Description

Des-(Dibutylpropylamine) Methanesulfonyl Dronedarone is a key pharmaceutical intermediate and impurity reference standard used in the development and quality control of the antiarrhythmic drug Dronedarone. This compound is critical for ensuring the purity, safety, and efficacy of the final active pharmaceutical ingredient (API) by serving as a benchmark for analytical methods. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in process development, regulatory filing, and stringent quality assurance protocols.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of process-related impurities in Dronedarone HCl API.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, and LC-MS methods in compliance with ICH guidelines.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing characterized impurity data.
• Quality Control (QC) Testing: Serves as an in-house working standard in QC laboratories for routine batch release testing of Dronedarone.
• Process Chemistry Research: Employed in research to study metabolic pathways and degradation products of Dronedarone.
• Stability Studies: Used to monitor the formation of specific degradants under various stress conditions (heat, light, humidity).

Basic Information

Product Name	Des-(Dibutylpropylamine) Methanesulfonyl Dronedarone
CAS No.	1448297-16-2
Molecular Formula	C25H30N2O5S2
Molecular Weight	502.65 g/mol
Synonyms	Dronedarone Des-butyl Impurity; Dronedarone Impurity F; N-Butyl-4-[2-[3-(dibutylamino)propoxy]-5-(methanesulfonyl)benzoyl]benzofuran-2-methanesulfonamide Des-butyl Analog; Dronedarone Related Compound F; SR 33589 Des-butyl Impurity; 4-[2-[3-(Dibutylamino)propoxy]-5-(methylsulfonyl)benzoyl]-N-butyl-1-benzofuran-2-methanesulfonamide Des-butyl Derivative
EINECS	Contact for details

Quality Control

Our Des-(Dibutylpropylamine) Methanesulfonyl Dronedarone is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, LC-MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) detailing all test results is provided to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

Specification

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

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