Description

Furosemide Impurity 5 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Furosemide. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Reference Standard for the identification and quantification of impurities in Furosemide API and finished dosage forms.
• Analytical Method Development and Validation in quality control (QC) and research & development (R&D) laboratories.
• Stability Studies to monitor the formation of degradation products in Furosemide formulations.
• Regulatory Compliance and Documentation, supporting submissions to agencies like the FDA and EMA.
• Pharmacopoeial Testing to meet the specifications of USP, EP, or other pharmacopoeias.
• Academic and Clinical Research investigating the metabolism and pharmacokinetics of Furosemide.

Basic Information

Product Name	Furosemide Impurity 5
CAS No.	518336-22-6
Molecular Formula	C₁₂H₁₁ClN₂O₅S
Molecular Weight	330.74 g/mol
Synonyms	4-Chloro-2-[(furan-2-ylmethyl)amino]-5-sulfamoylbenzoic Acid; Furosemide Related Compound 5; Furosemide EP Impurity C; Furosemide USP Related Compound C; Furosemide Impurity C; 5-(Aminocarbonyl)-4-chloro-2-[(2-furanylmethyl)amino]benzoic Acid; Lasix Impurity 5
EINECS	Contact for details

Quality Control

Our Furosemide Impurity 5 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, IR and MS for structural confirmation, and residual solvent analysis. We provide a detailed Certificate of Analysis (COA) with each shipment, ensuring traceability and compliance with current Good Manufacturing Practice (cGMP) principles and relevant pharmacopoeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under inert atmosphere to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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