Description

Desethyl Amiodarone Hydrochloride is a key pharmaceutical intermediate and metabolite of the antiarrhythmic drug Amiodarone. Its primary value lies in enabling advanced research into drug metabolism, pharmacokinetics, and the development of analytical reference standards. This high-purity compound is essential for pharmaceutical R&D laboratories, analytical testing facilities, and manufacturers involved in the production and quality control of cardiovascular medications.

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: Critical for studying the metabolic pathways, bioavailability, and elimination profiles of Amiodarone in preclinical and clinical research.
• Analytical Method Development: Serves as a pure standard for developing and validating chromatographic methods (HPLC, LC-MS) in quality control laboratories.
• Impurity Profiling: Employed to identify, quantify, and monitor process-related impurities and degradation products in Amiodarone hydrochloride API manufacturing.
• Pharmacokinetic Studies: Utilized in ADME (Absorption, Distribution, Metabolism, Excretion) studies to understand the drug's behavior in biological systems.
• Toxicology Assessment: Aids in the safety evaluation and toxicological profiling of Amiodarone therapy by studying its active metabolites.

Basic Information

Product Name	Desethyl Amiodarone Hydrochloride
CAS No.	96027-74-6
Molecular Formula	C23H28I2NO3 • HCl
Molecular Weight	696.69 g/mol (Free base: 660.18 g/mol)
Synonyms	2-Butyl-3-benzofuranyl 4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl ketone hydrochloride; N-Desethylamiodarone Hydrochloride; Amiodarone Metabolite I Hydrochloride; DEA HCl; 4-[2-(Diethylamino)ethoxy]-3,5-diiodobenzoyl-2-butylbenzofuran hydrochloride
EINECS	Contact for details

Quality Control

Our Desethyl Amiodarone Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by IR and MS, and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical research and reference standard applications. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with specified standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant conditions.

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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Single 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.