Description

Furosemide Related Compound B (100 Mg) (4-Chloro-5-Sulfamoylanthranilic Acid) is a high-purity analytical reference standard, essential for pharmaceutical research and quality control. This compound, also known as 4-Chloro-5-sulfamoylanthranilic acid, is a key impurity and degradation product of the diuretic drug Furosemide. It is critically needed by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and ensuring drug purity and safety. The product is supplied as a 100 mg unit, ideal for precise laboratory use.

Application

• Pharmaceutical Impurity Profiling and Control: Used as a certified reference material (CRM) for the identification and quantification of Furosemide impurities in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and other chromatographic methods in compliance with ICH Q2(R1) and USP guidelines.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of degradation products in Furosemide under various stress conditions (e.g., heat, light, humidity) as per ICH Q1A(R2).
• Quality Assurance/Quality Control (QA/QC): An essential component for in-house quality control testing to ensure batch-to-batch consistency and compliance with pharmacopoeial specifications (USP, EP, BP).
• Regulatory Submissions and Compliance: Provides documented evidence of impurity characterization for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Used in metabolic studies and pharmacokinetic research to understand the degradation pathways of Furosemide.

Basic Information

Product Name	Furosemide Related Compound B (100 Mg) (4-Chloro-5-Sulfamoylanthranilic Acid)
CAS No.	3086-91-7
Molecular Formula	C7H7ClN2O4S
Molecular Weight	250.66 g/mol
Synonyms	4-Chloro-5-sulfamoylanthranilic Acid; 2-Amino-4-chloro-5-sulfamoylbenzoic Acid; 5-(Aminosulfonyl)-4-chloro-2-aminobenzoic Acid; Furosemide Impurity B; Furosemide Related Substance B; Lasix Impurity B; Frusemide Impurity B; 4-Chloro-5-sulphamoylanthranilic Acid (British spelling)
EINECS	Contact for details

Quality Control

Our Furosemide Related Compound B is manufactured and tested under strict quality systems. Each batch undergoes rigorous analytical testing, including chromatographic purity, identity confirmation, and impurity profiling, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each unit, detailing the results for assay, related substances, and other critical parameters. Our quality commitment aligns with cGMP principles to support your regulatory 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 product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation due to moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.