Description

Lacosamide Impurity CAS NO 474534-78-6 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Lacosamide. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of this well-characterized impurity is essential for maintaining the highest standards in pharmaceutical production and quality control.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Lacosamide API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Serves as a critical component in developing and validating stability-indicating methods for Lacosamide.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Supports synthetic chemistry research for understanding degradation pathways and improving synthetic processes of Lacosamide.

Basic Information

Product Name	Lacosamide Impurity
CAS No.	474534-78-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(R)-2-Acetamido-N-benzyl-3-methoxypropanamide; Lacosamide Related Compound; Vimpat Impurity; (R)-N-Benzyl-2-acetamido-3-methoxypropanamide; Harkoseride Impurity; SPM 927 Impurity; SPM-927 Related Substance; (2R)-2-Acetamido-N-benzyl-3-methoxypropanamide
EINECS	Contact for details

Quality Control

Our Lacosamide Impurity is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch is subjected to comprehensive analytical testing, including identity confirmation by spectroscopic methods (IR, NMR) and purity determination by advanced chromatographic techniques (HPLC, LC-MS). A detailed Certificate of Analysis (COA) is provided, which includes batch-specific data, chromatograms, and traceability information. Our quality commitment aligns with cGMP principles and supports compliance with ICH, USP, and EP 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). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

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 single unknown impurity ≤ 0.5%
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.