Description

Norfluoxetine-D5 Hydrochloride is a deuterated internal standard of the selective serotonin reuptake inhibitor (SSRI) metabolite, norfluoxetine. This high-purity, isotopically labeled compound is essential for achieving precise and reliable quantification in advanced analytical workflows. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and forensic toxicology units for method development and validation.

Application

• Quantitative Bioanalysis: Serves as a critical internal standard for the accurate LC-MS/MS quantification of norfluoxetine and fluoxetine in biological matrices (plasma, serum, urine).
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables precise tracking of drug metabolite levels in clinical and preclinical research.
• Forensic and Clinical Toxicology: Used in confirmatory testing and therapeutic drug monitoring (TDM) to ensure assay accuracy and reproducibility.
• Drug Metabolism and Disposition Research: Facilitates studies on the metabolic pathways and clearance of fluoxetine.
• Method Development and Validation: A key reagent for developing robust, compliant analytical methods according to FDA, EMA, and ICH guidelines.
• Quality Control in Reference Material Production: Employed in the calibration and verification of certified reference materials (CRMs).

Basic Information

Product Name	Norfluoxetine-D5 Hydrochloride
CAS No.	1188265-34-0
Molecular Formula	C16H13D5F3NO • HCl
Molecular Weight	345.80 g/mol (approx.)
Synonyms	(±)-Norfluoxetine-D5 hydrochloride; N-Desmethylfluoxetine-D5 hydrochloride; (RS)-Norfluoxetine-D5 hydrochloride; 3-Phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propyl(methyl-d3)amine-D2 hydrochloride; Fluoxetine metabolite-D5 hydrochloride; LY-110140-D5 metabolite hydrochloride; Prozac metabolite-D5 hydrochloride
EINECS	Contact for details

Quality Control

Our Norfluoxetine-D5 Hydrochloride is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of isotopic purity and chemical identity. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for assay, isotopic enrichment, and related substances by HPLC and/or LC-MS. Quality systems support compliance with relevant pharmacopeial and ICH guidelines for reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (Mass Spectrometry)	Conforms
Purity (HPLC)	≥98.0%
Isotopic Purity (Deuterium Enrichment)	≥98 atom % D
Chemical Purity (by 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.