Description

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

Application

• Quantitative Bioanalysis: Serves as a critical internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the precise quantification of dronedarone and its metabolites in biological matrices like plasma and serum.
• Pharmacokinetic Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical research.
• Metabolite Identification & Profiling: Aids in the identification and characterization of dronedarone metabolites using stable isotope dilution techniques.
• Method Development & Validation: Used as a benchmark to develop, optimize, and validate robust analytical methods compliant with FDA, EMA, and ICH guidelines.
• Doping Control & Forensic Analysis: Supports accurate detection and confirmation of dronedarone in forensic and anti-doping testing protocols.
• Quality Control in Manufacturing: Can be employed in in-process control and final product testing to monitor drug substance and product quality.

Basic Information

Product Name	Dronedarone D6
CAS No.	1132693-87-8
Molecular Formula	C31H38D6N2O5S
Molecular Weight	562.77 g/mol
Synonyms	Dronedarone-d6; N-[2-Butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-5-benzofuranyl]methanesulfonamide-d6; 2-Butyl-3-(4-(3-(dibutylamino)propoxy)benzoyl)-5-(methylsulfonamido)benzofuran-d6; Dronedarone (hexadeuterated); Dronedarone Internal Standard; Multaq-d6 (labeled analog)
EINECS	Contact for details

Quality Control

Every batch of Dronedarone D6 is manufactured under strict quality management systems and undergoes comprehensive analytical testing. We guarantee high chemical and isotopic purity, supported by a detailed Certificate of Analysis (COA) that includes results from NMR, HPLC, and MS. Our quality protocols are designed to meet the stringent requirements of pharmaceutical reference standard applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. 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 (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (MS)	≥98.0 atom % D
Chemical Purity (NMR)	Conforms
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.