Description

Fluoxetine Hydrochloride CAS NO 59333-67-4 is the hydrochloride salt of fluoxetine, a selective serotonin reuptake inhibitor (SSRI) that is fundamental to modern neuropharmacology. This active pharmaceutical ingredient (API) is critical for ensuring the efficacy, safety, and batch-to-batch consistency of finished pharmaceutical products. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of antidepressant and anxiolytic medications.

Application

• Pharmaceutical API: The primary and most significant application is as the bulk active ingredient in the formulation of antidepressant medications, most notably in generic and proprietary versions of Prozac®.
• Neuropharmacological Research: Serves as a key reference standard and investigational compound in academic and industrial research focused on serotonin pathways, depression, and anxiety disorders.
• Generic Drug Manufacturing: Essential for companies producing bioequivalent generic fluoxetine hydrochloride capsules, tablets, and oral solutions after patent expiry.
• Veterinary Medicine: Used in specialized veterinary pharmaceuticals for treating behavioral disorders in companion animals, such as dogs and cats.
• Clinical Trial Material: Supplied as GMP-grade material for use in Phase I-III clinical trials for new dosage forms or combination therapies.
• Analytical Reference Standard: High-purity grades are used in quality control laboratories for HPLC, UV, and other analytical methods to assay finished drug products.

Basic Information

Product Name	Fluoxetine Hydrochloride
CAS No.	59333-67-4
Molecular Formula	C17H18F3NO • HCl
Molecular Weight	345.79 g/mol
Synonyms	Fluoxetine HCl; (±)-Fluoxetine hydrochloride; N-Methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propylamine hydrochloride; Prozac Hydrochloride; Lilly 110140; (RS)-Fluoxetine hydrochloride; 3-(p-Trifluoromethylphenoxy)-N-methyl-3-phenylpropylamine hydrochloride
EINECS	261-671-4

Quality Control

Our Fluoxetine Hydrochloride is manufactured and tested under a strict quality management system. We offer material compliant with major pharmacopoeial standards, including USP and EP monographs. Each batch undergoes comprehensive analytical testing, including identification, assay, impurity profiling, and residual solvent analysis. A Certificate of Analysis (COA) documenting all test results against specifications is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The product is hygroscopic and should be kept in a dry environment. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.5% - 101.5% (on anhydrous basis)
Water (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.1% Total impurities: ≤ 0.5%
Optical Rotation	-

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