Description

Amiodarone Ep Impurity C is a critical reference standard used in the pharmaceutical development and quality control of Amiodarone, a potent antiarrhythmic medication. This compound is essential for the accurate identification, quantification, and monitoring of process-related impurities during drug substance synthesis and formulation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product safety, efficacy, and compliance with stringent pharmacopeial standards such as USP and ICH guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Amiodarone API and finished dosage forms.
• Analytical Research: Used in HPLC, UPLC, and LC-MS analysis for the precise identification and quantification of Amiodarone Ep Impurity C in drug substances and products.
• Regulatory Compliance & Filings: Critical for preparing regulatory submission documents (e.g., ANDA, NDA) to demonstrate thorough impurity profiling as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Process Chemistry & R&D: Employed by research scientists to study impurity formation pathways, optimize synthesis processes, and develop effective purification strategies.
• Stability Studies: Used as a marker to monitor impurity levels in stability samples under various ICH-prescribed conditions, ensuring drug product shelf-life.
• Pharmacopeial Testing: Applied in testing to meet the specifications of United States Pharmacopeia (USP), European Pharmacopoeia (EP), and other international pharmacopeias.

Basic Information

Product Name	Amiodarone Ep Impurity C
CAS No.	1397201-93-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Amiodarone Impurity C; Amiodarone Related Compound C; Amiodarone EP Impurity C; 2-Butyl-3-benzofuranyl 4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl ketone impurity; Amiodarone Process Impurity C; 4-[2-(Diethylamino)ethoxy]-3,5-diiodobenzoyl-2-butylbenzofuran impurity C
EINECS	Contact for details

Quality Control

Every batch of Amiodarone Ep Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available for review upon request.

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 under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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