Description

Sulpiride Impurity 22 is a designated chemical reference standard used in the analytical profiling and quality control of Sulpiride, a widely prescribed antipsychotic and antiemetic drug. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure drug safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. 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 reference material (CRM) for the identification and quantification of impurities in Sulpiride Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-High-Performance Liquid Chromatography (UHPLC), and other chromatographic methods.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity levels, ensuring compliance with pharmacopeial standards (e.g., USP, EP, ICH Q3A/B guidelines).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (heat, light, humidity) to establish shelf-life and storage recommendations.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Utilized in synthetic chemistry research to understand degradation pathways and to synthesize purer forms of the API.

Basic Information

Product Name	Sulpiride Impurity 22
CAS No.	325724-62-7
Molecular Formula	C15H23N3O4S
Molecular Weight	341.43 g/mol
Synonyms	N-[(1-Ethyl-2-pyrrolidinyl)methyl]-2-methoxy-5-sulfamoylbenzamide; 5-(Aminosulfonyl)-N-[(1-ethyl-2-pyrrolidinyl)methyl]-2-methoxybenzamide; Sulpiride Related Compound 22; Sulpiride EP Impurity J; Sulpiride Impurity J; Sulpiride USP Related Compound A; Sulpiride Degradation Product; Benzamide, N-[(1-ethyl-2-pyrrolidinyl)methyl]-2-methoxy-5-sulfamoyl-
EINECS	Contact for details

Quality Control

Every batch of Sulpiride Impurity 22 is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques like HPLC, GC, MS, and NMR to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

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 -20°C to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Assay	≥ 98.0% (on anhydrous basis)
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm

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