Description

Fluoxetine CAS NO 57226-07-0 is a selective serotonin reuptake inhibitor (SSRI) widely recognized as the active pharmaceutical ingredient (API) in antidepressant and anti-anxiety medications. Its primary commercial value lies in its critical role in the synthesis of finished dosage forms for the treatment of major depressive disorder, obsessive-compulsive disorder, and panic disorder. This high-purity intermediate is essential for pharmaceutical manufacturers, research institutions, and contract development and manufacturing organizations (CDMOs) engaged in central nervous system (CNS) therapeutic development.

Application

• Active Pharmaceutical Ingredient (API) for the formulation of antidepressant medications.
• Key intermediate in the synthesis of fluoxetine hydrochloride, the salt form used in final drug products.
• Reference standard for analytical testing and quality control in pharmaceutical laboratories.
• Raw material for research and development of novel CNS-targeting therapeutics.
• Starting material for the production of generic pharmaceutical formulations.
• Biochemical research tool for studying serotonin reuptake mechanisms.

Basic Information

Product Name	Fluoxetine
CAS No.	57226-07-0
Molecular Formula	C17H18F3NO
Molecular Weight	309.33 g/mol
Synonyms	N-Methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine; (±)-Fluoxetine; (RS)-Fluoxetine; N-Methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine; Lilly 110140; LY-110140; Prozac (brand name API)
EINECS	Contact for details

Quality Control

Our fluoxetine is manufactured under strict quality management systems to ensure it meets the rigorous standards required for pharmaceutical use. Each batch undergoes comprehensive analytical testing, including identification, assay, and impurity profile analysis via HPLC and other pharmacopeial methods. A Certificate of Analysis (COA) detailing all test results against relevant specifications (including in-house and ICH guidelines) is provided with every shipment to guarantee traceability and 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). Due to its hygroscopic nature, the container must be kept tightly sealed to minimize exposure to atmospheric moisture.

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% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual impurity: ≤ 0.15% Total impurities: ≤ 0.5%
Heavy Metals	≤ 20 ppm

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