Description

Lamotrigine Impurity H is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) Lamotrigine by enabling the accurate identification and quantification of related substances. It is an essential tool for analytical chemists and quality assurance professionals working in pharmaceutical R&D, quality control laboratories, and regulatory affairs.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Lamotrigine API and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine quality control testing to ensure Lamotrigine batches meet stringent pharmacopeial (USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Employed to monitor the formation of degradation products in Lamotrigine formulations under various stress conditions.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of this specific impurity.

Basic Information

Product Name	Lamotrigine Impurity H
CAS No.	1373393-59-9
Molecular Formula	C9H7Cl2N5
Molecular Weight	256.09 g/mol
Synonyms	3,5-Diamino-6-(2,3-dichlorophenyl)-1,2,4-triazine; 6-(2,3-Dichlorophenyl)-1,2,4-triazine-3,5-diamine; Lamotrigine Related Compound H; Lamotrigine Impurity 8; Lamotrigine EP Impurity H; Lamotrigine USP Impurity H
EINECS	Contact for details

Quality Control

Every batch of Lamotrigine Impurity H is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing all test results, including chromatographic purity, is provided with each shipment.

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 material 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 (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%

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