Description

Amiodarone Hydrochloride is a high-purity pharmaceutical active ingredient, a class III antiarrhythmic agent primarily used for the treatment of severe ventricular and supraventricular arrhythmias. Its efficacy and critical role in cardiac care make it an essential compound for pharmaceutical manufacturing. This product is specifically targeted at manufacturers of finished dosage forms, such as tablets and injectables, within the global pharmaceutical and life sciences industries.

Application

• Pharmaceutical API: Primary use as the active pharmaceutical ingredient (API) in the formulation of antiarrhythmic medications.
• Tablet Manufacturing: Used in the production of oral solid dosage forms for the management of life-threatening cardiac arrhythmias.
• Injectable Solutions: Critical component in the formulation of intravenous injections for hospital use in acute arrhythmia cases.
• Research & Development: Serves as a reference standard and key intermediate in cardiovascular drug discovery and pharmacological studies.
• Generic Drug Production: Essential for manufacturers producing generic versions of branded antiarrhythmic drugs containing amiodarone.

Basic Information

Product Name	Amiodarone Hydrochloride
CAS No.	19774-82-4
Molecular Formula	C25H29I2NO3 • HCl
Molecular Weight	681.78 g/mol
Synonyms	Amiodarone HCl; 2-Butyl-3-benzofuranyl 4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl ketone hydrochloride; Cordarone; Atlansil; Aratac; Sedacoron; Amio-Aqueous; Amiodar
EINECS	243-304-7

Quality Control

Our Amiodarone Hydrochloride is manufactured and tested to meet stringent pharmaceutical standards. Quality assurance protocols are designed to ensure batch-to-batch consistency, high purity, and compliance with relevant pharmacopoeial monographs. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profiles is provided with each shipment to support your regulatory and manufacturing requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a low-humidity environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%

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