Description

n-Demethylfleroxacin is a key pharmaceutical intermediate and a primary metabolite of the fluoroquinolone antibiotic fleroxacin. This compound is essential for research and development in the pharmaceutical sector, particularly in the study of drug metabolism, pharmacokinetics, and the synthesis of novel antibacterial agents. It is primarily utilized by pharmaceutical R&D laboratories, analytical testing facilities, and manufacturers of active pharmaceutical ingredients (APIs) for quality control and reference standard applications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of fleroxacin and its metabolites in drug substance and finished product testing.
• Metabolite Research: Critical for in-vitro and in-vivo studies investigating the metabolic pathways, bioavailability, and clearance mechanisms of fleroxacin.
• Analytical Method Development: Serves as a high-purity standard for developing and validating HPLC, LC-MS, and other chromatographic methods in quality control laboratories.
• Impurity Profiling: Employed to identify, quantify, and monitor process-related impurities and degradation products during the manufacture and stability testing of fleroxacin API.
• Synthetic Intermediate: Acts as a building block in the chemical synthesis of fleroxacin derivatives and related fluoroquinolone compounds for new drug discovery programs.

Basic Information

Product Name	n-Demethylfleroxacin
CAS No.	79660-71-2
Molecular Formula	C16H17F2N3O3
Molecular Weight	337.32 g/mol
Synonyms	1,4-Dihydro-6,8-difluoro-1-(2-fluoroethyl)-7-(4-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic Acid; 9-Desmethylfleroxacin; Fleroxacin N-Oxide Impurity; Fleroxacin Metabolite; 6,8-Difluoro-1-(2-fluoroethyl)-7-(4-methylpiperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid; AM-833 Metabolite; Ro 23-6240 Metabolite
EINECS	Contact for details

Quality Control

Our n-Demethylfleroxacin is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR), purity determination by HPLC, and control of related substances and residual solvents. A detailed Certificate of Analysis (COA) is provided with each shipment, ensuring traceability and compliance with your research or quality specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

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 single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 0.5%

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