Haloperidol Decanoate is a long-acting ester prodrug of haloperidol, belonging to the butyrophenone class of antipsychotic pharmaceutical compounds. It is formulated as a long-acting intramuscular preparation that slowly releases haloperidol after administration.
Haloperidol Decanoate is chemically the decanoate ester of haloperidol. It has the molecular formula C31H41ClFNO3 and a molecular weight of approximately 530.12 g/mol. Its CAS Number is 74050-97-8.
Haloperidol Decanoate is a lipophilic ester designed for prolonged release following intramuscular administration. After administration, ester hydrolysis gradually releases active haloperidol, producing a substantially longer duration of action than immediate-release haloperidol formulations.
It is primarily associated with the maintenance treatment of schizophrenia and other psychotic disorders where long-acting antipsychotic therapy is appropriate.
The pharmacological activity of Haloperidol Decanoate is primarily attributable to haloperidol, which acts mainly as an antagonist at central dopamine D2 receptors.
Following intramuscular administration, Haloperidol Decanoate is slowly hydrolyzed to haloperidol. The released haloperidol exerts its antipsychotic effects through dopamine receptor blockade.
Haloperidol Decanoate API is used in the development and manufacture of long-acting antipsychotic formulations, including:
Haloperidol Decanoate is manufactured through controlled chemical synthesis involving esterification of haloperidol with the decanoate moiety, followed by purification and analytical quality control.
Quality assessment may include identity, assay, related substances, residual solvents, water content, elemental impurities and other applicable pharmaceutical-quality parameters.
Haloperidol Decanoate is generally described as a white to almost white crystalline powder. It is highly lipophilic and has very low water solubility, characteristics that contribute to its prolonged-release behavior following intramuscular administration.
Haloperidol Decanoate should be stored in a tightly closed container, protected from excessive heat, moisture and direct light. Storage should follow the manufacturer's current CoA, SDS and validated stability requirements.
Depending on the intended pharmaceutical application, documentation may include:
Haloperidol Decanoate is a long-acting haloperidol ester used in the development of depot antipsychotic formulations. Its defined chemical structure, high lipophilicity and slow conversion to haloperidol make it suitable for prolonged-release intramuscular pharmaceutical applications.
| 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% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |
| Melting Point | Approximately 151–153°C |