d6; Multaq-d6 (deuterated); 2-Butyl-3-(4-(3-(dibutylamino)propoxy)benzoyl)-5-(methylsulfonamido)benzofuran-d6 Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Dronedarone-D6 Hydrochloride is manufactured and tested under strict quality management systems. We provide comprehensive analytical data to support its use in regulated environments. Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request, detailing parameters such as chemical purity, isotopic purity (deuterium enrichment), and identity confirmation via advanced spectroscopic techniques.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This compound is hygroscopic (moisture-sensitive); the container must be kept in a dry environment and sealed after each use to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0% (Chemical Purity)
Isotopic Purity (MS)	≥ 98.0 atom % D
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.