Description

Norfluoxetine Hydrochloride is a key pharmaceutical intermediate and metabolite of the widely used antidepressant fluoxetine. This compound is of significant importance for research, development, and quality control within the pharmaceutical industry. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions for the synthesis of active pharmaceutical ingredients (APIs), method development, and impurity profiling.

Application

• Pharmaceutical Intermediate: Critical for the synthesis and research of selective serotonin reuptake inhibitor (SSRI) drugs.
• Reference Standard: Used as a certified reference material (CRM) in analytical laboratories for method validation and calibration.
• Metabolite Studies: Essential for pharmacokinetic and pharmacodynamic research to understand drug metabolism and activity.
• Impurity Standard: Serves as a known impurity standard in the quality control testing of fluoxetine and related pharmaceutical products.
• Biochemical Research: Employed in neuroscience and psychiatric disorder research to study serotonin transporter mechanisms.
• Generic Drug Development: A vital component in the development and regulatory filing of generic fluoxetine formulations.

Basic Information

Product Name	Norfluoxetine Hydrochloride
CAS No.	83891-03-6
Molecular Formula	C16H16F3NO • HCl
Molecular Weight	345.76 g/mol
Synonyms	(±)-Norfluoxetine Hydrochloride; (R,S)-Norfluoxetine HCl; N-Desmethylfluoxetine Hydrochloride; 3-Phenyl-3-[4-(trifluoromethyl)phenoxy]propylamine Hydrochloride; LY-110140 Hydrochloride; Fluoxetine Metabolite Hydrochloride; Benzenepropanamine, γ-[4-(trifluoromethyl)phenoxy]-N-methyl-, hydrochloride, (±)-
EINECS	Contact for details

Quality Control

Our Norfluoxetine Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identification by IR and NMR, and residual solvent analysis, to ensure it meets high-purity standards suitable for pharmaceutical research and development. Certificates of Analysis (COA) with detailed chromatograms and spectral data are provided to guarantee traceability and batch-to-batch consistency.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Single Maximum Impurity	≤ 0.5%
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.