Description

n-Methyl Amisulpride-D3 is a deuterium-labeled internal standard of the antipsychotic drug amisulpride, specifically designed for analytical applications. This high-purity compound is essential for ensuring the accuracy and reliability of quantitative mass spectrometry analyses in pharmaceutical research and development. It is primarily used by analytical chemists and researchers in pharmaceutical companies, contract research organizations (CROs), and forensic laboratories for method development, validation, and bioanalytical studies.

Application

• Quantitative Bioanalysis: Serves as a critical internal standard for the precise quantification of amisulpride and its metabolites in biological matrices (e.g., plasma, serum, urine) using LC-MS/MS.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion in clinical and preclinical trials.
• Drug Metabolism Studies: Used in metabolite identification and profiling to understand the metabolic pathways of amisulpride.
• Forensic Toxicology: Supports the accurate detection and quantification of amisulpride in forensic investigations.
• Method Development & Validation: A key reagent for developing, optimizing, and validating robust analytical methods in compliance with regulatory guidelines (e.g., FDA, EMA).
• Quality Control in Manufacturing: Can be utilized in impurity profiling and stability testing of amisulpride drug substances and products.

Basic Information

Item	Detail
Product Name	n-Methyl Amisulpride-D3
CAS No.	1794945-81-5
Molecular Formula	C17H23D3N3O4S
Molecular Weight	369.48 g/mol (approx.)
Synonyms	4-Amino-N-[(1-ethyl-2-pyrrolidinyl)methyl]-5-(ethylsulfonyl)-2-methoxy-D3-benzamide; Amisulpride-d3 (methyl-d3); Deuterated Amisulpride Internal Standard; Amisulpride Methyl-d3; 4-Amino-5-ethylsulfonyl-2-methoxy-N-[(1-ethylpyrrolidin-2-yl)methyl]benzamide-d3; Solian-d3 (labeled); n-Methyl-d3 Amisulpride
EINECS	Contact for details

Quality Control

Every batch of n-Methyl Amisulpride-D3 is manufactured and analyzed under strict quality systems. We guarantee high chemical and isotopic purity, supported by comprehensive analytical data including NMR, HPLC, and mass spectrometry. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting purity, isotopic enrichment, and confirming the absence of significant unlabeled impurities. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the product label or COA. Keep the container in a dry, well-ventilated place. For long-term storage, consider storing desiccated at -20°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC-MS)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (Deuterium Enrichment)	≥ 98 atom % D
Chemical Purity (by NMR)	Conforms to structure
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH guidelines

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