Description

Vigabatrin is a potent and selective irreversible inhibitor of the enzyme GABA transaminase, playing a critical role in modulating central nervous system activity. This pharmaceutical active ingredient is essential for the formulation of anticonvulsant medications, providing a targeted mechanism of action for specific neurological conditions. It is primarily required by global pharmaceutical manufacturers and research institutions engaged in the development and production of treatments for refractory complex partial seizures and infantile spasms.

Application

• Pharmaceutical Active Ingredient (API): Primary use in the formulation of oral tablets and powders for the treatment of epilepsy.
• Anticonvulsant Medication: Key component in therapies for managing refractory complex partial seizures in adults.
• Pediatric Neurology: Used in the treatment of infantile spasms (West syndrome) in pediatric patients.
• Neurological Research: Serves as a critical reference standard and tool compound in preclinical studies investigating GABAergic systems.
• Generic Drug Manufacturing: Essential for companies producing generic versions of established anticonvulsant drugs.
• Clinical Trial Materials: Supplied as a high-purity compound for Phase I-IV clinical studies in neurology.

Basic Information

Product Name	Vigabatrin
CAS No.	60643-86-9
Molecular Formula	C6H11NO2
Molecular Weight	129.16 g/mol
Synonyms	γ-Vinyl-GABA; GVG; (RS)-4-Aminohex-5-enoic Acid; Sabril (brand name); 4-Amino-5-hexenoic Acid; (±)-Vigabatrin; 60643-86-9
EINECS	Contact for details

Quality Control

Our Vigabatrin is manufactured under strict quality management systems to ensure it meets the exacting standards required for pharmaceutical applications. Each batch undergoes comprehensive analytical testing, including identification, assay, and impurity profiling via HPLC and other pharmacopoeial methods. Certificates of Analysis (COA) are provided with every shipment, confirming compliance with relevant specifications. We support compliance with GMP, ICH Q7, and major pharmacopoeia (USP, EP) guidelines for active pharmaceutical ingredients.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed to protect from moisture. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Optical Rotation	-0.10° to +0.10° (c=1 in H2O)

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.