Description

Desmethyl Lacosamide is a key pharmaceutical intermediate and reference standard of significant importance in modern medicinal chemistry. This compound is crucial for the research, development, and quality control of advanced active pharmaceutical ingredients (APIs). It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in the synthesis and validation of novel therapeutic agents.

Application

• Pharmaceutical Intermediate: A critical building block in the synthesis of Lacosamide and related pharmaceutical compounds.
• Reference Standard: Used for analytical method development, validation, and quality control (QC) testing in pharmaceutical manufacturing.
• Impurity Standard: Essential for the identification, qualification, and quantification of related substances and degradation products in API batches.
• Metabolite Studies: Employed in pharmacokinetic and drug metabolism research to understand the biotransformation pathways of the parent drug.
• Process Development: Supports research and development (R&D) efforts in optimizing synthetic routes and scaling up production processes.
• Regulatory Compliance: Aids in generating data for regulatory filings (e.g., FDA, EMA) to demonstrate product quality and safety.

Basic Information

Product Name	Desmethyl Lacosamide
CAS No.	175481-38-6
Molecular Formula	C12H16N2O3
Molecular Weight	236.27 g/mol
Synonyms	(2R)-2-Acetamido-N-benzyl-3-methoxypropanamide; (R)-2-Acetamido-N-benzyl-3-methoxypropionamide; Vimpat Impurity; Lacosamide Desmethyl Impurity; Vimpat Related Compound; Harkoseride Impurity; SPM 927 Impurity; R-2-Acetamido-N-benzyl-3-methoxypropionamide
EINECS	Contact for details

Quality Control

Our Desmethyl Lacosamide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, chiral analysis, and identification by spectroscopic methods, to ensure it meets the stringent requirements for pharmaceutical reference standards and intermediates. Certificates of Analysis (COA) with detailed chromatographic data are provided and can be tailored to support specific pharmacopeial (USP, EP) or internal quality standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is light-sensitive and should be handled and stored away from direct light exposure to maintain stability.

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%
Chiral Purity (HPLC)	≥ 99.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5%

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