Description

Furosemide Impurity 8 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Furosemide. This compound is critical for ensuring the purity, safety, and efficacy of Furosemide-based pharmaceutical formulations by serving as a reference marker in chromatographic analysis. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies focused on method development, validation, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Furosemide Impurity 8 in Furosemide API and finished drug products.
• Analytical Method Development & Validation: Critical component for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurities as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release: Used in routine QC testing to ensure Furosemide API batches meet specified impurity limits set by USP, EP, or other pharmacopeias.
• Stability Studies: Employed to track the formation of this specific impurity over time under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control of impurities.
• Research & Development: Supports impurity profiling during process chemistry development and optimization of Furosemide synthesis to minimize related substance formation.

Basic Information

Product Name	Furosemide Impurity 8
CAS No.	41332-59-6
Molecular Formula	C₁₂H₁₁ClN₂O₅S
Molecular Weight	330.74 g/mol
Synonyms	4-Chloro-2-[(furan-2-ylmethyl)amino]-5-sulfamoylbenzoic Acid; Furosemide Related Compound H (EP); Furosemide Impurity H; Furosemide EP Impurity H; 5-(Aminocarbonyl)-4-chloro-2-[(2-furanylmethyl)amino]benzenesulfonamide; Furosemide Process Impurity; Furosemide Degradant; Benzoic acid, 4-chloro-2-[(2-furanylmethyl)amino]-5-sulfamoyl-
EINECS	Contact for details

Quality Control

Every batch of Furosemide Impurity 8 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using validated analytical methods such as HPLC and LC-MS to ensure it meets the high standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing batch-specific results. Our quality commitment aligns with cGMP principles and supports compliance with pharmacopeial (USP, EP) and ICH regulatory guidelines.

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 low-humidity environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

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)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
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.