Perospirone API is an atypical antipsychotic active pharmaceutical ingredient (API) used in the development and manufacture of pharmaceutical formulations for the management of schizophrenia and related psychiatric conditions. The pharmaceutical API is commonly handled in its Perospirone Hydrochloride Hydrate (Dihydrate) form, which is the pharmacopoeial form listed in the Japanese Pharmacopoeia.
Perospirone belongs to the class of second-generation antipsychotic agents and exhibits pharmacological activity through interactions with several neurotransmitter receptors, particularly dopamine and serotonin receptors. Its receptor profile supports its application in pharmaceutical formulations intended for antipsychotic therapy.
The API is chemically identified as Perospirone Hydrochloride Hydrate, with the molecular formula C₂₃H₃₀N₄O₂S·HCl·2H₂O and a molecular weight of 499.07 g/mol. The corresponding equivalent formula is C₂₃H₃₅ClN₄O₄S. The API has CAS Number 192052-81-6.
Perospirone API is primarily associated with antipsychotic pharmaceutical products. It is used as an active ingredient in formulations designed for the treatment of schizophrenia and other psychotic disorders. As an atypical antipsychotic, perospirone has a pharmacological profile involving both dopamine and serotonin receptor systems.
Its pharmaceutical properties make appropriate control of identity, assay, related substances, water content, residual solvents, elemental impurities, and other quality attributes important during API manufacturing and formulation development.
The Perospirone Hydrochloride Hydrate specification can be evaluated against applicable pharmacopoeial requirements. The Japanese Pharmacopoeia provides an assay range of 98.0%–102.0% on the dried basis, calculated as Perospirone Hydrochloride. Because the API is supplied as a hydrate, water determination is an important quality attribute rather than treating loss on drying as a universal specification.
Related substances and other quality characteristics should be controlled according to the applicable pharmacopoeial or approved product specification. Parameters such as total impurities, residual solvents, elemental impurities, particle size, and polymorphic characteristics can be specification-dependent.
Perospirone API manufacturing requires controlled processing and analytical testing to maintain consistency between batches. Appropriate analytical methods such as chromatographic identification and assay testing can be used together with relevant physicochemical and impurity testing.
For pharmaceutical manufacturers and formulation developers, accurate control of the API form is particularly important because Perospirone Hydrochloride Hydrate is a dihydrate, with a molecular weight of 499.07 g/mol, while anhydrous perospirone hydrochloride has a different molecular weight of approximately 463.04 g/mol.
Perospirone API is therefore suitable for pharmaceutical development and manufacturing applications where a controlled, pharmacopoeially aligned atypical antipsychotic active ingredient is required.
| 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 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | ≤ 1.5% |
| Water Content | NMT 0.5% |