Description

Furosemide Impurity 16 is a specified impurity and degradation product of the potent loop diuretic, Furosemide. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development and validation. It is primarily used by quality control laboratories, regulatory affairs departments, and R&D teams in the pharmaceutical industry to ensure the purity, safety, and efficacy of Furosemide drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Furosemide Impurity 16 in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurities in Furosemide batches.
• Stability Studies: Employed in forced degradation studies to understand the degradation pathways of Furosemide and to establish appropriate shelf-life and storage conditions.
• Quality Control & Assurance: A critical component in routine QC testing to ensure Furosemide products meet stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Regulatory Compliance: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity profile data as required by ICH guidelines.
• Research & Synthesis: Used in synthetic chemistry research to study the formation mechanism of this impurity and to develop mitigation strategies during API manufacturing.

Basic Information

Product Name	Furosemide Impurity 16
CAS No.	133989-65-8
Molecular Formula	C12H11ClN2O5S
Molecular Weight	330.74 g/mol
Synonyms	4-Chloro-2-[(furan-2-ylmethyl)amino]-5-sulfamoylbenzoic Acid; Furosemide EP Impurity B; Furosemide Related Compound B; Furosemide USP Related Compound B; 5-(Aminocarbonyl)-4-chloro-2-[(2-furanylmethyl)amino]benzenesulfonic Acid; Furosemide Degradation Product; Lasix Impurity B
EINECS	Contact for details

Quality Control

Our Furosemide Impurity 16 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from tests including identification (IR, HPLC), assay (by HPLC), and related substance analysis. The quality standards are aligned with current pharmacopeial requirements (USP, EP) and ICH guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions 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
Assay (HPLC)	≥ 98.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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