Lamotrigine

Lamotrigine

Nombre del producto Lamotrigine
Número CAS 84057-84-1
Fórmula molecular C9H7Cl2N5
Peso molecular 256.09 g/mol
Apariencia Polvo cristalino de color blanco a blanquecino
Ensayo (HPLC) 98.0% – 102.0%
Punto de fusión 216–218 °C
Solubilidad Sparingly soluble in water; soluble in dimethyl sulfoxide, dimethylformamide
Paquete 25 kg fiber drum with double polyethylene liner

Lamotrigine Structure

Sinónimos: 3,5-Diamino-6-(2,3-dichlorophenyl)-1,2,4-triazine, Lamictal, LTG, BW-430C, 6-(2,3-Dichlorophenyl)-1,2,4-triazine-3,5-diamine

Lamotrigine is a phenyltriazine derivative that has carved out a distinct place in the anticonvulsant and mood-stabilizer markets since its approval in the 1990s. Unlike older antiepileptics that emerged from serendipitous screening, lamotrigine was designed to inhibit glutamate release—a mechanism that translates into broad-spectrum efficacy across partial and generalized seizures. For procurement teams, it represents a reliable, well-characterized API with steady demand from both generic and branded formulators.

From a chemical standpoint, lamotrigine is a small molecule (C9H7Cl2N5) with a dichlorophenyl ring attached to a diaminotriazine core. This structure gives it moderate lipophilicity and a low aqueous solubility, which formulators often address through salt formation or particle-size engineering. The compound is chemically stable under normal storage conditions, though it is light-sensitive and should be protected from prolonged exposure to strong UV light.

Manufacturing lamotrigine at commercial scale typically involves a multi-step synthesis starting from 2,3-dichlorobenzoyl chloride or related precursors. The critical quality attributes—assay, related substances, and residual solvents—are tightly controlled to meet pharmacopeial monographs (USP, EP, BP). Our material is produced under cGMP conditions and is available with full regulatory support, including DMF and CEP where applicable.

While lamotrigine is best known for epilepsy, its use in bipolar disorder—particularly for delaying depressive episodes—has expanded its clinical footprint. This dual indication keeps demand stable across multiple therapeutic categories, making it a strategic API for companies serving both neurology and psychiatry markets.

Función

  • Anticonvulsant activity: Blocks voltage-gated sodium channels, stabilizing neuronal membranes and reducing seizure spread.
  • Glutamate inhibition: Suppresses excessive glutamate release, which contributes to its broad-spectrum efficacy.
  • Mood stabilization: Effective in delaying depressive episodes in bipolar I disorder, likely through limbic system modulation.
  • Neuroprotective potential: Under investigation for conditions involving glutamate excitotoxicity, such as neuropathic pain.

Source & Standardization

  • Source: Synthetic chemical synthesis (not botanical)
  • Standardization: Complies with USP/EP/BP monographs; assay 98.0–102.0% (HPLC)
  • Forms: White to off-white crystalline powder
  • Aplicaciones: Antiepileptic and mood-stabilizer finished dosage forms

Especificaciones

Parámetro Especificaciones
Assay (HPLC, dried basis) 98.0% – 102.0%
Identificación IR, UV conforms to reference standard
Pérdida por secado ≤ 0,51 TP3T
Residuo tras la combustión ≤ 0,11 TP3T
Metales pesados ≤ 20 ppm
Sustancias relacionadas Total impurities ≤ 0.5%; each unspecified ≤ 0.1%
Disolventes residuales Meets USP / EP 5.4 requirements

Documentation & Supply

  • Monthly capacity: 2–3 metric tons
  • Plazo de entrega: 3-5 días laborables (artículos en stock)
  • Documentación: COA, MSDS, TDS, DMF (where applicable), stability data
  • Embalaje: 25 kg fiber drum with double polyethylene liner, or as requested

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