Description

Sulpiride Impurity 21 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antipsychotic drug Sulpiride by serving as a well-characterized impurity marker. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this certified impurity standard is essential for maintaining stringent pharmacopeial standards and supporting robust drug development processes.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Sulpiride Impurity 21 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling of Sulpiride.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines and pharmacopeial monographs (USP, EP).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing programs.
• Regulatory Submissions: Provides necessary data and reference materials for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate thorough impurity characterization.
• Research & Development: Supports synthetic chemistry research, including route scouting and process optimization, to understand and minimize impurity formation.

Basic Information

Product Name	Sulpiride Impurity 21
CAS No.	313225-61-5
Molecular Formula	C15H23N3O4S
Molecular Weight	341.43 g/mol
Synonyms	N-[(1-Ethyl-2-pyrrolidinyl)methyl]-5-(ethylsulfonyl)-2-methoxybenzamide; 5-(Ethylsulfonyl)-2-methoxy-N-[(1-ethyl-2-pyrrolidinyl)methyl]benzamide; Sulpiride Related Compound; Sulpiride EP Impurity; Sulpiride USP Impurity; Benzamide, 5-(ethylsulfonyl)-2-methoxy-N-[(1-ethyl-2-pyrrolidinyl)methyl]-
EINECS	Contact for details

Quality Control

Our Sulpiride Impurity 21 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, residual solvent analysis, and structural confirmation (IR, NMR, MS) to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is supplied with each shipment, detailing batch-specific results and confirming compliance with relevant specifications.

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 powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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