Description

(±)-Fluoxetine-D4 Oxalate (Trifluoromethylphen-D4-Oxy) CAS NO 114414-02-7 is a deuterated internal standard of the widely prescribed antidepressant fluoxetine, essential for ensuring analytical accuracy and reliability in quantitative mass spectrometry. This high-purity reference material is critical for pharmaceutical research and development, enabling precise pharmacokinetic studies, bioanalytical method validation, and drug metabolism investigations. It is primarily required by analytical laboratories, CROs (Contract Research Organizations), and pharmaceutical companies engaged in bioequivalence testing and regulatory compliance for generic drug development.

Application

• Quantitative Bioanalysis: Serves as a critical internal standard in LC-MS/MS and GC-MS methods for the accurate quantification of fluoxetine and norfluoxetine in biological matrices (plasma, serum, urine).
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables precise tracking of drug concentration over time in clinical and pre-clinical studies.
• Drug Metabolism and Disposition Research: Used in metabolite identification and profiling studies to understand the biotransformation pathways of fluoxetine.
• Method Development and Validation: A key component in developing and validating robust, regulatory-compliant analytical methods for bioanalytical assays.
• Forensic and Clinical Toxicology: Assists in the accurate measurement of fluoxetine levels for therapeutic drug monitoring (TDM) or forensic investigations.
• Quality Control in Pharmaceutical Manufacturing: Can be used in impurity profiling and stability-indicating methods for drug substance and product analysis.

Basic Information

Product Name	(±)-Fluoxetine-D4 Oxalate (Trifluoromethylphen-D4-Oxy)
CAS No.	114414-02-7
Molecular Formula	C17H14D4F3NO • C2H2O4
Molecular Weight	419.39 g/mol
Synonyms	Fluoxetine-d4 Oxalate; N-Methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propylamine-d4 Oxalate; (±)-Fluoxetine-d4 Oxalate Salt; Prozac-d4 Oxalate; 3-(p-Trifluoromethylphenoxy)-N-methyl-3-phenylpropylamine-d4 Oxalate; N-Methyl-γ-[4-(trifluoromethyl)phenoxy]benzenepropanamine-d4 Oxalate; (RS)-Fluoxetine-d4 Oxalate
EINECS	Contact for details

Quality Control

Every batch of (±)-Fluoxetine-D4 Oxalate is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to support its use as a certified reference material. Certificates of Analysis (COA) are supplied with each shipment, detailing parameters such as isotopic purity, chemical purity, and absence of interfering impurities. Our quality protocols are designed to meet the stringent requirements of GMP/GLP environments for pharmaceutical analysis.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C. This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (Deuterium Content)	≥98 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%

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