Description

Lamotrigine-5N-Glucuronide is a key metabolite of the anticonvulsant and mood stabilizer drug lamotrigine, formed via glucuronidation. This compound is of critical importance in pharmaceutical research and development, particularly for drug metabolism and pharmacokinetic (DMPK) studies. It serves as an essential reference standard for analytical laboratories in the pharmaceutical and biotechnology sectors, enabling accurate quantification and characterization of lamotrigine metabolism in biological samples to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the calibration of analytical instruments in bioanalytical method development and validation.
• Drug Metabolism Studies (DMPK): Critical for investigating the metabolic pathways, pharmacokinetics, and bioavailability of lamotrigine in preclinical and clinical research.
• Bioanalytical Testing: Used as a quantitative standard in LC-MS/MS, HPLC, and other chromatographic assays to measure lamotrigine and its metabolites in plasma, serum, and urine.
• Toxicology and Safety Assessment: Employed in studies to understand the metabolite profile and potential toxicological implications of lamotrigine therapy.
• Clinical Research: Supports therapeutic drug monitoring (TDM) programs and clinical trials to correlate drug metabolite levels with patient response or side effects.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) requiring detailed characterization of drug metabolites.

Basic Information

Product Name	Lamotrigine-5N-Glucuronide
CAS No.	76866-91-6
Molecular Formula	C22H21Cl2N5O7
Molecular Weight	522.34 g/mol
Synonyms	Lamotrigine N5-Glucuronide; 5N-Glucuronide Lamotrigine; Lamotrigine Glucuronide Metabolite; 3,5-Diamino-6-(2,3-dichlorophenyl)-1,2,4-triazin-2(1H)-one 5-N-Glucuronide; Lamotrigine N-5-Glucuronide; Lamotrigine Major Inactive Metabolite; Lamotrigine-5N-β-D-Glucuronide
EINECS	Contact for details

Quality Control

Every batch of Lamotrigine-5N-Glucuronide is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic methods, to ensure high purity and identity confirmation suitable for use as a reference standard. Certificates of Analysis (COA) detailing batch-specific results for purity, identity, and impurities are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing desiccated at -20°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥95.0%
Water Content (KF)	≤5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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