Fluphenazine is a synthetic phenothiazine antipsychotic and dopamine receptor antagonist. The pharmaceutical API is commonly supplied as Fluphenazine Hydrochloride, also referred to as Fluphenazine Dihydrochloride. The USP monograph identifies the substance as C₂₂H₂₆F₃N₃OS·2HCl, with a molecular weight of 510.44 g/mol.
Fluphenazine hydrochloride is used in pharmaceutical formulations for the management of schizophrenia and other psychotic disorders. It exerts its principal antipsychotic effect through antagonism of central dopamine receptors.
IUPAC Name:
2-[4-[3-[2-(Trifluoromethyl)phenothiazin-10-yl]propyl]piperazin-1-yl]ethanol dihydrochloride.
Fluphenazine Hydrochloride is an antipsychotic API used in pharmaceutical products for the management of schizophrenia and psychotic disorders. Current U.S. labeling describes fluphenazine hydrochloride as a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia.
Fluphenazine produces its principal antipsychotic effects through dopamine receptor antagonism, particularly blockade of postsynaptic dopamine receptors in the central nervous system
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 97.0%–103.0% |
| Loss on Drying | NMT 5.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Melting Point | 150°C – 154°C |