Description

Lamotrigine Impurity D 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, efficacy, and regulatory compliance of the active pharmaceutical ingredient Lamotrigine. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories involved in method development, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Lamotrigine API and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and other chromatographic methods to meet ICH guidelines.
• Quality Control and Batch Release: Essential for routine quality control testing to ensure Lamotrigine batches meet stringent pharmacopeial specifications (USP, EP, JP).
• Stability Studies: Employed to monitor the formation of degradation products in Lamotrigine under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA) to agencies like the FDA and EMA.
• Research and Development: Used in R&D to study the metabolic pathways, degradation mechanisms, and synthesis pathways of Lamotrigine.

Basic Information

Item	Detail
Product Name	Lamotrigine Impurity D
CAS No.	661463-79-2
Molecular Formula	C9H7Cl2N5
Molecular Weight	264.09 g/mol
Synonyms	3-Amino-6-(2,3-dichlorophenyl)-1,2,4-triazine-5(4H)-one; 6-(2,3-Dichlorophenyl)-1,2,4-triazine-3,5(2H,4H)-dione; Lamotrigine Related Compound D; Lamotrigine EP Impurity D; Lamotrigine USP Impurity D; Lamotrigine Degradant D
EINECS	Contact for details

Quality Control

Every batch of Lamotrigine Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous testing to ensure identity, purity, and consistency, meeting the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC purity assay, related substance analysis, and spectroscopic identification (IR, NMR, MS). We support compliance with ICH Q3A, Q3B, and relevant pharmacopeial (USP, EP) guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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