Description

Sulpiride Impurity 8 CAS NO 950226-51-4 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. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) to identify, quantify, and monitor Sulpiride Impurity 8 during drug substance and drug product development.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to ensure accurate impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing of Sulpiride Active Pharmaceutical Ingredients (APIs) and finished dosage forms to meet ICH guidelines.
• Regulatory Compliance & Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Stability Studies: Used as a marker to track the formation of this specific impurity under various stress conditions and during shelf-life studies.
• Research & Development: Utilized in pharmaceutical R&D to study the degradation pathways and chemical behavior of Sulpiride.

Basic Information

Product Name	Sulpiride Impurity 8
CAS No.	950226-51-4
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 8; Sulpiride EP Impurity G; Sulpiride USP Impurity; Benzamide, 5-(ethylsulfonyl)-2-methoxy-N-[(1-ethyl-2-pyrrolidinyl)methyl]-
EINECS	Contact for details

Quality Control

Every batch of Sulpiride Impurity 8 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing to ensure compliance with pharmaceutical reference standard requirements. Comprehensive Certificates of Analysis (COA) detailing results from HPLC, NMR, and MS are provided to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity.

Specification

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