Description

Lacosamide Impurity I is a high-purity reference standard specifically identified for the quality control and analytical development of the active pharmaceutical ingredient (API) Lacosamide. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical products by enabling the accurate identification and quantification of related substances. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and research institutions focused on method validation, stability studies, and impurity profiling in line with ICH guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the analysis of Lacosamide API and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, and other chromatographic methods for impurity detection.
• Quality Control & Assurance (QC/QA): Critical for routine batch release testing to monitor and control impurity levels in pharmaceutical manufacturing.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity characterization data for health authorities like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to understand impurity formation pathways and to develop purification processes.

Basic Information

Product Name	Lacosamide Impurity I
CAS No.	2295925-90-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lacosamide Related Compound I; (2R)-2-Acetamido-N-benzyl-3-methoxypropanamide Impurity I; (R)-2-Acetamido-N-benzyl-3-methoxypropionamide Impurity; Vimpat Impurity I; Harkoseride Impurity I; SPM 927 Impurity I
EINECS	Contact for details

Quality Control

Our Lacosamide Impurity I is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity analysis and structural confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profile is provided with every shipment to support your quality and regulatory requirements.

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 must be kept in a desiccated environment to maintain stability and purity.

Specification

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