Description

Furosemide Impurity 7 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Furosemide by serving as a key marker in impurity profiling and method validation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development, quality control, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Furosemide API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating chromatographic methods, such as HPLC and UPLC, to meet ICH guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to monitor and control impurity levels to specified limits.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data for impurity identification and qualification as per ICH Q3A/B.
• Stability Studies: Used to track the formation of this specific impurity over time under various stress conditions to establish product shelf-life.
• Research & Development: Serves as a critical tool in pharmaceutical R&D for studying degradation pathways and synthesis processes of Furosemide.

Basic Information

Product Name	Furosemide Impurity 7
CAS No.	4753-68-8
Molecular Formula	C₁₂H₁₁ClN₂O₅S
Molecular Weight	330.74 g/mol
Synonyms	4-Chloro-2-[(furan-2-ylmethyl)amino]-5-sulfamoylbenzoic Acid; 5-(Aminocarbonyl)-4-chloro-2-[(2-furanylmethyl)amino]benzenesulfonamide; Furosemide Impurity F; Furosemide Related Compound F; Furosemide EP Impurity F; Lasix Impurity F; Frusemide Impurity F
EINECS	Contact for details

Quality Control

Every batch of Furosemide Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques to ensure compliance with pharmacopeial standards (e.g., USP, EP) and customer specifications. A comprehensive Certificate of Analysis (COA) detailing all test results, including HPLC purity, is provided with each shipment to guarantee traceability and reliability for your critical applications.

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 must be kept in a desiccated environment to maintain stability and purity.

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 impurity ≤ 0.5%
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.