Description

Lamotrigine is a high-purity pharmaceutical active ingredient, a phenyltriazine derivative primarily used as an anticonvulsant and mood stabilizer. Its consistent quality and reliable synthesis are critical for ensuring the safety and efficacy of final drug formulations. This compound is essential for manufacturers in the pharmaceutical industry engaged in the production of generic and branded medications for neurological and psychiatric conditions.

Application

• Pharmaceutical Active Ingredient (API): Primary use in the formulation of antiepileptic drugs for the treatment of partial seizures and generalized tonic-clonic seizures.
• Mood Stabilizer: Key component in medications for the long-term treatment of bipolar disorder to prevent depressive and manic episodes.
• Generic Drug Manufacturing: Sourcing for the production of bioequivalent generic versions of brand-name lamotrigine tablets and extended-release formulations.
• Clinical Research & Development: Used as a reference standard or raw material in preclinical and clinical studies for new neurological therapies.
• Dosage Form Development: Utilized in the R&D of various dosage forms, including orally disintegrating tablets and sustained-release systems.

Basic Information

Product Name	Lamotrigine
CAS No.	84057-84-1
Molecular Formula	C9H7Cl2N5
Molecular Weight	256.09 g/mol
Synonyms	3,5-Diamino-6-(2,3-dichlorophenyl)-1,2,4-triazine; Lamictal (Brand Name); LTG; BW430C; NSC-106569; LAM
EINECS	Contact for details

Quality Control

Our Lamotrigine is manufactured under strict quality management systems, targeting compliance with major pharmacopoeial standards such as USP and EP. Every batch undergoes comprehensive analytical testing including identification, assay, and impurity profiling to ensure it meets stringent specifications for pharmaceutical use. A Certificate of Analysis (COA) detailing all test results is provided with each shipment to guarantee traceability and batch-to-batch consistency.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture absorption.

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 Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual impurity: ≤ 0.15% Total impurities: ≤ 0.5%
Heavy Metals	≤ 20 ppm

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