Fluoxetine HCl API Manufacturer in India

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Fluoxetine Hydrochloride API

Fluoxetine Hydrochloride (Fluoxetine HCl) is the hydrochloride salt of fluoxetine, a selective serotonin reuptake inhibitor (SSRI). It is used as an active pharmaceutical ingredient in medicines for major depressive disorder and other approved psychiatric conditions. Fluoxetine HCl has the molecular formula C₁₇H₁₈F₃NO·HCl and molecular weight 345.79 g/mol. Its CAS Registry Number is 59333-67-4.

Fluoxetine Hydrochloride is the hydrochloride salt of the racemic fluoxetine molecule. It is commonly incorporated into oral pharmaceutical formulations such as capsules, tablets and oral solutions.

Key Features

  • Product Name: Fluoxetine Hydrochloride
  • Common Name: Fluoxetine HCl
  • CAS Number: 59333-67-4
  • Molecular Formula: C₁₇H₁₈F₃NO·HCl
  • Molecular Weight: 345.79 g/mol
  • Chemical Class: SSRI
  • Pharmacological Class: Selective Serotonin Reuptake Inhibitor
  • Therapeutic Class: Antidepressant
  • Physical Form: Crystalline solid
  • Route: Oral

Chemical Identity

Chemical Name:
N-Methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine hydrochloride

Pharmaceutical Application

Fluoxetine Hydrochloride is used in pharmaceutical formulations as an SSRI antidepressant. It is approved for indications including major depressive disorder, obsessive-compulsive disorder, bulimia nervosa and panic disorder, depending on the specific product and regulatory jurisdiction.

Mechanism of Action

Fluoxetine selectively inhibits the neuronal reuptake of serotonin (5-HT), increasing serotonergic activity in the central nervous system. Its pharmacological effects are associated with increased serotonin availability at neuronal synapses.

Physical Characteristics

Fluoxetine Hydrochloride is a crystalline solid. It is freely soluble in water and soluble in alcohol according to pharmaceutical reference information.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.2%
Heavy Metals NMT 10 ppm
pH (1% Solution) 4.5–6.5
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 1.0%
Melting Point 168°C – 172°C
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