Description

Lacosamide Impurity 8/Lacosamide Ep Impurity H/(S)-2-Acetamido-n-((S)-1-(Benzylamino)-3-Methoxy-1-Oxopropan-2-Yl)-3-Methoxypropanamide CAS NO 1375090-19-9 is a high-purity chemical reference standard, specifically a stereoisomeric impurity of the active pharmaceutical ingredient Lacosamide. This compound is critical for pharmaceutical research, development, and quality control, enabling the accurate identification, quantification, and monitoring of impurities during drug manufacturing. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable standards to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Lacosamide Impurity 8 in active pharmaceutical ingredient (API) and finished drug product batches.
• Analytical Method Development & Validation: A critical component in developing and validating sensitive HPLC, UPLC, or LC-MS methods for impurity profiling of Lacosamide.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity) to establish drug shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough understanding and control of the drug substance impurity profile.
• Process Chemistry Research: Aids in optimizing synthetic pathways for Lacosamide by helping to identify and minimize the formation of this stereochemical impurity.

Basic Information

Item	Details
Product Name	Lacosamide Impurity 8/Lacosamide Ep Impurity H/(S)-2-Acetamido-n-((S)-1-(Benzylamino)-3-Methoxy-1-Oxopropan-2-Yl)-3-Methoxypropanamide
CAS No.	1375090-19-9
Molecular Formula	C17H25N3O5
Molecular Weight	351.40 g/mol
Synonyms	Lacosamide Impurity 8; Lacosamide EP Impurity H; (2S)-2-Acetamido-N-[(2S)-1-(Benzylamino)-3-methoxy-1-oxopropan-2-yl]-3-methoxypropanamide; (S)-2-Acetamido-N-((S)-1-(Benzylamino)-3-methoxy-1-oxopropan-2-yl)-3-methoxypropanamide; UNII-9H8K1P8U2S; 9H8K1P8U2S; Lacosamide Related Compound H; Vimpat Impurity H
EINECS	Contact for details

Quality Control

This high-purity reference standard is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, GC, NMR, and MS to confirm identity and purity. Certificates of Analysis (COA) are provided, detailing batch-specific results for purity, related substances, and residual solvents, ensuring traceability and compliance with ICH Q3A/B guidelines and pharmacopeial expectations. Our quality commitment supports your regulatory and research requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. Keep the container tightly sealed in a cool, dry, and well-ventilated place, away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white solid
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 unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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