Felbamate is a synthetic antiepileptic active pharmaceutical ingredient (API) used as an anticonvulsant. It is a dicarbamate derivative with activity involving multiple neuronal mechanisms, including modulation of NMDA receptor-mediated excitatory neurotransmission and enhancement of inhibitory GABAergic activity.
Felbamate is chemically identified by CAS Number 25451-15-4, molecular formula C₁₁H₁₄N₂O₄, and molecular weight 238.24 g/mol.
Felbamate is an orally active anticonvulsant used in the treatment of certain forms of epilepsy. It has been used particularly in partial seizures and Lennox-Gastaut syndrome, although its use is restricted because of serious safety risks associated with the drug.
Felbamate is a small-molecule pharmaceutical API and is available as a pharmaceutical active ingredient for formulation and pharmaceutical development.
The precise anticonvulsant mechanism of Felbamate is not completely established. Its pharmacological activity is associated with modulation of excitatory and inhibitory neurotransmission.
Felbamate:
Felbamate has been used in pharmaceutical formulations for:
Because Felbamate has been associated with aplastic anemia and serious hepatic toxicity, its clinical use is restricted and requires appropriate medical supervision and monitoring.
Felbamate is a synthetic small-molecule API used in pharmaceutical manufacturing and drug development. Typical API quality evaluation may include:
Exact numerical acceptance criteria should be taken from the current approved manufacturer specification and Certificate of Analysis (CoA).
Pharmaceutical-grade Felbamate should be manufactured and tested according to applicable GMP and regulatory requirements. Technical documentation may include:
Store Felbamate API in a tightly closed container, protected from excessive moisture, heat and direct light, according to the manufacturer's approved storage and stability 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 0.2% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |