Lamotrigine is an antiepileptic drug and active pharmaceutical ingredient used in the management of epilepsy and certain mood disorders. It belongs to the phenyltriazine class of compounds and is available as a pharmaceutical-grade API for the development and manufacture of appropriate formulations.
Lamotrigine primarily works by inhibiting voltage-gated sodium channels, thereby reducing excessive neuronal excitability and the release of excitatory neurotransmitters. It is used as an anticonvulsant and, in appropriate formulations and indications, as a mood-stabilizing agent.
Lamotrigine is a synthetic heterocyclic compound with the molecular formula C9H7Cl2N5 and a molecular weight of 256.09 g/mol. Its CAS Number is 84057-84-1.
Lamotrigine is generally described as a white to pale cream crystalline powder. It is practically insoluble in water and has limited solubility in several organic solvents.
Lamotrigine primarily inhibits voltage-sensitive sodium channels in neuronal membranes. This stabilizes neuronal membranes and reduces the excessive release of excitatory neurotransmitters, particularly glutamate and aspartate.
Lamotrigine is used in pharmaceutical formulations for the management of epilepsy, including certain focal and generalized seizure disorders. It is also used in the maintenance treatment of bipolar disorder in appropriate approved formulations.
Lamotrigine API can be evaluated using validated analytical procedures for identification, assay, related substances, water content, residual solvents and other applicable quality attributes. HPLC and suitable spectroscopic techniques may be used for identity and purity assessment.
Acceptance criteria should be based on the applicable pharmacopoeial monograph or approved manufacturer's drug-substance specification and Certificate of Analysis.
Lamotrigine should be stored in a tightly closed pharmaceutical-grade container under controlled storage conditions. The material should be protected from excessive heat, moisture, direct light and contamination. Specific storage requirements should follow the applicable manufacturer's specification.
Lamotrigine API may be supplied for qualified pharmaceutical manufacturing, formulation development, research and analytical applications. Product specifications, Certificate of Analysis, packaging details and regulatory documentation should be confirmed according to the intended application.
Lamotrigine API is available for pharmaceutical development and manufacturing requirements subject to applicable quality and regulatory requirements. Customers can request product specifications, analytical documentation, Certificate of Analysis, packaging information and commercial details for their specific requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 2.0% |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 2.0% |
| Melting Point | Approximately 217–221°C |