Description

Lacosamide Usp Rc D is a high-purity pharmaceutical reference standard and intermediate, designated for research and development as well as quality control applications. This compound is critical for ensuring the accuracy, consistency, and regulatory compliance of analytical methods in the development and production of lacosamide-based active pharmaceutical ingredients (APIs). It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in the synthesis, validation, and quality assurance of antiepileptic medications.

Application

• Pharmaceutical Reference Standard: Serves as a primary standard for the identification, assay, and impurity profiling of Lacosamide in finished drug products and raw materials via HPLC, GC, or spectroscopic methods.
• API Development & Synthesis: Used as a key intermediate or starting material in the research-scale and pilot-scale synthesis of Lacosamide API.
• Analytical Method Development & Validation: Essential for developing, qualifying, and validating chromatographic and spectroscopic analytical methods in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Employed in in-house quality control laboratories to verify the purity, potency, and identity of production batches of Lacosamide.
• Regulatory Submissions: Provides critical data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Stability Studies: Used as a benchmark in forced degradation and long-term stability studies to monitor the integrity of Lacosamide under various environmental conditions.

Basic Information

Item	Details
Product Name	Lacosamide Usp Rc D
CAS No.	1379592-19-4
Molecular Formula	C13H18N2O3
Molecular Weight	250.29 g/mol
Synonyms	(2R)-2-Acetamido-N-benzyl-3-methoxypropanamide; (R)-2-Acetamido-N-benzyl-3-methoxypropionamide; Vimpat Impurity D; Lacosamide Related Compound D; USP Lacosamide Related Compound D RS; Erlosamide; Harkoseride; SPM 927
EINECS	Contact for details

Quality Control

Our Lacosamide Usp Rc D is manufactured and tested under strict quality management systems to meet the exacting standards of the pharmaceutical industry. Each batch is rigorously analyzed against relevant pharmacopeial specifications, including USP monographs, to ensure identity, purity, strength, and composition. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time corresponds to reference standard
Assay (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)	≤ 0.5%
Heavy Metals	≤ 20 ppm

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