Description

Lamotrigine 5-n-β-D-Glucuronide is a major, pharmacologically inactive metabolite of the anticonvulsant drug Lamotrigine, formed via glucuronidation. This compound is of critical importance for pharmaceutical research and development, serving as a primary reference standard for bioanalytical studies. It is essential for scientists and quality control laboratories in the pharmaceutical and biotechnology industries who require precise quantification of Lamotrigine and its metabolites in biological matrices for pharmacokinetic profiling, drug metabolism studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary application as a certified reference material (CRM) for the calibration and validation of analytical methods.
• Bioanalytical Research: Used in the development and validation of HPLC, LC-MS, and LC-MS/MS assays for quantifying Lamotrigine and its metabolites in plasma, serum, and urine.
• Drug Metabolism and Pharmacokinetics (DMPK): Critical for studying the metabolic pathways, clearance rates, and excretion profiles of Lamotrigine.
• Toxicology Studies: Employed as an analytical standard in forensic and clinical toxicology to understand drug exposure and interactions.
• Quality Control in Manufacturing: Used by API and finished dosage form manufacturers to monitor and control potential metabolite impurities.
• Academic and Clinical Research: Supports investigations into Lamotrigine's efficacy, safety profile, and individual metabolic variability.

Basic Information

Product Name	Lamotrigine 5-n-β-D-Glucuronide
CAS No.	136565-77-0
Molecular Formula	C22H24Cl2N6O8
Molecular Weight	547.36 g/mol
Synonyms	Lamotrigine N5-Glucuronide; Lamotrigine 5-N-Glucuronide; Lamotrigine N-5-Glucuronide; 3,5-Diamino-6-(2,3-dichlorophenyl)-1,2,4-triazin-2(1H)-one 5-N-Glucuronide; Lamotrigine Glucuronide Metabolite; Lamotrigine Major Inactive Metabolite; Glucuronide conjugate of Lamotrigine; Lamotrigine N-β-D-Glucuronide
EINECS	Contact for details

Quality Control

Our Lamotrigine 5-n-β-D-Glucuronide is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis to ensure compliance with high-purity reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Water Content (KF)	≤2.0%
Residual Solvents (GC)	Complies with ICH guidelines
Heavy Metals	<20 ppm

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