Description

Lacosamide Impurity R is a designated impurity standard used in the pharmaceutical development and quality control of the active pharmaceutical ingredient (API) Lacosamide. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of related substances. It is an essential tool for analytical laboratories, quality assurance departments, and research scientists in the pharmaceutical and biotechnology industries.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Lacosamide API and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine quality control testing to ensure batches of Lacosamide meet stringent pharmacopeial (USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Employed to monitor the formation of degradation products in Lacosamide formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity profiles and justify specification limits.
• Research & Development: Supports synthetic route optimization and process chemistry studies to understand and minimize impurity formation during API manufacturing.

Basic Information

Product Name	Lacosamide Impurity R
CAS No.	93782-09-3
Molecular Formula	C13H18N2O3
Molecular Weight	250.29 g/mol
Synonyms	(2R)-2-Acetamido-N-benzyl-3-methoxypropanamide; (R)-2-Acetamido-N-benzyl-3-methoxypropionamide; (R)-N-Benzyl-2-acetamido-3-methoxypropionamide; Lacosamide Related Compound R; (R)-Harkoseride; SPM 927 Impurity R; Vimpat Impurity R
EINECS	Contact for details

Quality Control

Every batch of Lacosamide Impurity R is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure high purity and structural identity as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay, and impurity profile. We support compliance with ICH Q3A/B, 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). This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.