Description

Amisulpride Impurity D is a specified impurity used as a critical reference standard in the analytical profiling and quality control of the antipsychotic drug substance Amisulpride. This compound is essential for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily used in research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Amisulpride Impurity D in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, calibrate, and validate chromatographic methods for impurity profiling and assay determination.
• Quality Control & Batch Release Testing: A critical component in routine QC testing to monitor impurity levels and ensure batches meet pharmacopeial (e.g., USP, EP) or internal specifications.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Research & Synthesis Purification: Used by chemists to identify and isolate this impurity during process development and optimization of the Amisulpride synthesis route.

Basic Information

Product Name	Amisulpride Impurity D
CAS No.	71676-00-1
Molecular Formula	C17H27N3O4S
Molecular Weight	369.48 g/mol
Synonyms	4-Amino-N-[(1-ethyl-2-pyrrolidinyl)methyl]-5-(ethylsulfonyl)-2-methoxybenzamide; 1-(2-{[(4-Amino-5-ethylsulfonyl-2-methoxyphenyl)carbonyl]amino}ethyl)pyrrolidine; Amisulpride Related Compound D; Amisulpride EP Impurity D; Amisulpride USP Impurity D; Amisulpride Process Impurity; Benzamide, 4-amino-N-[(1-ethyl-2-pyrrolidinyl)methyl]-5-(ethylsulfonyl)-2-methoxy-
EINECS	Contact for details

Quality Control

Every batch of Amisulpride Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC and mass spectrometry to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Assay (HPLC)	95.0% - 105.0% on anhydrous basis
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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