Description

Furosemide Impurity 6 is a specified impurity and degradation product of the loop diuretic Furosemide, identified by CAS NO 74793-12-7. This high-purity reference standard is critical for pharmaceutical research, development, and quality control, enabling accurate identification, quantification, and monitoring of this specific impurity in active pharmaceutical ingredients (APIs) and finished drug products. It is an essential material for analytical laboratories, regulatory compliance, and manufacturers within the global pharmaceutical supply chain who require rigorous impurity profiling to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Furosemide and related substances.
• Method Development and Validation: Critical for developing and validating analytical methods, such as HPLC, UPLC, and LC-MS, for impurity detection in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Used in-house by API and finished dosage form manufacturers to monitor and control impurity levels during production and stability studies.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed to identify and track degradation products that may form under various stress conditions (e.g., heat, light, humidity).
• Pharmacopoeial Testing: Aids in testing to meet the stringent purity requirements of pharmacopoeias such as USP, EP, and BP.
• Research and Development: Facilitates research into the degradation pathways, metabolism, and toxicological profile of Furosemide.

Basic Information

Product Name	Furosemide Impurity 6
CAS No.	74793-12-7
Molecular Formula	C₁₂H₁₁ClN₂O₅S
Molecular Weight	330.74 g/mol
Synonyms	4-Chloro-2-[(furan-2-ylmethyl)amino]-5-sulfamoylbenzoic Acid; Furosemide Related Compound B (USP); Furosemide Impurity B; Furosemide EP Impurity B; 2,4-Dichloro-5-sulfamoylbenzoic Acid Furan-2-ylmethylamide Impurity; Lasix Impurity; Frusemide Impurity 6
EINECS	Contact for details

Quality Control

Every batch of Furosemide Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic and spectroscopic techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopoeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for assay, 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). This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

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 individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
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.