Description

Amiodarone Impurity 24 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the antiarrhythmic drug Amiodarone by enabling the accurate identification and quantification of related substances. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies focused on impurity profiling and method validation. The reliable supply of this well-characterized impurity is fundamental to maintaining compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of Amiodarone Impurity 24 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Used as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for Amiodarone analysis.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency of Amiodarone, supporting GMP compliance.
• Stability Studies: Used to track the formation of this specific impurity during forced degradation and long-term stability studies of Amiodarone formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and justify specifications.
• Research and Development: Utilized in synthetic chemistry and pharmacology research to study the degradation pathways and metabolic byproducts of Amiodarone.

Basic Information

Product Name	Amiodarone Impurity 24
CAS No.	290295-98-6
Molecular Formula	C25H29I2NO3
Molecular Weight	685.31 g/mol
Synonyms	2-Butyl-3-benzofuranyl 4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl ketone impurity; Amiodarone Related Compound 24; Desethylamiodarone Iodinated Impurity; 4-[2-(Diethylamino)ethoxy]-3,5-diiodobenzoyl-2-butylbenzofuran; Amiodarone EP Impurity I; Amiodarone USP Related Compound; (2-Butylbenzofuran-3-yl)-[4-(2-diethylaminoethoxy)-3,5-diiodophenyl]methanone
EINECS	Contact for details

Quality Control

Every batch of Amiodarone Impurity 24 is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and impurity testing to ensure compliance with relevant pharmacopeial standards (e.g., USP, EP) and customer specifications. Comprehensive analytical data, including HPLC purity, related substance profiles, and structural confirmation (NMR, MS), are documented. A Certificate of Analysis (COA) is provided with each shipment, detailing all test results and methods.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or 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 ≤ 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.