Description

Lacosamide Impurity 11 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) lacosamide by enabling accurate identification, quantification, and control of related substances. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing, particularly for method validation and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of lacosamide and its related substances.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release Testing: Serves as a system suitability standard and for establishing impurity limits in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to monitor the formation and levels of this specific impurity in lacosamide drug substance and product under various storage conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Pharmacopoeial Testing: Supports testing to meet the specifications of pharmacopoeias such as USP, EP, or JP.

Basic Information

Item	Detail
Product Name	Lacosamide Impurity 11
CAS No.	1695551-74-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(2R)-2-Acetamido-N-benzyl-3-methoxypropanamide Impurity 11; Lacosamide Related Compound 11; UNII-9J8U3Q9I6T; 2-Acetamido-N-benzyl-3-methoxypropanamide Impurity; HMR Lacosamide Impurity 11; (R)-2-Acetamido-N-benzyl-3-methoxypropionamide Impurity; Lacosamide EP Impurity J; Lacosamide Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Lacosamide Impurity 11 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request, providing detailed results for identity, purity, and impurity profile as determined by validated chromatographic methods (e.g., HPLC).

Storage

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

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