Swapnroop Drugs & Pharmaceuticals is a manufacturer and supplier of Vilazodone API for pharmaceutical formulation, development, research and regulated pharmaceutical manufacturing applications.
Vilazodone is a synthetic small-molecule antidepressant active pharmaceutical ingredient (API). The pharmaceutical active ingredient is commonly supplied as Vilazodone Hydrochloride, a hydrochloride salt of vilazodone. It has a dual pharmacological profile, functioning as a selective serotonin reuptake inhibitor (SSRI) and a 5-HT1A receptor partial agonist.
Vilazodone Hydrochloride is identified by CAS No. 163521-08-2, with molecular formula C26H28ClN5O2 and molecular weight approximately 477.99 g/mol. It is used in pharmaceutical formulations for the treatment of major depressive disorder in adults.
Vilazodone is a complex synthetic small-molecule pharmaceutical compound containing benzofuran, indole and piperazine structural groups. The hydrochloride salt is the active pharmaceutical ingredient used in the marketed oral pharmaceutical product.
Vilazodone combines serotonin reuptake inhibition with partial agonist activity at the 5-HT1A receptor. This pharmacological profile distinguishes Vilazodone from conventional selective serotonin reuptake inhibitors.
Vilazodone Hydrochloride is commercially important as an API for pharmaceutical formulations intended for the treatment of major depressive disorder (MDD) in adults.
Vilazodone API is primarily used in pharmaceutical development and manufacturing of antidepressant formulations for major depressive disorder.
Key applications include:
Vilazodone Hydrochloride is used as the active ingredient in oral pharmaceutical formulations indicated for the treatment of major depressive disorder in adults.
The pharmacological activity of Vilazodone is associated with inhibition of serotonin reuptake and partial agonist activity at 5-HT1A receptors. This combined mechanism contributes to its antidepressant pharmacological profile.
Vilazodone Hydrochloride requires appropriate controls for identity, assay, related substances, residual solvents, water content and other applicable quality attributes as part of pharmaceutical API quality management.
Because Vilazodone Hydrochloride is a structurally complex small molecule containing multiple functional groups, appropriate analytical control is important for maintaining consistent pharmaceutical quality.
For pharmaceutical manufacturing, Vilazodone API should be evaluated using validated analytical methods appropriate to the drug substance and intended regulatory market.
Quality evaluation may include testing for identity, assay, related substances and process-related impurities. Additional controls may be applied for residual solvents, elemental impurities, water content and other critical quality attributes according to the applicable specification.
Acceptance criteria should be established according to the applicable controlled API specification, pharmacopoeial requirements where applicable, validated analytical methods and customer requirements.
Swapnroop Drugs & Pharmaceuticals provides Vilazodone API manufacturing and supply support for pharmaceutical companies, formulation developers and qualified customers involved in CNS and antidepressant pharmaceutical development and manufacturing.
As a Vilazodone API manufacturer and supplier in India, Swapnroop supports requirements involving:
Vilazodone API should be stored in suitable tightly closed pharmaceutical-grade containers under controlled environmental conditions.
The material should be protected from excessive moisture, heat, light and unsuitable environmental exposure. Storage conditions should follow the applicable product specification, safety documentation and validated stability requirements.
For commercial pharmaceutical API handling, exact storage conditions should be established according to the manufacturer's stability data, packaging configuration and applicable regulatory documentation.
Typical pharmaceutical documentation may include:
Documentation requirements may vary according to the customer's intended market, regulatory requirements and qualification process.
Quality control for Vilazodone API may include analytical evaluation of identity, assay, related substances, residual solvents, water content and other applicable pharmaceutical quality attributes.
Vilazodone Hydrochloride has the molecular formula C26H28ClN5O2 and molecular weight of approximately 477.99 g/mol. The active pharmaceutical ingredient is the hydrochloride salt of Vilazodone.
Appropriate analytical methods should be used to confirm the identity and purity of the active pharmaceutical ingredient. Chromatographic, spectroscopic and other validated analytical techniques may be applied according to the applicable specification and regulatory requirements.
Control of related substances is particularly important for a complex synthetic API. Manufacturing-process impurities, degradation products and other specified or unspecified impurities should be controlled according to the applicable pharmaceutical specification.
Vilazodone Hydrochloride has reported low aqueous solubility. The available experimental data report a solubility of approximately 0.123 g/L, equivalent to 0.123 mg/mL, for Vilazodone Hydrochloride. Solubility can vary with experimental conditions and should not be treated as a universal release specification.
Swapnroop Drugs & Pharmaceuticals supports pharmaceutical manufacturers and qualified customers seeking Vilazodone API for formulation, development and regulated pharmaceutical manufacturing applications.
Our approach focuses on:
Swapnroop supports customers looking for Vilazodone API Manufacturer and Supplier in India for antidepressant, CNS and pharmaceutical applications.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Melting Point | 227–279°C |
| Solubility | 0.123 mg/mL |