Description

n-Descarboxymethyl-n-Carboxyethyl Lacosamide (Impurity) is a defined process-related impurity and a key reference standard in the synthesis and quality control of the active pharmaceutical ingredient (API) Lacosamide. This compound matters as a critical marker for ensuring the purity, safety, and regulatory compliance of the final drug substance, directly impacting pharmaceutical manufacturing quality. It is essential for analytical laboratories, API manufacturers, and regulatory affairs professionals involved in the development and production of antiepileptic medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for HPLC, LC-MS, and other chromatographic methods in Lacosamide API analysis.
• Method Development and Validation: Critical for developing, validating, and transferring analytical procedures in quality control (QC) and research & development (R&D) laboratories.
• Stability Studies: Used to monitor and quantify the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA) to meet ICH guidelines.
• Process Chemistry Optimization: Serves as a marker to monitor and control synthetic pathways, helping to minimize impurity formation during Lacosamide manufacturing.
• Quality Assurance/Quality Control (QA/QC): For routine batch release testing and setting impurity specifications to ensure API meets pharmacopeial standards (e.g., USP, EP).

Basic Information

Product Name	n-Descarboxymethyl-n-Carboxyethyl Lacosamide (Impurity)
CAS No.	1318777-56-8
Molecular Formula	C13H18N2O4
Molecular Weight	266.29 g/mol
Synonyms	Lacosamide Impurity; Lacosamide Related Compound; (2R)-2-Acetamido-N-benzyl-3-methoxypropanamide Impurity; Des-Carboxymethyl-Carboxyethyl Lacosamide; Vimpat Impurity; SPM 927 Impurity; Harkoseride Impurity; R-2-acetamido-N-benzyl-3-methoxypropanamide derivative
EINECS	Contact for details

Quality Control

Every batch of n-Descarboxymethyl-n-Carboxyethyl Lacosamide (Impurity) is manufactured under controlled conditions and undergoes rigorous analytical characterization to ensure identity, purity, and consistency. Our quality system is designed to meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing results from tests including identification (IR, NMR), assay (HPLC), and related substance analysis. We support compliance with ICH Q3A, Q3B, and relevant pharmacopeial 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 material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent absorption of water vapor. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.