Description

Lacosamide Related Compound F (30 Mg) (2-Acetamido-n-Benzyl-3-Hydroxypropanamide) is a high-purity reference standard and impurity used in the research, development, and quality control of the antiepileptic drug Lacosamide. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical products by enabling precise identification and quantification of related substances. It is an essential material for analytical laboratories, pharmaceutical manufacturers, and research institutions focused on neurology and CNS drug development.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for calibrating analytical instruments and validating methods in QC/QA labs.
• Impurity Profiling & Control: Used to identify, monitor, and quantify this specific related substance in Lacosamide Active Pharmaceutical Ingredient (API) and finished drug products to meet ICH Q3A/B guidelines.
• Method Development & Validation: Critical for developing and validating stability-indicating analytical methods such as HPLC, UPLC, and LC-MS for Lacosamide.
• Stability Studies: Employed in forced degradation and long-term stability studies to understand the degradation pathways of Lacosamide.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to regulatory bodies like the FDA and EMA.
• Academic & Clinical Research: Supports pharmacological and metabolic studies investigating the properties and behavior of Lacosamide and its related compounds.

Basic Information

Product Name	Lacosamide Related Compound F (30 Mg) (2-Acetamido-n-Benzyl-3-Hydroxypropanamide)
CAS No.	171623-02-2
Molecular Formula	C13H18N2O3
Molecular Weight	250.29 g/mol
Synonyms	2-Acetamido-N-benzyl-3-hydroxypropanamide; (2R)-2-Acetamido-N-benzyl-3-hydroxypropanamide; Lacosamide Impurity F; Lacosamide Related Substance F; Vimpat Related Compound F; R-2-Acetamido-N-benzyl-3-hydroxypropionamide; Harkoseride Related Compound; SPM 927 Related Compound F
EINECS	Contact for details

Quality Control

This high-grade reference material is produced under strict quality control conditions suitable for pharmaceutical analysis. Each batch is characterized using advanced spectroscopic and chromatographic techniques to ensure identity, purity, and traceability. A comprehensive Certificate of Analysis (COA) is provided, detailing results for assay, related substances, and identification tests performed in compliance with ICH guidelines. Our quality system ensures reliability for your most critical analytical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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