Fluvoxamine Maleate API Manufacturer in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Fluvoxamine Maleate API

Fluvoxamine Maleate is a selective serotonin reuptake inhibitor (SSRI) belonging to the chemical class of 2-aminoethyl oxime ethers of aralkylketones. It is the maleate salt of fluvoxamine and is used as an active pharmaceutical ingredient in oral pharmaceutical formulations.

Fluvoxamine Maleate is primarily used in the treatment of obsessive-compulsive disorder (OCD). Its pharmacological activity is associated with potent inhibition of the serotonin reuptake transporter, increasing serotonin availability in the brain.

Fluvoxamine Maleate is described as a white to off-white, odorless crystalline powder. It is sparingly soluble in water, freely soluble in ethanol and chloroform, and practically insoluble in diethyl ether.

Key Features

  • Product Name: Fluvoxamine Maleate
  • Active Moiety: Fluvoxamine
  • CAS Number: 61718-82-9
  • Molecular Formula: C₁₉H₂₅F₃N₂O₆
  • Molecular Weight: 434.41 g/mol
  • Chemical Class: 2-Aminoethyl oxime ether of aralkylketone
  • Pharmacological Class: Selective Serotonin Reuptake Inhibitor
  • Therapeutic Class: Antidepressant / Anti-OCD agent
  • Physical Form: White to off-white crystalline powder
  • Route: Oral
  • Common Pharmaceutical Strengths: 25 mg, 50 mg and 100 mg tablets

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Heavy Metals NMT 10 ppm
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
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