Description

Lacosamide Related Compound B (30 Mg) (2-Acetamido-3-(Benzylamino)-3-Oxopropyl Acetate) is a high-purity reference standard and synthetic intermediate of critical importance in the pharmaceutical development and quality control lifecycle. This compound is essential for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Lacosamide, a medication used to treat epilepsy. It is primarily required by analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method development, stability studies, and regulatory compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Lacosamide API and finished drug products according to ICH guidelines.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring product meets pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Used to track the formation of degradation products under various stress conditions (heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings to health authorities like the FDA and EMA.
• Process Chemistry Research: Acts as a key intermediate or marker in researching and optimizing the synthetic pathway for Lacosamide.

Basic Information

Product Name	Lacosamide Related Compound B (30 Mg) (2-Acetamido-3-(Benzylamino)-3-Oxopropyl Acetate)
CAS No.	1822463-67-1
Molecular Formula	C14H19N3O4
Molecular Weight	293.32 g/mol
Synonyms	2-Acetamido-3-(benzylamino)-3-oxopropyl acetate; Lacosamide Impurity B; Lacosamide Related Substance B; (2R)-2-Acetamido-N-benzyl-3-oxo-3-(prop-2-yn-1-yloxy)propanamide derivative; Acetylated Lacosamide Intermediate; Vimpat Related Compound B; (R)-2-Acetamido-3-(benzylamino)-3-oxopropyl acetate; SPM 927 Impurity B
EINECS	Contact for details

Quality Control

Every batch of our Lacosamide Related Compound B is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for identity, purity, and impurity profiles as determined by validated analytical methods (HPLC, NMR, MS). Our quality commitment aligns with cGMP principles where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
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)	≤ 0.5%

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