Description

Lamotrigine-2N-Glucuronide is a crucial glucuronide metabolite of the widely prescribed antiepileptic drug, Lamotrigine. This reference standard is essential for pharmaceutical research and development, enabling precise pharmacokinetic studies and bioanalytical method validation. It is primarily used by analytical laboratories, pharmaceutical manufacturers, and contract research organizations (CROs) focused on drug metabolism, therapeutic drug monitoring, and regulatory compliance.

Application

• Pharmacokinetic and Bioanalytical Research: Serves as a critical reference standard for quantifying Lamotrigine and its metabolites in biological matrices (plasma, serum, urine) using LC-MS/MS or HPLC.
• Drug Metabolism and Disposition (DMPK) Studies: Used to investigate the metabolic pathways, clearance mechanisms, and excretion profiles of Lamotrigine.
• Therapeutic Drug Monitoring (TDM) Assay Development: Essential for calibrating and validating assays that monitor Lamotrigine levels in patients to ensure therapeutic efficacy and avoid toxicity.
• Impurity Profiling and Characterization: Acts as a known impurity or degradation product reference in the quality control of Lamotrigine active pharmaceutical ingredient (API) and finished dosage forms.
• Clinical Research: Supports studies on drug-drug interactions, pharmacogenomics, and the impact of renal or hepatic impairment on Lamotrigine metabolism.
• Regulatory Submissions: Provides certified material for inclusion in regulatory filings (e.g., FDA, EMA) to support analytical methods and impurity control strategies.

Basic Information

Product Name	Lamotrigine-2N-Glucuronide
CAS No.	135288-68-5
Molecular Formula	C22H24N6O8
Molecular Weight	500.46 g/mol
Synonyms	Lamotrigine N2-Glucuronide; 2N-Glucuronide Lamotrigine; Lamotrigine Glucuronide Metabolite; 3,5-Diamino-6-(2,3-dichlorophenyl)-1,2,4-triazin-2-yl β-D-Glucopyranosiduronic Acid; LTG-2N-G; Lamotrigine Major Inactive Metabolite; NSC 339586
EINECS	Contact for details

Quality Control

Our Lamotrigine-2N-Glucuronide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR, MS), to ensure it meets the high standards required for reference materials. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below for long-term stability. This compound is hygroscopic (moisture-sensitive). Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular 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.