Description

Lacosamide Impurity CAS NO 1219042-50-8 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the active pharmaceutical ingredient (API) Lacosamide. This impurity 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 material for analytical chemists and quality assurance professionals in pharmaceutical R&D, manufacturing, and contract research organizations (CROs).

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Lacosamide API and finished dosage forms.
• Method Development and Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, in compliance with ICH guidelines.
• Quality Control & Batch Release: Serves as a system suitability standard and for setting specification limits in the routine QC testing of Lacosamide batches.
• Stability Studies: Employed to monitor impurity profiles and degradation pathways of Lacosamide under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for impurity characterization reports required by regulatory bodies like the FDA and EMA.
• Process Chemistry Research: Used to study and optimize synthetic pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Lacosamide Impurity
CAS No.	1219042-50-8
Molecular Formula	C13H18N2O3
Molecular Weight	250.29 g/mol
Synonyms	(2R)-2-Acetamido-N-benzyl-3-methoxypropanamide; (R)-2-Acetamido-N-benzyl-3-methoxypropionamide; Lacosamide Related Compound; Vimpat Impurity; (R)-N-Benzyl-2-acetamido-3-methoxypropionamide; Harkoseride Impurity; SPM 927 Impurity
EINECS	Contact for details

Quality Control

Every batch of Lacosamide Impurity (CAS 1219042-50-8) is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity assay, related substance profiling, and structural confirmation (IR, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances.

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) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
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%
Heavy Metals	≤ 20 ppm

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