Sertindole API is a synthetic atypical antipsychotic active pharmaceutical ingredient belonging to the indole derivative class. Chemically identified as 1-[2-[4-[5-chloro-1-(4-fluorophenyl)-1H-indol-3-yl]piperidin-1-yl]ethyl]imidazolidin-2-one, Sertindole has the molecular formula C₂₄H₂₆ClFN₄O and a molecular weight of approximately 440.94 g/mol. Its CAS Number is 106516-24-9 and its FDA GSRS UNII is GVV4Z879SP.
Sertindole acts primarily through interactions with dopamine and serotonin receptors. It has affinity for dopamine D₂ receptors, serotonin 5-HT₂A and 5-HT₂C receptors, as well as α₁-adrenergic receptors. The compound is classified under the WHO ATC system as N05AE03, within the indole derivatives category of antipsychotic medicines.
Sertindole is a small-molecule pharmaceutical compound containing chlorine, fluorine, nitrogen and oxygen. PubChem reports the molecular formula as C₂₄H₂₆ClFN₄O, molecular weight as approximately 440.9 g/mol, and an InChIKey of GZKLJWGUPQBVJQ-UHFFFAOYSA-N. It has no defined stereocenters.
The API is generally described as a white to off-white crystalline powder or solid. Commercial analytical references report a melting point around 154–156°C, while another crystalline modification has been reported with a melting point around 166°C, demonstrating that solid-state form can influence the observed thermal transition.
Sertindole has been developed and used as an atypical antipsychotic for the management of schizophrenia. It was originally authorised in European markets in the 1990s. Following concerns regarding cardiovascular safety, regulatory authorities introduced suspension and later reintroduction measures with safeguards, including ECG monitoring and restrictions for patients at risk of cardiac dysrhythmias.
The compound remains an important pharmaceutical research API for studies involving dopamine and serotonin receptor pharmacology, antipsychotic drug development, analytical method development and related pharmaceutical research.
Quality control of Sertindole API requires appropriate identity, purity and physicochemical testing. HPLC is particularly important for determining assay and monitoring related substances. Published research has documented process-related impurities associated with Sertindole synthesis and demonstrated their identification using HPLC and LC-MS techniques.
Because a universally accessible current USP/Ph. Eur. API monograph specification was not identified during this research, product-specific release specifications should be established according to the applicable regulatory dossier, customer specification and validated analytical methods. Commercial analytical-grade references report HPLC purity levels such as ≥97.5%, but this should not be represented as a universal pharmacopoeial Sertindole API specification.
Swapnroop Drugs and Pharmaceuticals provides pharmaceutical API manufacturing and quality-focused capabilities for a broad portfolio of active pharmaceutical ingredients. Sertindole API can be evaluated for pharmaceutical development, analytical requirements and bulk API applications according to applicable customer specifications and documentation requirements.
Quality systems for API manufacturing include controlled processing, analytical testing, batch documentation and appropriate quality-control procedures. Product documentation can be provided according to the applicable commercial and regulatory requirements.
Sertindole is a solid API and should be stored in a tightly closed container, protected from unsuitable environmental conditions such as excessive heat, moisture and light. Commercial analytical references commonly recommend refrigerated storage, with TCI specifying 0–10°C and other references recommending 2–8°C. Actual storage conditions should follow the validated stability data and product-specific specification.
Depending on the commercial requirement, documentation associated with Sertindole API may include:
Sertindole requires careful control of identity, chromatographic purity and process-related impurities. Swapnroop Drugs and Pharmaceuticals focuses on controlled API manufacturing, analytical quality assessment and documentation support. Customers requiring Sertindole API for pharmaceutical development, formulation development or bulk API requirements can discuss applicable specifications and documentation requirements with the company.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | NLT 97.5% |
| Melting Point | 154–156°C |
| Solubility | 9.63 mg/L in water |