Description

Sulpiride Ep Impurity F is a high-purity reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient Sulpiride by accurately identifying and quantifying this specific impurity. It is essential for analytical chemists, quality assurance professionals, and researchers working in pharmaceutical R&D and production. The material is supplied with comprehensive analytical data to support regulatory filings and internal quality protocols.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Sulpiride Ep Impurity F in drug substances and products.
• Method Development and Validation: Critical for developing, optimizing, and validating analytical methods, particularly HPLC and UPLC, in compliance with ICH guidelines.
• Quality Control and Batch Release: Used in routine QC testing to monitor impurity profiles and ensure Sulpiride API and finished dosage forms meet stringent pharmacopeial specifications (e.g., EP, USP).
• Stability Studies: Employed to track the formation of this impurity over time under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for impurity identification and qualification reports required for FDA, EMA, and other global regulatory agency filings.
• Research and Development: Supports impurity profiling and route scouting during the synthesis and process optimization of Sulpiride.

Basic Information

Product Name	Sulpiride Ep Impurity F
CAS No.	2214214-03-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sulpiride Impurity F; Sulpiride Related Compound F; EP Impurity F of Sulpiride; (S)-N-[(1-Ethyl-2-pyrrolidinyl)methyl]-2-methoxy-5-sulfamoylbenzamide Impurity; 5-(Aminosulfonyl)-2-methoxy-N-[(2S)-1-ethyl-2-pyrrolidinyl]methyl]benzamide Impurity F
EINECS	Contact for details

Quality Control

Every batch of Sulpiride Ep Impurity F is manufactured and controlled under a strict quality management system. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a 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. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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