Description

Imp. B (Ep): 4-Chloro-n-(2-Methyl-1H-Indol-1-Yl)-3-Sulphamoylbenzamide is a high-purity pharmaceutical intermediate and reference standard. This compound is critical for quality control and analytical method development in the synthesis of active pharmaceutical ingredients (APIs). It is primarily required by pharmaceutical manufacturers and research organizations for ensuring batch consistency and regulatory compliance in drug development and production.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard (Impurity B) for analytical testing and method validation in accordance with pharmacopeial monographs.
• API Synthesis Intermediate: Serves as a key building block in the research and development of novel therapeutic agents.
• Quality Control & Assurance: Essential for HPLC, LC-MS, and other chromatographic assays to identify and quantify impurities in drug substances and finished products.
• Regulatory Compliance: Supports drug registration dossiers by providing a characterized impurity for stability studies and specification setting.
• Contract Research Organizations (CROs): Utilized in analytical research services for pharmaceutical clients.
• Academic & Institutional Research: Employed in medicinal chemistry programs for structure-activity relationship (SAR) studies.

Basic Information

Product Name	Imp. B (Ep): 4-Chloro-n-(2-Methyl-1H-Indol-1-Yl)-3-Sulphamoylbenzamide
CAS No.	31529-47-2
Molecular Formula	C16H14ClN3O3S
Molecular Weight	363.82 g/mol
Synonyms	4-Chloro-N-(2-methyl-1H-indol-1-yl)-3-sulfamoylbenzamide; 4-Chloro-3-sulfamoyl-N-(2-methylindol-1-yl)benzamide; Benzamide, 4-chloro-N-(2-methyl-1H-indol-1-yl)-3-sulfamoyl-; Impurity B of Ep; European Pharmacopoeia Impurity B; 1H-Indole-1-carboxamide, 4-chloro-N-(2-methyl-1H-indol-1-yl)-3-sulfamoyl- (9CI)
EINECS	Contact for details

Quality Control

This product is manufactured and tested to meet stringent standards for pharmaceutical impurities and reference materials. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile. Our quality system ensures compliance with relevant pharmacopeial guidelines, including the European Pharmacopoeia (EP), for use as a qualified impurity standard.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Keep the container tightly sealed in a dry environment to preserve stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines
Loss on Drying	≤ 0.5%

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