Fluoxetine Hydrochloride API is the hydrochloride salt of fluoxetine and belongs to the selective serotonin reuptake inhibitor (SSRI) class. It is identified by CAS Number 59333-67-4, with the molecular formula C₁₇H₁₈F₃NO·HCl and molecular weight 345.79 g/mol.
Fluoxetine Hydrochloride is described as a white or almost white crystalline powder. It is sparingly soluble in water, freely soluble in methanol, and sparingly soluble in methylene chloride. The pharmacopoeial specification defines the content at 98.0%–102.0% on an anhydrous basis.
Fluoxetine Hydrochloride has a molecular weight of 345.79 g/mol and CAS Number 59333-67-4. Its chemical name is (3RS)-N-Methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine hydrochloride.
The material has a reported melting point of approximately 158–159°C.
Fluoxetine Hydrochloride can be evaluated using identification by infrared spectroscopy and chloride reaction, chromatographic assay, related-substance testing, water determination and other applicable quality-control tests. USP specifies an assay range of 98.0%–102.0% on an anhydrous basis.
Published commercial specifications additionally report limits for loss on drying, heavy metals, residue on ignition, water and related substances.
Fluoxetine Hydrochloride is an active pharmaceutical ingredient used in pharmaceutical formulations containing fluoxetine. It is associated with the SSRI class and is used in medicinal products for conditions including major depressive disorder, obsessive-compulsive disorder and panic disorder.
Fluoxetine Hydrochloride API can be supplied for pharmaceutical manufacturing and formulation applications subject to applicable quality, regulatory and documentation requirements. Product quality should be confirmed against the applicable approved specification and batch-specific Certificate of Analysis.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 2.0% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 4.0 – 7.0 |
| Individual Impurity | NMT 0.15% |
| Total Impurities | NMT 0.50% |