Levomepromazine is a phenothiazine derivative with antipsychotic, sedative, analgesic and antiemetic properties. It is a pharmaceutical active ingredient used in selected clinical applications, particularly where sedation and symptom control are required.
Levomepromazine acts on several neurotransmitter systems. Its pharmacological activity includes antagonism of dopamine D2 receptors, along with significant effects on histamine H1, muscarinic cholinergic and alpha-adrenergic receptors. This broad receptor profile contributes to its antipsychotic, sedative, antiemetic and hypotensive effects.
Levomepromazine is a synthetic phenothiazine compound with the molecular formula C19H24N2OS and a molecular weight of approximately 328.47 g/mol. Its CAS Number is 60-99-1.
The compound is also known as methotrimeprazine and may be encountered as levomepromazine maleate or other pharmaceutical forms depending on the formulation and market.
Levomepromazine produces its effects through antagonism of multiple receptors in the central and peripheral nervous systems.
Its dopamine receptor antagonism contributes to antipsychotic and antiemetic activity, while H1 histamine receptor blockade contributes substantially to sedation. Antagonism of alpha-adrenergic and muscarinic receptors also contributes to its overall pharmacological profile.
Levomepromazine is used in selected markets for the management of psychotic disorders and for its sedative and antiemetic properties. It is also used in specialist and palliative-care settings for symptom control, including nausea, vomiting, agitation and distress.
The approved indications and formulations vary by country and regulatory authority.
Levomepromazine API can be evaluated using validated analytical procedures for identification, assay, related substances, water content, residual solvents, elemental impurities and other applicable quality attributes.
Chromatographic and spectroscopic methods may be used for identity, assay and purity determination. Where a stereochemically defined pharmaceutical form is manufactured, appropriate control of stereochemical purity may also be included in the specification.
Acceptance criteria should be based on the applicable manufacturer's drug-substance specification, Certificate of Analysis and relevant pharmacopoeial and regulatory requirements.
Levomepromazine should be stored in a tightly closed pharmaceutical-grade container under controlled storage conditions. It should be protected from excessive heat, moisture and direct light.
Specific storage requirements should follow the applicable manufacturer's approved specification.
Levomepromazine API may be supplied for qualified pharmaceutical manufacturing, formulation development, analytical and research applications, subject to applicable quality and regulatory requirements.
Levomepromazine API is available for qualified pharmaceutical development and manufacturing requirements subject to applicable quality and regulatory standards. Customers can request product specifications, Certificate of Analysis, analytical documentation, packaging information and commercial details according to their requirements.
| 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) | 5.5 – 6.5 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |