Description

Lacosamide Impurity 4 CAS NO 1932811-49-8 is a specified impurity of the active pharmaceutical ingredient (API) Lacosamide, a medication used to treat partial-onset seizures and diabetic neuropathy. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method development, validation, and quality control processes. It is essential for manufacturers and analytical laboratories in the pharmaceutical industry who require high-purity materials to ensure the safety, efficacy, and regulatory compliance of their final drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Lacosamide API and finished dosage forms.
• Analytical Method Development: Used in HPLC, UPLC, and GC methods to establish system suitability, specificity, and detection limits.
• Stability Studies: Employed to identify and quantify degradation products in forced degradation and long-term stability testing of Lacosamide.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing characterized impurity profiles.
• Process Chemistry Research: Aids in the identification and control of process-related impurities during the synthesis and purification of Lacosamide.
• Pharmacopoeial Testing: Used to verify compliance with purity specifications outlined in pharmacopoeias such as USP, EP, or BP.

Basic Information

Product Name	Lacosamide Impurity 4
CAS No.	1932811-49-8
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 4; Lacosamide EP Impurity D; Lacosamide USP Impurity D; Vimpat Impurity 4; (R)-N-Benzyl-2-acetamido-3-methoxypropanamide
EINECS	Contact for details

Quality Control

Every batch of Lacosamide Impurity 4 is manufactured and tested under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity determination by advanced chromatographic techniques (HPLC, GC). Certificates of Analysis (COA) detailing batch-specific results are available upon request to support your regulatory and quality assurance needs.

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 storing under an 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 guidelines
Water Content (KF)	≤ 1.0% w/w

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