Flupentixol Dihydrochloride API Manufacturer in India

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Flupentixol Dihydrochloride API

Flupentixol is a thioxanthene-class antipsychotic compound that acts primarily as a dopamine receptor antagonist. Pharmaceutical products commonly use Flupentixol Dihydrochloride, the dihydrochloride salt of flupentixol. The BP/Ph. Eur. monograph identifies Flupentixol Hydrochloride as Flupentixol Dihydrochloride, with molecular formula C₂₃H₂₇Cl₂F₃N₂OS and molecular mass 507.4 g/mol.

Flupentixol exists as geometric isomers. The Z (cis) isomer is pharmacologically active, while the pharmaceutical monograph controls the proportion of the Z-isomer.

Key Features

  • Product Name: Flupentixol Dihydrochloride
  • Also Listed As: Flupentixol Hydrochloride
  • CAS Number: 2413-38-9
  • Molecular Formula: C₂₃H₂₇Cl₂F₃N₂OS
  • Molecular Weight: 507.4 g/mol
  • Chemical Class: Thioxanthene derivative
  • Pharmacological Class: Dopamine receptor antagonist
  • Therapeutic Class: Antipsychotic / Neuroleptic
  • Physical Form: White or almost white powder
  • Solubility: Very soluble in water; soluble in ethanol (96%); practically insoluble in methylene chloride
  • Key Stereochemical Requirement: (Z)-isomer 42.0%–52.0% 

Chemical Identity

IUPAC/Systematic Name:

2-[4-[3-[(EZ)-2-(Trifluoromethyl)-9H-thioxanthen-9-ylidene]propyl]piperazin-1-yl]ethan-1-ol dihydrochloride.

Pharmaceutical Application

Flupentixol Dihydrochloride is an antipsychotic API belonging to the thioxanthene group. It acts primarily through dopamine receptor antagonism and is used in pharmaceutical products for psychiatric disorders.

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%
Residue on Ignition NMT 0.1%
Heavy Metals NMT 10 ppm
pH (1% Solution) 2.0 – 4.0
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Melting Point 150°C – 154°C
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