Description

Lacosamide Impurity CAS NO 705283-63-2 is a high-purity reference standard used in the pharmaceutical development and quality control of the active pharmaceutical ingredient (API) Lacosamide. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of related substances. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical and biotechnology industries.

Application

• Primary use as a certified reference standard for the analytical method development and validation of Lacosamide API.
• Critical component in impurity profiling and stability studies to monitor degradation pathways.
• Essential for pharmacopoeial compliance testing (e.g., USP, EP, ICH guidelines) to establish specification limits.
• Used in quality control (QC) laboratories for the routine batch release testing of Lacosamide drug substances and products.
• Serves as a key material in regulatory submissions (e.g., ANDA, NDA) to support impurity identification and qualification.
• Valuable for research and development to understand the synthesis and degradation chemistry of Lacosamide.

Basic Information

Product Name	Lacosamide Impurity
CAS No.	705283-63-2
Molecular Formula	C13H18N2O3
Molecular Weight	250.29 g/mol
Synonyms	(2R)-2-Acetamido-N-benzyl-3-methoxypropanamide; (R)-2-Acetamido-N-benzyl-3-methoxypropionamide; Lacosamide Related Compound; (R)-N-Benzyl-2-acetamido-3-methoxypropionamide; Harkoseride Impurity; SPM 927 Impurity; Vimpat Impurity; R-2-Acetamido-N-benzyl-3-methoxypropionamide
EINECS	Contact for details

Quality Control

Every batch of Lacosamide Impurity (705283-63-2) is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and consistency meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopoeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

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%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 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.