Description

Dronedarone Hcl Impurity is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the antiarrhythmic drug Dronedarone Hydrochloride. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical testing laboratories involved in impurity profiling, method validation, and stability studies.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material to identify, quantify, and monitor this specific impurity in Dronedarone Hydrochloride active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating sensitive HPLC, UPLC, or LC-MS/MS methods to ensure accurate impurity detection.
• Quality Control and Release Testing: Employed in routine QC laboratories to confirm that Dronedarone API and drug products meet stringent pharmacopeial (e.g., USP, EP) specifications for impurity limits.
• Stability Studies and Forced Degradation: Used to assess the formation of this impurity under various stress conditions (heat, light, humidity) to establish product shelf-life and storage recommendations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive understanding and control of the drug substance's impurity profile.
• Research and Development: Facilitates synthetic route optimization and process chemistry research to minimize the formation of this impurity during API manufacturing.

Basic Information

Product Name	Dronedarone Hcl Impurity
CAS No.	1310430-09-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dronedarone Related Compound; Dronedarone Hydrochloride Impurity; Dronedarone Process Impurity; Dronedarone Degradant; N-[2-Butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-5-benzofuranyl]methanesulfonamide Hydrochloride Impurity; SR 33589 Impurity; Multaq Impurity
EINECS	Contact for details

Quality Control

Our Dronedarone Hcl Impurity is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and related substances.

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 Certificate of Analysis. The material should be kept in a dry environment to prevent moisture uptake.

Specification

Item	Specification
Appearance	White to off-white powder
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 guidelines
Water Content (KF)	≤ 5.0%

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