Description

Lamotrigine-13C3 is a stable isotope-labeled analog of the widely used anticonvulsant and mood stabilizer, Lamotrigine. This high-purity reference material is essential for ensuring the accuracy and reliability of quantitative analytical methods. It is primarily utilized by pharmaceutical research and development laboratories, contract research organizations (CROs), and quality control departments for applications in bioanalysis, pharmacokinetic studies, and method validation.

Application

• Internal Standard for LC-MS/MS: Serves as a critical internal standard for the precise quantification of Lamotrigine in biological matrices (plasma, serum, urine) using liquid chromatography-tandem mass spectrometry.
• Drug Metabolism and Pharmacokinetics (DMPK): Used in studies to investigate the absorption, distribution, metabolism, and excretion (ADME) profile of Lamotrigine.
• Bioanalytical Method Development and Validation: A key component in developing and validating robust, sensitive, and specific analytical methods compliant with FDA, EMA, and ICH guidelines.
• Therapeutic Drug Monitoring (TDM): Enables accurate measurement of Lamotrigine concentrations in patient samples to optimize dosage and ensure therapeutic efficacy while minimizing side effects.
• Clinical Research: Supports clinical trials by providing reliable data on drug exposure and patient compliance.
• Forensic and Toxicology Analysis: Assists in the definitive identification and quantification of Lamotrigine in forensic investigations.

Basic Information

Product Name	Lamotrigine-13C3
CAS No.	1188265-38-4
Molecular Formula	C6H7Cl2N5-13C3
Molecular Weight	259.09 g/mol (approx.)
Synonyms	6-(2,3-Dichlorophenyl)-1,2,4-triazine-3,5-diamine-13C3; 3,5-Diamino-6-(2,3-dichlorophenyl)-1,2,4-triazine-13C3; Lamictal-13C3 (labeled analog); Lamotrigine (phenyl-13C3); Lamotrigine-13C3 (phenyl labeled); [phenyl-13C3]-Lamotrigine; Stable Isotope-Labeled Lamotrigine
EINECS	Contact for details

Quality Control

Every batch of Lamotrigine-13C3 is manufactured and tested under strict quality management systems. We guarantee high chemical and isotopic purity, supported by comprehensive analytical data including NMR, MS, and HPLC. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting purity, isotopic enrichment, and confirming the absence of unlabeled Lamotrigine. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to minimize exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity	≥99 atom % 13C
Chemical Purity	≥95%
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%

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