Description

Fluoxetine Hydrochloride is the hydrochloride salt of fluoxetine, a selective serotonin reuptake inhibitor (SSRI). This high-purity active pharmaceutical ingredient (API) is critical for ensuring the efficacy and safety of finished pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers and research institutions for the production of antidepressant medications and related clinical studies.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of antidepressant capsules, tablets, and oral solutions.
• Generic Drug Production: Sourcing for the formulation of bioequivalent generic versions of fluoxetine-based medications.
• Clinical Research: Utilization in preclinical and clinical studies for investigating depression, anxiety disorders, and other CNS-related conditions.
• Reference Standard: Serving as a high-purity analytical standard for quality control laboratories in pharmacopoeial testing (USP, EP).
• Veterinary Medicine: Potential application in veterinary pharmaceuticals for behavioral disorders in animals.

Basic Information

Product Name	Fluoxetine Hydrochloride
CAS No.	56296-78-7
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 (trade name); (RS)-Fluoxetine hydrochloride; 3-(p-Trifluoromethylphenoxy)-N-methyl-3-phenylpropylamine hydrochloride; Lilly 110140
EINECS	Contact for details

Quality Control

Our Fluoxetine Hydrochloride is manufactured under strict quality management systems. It is tested to meet or exceed relevant pharmacopoeial standards (such as USP/EP monographs) for identity, purity, and potency. A comprehensive Certificate of Analysis (COA) detailing all test results, including assay, related substances, residual solvents, and heavy metals, is provided with each batch to ensure full traceability and regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms to reference standard
Assay (HPLC)	98.5% - 101.0% (on anhydrous basis)
Water Content (KF)	≤ 0.5%
Related Substances (HPLC)	Individual impurity: ≤ 0.1% Total impurities: ≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C

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