Description

Sulpiride Impurity 9 CAS NO 950253-88-0 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 key marker for impurity profiling. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and quality control departments involved in drug development and production. This standard is essential for method validation, stability studies, and meeting stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Sulpiride Active Pharmaceutical Ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): A critical component for developing, calibrating, and validating chromatographic methods to ensure accurate impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring product consistency and compliance with ICH guidelines.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish shelf life.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to regulatory bodies like the FDA and EMA.
• Research & Development: Serves as a tool in pharmaceutical R&D for studying the degradation pathways and metabolism of Sulpiride.

Basic Information

Product Name	Sulpiride Impurity 9
CAS No.	950253-88-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sulpiride Related Compound 9; Sulpiride Impurity C; N-[(1-Ethyl-2-pyrrolidinyl)methyl]-2-methoxy-5-sulfamoylbenzamide (proposed); Benzamide, N-[(1-ethyl-2-pyrrolidinyl)methyl]-2-methoxy-5-sulfamoyl-; Sulpiride EP Impurity C; Sulpiride USP Impurity; A potential degradation product of Sulpiride
EINECS	Contact for details

Quality Control

Every batch of Sulpiride Impurity 9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure identity, purity, and compliance with industry standards. Certificates of Analysis (COA) detailing batch-specific results are provided and 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. Handle the material in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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