Description

Desbutyl Dronedarone-D6 Hydrochloride is a high-purity, deuterium-labeled internal standard critical for advanced analytical chemistry. This compound is essential for ensuring the accuracy and reliability of quantitative bioanalytical methods, particularly in pharmacokinetic and metabolism studies. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory testing facilities for the precise analysis of dronedarone and its metabolites.

Application

• Quantitative Bioanalysis: Serves as a stable isotope-labeled internal standard for the accurate LC-MS/MS quantification of dronedarone and its desbutyl metabolite in biological matrices (e.g., plasma, serum).
• Pharmacokinetic (PK) Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical research.
• Drug Metabolism Studies: Used as a reference standard to identify and quantify specific metabolic pathways and degradation products.
• Method Development & Validation: Critical for developing, optimizing, and validating robust analytical methods in compliance with GLP and ICH guidelines.
• Quality Control in Manufacturing: Supports impurity profiling and stability testing of active pharmaceutical ingredients (APIs) and finished drug products.
• Forensic & Anti-Doping Analysis: Applied in specialized testing for the detection and confirmation of the parent drug in forensic or sports doping control samples.

Basic Information

Product Name	Desbutyl Dronedarone-D6 Hydrochloride
CAS No.	1346598-70-6
Molecular Formula	C30D6H35N2O5S • HCl
Molecular Weight	~ 607.2 g/mol
Synonyms	N-[2-Butyl-3-[4-(3-(dibutylamino)propoxy)benzoyl]-5-benzofuranyl]methanesulfonamide-d6 Hydrochloride; Dronedarone Desbutyl Metabolite-D6 HCl; Dronedarone Impurity-D6 Hydrochloride; Dronedarone Related Compound-D6; SR 33589 Desbutyl-D6 Hydrochloride; Deuterated Desbutyl Dronedarone HCl; Internal Standard for Dronedarone Analysis-D6
EINECS	Contact for details

Quality Control

Our Desbutyl Dronedarone-D6 Hydrochloride is manufactured under strict quality systems to ensure the highest standards of purity and isotopic enrichment. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for assay, isotopic purity, chemical purity, and identity confirmation. We adhere to relevant industry standards for reference materials, supporting compliance with GMP, GLP, and ICH guidelines for analytical 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 material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (Mass Spectrometry)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (Deuterium Incorporation)	≥ 98.0 atom % D
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Single Maximum Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%

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