Description

Sulpiride Impurity 16 is a designated reference standard used in the analytical profiling and quality control of the pharmaceutical substance Sulpiride. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a known benchmark for identification and quantification. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance processes.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Sulpiride Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to ensure specificity and accuracy in impurity detection.
• Quality Control & Batch Release: Employed in routine QC testing to monitor impurity levels against established specifications, ensuring compliance with pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation and increase of this specific degradation product under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides critical data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity characterization and control strategies.
• Research & Development: Aids in synthetic route optimization and process chemistry to understand and minimize the formation of this impurity during API manufacturing.

Basic Information

Product Name	Sulpiride Impurity 16
CAS No.	109029-89-2
Molecular Formula	C15H23N3O4S
Molecular Weight	341.43 g/mol
Synonyms	N-[(1-Ethyl-2-pyrrolidinyl)methyl]-2-methoxy-5-sulfamoylbenzamide; 5-(Aminosulfonyl)-2-methoxy-N-[(1-ethyl-2-pyrrolidinyl)methyl]benzamide; Sulpiride Related Compound; Sulpiride EP Impurity; Sulpiride USP Impurity; Benzamide, 5-(aminosulfonyl)-2-methoxy-N-[(1-ethyl-2-pyrrolidinyl)methyl]-
EINECS	Contact for details

Quality Control

Our Sulpiride Impurity 16 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for use as a reference material. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile, supporting compliance with ICH guidelines and pharmacopeial requirements. Certificates are 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. The material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
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.