Description

Lacosamide Impurity 2 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Lacosamide. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of Lacosamide-based medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Lacosamide API and finished dosage forms.
• Method Development and Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control (QC) Testing: Employed in routine QC laboratories to ensure batch-to-batch consistency and compliance with stringent pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of drug stability programs.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate control over the impurity profile of the drug substance.
• Research and Development: Supports synthetic route optimization and process chemistry research by helping to identify and characterize process-related impurities.

Basic Information

Product Name	Lacosamide Impurity 2
CAS No.	1325220-60-7
Molecular Formula	C13H18N2O3
Molecular Weight	250.29 g/mol
Synonyms	(2R)-2-Acetamido-N-benzyl-3-methoxypropanamide; (R)-2-Acetamido-N-benzyl-3-methoxypropanamide; Lacosamide Related Compound; Lacosamide EP Impurity B; Lacosamide USP Impurity; Vimpat Impurity; (R)-N-Benzyl-2-acetamido-3-methoxypropanamide; Harkoseride Impurity
EINECS	Contact for details

Quality Control

Our Lacosamide Impurity 2 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We ensure compliance with relevant guidelines for impurity standards used in regulatory submissions.

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 hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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