Description

Amisulpride-002 is a high-purity pharmaceutical intermediate and reference standard, identified by CAS NO 81487-05-0. This compound is critical for ensuring the quality, efficacy, and consistency of active pharmaceutical ingredients (APIs) in the final drug product. It is primarily required by pharmaceutical manufacturers, research institutions, and analytical laboratories engaged in the development, production, and quality control of antipsychotic medications.

Application

• Pharmaceutical Intermediate: A key building block in the synthesis of the antipsychotic drug Amisulpride.
• Reference Standard: Used for analytical method development, validation, and routine quality control (QC) testing in pharmaceutical laboratories.
• Impurity Standard: Employed for the identification and quantification of related substances and degradation products in Amisulpride API and finished dosage forms.
• Research & Development: Serves as a starting material or precursor in medicinal chemistry research for developing new therapeutic agents targeting the central nervous system.
• Regulatory Compliance: Essential for generating data to meet regulatory submission requirements (e.g., for FDA, EMA) for drug master files (DMFs).
• Calibration: Used to calibrate analytical instruments such as High-Performance Liquid Chromatography (HPLC) and Mass Spectrometry (MS) systems.

Basic Information

Product Name	Amisulpride-002
CAS No.	81487-05-0
Molecular Formula	C17H27N3O4S
Molecular Weight	369.48 g/mol
Synonyms	4-Amino-N-[(1-ethyl-2-pyrrolidinyl)methyl]-5-(ethylsulfonyl)-2-methoxybenzamide; Amisulpride Impurity; Amisulpride Related Compound; Solian Impurity; Deniban Impurity; Socian Impurity; (RS)-4-Amino-5-ethylsulfonyl-2-methoxy-N-[(1-ethylpyrrolidin-2-yl)methyl]benzamide
EINECS	Contact for details

Quality Control

Our Amisulpride-002 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods, purity assay by HPLC, and control of specified impurities. We provide a detailed Certificate of Analysis (COA) with each shipment, ensuring traceability and compliance with current Good Manufacturing Practice (cGMP) principles and ICH guidelines for pharmaceutical intermediates.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed to prevent moisture absorption, which may affect stability and purity. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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