Description

Flecainide is a high-purity pharmaceutical active ingredient, a class IC antiarrhythmic agent primarily used for the management of cardiac rhythm disorders. Its efficacy in stabilizing heart muscle cell membranes makes it a critical component in the formulation of life-saving cardiovascular medications. This compound is essential for pharmaceutical manufacturers and research institutions focused on developing and producing treatments for conditions such as paroxysmal supraventricular tachycardia and ventricular arrhythmias.

Application

• Pharmaceutical API: Primary active ingredient in antiarrhythmic drug formulations for oral tablets and injectables.
• Cardiac Rhythm Management: Used in medications to treat and prevent paroxysmal supraventricular tachycardia (PSVT).
• Ventricular Arrhythmia Control: Key component in therapies for life-threatening ventricular tachycardia and fibrillation.
• Clinical Research: Reference standard and raw material for pharmacokinetic, pharmacodynamic, and safety studies.
• Generic Drug Manufacturing: Critical for the production of bioequivalent generic versions of branded antiarrhythmic drugs.
• Hospital Compounding: Used in specialized pharmacy compounding for patient-specific dosage forms where commercial products are unsuitable.

Basic Information

Product Name	Flecainide
CAS No.	54143-55-4
Molecular Formula	C17H20F6N2O3
Molecular Weight	414.35 g/mol
Synonyms	Flecainide Acetate; Tambocor; R-818; Flecainide acetate salt; N-(2-Piperidylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide acetate; 2,5-Bis(2,2,2-trifluoroethoxy)-N-(2-piperidylmethyl)benzamide acetate; BID 150
EINECS	Contact for details

Quality Control

Our Flecainide is manufactured under strict quality management systems, targeting purity levels suitable for pharmaceutical applications. Each batch is subjected to comprehensive analytical testing including identification, assay, and impurity profiling to ensure it meets stringent specifications. A Certificate of Analysis (COA) documenting results for appearance, purity (HPLC), residual solvents, heavy metals, and related substances is provided with every shipment. We support compliance with ICH Q7 guidelines and relevant pharmacopeial standards (USP/EP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed to minimize exposure to atmospheric moisture. Keep away from heat, sparks, and open flame.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to 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 ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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