Description

5-Hydroxyflecainide is a significant pharmacologically active metabolite of the Class IC antiarrhythmic drug flecainide. This compound matters for its critical role in pharmacokinetic studies, drug metabolism research, and as a reference standard in analytical chemistry. Pharmaceutical R&D laboratories, contract research organizations (CROs), and manufacturers of analytical standards require high-purity 5-Hydroxyflecainide for method development, bioanalytical testing, and impurity profiling.

Application

• Pharmacological Reference Standard: Used as a certified reference material (CRM) for quantifying flecainide and its metabolites in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Essential for investigating the metabolic pathways, clearance, and exposure levels of flecainide in preclinical and clinical research.
• Impurity Profiling: Serves as a specified impurity standard in the quality control of flecainide acetate active pharmaceutical ingredient (API) to ensure compliance with pharmacopeial limits (e.g., USP, EP).
• Bioanalytical Method Development: A key analyte for developing and validating robust HPLC, LC-MS/MS, or UPLC methods in therapeutic drug monitoring (TDM) and toxicology.
• Clinical Research: Supports studies on the efficacy, safety, and individual variability in flecainide therapy by enabling accurate metabolite measurement.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) concerning drug safety and metabolism.

Basic Information

Product Name	5-Hydroxyflecainide
CAS No.	83526-33-4
Molecular Formula	C17H20F6N2O3
Molecular Weight	414.35 g/mol
Synonyms	5-Hydroxy Flecainide; Flecainide Metabolite; 2,5-Bis(2,2,2-trifluoroethoxy)-N-(4-hydroxy-2,5-bis(1-methylethyl)phenyl)benzamide; 1-(2,5-Bis(2,2,2-trifluoroethoxy)phenyl)-3-(4-hydroxy-2,5-diisopropylphenyl)urea (tautomeric form); Flecainide Hydroxy Metabolite; Flecainide Related Compound C (EP); UNII-2K5F5V6Z2I
EINECS	Contact for details

Quality Control

Our 5-Hydroxyflecainide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the stringent requirements for use as a reference standard. Certificates of Analysis (COA) detailing batch-specific results are provided and can be tailored to support compliance with USP, EP, or ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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