Description

Desethylamiodarone is a key pharmaceutical intermediate and metabolite of the antiarrhythmic drug amiodarone. This compound is critical for research and development in the pharmaceutical industry, particularly in the study of drug metabolism, pharmacokinetics, and the synthesis of related therapeutic agents. It is primarily utilized by pharmaceutical R&D laboratories, analytical testing facilities, and manufacturers of active pharmaceutical ingredients (APIs) for quality control and reference standard applications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of amiodarone and its metabolites in drug substances and finished products.
• Metabolite Research: Serves as a critical standard in pharmacokinetic and pharmacodynamic studies to understand the metabolic pathway and biological activity of amiodarone.
• Analytical Method Development: Essential for developing and validating analytical methods, such as HPLC and LC-MS, for impurity profiling and assay determination in pharmaceutical formulations.
• Active Pharmaceutical Ingredient (API) Synthesis: Employed as a building block or intermediate in the research-scale synthesis of amiodarone and its structural analogs.
• Quality Control & Assurance: Used by quality control laboratories to identify and quantify desethylamiodarone as a specified impurity in amiodarone drug substances, ensuring compliance with pharmacopeial standards (e.g., USP, EP).
• Toxicological Studies: Applied in research investigating the safety profile and potential toxic effects of amiodarone metabolites.

Basic Information

Product Name	Desethylamiodarone
CAS No.	83409-32-9
Molecular Formula	C23H27I2NO3
Molecular Weight	627.28 g/mol
Synonyms	N-Desethylamiodarone; 2-Butyl-3-benzofuranyl 4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl ketone (de-ethylated); Amiodarone Metabolite I; Desethyl Amiodarone; 2-Butyl-3-(4-hydroxy-3,5-diiodobenzoyl)benzofuran; DEA
EINECS	Contact for details

Quality Control

Our Desethylamiodarone is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR), purity determination by HPLC, and control of related substances and residual solvents. Certificates of Analysis (COA) detailing all test results against relevant specifications are provided to ensure traceability and compliance with research and pharmaceutical industry requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

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 impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 0.5%

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