Description

Di-n-Desethylamiodarone is a key pharmaceutical intermediate and metabolite of the antiarrhythmic drug amiodarone. This compound is of significant importance for research and development in the pharmaceutical industry, particularly in the study of drug metabolism, pharmacokinetics, and the synthesis of novel therapeutic agents. It is primarily needed by pharmaceutical manufacturers, contract research organizations (CROs), and academic research institutions focused on cardiovascular drug development and analytical method validation.

Application

• Pharmaceutical Intermediate: Critical for the synthesis and development of amiodarone analogs and related cardiovascular drugs.
• Metabolite Reference Standard: Used as a certified reference material (CRM) in bioanalytical laboratories for pharmacokinetic and metabolism studies.
• Drug Impurity Profiling: Serves as a known impurity standard in the quality control of amiodarone active pharmaceutical ingredient (API) and finished dosage forms.
• Pharmacological Research: Employed in in-vitro and in-vivo studies to understand the metabolic pathways and activity of amiodarone.
• Analytical Method Development: Essential for developing and validating HPLC, LC-MS, and other chromatographic methods in regulatory compliance environments.

Basic Information

Product Name	Di-n-Desethylamiodarone
CAS No.	94317-95-0
Molecular Formula	C23H24I2NO3
Molecular Weight	615.25 g/mol
Synonyms	2-Butyl-3-benzofuranyl 4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl ketone; Desethylamiodarone; Bisnoramiodarone; Amiodarone Impurity; Amiodarone Metabolite; NSC 339539; L 3428
EINECS	Contact for details

Quality Control

Our Di-n-Desethylamiodarone is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification, purity assay, and impurity profiling via HPLC and other validated methods, to ensure it meets the stringent requirements for pharmaceutical research and development. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and light-sensitive; ensure containers are kept tightly sealed in a desiccated environment away from direct light exposure.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 1.0%

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