Lamotrigine is a phenyltriazine class active pharmaceutical ingredient functioning as a voltage-gated sodium channel blocker. It suppresses rapid neuronal firing, inhibits sustained repetitive high-frequency firing, and modulates glutamate release. As a core anticonvulsant and mood-stabilizing raw material, it is utilized globally for formulating treatments targeting partial seizures, generalized tonic-clonic seizures, and maintenance therapy for bipolar I disorder. Produced via controlled organic synthesis, this API maintains strict structural integrity, predictable impurity profiles, and controlled particle morphology to support seamless downstream solid oral dosage formulation development and scale-up.
Technical Specifications
|
Parameter |
Specification Details |
|
International Nonproprietary Name |
Lamotrigine |
|
Chemical Name |
6-(2,3-dichlorophenyl)-1,2,4-triazine-3,5-diamine |
|
CAS Number |
84057-84-1 |
|
Appearance |
White to pale yellow crystalline powder |
|
Solubility |
Practically insoluble in water; slightly soluble in methanol and boiling ethanol; soluble in dilute mineral acids |
|
Assay (Dried basis) |
98.5% – 101.5% (HPLC) |
|
Identification |
Infrared Absorption matches reference standard; HPLC retention time conforms |
|
Loss on Drying |
Max 0.5% (105°C, 3 hours) |
|
Residue on Ignition |
Max 0.1% |
|
Heavy Metals |
Max 20 ppm |
|
Individual Specified Impurity |
Max 0.10% |
|
Unspecified Impurities |
Max 0.05% |
|
Total Impurities |
Max 0.30% |
|
Residual Solvents (Class 3) |
Complies with ICH Q3C limits (Ethanol max 0.5%, Acetone max 0.5%) |
|
Particle Size Distribution |
Controlled particle size distribution upon request for direct compression or micronization requirements |
|
Storage Conditions |
Store in a tightly closed container, protected from light and moisture, at controlled room temperature |
|
Re-test Period |
36 months from manufacturing date |
Manufacturing & Quality Control
Synthesis Route: Multi-step catalytic condensation and purification avoiding high-risk genotoxic intermediates.
Production Environment: Cleanroom manufacturing facilities operating under current Good Manufacturing Practice standards.
Equipment Materials: Glass-lined and high-grade stainless steel reactors to eliminate metallic leaching.
In-Process Controls: High-performance liquid chromatography, gas chromatography, and titration monitoring at each reaction and crystallization stage.
Supply Stability: Dedicated sourcing of key raw materials and validated secondary manufacturing lines to ensure continuous supply.
Regulatory Documentation
Drug Master File: Available in ICH format for regulatory filing and customer cross-reference.
Certificate of Analysis: Provided with every commercial shipment detailing exact analytical parameters.
Material Safety Data Sheet: Comprehensive hazard, handling, and personal protective equipment specifications provided.
Stability Data: Long-term and accelerated stability study summaries available.
Genotoxic Impurity Evaluation: Risk assessment and analytical testing reports conforming to ICH M7 guidelines.
Compliance Statements: Certified free from animal-origin raw materials and verified compliance under ICH Q3C residual solvent guidelines.
Packaging & Logistics
Food-grade, double-layer low-density polyethylene bags, heat-sealed under tamper-evident conditions.
Rigid UN-certified fiber drums with desiccant sachets placed between layers to prevent moisture ingress.
25 kg per drum, with customized packaging configurations available upon technical agreement.
Product name, CAS number, batch number, net weight, gross weight, manufacturing date, re-test date, and storage instructions clearly affixed.
Pharmaceutical Applications
Immediate-Release Tablets: Utilized as the active pharmaceutical ingredient for standard oral tablets treating epilepsy monotherapy and adjunctive therapy, enabling consistent disintegration rates and reproducible dissolution profiles.
Dispersible and Chewable Tablets: Serves pediatric and adult formulations requiring specific particle size distributions, facilitating uniform suspension and pleasant mouthfeel characteristics.
Extended-Release Formulations: Integrated into modified-release polymer matrix systems for once-daily maintenance dosing regimens with predictable in-vivo pharmacokinetic release kinetics.
Bipolar Disorder Maintenance Therapies: Manufactured to strict purity parameters for psychiatric drug formulations, minimizing trace organic impurities for long-term chronic treatments.
FAQ
Q: What regulatory documentation accompanies commercial shipments?
A: Each shipment is dispatched with a batch-specific Certificate of Analysis, analytical methods validation summaries, and complete chain of custody documentation aligned with current regulatory submission standards.
Q: Is the manufacturing process compliant with ICH Q7 standards?
A: Yes. Synthesis, purification, isolation, packaging, and quality control testing are executed strictly under ICH Q7 Good Manufacturing Practice guidelines for active pharmaceutical ingredients.
Q: Can particle size distribution be customized for specific formulation needs?
A: Yes. Milling and micronization parameters can be adjusted to meet specific particle size distribution requirements, such as target median and upper threshold limits, to optimize powder flow and tableting performance.
Q: What is the standard minimum order quantity for commercial evaluation?
A: Sample quantities for laboratory evaluation start from 100 grams to 1 kilogram, while commercial trial orders and standard manufacturing batch quantities are tailored to contractual supply agreements.
Q: How is moisture protection managed during international transit?
A: Packaging utilizes dual-layer heat-sealed polyethylene liners encased within UN-approved fiber drums with integrated desiccants, mitigating humidity exposure throughout global shipping routes.
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