Description

Lacosamide Impurity 22 is a designated impurity standard of the active pharmaceutical ingredient (API) Lacosamide, a medication used to treat partial-onset seizures and diabetic neuropathy. This high-purity reference material is critical for pharmaceutical research, development, and quality control, ensuring the safety and efficacy of the final drug product. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method validation, impurity profiling, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the qualitative and quantitative analysis of Lacosamide API and its formulations.
• Method Development and Validation (HPLC/GC): Essential for developing, optimizing, and validating chromatographic methods to separate, identify, and quantify this specific impurity.
• Stability Studies and Forced Degradation: Employed to monitor the formation of this impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Quality Control and Batch Release: A critical component in the QC testing of Lacosamide batches to ensure impurity levels remain within International Council for Harmonisation (ICH) guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Lacosamide, supporting improved formulation and packaging strategies.

Basic Information

Item	Details
Product Name	Lacosamide Impurity 22
CAS No.	201938-49-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(2R)-2-Acetamido-N-benzyl-3-methoxypropanamide; Lacosamide Related Compound 22; UNII-9I5K8J2B6H; Lacosamide EP Impurity J; Lacosamide Impurity J; Benzyl (2R)-2-acetamido-3-methoxypropanoate impurity; A potential degradation product or process-related impurity of Lacosamide.
EINECS	Contact for details

Quality Control

Every batch of Lacosamide Impurity 22 (CAS 201938-49-0) is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive testing, including identity confirmation by spectroscopic methods (IR, NMR), purity assessment by advanced chromatographic techniques (HPLC), and determination of residual solvents and moisture content. A Certificate of Analysis (COA) detailing all test results and specifications is provided with each shipment, ensuring traceability and compliance with current industry and regulatory standards for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment. 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
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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