Description

Dideiodo Amiodarone Hydrochloride is a key pharmaceutical intermediate and reference standard derived from the antiarrhythmic agent amiodarone. This compound is of significant value for research and development in the synthesis of novel cardiac drugs and for analytical quality control purposes. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in cardiovascular drug development and regulatory compliance testing.

Application

• Pharmaceutical Intermediate: Critical starting material or building block in the synthesis of novel amiodarone analogs and related antiarrhythmic agents.
• Reference Standard: Used as a certified standard in analytical methods for the identification, assay, and impurity profiling of amiodarone and its derivatives.
• Metabolite Studies: Employed in pharmacological and toxicological research to study the metabolic pathways and degradation products of amiodarone.
• Process Development & Validation: Essential for developing and validating manufacturing processes for amiodarone-based active pharmaceutical ingredients (APIs).
• Quality Control (QC) Testing: Serves as a system suitability standard and impurity marker in HPLC, LC-MS, and other chromatographic analyses within QC laboratories.
• Regulatory Submissions: Provides necessary data and characterization for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).

Basic Information

Product Name	Dideiodo Amiodarone Hydrochloride
CAS No.	95820-13-6
Molecular Formula	C25H29NO3 • HCl
Molecular Weight	443.97 g/mol (Free base: 407.51 g/mol)
Synonyms	2-Butyl-3-benzofuranyl 4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl ketone hydrochloride (Deiodinated Amiodarone HCl); Desiodoamiodarone Hydrochloride; Amiodarone Impurity; 2-Butyl-3-(4-hydroxy-3,5-diiodobenzoyl)benzofuran Hydrochloride; L 3428 (Hydrochloride); NSC 759434
EINECS	Contact for details

Quality Control

Our Dideiodo Amiodarone Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification (IR, HPLC), assay (HPLC), and impurity profiling, to ensure it meets high-purity standards suitable for pharmaceutical research and development. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and regulatory support.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
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.