Description

Flecainide-D4 Acetate [Bis(2,2,2-Trifluoroethoxy-1,1-D2)] is a high-purity, deuterium-labeled internal standard critical for ensuring analytical accuracy and reliability in quantitative bioanalysis. This stable isotope-labeled compound is essential for researchers and quality control laboratories requiring precise and interference-free measurements of the antiarrhythmic drug flecainide. It is primarily used by pharmaceutical development teams, contract research organizations (CROs), and forensic toxicology labs engaged in pharmacokinetic studies, therapeutic drug monitoring, and metabolism research.

Application

• Quantitative Bioanalysis & LC-MS/MS: Serves as an essential internal standard for the accurate quantification of flecainide in biological matrices (plasma, serum, urine) using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables precise tracking of drug concentration over time in clinical and pre-clinical research to determine absorption, distribution, metabolism, and excretion (ADME) profiles.
• Therapeutic Drug Monitoring (TDM): Used in clinical laboratory settings to ensure accurate measurement of flecainide levels in patient samples, aiding in dose optimization and minimizing toxicity risks.
• Drug Metabolism and Metabolite Identification: Facilitates the study of flecainide's metabolic pathways and the identification of its metabolites in complex biological systems.
• Forensic and Clinical Toxicology: Provides a reliable reference standard for the confirmatory analysis of flecainide in forensic investigations or overdose cases.
• Method Development and Validation: Critical for developing, optimizing, and validating robust analytical methods in compliance with regulatory guidelines (e.g., FDA, EMA).
• Quality Control in Pharmaceutical Manufacturing: Supports impurity profiling and assay validation for flecainide acetate drug substance and finished dosage forms.

Basic Information

Product Name	Flecainide-D4 Acetate [Bis(2,2,2-Trifluoroethoxy-1,1-D2)]
CAS No.	1276197-21-7
Molecular Formula	C17H16D4F6N2O3
Molecular Weight	426.36 g/mol (for deuterated form)
Synonyms	Flecainide-d4 Acetate; Flecainide Acetate-d4; N-(2-Piperidylmethyl)-2,5-bis(2,2,2-trifluoroethoxy-d2)benzamide Acetate; 2,5-Bis(2,2,2-trifluoroethoxy-d2)-N-(2-piperidylmethyl)benzamide Acetate; Tambocor-d4 Acetate (labeled form); Flecainide-D4 (Acetate Salt); Deuterated Flecainide Acetate Internal Standard
EINECS	Contact for details

Quality Control

Every batch of Flecainide-D4 Acetate is manufactured and analyzed under strict quality systems. We guarantee high chemical and isotopic purity to meet the exacting demands of analytical reference standard applications. Comprehensive testing includes assay (HPLC), isotopic enrichment (NMR/MS), and identification (IR, MS). A detailed Certificate of Analysis (COA) providing batch-specific results is supplied with each product, ensuring full traceability and compliance with relevant industry standards for research and development.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This compound is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (Deuterium Enrichment)	≥ 98.0 atom % D
Chemical Purity (by HPLC)	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH limits

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