Description

Amiodarone Impurity 13 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 regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Amiodarone Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels in compliance with ICH Q3A/B guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure Amiodarone batches meet stringent pharmacopeial (USP, EP) specifications for impurity limits.
• Stability Studies: Used to track the formation of this specific impurity during forced degradation and long-term stability studies of Amiodarone formulations.
• Regulatory Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Utilized in R&D to study the degradation pathways, synthesis by-products, and metabolism of Amiodarone.

Basic Information

Product Name	Amiodarone Impurity 13
CAS No.	516508-80-8
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; Desethylamiodarone Impurity; Amiodarone EP Impurity; Amiodarone USP Impurity; 4-[2-(Diethylamino)ethoxy]-3,5-diiodobenzoyl-2-butylbenzofuran impurity
EINECS	Contact for details

Quality Control

Every batch of Amiodarone Impurity 13 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under 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 ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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