Pipotiazine is a synthetic phenothiazine-class antipsychotic active pharmaceutical ingredient (API). It belongs to the typical antipsychotic group and has pharmacological properties associated with dopamine receptor antagonism. Pipotiazine has been used in the treatment and maintenance management of schizophrenia.
Pipotiazine is identified by CAS Number 39860-99-6, molecular formula C₂₄H₃₃N₃O₃S₂, and molecular weight 475.67 g/mol. FDA Global Substance Registration System assigns Pipotiazine the UNII L903J9JPYV.
Pipotiazine is chemically classified as a phenothiazine derivative containing a dimethylsulfamoyl group and a substituted piperidine side chain. Its systematic chemical name is 10-[3-[4-(2-hydroxyethyl)piperidin-1-yl]propyl]-N,N-dimethyl-10H-phenothiazine-2-sulfonamide.
The API is associated with antipsychotic pharmaceutical applications. Pipotiazine has also been developed as a long-acting injectable formulation in the form of Pipotiazine Palmitate, which is an ester prodrug of Pipotiazine.
Pipotiazine API is associated with pharmaceutical preparations used in antipsychotic therapy. Its applications include:
Pipotiazine Palmitate is the long-acting ester formulation associated with depot administration, and FDA's substance hierarchy identifies Pipotiazine as its active moiety.
Pipotiazine intended for pharmaceutical manufacturing should be evaluated using validated analytical methods appropriate to the approved API specification. Testing may include identity, assay, related substances, residual solvents, water content, elemental impurities and other applicable quality attributes.
I could not verify a current public USP/IP/Ph. Eur. monograph containing a complete numerical release specification for Pipotiazine free base. Therefore, I have not incorrectly assigned pharmacopoeial assay or impurity limits to the API.
A current chemical reference listing reports 95.0% Pipotiazine as research-grade material, but this should not be treated as a pharmaceutical API release specification.
Pipotiazine API intended for pharmaceutical use should be manufactured under appropriate pharmaceutical quality systems and controlled through validated analytical procedures. The final specification should correspond to the applicable regulatory filing, pharmacopoeial requirement where applicable, and manufacturer's approved API specification.
For pharmaceutical manufacturers, Pipotiazine can be considered for formulation-development and antipsychotic API applications where the substance is approved for the intended market.
| 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 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 5.0 – 7.0 |
| Individual Impurity | NMT 1.0% |
| Total Impurities | NMT 5.0% |
| Water Content | NMT 1.0% |