Description

Amiodarone Impurity 8 Hcl is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antiarrhythmic drug Amiodarone. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in drug development and quality control. The precise characterization of this impurity is essential for method validation and meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Amiodarone Hydrochloride active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating High-Performance Liquid Chromatography (HPLC), UPLC, or LC-MS methods in quality control laboratories.
• Stability Studies & Forced Degradation: Employed to monitor impurity profiles during drug stability testing and to understand degradation pathways of Amiodarone.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on specified and unspecified impurities as per ICH guidelines.
• Pharmacopeial Testing: Used to comply with testing requirements outlined in pharmacopeias such as USP, EP, or BP for Amiodarone-related substances.
• Research & Development: Serves as a key intermediate or impurity marker in synthetic chemistry research and the development of improved synthetic routes for Amiodarone.

Basic Information

Item	Details
Product Name	Amiodarone Impurity 8 Hcl
CAS No.	1548369-35-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Amiodarone Related Compound 8 Hydrochloride; Amiodarone Impurity 8 Hydrochloride; Amiodarone EP Impurity 8 HCl; Amiodarone USP Impurity 8 Hydrochloride; Amiodarone Process Impurity 8 HCl; Specific Amiodarone Degradant Hydrochloride; 2-Butyl-3-benzofuranyl 4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl ketone impurity 8 hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Amiodarone Impurity 8 Hcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment to support your regulatory and research needs.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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