Description

Bis Des-Iodo Amiodarone HCl (Amiodarone Impurity) is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a key impurity in the quality control and validation of Amiodarone hydrochloride, a widely used antiarrhythmic medication. It is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable reference materials to ensure drug safety, efficacy, and regulatory compliance. The availability of well-characterized impurities like this is fundamental for method development, stability studies, and meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Amiodarone HCl active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical component in developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods for purity analysis.
• Stability Indicating Studies: Used to monitor the degradation profile of Amiodarone HCl under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data for drug master files and quality control documentation.
• Pharmacopeial Testing: Employed in testing to comply with monographs from the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and other international pharmacopeias.
• Research & Development: Used in metabolic studies, pharmacokinetic research, and the synthesis of related compounds within medicinal chemistry programs.

Basic Information

Product Name	Bis Des-Iodo Amiodarone HCl (Amiodarone Impurity)
CAS No.	23551-25-9
Molecular Formula	C25H29ClNO3
Molecular Weight	426.96 g/mol
Synonyms	2-Butyl-3-benzofuranyl 4-[2-(diethylamino)ethoxy]-3,5-dimethylphenyl ketone hydrochloride; Desiodoamiodarone Impurity; Amiodarone Related Compound; 2-Butyl-3-(4-[2-(diethylamino)ethoxy]-3,5-dimethylbenzoyl)benzofuran hydrochloride; Bis-Desiodo Amiodarone Hydrochloride; Amiodarone Impurity C (as per some references); DBZ 110; L 3428
EINECS	Contact for details

Quality Control

Every batch of Bis Des-Iodo Amiodarone HCl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, UPLC, NMR, and Mass Spectrometry to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with cGMP, ICH Q3A/B, and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

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 individual impurity ≤ 0.5%
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.