Description

Furosemide Impurity 5 is a specified impurity and degradation product of the loop diuretic Furosemide, identified by the CAS registry number 62971-57-7. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical method development and validation required for drug substance and product quality control. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Furosemide-based medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Furosemide Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor degradation pathways.
• Quality Control & Assurance: Employed in routine QC testing to comply with pharmacopeial monographs (USP, EP, BP) and ICH guidelines Q3A(R2) and Q3B(R2) on impurities.
• Stability Studies: Acts as a marker to study the forced degradation and long-term stability profile of Furosemide under various environmental conditions.
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and regulatory filings to agencies like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to understand and control impurity formation during the manufacturing process of Furosemide.

Basic Information

Product Name	Furosemide Impurity 5
CAS No.	62971-57-7
Molecular Formula	C₁₂H₁₁ClN₂O₅S
Molecular Weight	330.74 g/mol
Synonyms	4-Chloro-2-[(furan-2-ylmethyl)amino]-5-sulfamoylbenzoic Acid; Furosemide Impurity E; Furosemide Related Compound E; Furosemide EP Impurity E; Furosemide USP Impurity; 2,4-Dichloro-5-sulfamoylbenzoic Acid Furan-2-ylmethyl Amide Impurity; FUR-Imp-5
EINECS	Contact for details

Quality Control

Every batch of Furosemide Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, 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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Water Content (KF)	≤ 1.0%
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.