Description

Dronedarone Related Compound B (20 Mg) ((5-Amino-2-Butylbenzofuran-3-Yl){4-[3-(Dibutylamino)Propoxy]Phenyl}Methanone, Dihydrochloride) is a high-purity reference standard and impurity used in the pharmaceutical development and quality control of the antiarrhythmic drug Dronedarone. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling precise identification and quantification of related substances. It is an essential material for analytical laboratories, pharmaceutical R&D teams, and quality assurance departments focused on cardiovascular drug development.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for calibrating analytical instruments and validating methods in Dronedarone analysis.
• Impurity Profiling & Control: Used to identify, monitor, and quantify this specific related substance during drug substance (API) and finished product manufacturing to meet ICH Q3A/B guidelines.
• Method Development & Validation: Essential for developing and validating stability-indicating analytical methods such as HPLC, UPLC, and LC-MS for Dronedarone.
• Stability Studies: Employed as a marker to track degradation pathways and establish the shelf-life of Dronedarone formulations under various stress conditions.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., FDA, EMA) to support New Drug Applications (NDAs) and Marketing Authorisation Applications (MAAs).
• Quality Control (QC) Testing: Routinely used in QC laboratories for batch release testing to ensure Dronedarone API and drug products meet stringent purity specifications.

Basic Information

Product Name	Dronedarone Related Compound B (20 Mg) ((5-Amino-2-Butylbenzofuran-3-Yl){4-[3-(Dibutylamino)Propoxy]Phenyl}Methanone, Dihydrochloride)
CAS No.	1309476-91-2
Molecular Formula	C30H41N2O3 · 2HCl
Molecular Weight	541.58 g/mol (Free base: 477.66 g/mol)
Synonyms	Dronedarone Impurity B; Dronedarone Related Substance B; (5-Amino-2-Butyl-1-benzofuran-3-yl)[4-[3-(dibutylamino)propoxy]phenyl]methanone dihydrochloride; UNII-9J9734Y4H5; Dronedarone HCl Related Compound B; SR 33589 Related Compound B; Multaq Impurity B
EINECS	Contact for details

Quality Control

Our Dronedarone Related Compound B is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch undergoes comprehensive analytical testing, including HPLC purity determination, identity confirmation (IR, MS), and residual solvent analysis, to guarantee consistency and traceability. A detailed Certificate of Analysis (COA) is provided with each unit, documenting the results against predefined specifications. Our quality commitment aligns with the principles of GMP and ICH guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This material is hygroscopic (moisture-sensitive) and light-sensitive; the container must be kept tightly sealed in a dry place and opened only under controlled, low-humidity conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
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.