Description

Lamotrigine Impurity 11 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Lamotrigine by serving as a key marker in impurity profiling and method validation. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies engaged in drug development and quality control.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Lamotrigine API and finished drug products.
• Analytical Method Development & Validation: Critical for developing, validating, and verifying HPLC, UPLC, and GC analytical methods in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (USP, EP, JP).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress and storage conditions.
• Research & Development: Facilitates studies on the degradation pathways, synthesis impurities, and metabolic profiling of Lamotrigine.

Basic Information

Product Name	Lamotrigine Impurity 11
CAS No.	1051437-86-5
Molecular Formula	C9H7Cl2N5
Molecular Weight	256.09 g/mol
Synonyms	3,5-Diamino-6-(2,3-dichlorophenyl)-1,2,4-triazine; Lamotrigine Related Compound H; Lamotrigine Impurity H; Lamotrigine EP Impurity H; Lamotrigine USP Impurity; 6-(2,3-Dichlorophenyl)-1,2,4-triazine-3,5-diamine; Lamotrigine Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Lamotrigine Impurity 11 is manufactured and controlled under a strict quality management system. Comprehensive analytical testing, including HPLC for purity and structural confirmation via NMR and MS, is performed to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) with batch-specific data, traceable to primary standards, is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 0.5% w/w
Residue on Ignition	≤ 0.1%

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