Description

Lamotrigine N2-Glucuronide is a major, pharmacologically inactive metabolite of the anticonvulsant and mood stabilizer drug Lamotrigine. This compound is of critical importance in pharmaceutical research and development, primarily serving as a reference standard for bioanalytical studies. It is essential for scientists and quality control laboratories in the pharmaceutical and contract research organization (CRO) sectors who require high-purity metabolites for pharmacokinetic profiling, drug metabolism and pharmacokinetics (DMPK) studies, and the validation of analytical methods.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for quantifying Lamotrigine and its metabolites in biological matrices during clinical trials and therapeutic drug monitoring.
• Drug Metabolism & Pharmacokinetics (DMPK): Critical for in vitro and in vivo studies to understand the metabolic pathways, clearance mechanisms, and excretion profiles of Lamotrigine.
• Bioanalytical Method Development & Validation: Used as a key calibrant and quality control sample in developing and validating LC-MS/MS, HPLC, and other chromatographic assays.
• Pharmacology & Toxicology Research: Employed in studies to investigate potential drug-drug interactions and the safety profile of Lamotrigine therapy.
• Impurity Profiling: Acts as a specified impurity standard in the quality control of Lamotrigine active pharmaceutical ingredient (API) and finished drug products to ensure compliance with ICH guidelines.
• Academic Research: Utilized in university and institutional labs for fundamental research on antiepileptic drugs and glucuronidation processes.

Basic Information

Product Name	Lamotrigine N2-Glucuronide
CAS No.	133310-19-7
Molecular Formula	C22H24Cl2N6O7
Molecular Weight	555.37 g/mol
Synonyms	Lamotrigine N-2 Glucuronide; Lamotrigine N2-Glucuronide; 3,5-Diamino-6-(2,3-dichlorophenyl)-1,2,4-triazin-2-yl 2-(β-D-Glucopyranosiduronic acid); Lamotrigine Glucuronide (N2); Lamotrigine N-2-β-D-Glucuronide; Lamotrigine N2-β-D-Glucuronide; Lamotrigine Major Inactive Metabolite; LTG N2-Glucuronide
EINECS	Contact for details

Quality Control

Our Lamotrigine N2-Glucuronide is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment. We support compliance with relevant pharmacopeial and ICH guidelines for impurities and reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). This product is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Specific Optical Rotation	Contact for details

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