Description

Amisulpride Ep Impurity H is a high-purity reference standard used in the analytical profiling and quality control of the antipsychotic drug Amisulpride. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying this specific impurity. It is essential for method development, validation, and stability studies within the pharmaceutical and analytical chemistry sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Amisulpride Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity profiling.
• Stability Studies & Forced Degradation: Employed to monitor the formation of Impurity H under various stress conditions to establish product shelf-life.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Research & Development: Serves as a key reagent in metabolic pathway studies and impurity synthesis research related to Amisulpride.
• Quality Assurance/Quality Control (QA/QC) Testing: Integral for routine batch release testing in GMP-compliant manufacturing environments to ensure impurity limits are met.

Basic Information

Product Name	Amisulpride Ep Impurity H
CAS No.	1391054-22-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Amisulpride Impurity H; Amisulpride Related Compound H; 4-Amino-N-[(1-ethyl-2-pyrrolidinyl)methyl]-5-(ethylsulfonyl)-2-methoxybenzamide Impurity; 4-Amino-5-ethylsulfonyl-2-methoxy-N-[(1-ethylpyrrolidin-2-yl)methyl]benzamide Impurity; Amisulpride EP Impurity H; Amisulpride USP Impurity H; Amisulpride Process Impurity H
EINECS	Contact for details

Quality Control

Our Amisulpride Ep Impurity H is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We ensure compliance with relevant pharmacopoeial guidelines (EP, USP) and support regulatory requirements for impurity qualification.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 1.0%

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