Lumateperone is an atypical antipsychotic pharmaceutical API used in the treatment of schizophrenia and depressive episodes associated with bipolar disorder. It is a small-molecule compound with a unique pharmacological profile involving serotonin, dopamine and glutamate neurotransmission.
Lumateperone is marketed as lumateperone tosylate and is also known by the development code ITI-007. It is formulated for oral administration.
Lumateperone is a specialized CNS pharmaceutical API used in the development and manufacture of antipsychotic and psychiatric formulations.
Important quality attributes include identity, assay, related substances, water content, residue on ignition, residual solvents and elemental impurities.
CAS Number: 313368-91-1
Molecular Formula: C24H30N2O·C7H8O3S
Molecular Weight: 577.76 g/mol
Synonym: Lumateperone Tosylate
Development Code: ITI-007
Drug Class: Atypical Antipsychotic
Therapeutic Class: Antipsychotic Agent
Therapeutic Area: Psychiatry / CNS
Molecule Type: Synthetic Small Molecule
Lumateperone has a multimodal pharmacological profile.
It acts as:
This combination of activities contributes to its antipsychotic and mood-related pharmacological effects.
Lumateperone API is used in pharmaceutical formulations for:
Lumateperone is primarily developed for oral pharmaceutical formulations, including capsule-based dosage forms.
The commercially used active moiety is generally supplied as lumateperone tosylate.
Lumateperone Tosylate is generally described as a white to off-white solid. It is suitable for incorporation into oral pharmaceutical formulations following appropriate formulation and stability development.
A controlled Lumateperone API manufacturing process may involve:
Typical Lumateperone Tosylate API testing may include:
Store Lumateperone API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive heat, moisture and direct light. Final storage conditions should follow the manufacturer's validated stability data.
Lumateperone is relevant to research involving:
Lumateperone is an atypical antipsychotic API commonly supplied as lumateperone tosylate, with CAS 313368-91-1, molecular formula C24H30N2O·C7H8O3S, and molecular weight 577.76 g/mol. Its multimodal activity involves serotonin, dopamine and glutamatergic neurotransmission.
| 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) | 4.0 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |
| Melting Point | Approximately 198°C – 202°C |