Description

(2R)-Lacosamide-D3 is a deuterium-labeled isotopologue of the active pharmaceutical ingredient (API) lacosamide, specifically designed for use as an internal standard in quantitative analytical methods. This high-purity reference material is critical for ensuring the accuracy, precision, and regulatory compliance of bioanalytical studies, particularly in pharmacokinetics and metabolism research. It is an essential tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and quality control units involved in the development and analysis of antiepileptic drugs.

Application

• Bioanalytical Internal Standard: Primary use as a stable isotope-labeled internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the precise quantification of lacosamide in biological matrices (plasma, serum, urine).
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical trials.
• Metabolite Identification and Profiling: Aids in distinguishing drug-derived metabolites from endogenous compounds in complex biological samples.
• Method Development and Validation: Serves as a critical component for developing, optimizing, and validating GLP/GCP-compliant analytical methods.
• Drug Impurity and Degradation Studies: Used as a reference marker in stability-indicating methods to monitor API purity and identify degradation products.
• Forensic and Clinical Toxicology: Supports accurate measurement of lacosamide levels for therapeutic drug monitoring (TDM) or forensic investigations.

Basic Information

Product Name	(2R)-Lacosamide-D3
CAS No.	1217689-95-6
Molecular Formula	C13H15D3N2O3
Molecular Weight	253.31 g/mol (for D3 isotopologue)
Synonyms	(R)-2-Acetamido-N-benzyl-3-methoxy-3-(trideuteriomethyl)propanamide; (2R)-2-(Acetylamino)-N-benzyl-3-methoxy-3-[(2H3)methyl]propanamide; Lacosamide-d3; Deuterated Lacosamide; Vimpat-d3 (labeled analog); (R)-N-benzyl 2-acetamido-3-methoxy-3-(trideuteriomethyl)propionamide; ERY500-d3; Harkoseride-d3
EINECS	Contact for details

Quality Control

Every batch of (2R)-Lacosamide-D3 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and isotopic enrichment meet the stringent requirements for reference standards. Our quality commitment includes comprehensive characterization by NMR, MS, and HPLC. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific data for chemical purity, isotopic purity (D-enrichment), and residual solvents, supporting compliance with ICH guidelines and GLP standards.

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 compound is hygroscopic (moisture-sensitive); therefore, containers must be kept tightly sealed and consideration should be given to storage under an inert atmosphere for long-term preservation of quality.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0% (Chemical Purity)
Isotopic Purity (MS)	≥ 98.0 atom % D
Isomeric Purity (Chiral HPLC)	≥ 99.0% (2R-enantiomer)
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C

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