Description

Dronedarone Impurity 1 CAS NO 141626-26-8 is a high-purity 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. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories for method validation, impurity profiling, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Dronedarone API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, and GC methods to monitor impurity levels during drug synthesis and formulation.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch release testing to ensure drug product purity meets pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (heat, light, humidity) to establish drug shelf-life.
• Regulatory Submissions: Provides necessary data for impurity characterization reports required by regulatory bodies like the FDA, EMA, and PMDA.
• Process Chemistry Research: Used by R&D scientists to understand and optimize synthesis pathways to minimize the formation of this impurity.

Basic Information

Item	Details
Product Name	Dronedarone Impurity 1
CAS No.	141626-26-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dronedarone Related Compound 1; Dronedarone EP Impurity 1; Dronedarone USP Impurity 1; N-[2-Butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-5-benzofuranyl]methanesulfonamide Impurity; SR 33589 Impurity; Multaq Impurity 1
EINECS	Contact for details

Quality Control

Our Dronedarone Impurity 1 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis, identity confirmation (IR, MS), and residual solvent screening, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with every shipment, detailing batch-specific results and traceability.

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 conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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