Description

Flecainide Hydrochloride CAS NO 57415-44-8 is a high-purity pharmaceutical active ingredient (API) belonging to the class Ic antiarrhythmic agents. It is a critical component in the formulation of medications used to treat and manage serious cardiac arrhythmias, such as ventricular tachycardia and atrial fibrillation. This compound is essential for pharmaceutical manufacturers, research institutions, and contract development and manufacturing organizations (CDMOs) engaged in the production of cardiovascular drugs, generic formulations, and clinical research.

Application

• Pharmaceutical API Manufacturing: Primary active ingredient in antiarrhythmic drug formulations.
• Generic Drug Production: Sourcing for bioequivalent generic versions of branded antiarrhythmic medications.
• Clinical Research & Development: Use in preclinical and clinical studies for new cardiovascular therapies.
• Reference Standard: Serves as an analytical standard in quality control laboratories for HPLC, LC-MS, and other assay methods.
• Formulation Development: Used in R&D for developing new dosage forms such as tablets or capsules.
• Contract Manufacturing: Supply to CDMOs for the production of finished dosage forms under GMP conditions.

Basic Information

Product Name	Flecainide Hydrochloride
CAS No.	57415-44-8
Molecular Formula	C17H20F6N2O3 • HCl
Molecular Weight	474.81 g/mol
Synonyms	Flecainide HCl; Flecainide Acetamide Hydrochloride; (±)-N-(2-Piperidylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide Hydrochloride; Tambocor (brand name); R-818; McN-485; BID-150; 2,5-Bis(2,2,2-trifluoroethoxy)-N-(2-piperidylmethyl)benzamide Hydrochloride
EINECS	Contact for details

Quality Control

Our Flecainide Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, suitable for pharmaceutical applications. We provide full traceability and support regulatory submissions with comprehensive documentation. Certificates of Analysis (COA) are available 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). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Specific Rotation	Contact for details

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