Description

Lamotrigine N2-Oxide is a key pharmaceutical intermediate and a significant metabolite of the active pharmaceutical ingredient Lamotrigine. This compound is of critical importance for research and development in the pharmaceutical industry, particularly in the study of drug metabolism, pharmacokinetics, and the synthesis of related chemical entities. It is primarily utilized by pharmaceutical R&D laboratories, analytical service providers, and manufacturers engaged in the development of central nervous system (CNS) therapeutics and generic drugs.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis and research of Lamotrigine and its structural analogs.
• Metabolite Reference Standard: Used as an analytical standard in bioanalytical studies to identify and quantify Lamotrigine metabolites in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK) Research: Essential for studying the metabolic pathways, bioavailability, and clearance mechanisms of Lamotrigine.
• Impurity Profiling: Serves as a known impurity or degradation product reference in the quality control and stability testing of Lamotrigine drug substances and products.
• Chemical Research: Used in academic and industrial research to investigate the chemical properties and reactivity of triazine derivatives.
• Regulatory Compliance Testing: Supports the generation of data for regulatory filings (e.g., FDA, EMA) requiring characterization of drug metabolites.

Basic Information

Product Name	Lamotrigine N2-Oxide
CAS No.	136565-76-9
Molecular Formula	C9H7Cl2N5O
Molecular Weight	272.09 g/mol
Synonyms	3,5-Diamino-6-(2,3-dichlorophenyl)-1,2,4-triazine 2-Oxide; Lamotrigine N-Oxide; Lamotrigine Impurity F (EP); Lamotrigine Metabolite; 1,2,4-Triazine, 3,5-diamino-6-(2,3-dichlorophenyl)-, 2-oxide; GSK 56572; BRN 11324653
EINECS	Contact for details

Quality Control

Our Lamotrigine N2-Oxide is produced and tested under a strict quality management system. Each batch is analyzed to ensure high purity and consistency, meeting the requirements for use as a reference standard and intermediate. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic and spectroscopic data, including HPLC purity, identity confirmation (IR, NMR), and related substance profiles. Our quality commitment supports GMP/GLP-compliant research and regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Single Unknown Impurity	≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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