Swapnroop Drugs & Pharmaceuticals is a manufacturer and supplier of Vigabatrin API for pharmaceutical formulation, development, research and regulated pharmaceutical manufacturing applications.
Vigabatrin is a synthetic small-molecule antiepileptic active pharmaceutical ingredient (API) and a structural analogue of gamma-aminobutyric acid (GABA). It acts as an irreversible inhibitor of gamma-aminobutyric acid transaminase (GABA-T), an enzyme involved in the metabolism of GABA in the central nervous system. By inhibiting GABA-T, Vigabatrin increases GABA concentrations and supports its anticonvulsant activity.
Vigabatrin is identified by CAS No. 68506-86-5, with molecular formula C6H11NO2 and molecular weight approximately 129.16 g/mol. It is a synthetic pharmaceutical compound used in the development and manufacture of medicines for specific seizure disorders.
Vigabatrin is a synthetic gamma-vinyl GABA analogue belonging to the class of antiepileptic pharmaceutical compounds. Its mechanism of action is associated with irreversible inhibition of GABA transaminase, resulting in increased levels of the inhibitory neurotransmitter GABA in the brain.
Vigabatrin is commercially important as an API for pharmaceutical formulations used in the management of specific seizure disorders. It is used in pharmaceutical products intended for patients with refractory complex partial seizures and infantile spasms, according to applicable approved indications.
Vigabatrin API is primarily used in pharmaceutical development and manufacturing of antiepileptic medicines.
Key applications include:
Vigabatrin increases the concentration of GABA in the central nervous system by irreversibly inhibiting GABA transaminase. This pharmacological activity contributes to its anticonvulsant effect.
Vigabatrin API can be used in the development of pharmaceutical products in different oral dosage forms. The applicable dosage form, strength and therapeutic indication depend on the finished pharmaceutical product and the regulatory requirements of the intended market.
Vigabatrin 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 Vigabatrin is a structurally defined small molecule and is supplied as a racemic form, appropriate analytical control is important for maintaining consistent pharmaceutical quality.
For pharmaceutical manufacturing, Vigabatrin API should be evaluated using validated analytical methods suitable for the drug substance and intended pharmaceutical application.
Quality evaluation may include testing for identity, assay, related substances and process-related impurities. Additional testing may be performed for residual solvents, water content, elemental impurities and other critical quality attributes according to the applicable product specification.
Acceptance criteria should be established according to the applicable controlled API specification, regulatory requirements, validated analytical methods and customer requirements.
Swapnroop Drugs & Pharmaceuticals provides Vigabatrin API manufacturing and supply support for pharmaceutical companies, formulation developers and qualified customers involved in neurological and antiepileptic pharmaceutical development and manufacturing.
As a Vigabatrin API manufacturer and supplier in India, Swapnroop supports requirements involving:
Vigabatrin 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 Vigabatrin API may include analytical evaluation of identity, assay, related substances, residual solvents, water content and other applicable pharmaceutical quality attributes.
Identity testing helps confirm the chemical identity of Vigabatrin, while assay testing is used to determine the content of the active pharmaceutical ingredient. Related-substance testing is important for monitoring organic impurities and maintaining appropriate purity levels.
Additional analytical controls may be applied based on the intended pharmaceutical application and applicable regulatory requirements. Validated analytical procedures help ensure consistency between manufacturing batches.
Vigabatrin is freely soluble in water and has a reported pH of approximately 6.9 for a 1% aqueous solution. Its reported melting range is approximately 171–176°C with decomposition.
Swapnroop Drugs & Pharmaceuticals supports pharmaceutical manufacturers and qualified customers seeking Vigabatrin API for formulation, development and regulated pharmaceutical manufacturing applications.
Our approach focuses on:
Swapnroop supports customers looking for Vigabatrin API Manufacturer and Supplier in India for neurological, antiepileptic and pharmaceutical applications.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| pH (1% Solution) | 6.9 |
| Melting Point | 171–176°C (with decomposition) |
| Solubility | 55.1 mg/mL in water |