Description

Amisulpride Impurity CAS NO 84859-26-7 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Amisulpride. This compound is critical for pharmaceutical manufacturers and research laboratories to identify, quantify, and control this specific impurity, ensuring the final drug product meets stringent safety and efficacy standards. It is an essential material for method development, validation, and regulatory compliance in the pharmaceutical industry.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of a specific impurity in Amisulpride API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to ensure impurity levels are within ICH/USP/EP specified limits.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Used as a marker to monitor the formation of degradation products during forced degradation and long-term stability studies of Amisulpride.
• Research & Development: Facilitates chemical research into the synthesis, degradation pathways, and metabolism of Amisulpride.

Basic Information

Product Name	Amisulpride Impurity
CAS No.	84859-26-7
Molecular Formula	C17H27N3O4S
Molecular Weight	369.48 g/mol
Synonyms	4-Amino-N-[(1-ethyl-2-pyrrolidinyl)methyl]-5-(ethylsulfonyl)-2-methoxybenzamide; Amisulpride Related Compound; Amisulpride EP Impurity; Amisulpride USP Impurity; 4-Amino-5-ethylsulfonyl-2-methoxy-N-[(1-ethylpyrrolidin-2-yl)methyl]benzamide; Benzamide, 4-amino-N-[(1-ethyl-2-pyrrolidinyl)methyl]-5-(ethylsulfonyl)-2-methoxy-; Amisulpride Degradant
EINECS	Contact for details

Quality Control

Every batch of Amisulpride Impurity (CAS 84859-26-7) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to guarantee traceability and support your regulatory needs.

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 at 2-8°C 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)	≥ 98.0%
Related Substances (HPLC)	Single impurity ≤ 0.5%; Total impurities ≤ 1.0%
Water Content (KF)	≤ 0.5% w/w
Residue on Ignition	≤ 0.1%

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