Description

Lamotrigine Impurity 3 is a designated reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient Lamotrigine. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by enabling the accurate identification and quantification of related substances. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory compliance teams involved in the development and manufacturing of Lamotrigine-based medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for method development, validation, and routine quality control testing of Lamotrigine API and finished dosage forms.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods (HPLC, UPLC) to separate, identify, and quantify this specific impurity.
• Stability Studies: Used to monitor the formation of degradation products in Lamotrigine formulations under various stress conditions (heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity profiles required for drug approval.
• Pharmacopoeial Testing: Employed to ensure compliance with monograph specifications in pharmacopoeias such as USP, EP, or BP.
• Process Chemistry & Optimization: Helps in identifying and controlling the impurity during the synthesis and purification stages of Lamotrigine manufacturing.

Basic Information

Product Name	Lamotrigine Impurity 3
CAS No.	35022-44-7
Molecular Formula	C9H7Cl2N5
Molecular Weight	256.09 g/mol
Synonyms	3,5-Diamino-6-(2,3-dichlorophenyl)-1,2,4-triazine; Lamotrigine Impurity C; Lamotrigine Related Compound C; 6-(2,3-Dichlorophenyl)-1,2,4-triazine-3,5-diamine; Lamotrigine EP Impurity C; Lamotrigine USP Related Compound C; Lamotrigine Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Lamotrigine Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated analytical methods (HPLC, NMR, MS) to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, keep the container under inert atmosphere to prevent potential degradation.

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%
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.