Description

Lacosamide n-Methyl Impurity is a critical pharmaceutical reference standard used in the quality control and analytical development of the antiepileptic drug Lacosamide. This compound is essential for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark for identifying and quantifying process-related impurities. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of the n-Methyl impurity in Lacosamide Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): A critical component for developing, optimizing, and validating chromatographic methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: Essential for routine QC testing to ensure drug substance and product batches meet ICH Q3A/B guidelines for impurities.
• Stability Studies: Employed to track the formation of degradation impurities in Lacosamide formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Used in synthetic chemistry R&D to understand and optimize the Lacosamide manufacturing process to minimize impurity formation.

Basic Information

Product Name	Lacosamide n-Methyl Impurity
CAS No.	388619-64-5
Molecular Formula	C13H18N2O3
Molecular Weight	250.30 g/mol
Synonyms	(2R)-2-Acetamido-N-methyl-3-methoxypropionamide; N-Methyl Lacosamide; (R)-2-Acetamido-N-methyl-3-methoxypropanamide; Lacosamide Impurity F; Lacosamide EP Impurity F; Lacosamide Related Compound F; (R)-N-Methyl-2-(acetylamino)-3-methoxypropanamide; UNII-9V4F6U8Q5N
EINECS	Contact for details

Quality Control

Every batch of Lacosamide n-Methyl Impurity CAS 388619-64-5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with ICH guidelines and relevant pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results 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 cool, dry place. This material is hygroscopic (moisture-sensitive) and should be handled under dry conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Single Unknown Impurity	≤ 0.5%
Total Impurities	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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