Description

Lamotrigine-13C3,D3, Major is a high-purity, stable isotope-labeled analog of the pharmaceutical compound Lamotrigine. This material is essential for use as an internal standard in quantitative bioanalytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolism studies. It is primarily required by pharmaceutical research and development laboratories, contract research organizations (CROs), and analytical testing facilities engaged in drug development and therapeutic drug monitoring.

Application

• Bioanalytical Internal Standard: Critical for the accurate quantification of Lamotrigine in biological matrices (e.g., plasma, serum, urine) using LC-MS/MS and GC-MS methodologies.
• Pharmacokinetic (PK) Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) in clinical and pre-clinical research.
• Metabolite Identification & Profiling: Aids in the structural elucidation and quantification of Lamotrigine metabolites in complex biological samples.
• Method Development & Validation: Serves as a reference compound for developing, optimizing, and validating robust analytical assays in compliance with GLP and FDA/EMA guidelines.
• Therapeutic Drug Monitoring (TDM): Supports the development of precise assays for monitoring Lamotrigine concentrations in patient samples to optimize dosing regimens.
• Stability-Indicating Assays: Used in forced degradation studies to assess the stability of Lamotrigine drug products and formulations.

Basic Information

Product Name	Lamotrigine-13C3,D3, Major
CAS No.	1246815-13-3
Molecular Formula	C9H413C3H4D3Cl2N5
Molecular Weight	~259.1 g/mol
Synonyms	6-(2,3-Dichlorophenyl)-1,2,4-triazine-3,5-diamine-13C3,D3; Lamotrigine-13C3,D3 (Major); Lamotrigine Internal Standard-13C3,D3; 3,5-Diamino-6-(2,3-dichlorophenyl)-as-triazine-13C3,D3; [13C3,D3]-Lamotrigine; Stable Isotope-Labeled Lamotrigine; Lamotrigine-d3-13C3; Lamotrigine (phenyl-13C3, 3,5-d3)
EINECS	Contact for details

Quality Control

Every batch of Lamotrigine-13C3,D3, Major is manufactured and analyzed under strict quality systems. We guarantee high chemical and isotopic purity to meet the exacting demands of quantitative mass spectrometry. Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are provided with each shipment, detailing isotopic enrichment, chemical purity (by HPLC), and confirming identity and structure.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storage under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (Mass Spec)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Enrichment	≥99 atom % 13C; ≥98 atom % D
Chemical Purity (by HPLC)	≥95.0%
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Complies with ICH limits

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