Description

Lamotrigine Impurity I CAS NO 2250242-15-8 is a high-purity reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient Lamotrigine. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is an essential tool for research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Lamotrigine Impurity I in drug substances and products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing in pharmaceutical manufacturing to monitor and control impurity levels, ensuring compliance with ICH guidelines.
• Stability Studies: Employed to track the formation of degradation impurities in Lamotrigine formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to regulatory bodies like the FDA and EMA.
• Research & Development: Supports synthetic route optimization and process chemistry research by helping to understand and control impurity formation.

Basic Information

Product Name	Lamotrigine Impurity I
CAS No.	2250242-15-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lamotrigine Related Compound I; Lamotrigine Impurity 1; 3,5-Diamino-6-(2,3-dichlorophenyl)-1,2,4-triazine; Lamotrigine EP Impurity I; Lamotrigine USP Impurity I; Lamotrigine Process Impurity; Lamotrigine Degradant
EINECS	Contact for details

Quality Control

Our Lamotrigine Impurity I is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatograms and spectral data are provided to support your regulatory and quality needs.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
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.