Description

Ibutilide Fumarate is a high-purity pharmaceutical intermediate and active pharmaceutical ingredient (API) with the CAS registry number 122647-32-9. This compound is critical for the synthesis of antiarrhythmic medications, offering reliable performance in complex pharmaceutical manufacturing processes. It is primarily utilized by pharmaceutical companies, research institutions, and fine chemical manufacturers engaged in cardiovascular drug development and production.

Application

• Pharmaceutical API Synthesis: Key intermediate in the production of Ibutilide, a Class III antiarrhythmic agent used for the conversion of atrial fibrillation and flutter.
• Cardiovascular Research: Serves as a critical reference standard and building block in preclinical and clinical research for novel antiarrhythmic therapies.
• Fine Chemical Manufacturing: Used in the synthesis of complex organic molecules requiring high-purity fumarate salt formations.
• GMP Production: Supplied for use in Good Manufacturing Practice (GMP) compliant processes for finished dosage form manufacturing.
• Analytical Development: Employed as a system suitability standard and for method validation in quality control laboratories (HPLC, LC-MS).
• Regulatory Submissions: Provides the necessary quality documentation (COA, DMF) to support regulatory filings with agencies like the FDA and EMA.

Basic Information

Item	Details
Product Name	Ibutilide Fumarate
CAS No.	122647-32-9
Molecular Formula	C20H36N2O3 • C4H4O4
Molecular Weight	492.56 g/mol
Synonyms	N-[4-[4-(Ethylheptylamino)-1-hydroxybutyl]phenyl]methanesulfonamide fumarate; (R*,S*)-α-[4-[(Ethylheptyl)amino]-1-hydroxybutyl]-α-(methanesulfonamido)toluene fumarate; Ibutilide hydrogen fumarate; Ibutilide (as fumarate); Corvert (brand name related); 1-[4-(Ethylheptylamino)-1-hydroxybutyl]phenyl]methanesulfonamide fumarate; UNII-4JKY8Y0B3J
EINECS	Contact for details

Quality Control

Our Ibutilide Fumarate is manufactured under strict quality systems to ensure it meets the rigorous standards required for pharmaceutical applications. Each batch is tested against comprehensive specifications, including identity, purity, and impurity profiles via validated analytical methods such as HPLC and IR spectroscopy. A Certificate of Analysis (COA) is provided with each shipment, and we support regulatory needs with relevant documentation. Production can be aligned with cGMP guidelines upon request.

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 crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Total impurities ≤ 2.0%; Any single impurity ≤ 0.5%
Specific Rotation	Contact for details

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