Description

4-Hydroxyflecainide is a significant pharmaceutical intermediate and metabolite of the Class IC antiarrhythmic agent flecainide. This compound is critical for analytical and research purposes, particularly in pharmacokinetic studies, drug metabolism research, and the development of bioanalytical methods. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and manufacturers of reference standards and diagnostic kits who require high-purity materials for method validation and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantification of flecainide and its metabolites in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Essential for investigating the metabolic pathways, bioavailability, and excretion profiles of flecainide.
• Impurity Profiling: Used as a known impurity standard in the quality control of flecainide acetate active pharmaceutical ingredient (API) to ensure compliance with ICH guidelines.
• Clinical Toxicology and Therapeutic Drug Monitoring (TDM): Employed in the calibration of assays to measure flecainide levels in patient plasma for dose optimization and safety.
• Academic and Biomedical Research: Facilitates studies on cardiac electrophysiology, structure-activity relationships (SAR), and the pharmacological effects of flecainide metabolites.

Basic Information

Product Name	4-Hydroxyflecainide
CAS No.	152171-74-9
Molecular Formula	C17H20F6N2O3
Molecular Weight	438.35 g/mol
Synonyms	4-Hydroxy Flecainide; Flecainide Metabolite (4-OH); N-(2-Piperidinylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)-4-hydroxybenzamide; 2,5-Bis(2,2,2-trifluoroethoxy)-4-hydroxy-N-(2-piperidinylmethyl)benzamide; 4'-Hydroxyflecainide; Flecainide 4'-Hydroxy Metabolite
EINECS	Contact for details

Quality Control

Our 4-Hydroxyflecainide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and stringent control of related substances and residual solvents. A detailed Certificate of Analysis (COA) is provided with each shipment, ensuring traceability and compliance with relevant standards for pharmaceutical intermediates and reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is light-sensitive and should be handled under appropriate 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%
Single Unknown Impurity	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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