Description

Difluoxacin Hydrochloride is a synthetic fluoroquinolone antibiotic compound, specifically the hydrochloride salt form of difluoxacin. This high-purity active pharmaceutical ingredient (API) is critical for its potent antibacterial activity against a broad spectrum of Gram-positive and Gram-negative pathogens. It is primarily utilized by pharmaceutical manufacturers and research institutions in the development and production of advanced antibacterial formulations. Difluoxacin Hydrochloride CAS NO 91296-86-5 is essential for addressing complex bacterial infections.

Application

• Pharmaceutical API: Core active ingredient in the manufacture of antibacterial injectable and oral dosage forms.
• Veterinary Medicine: Used in formulations for treating bacterial infections in livestock and companion animals.
• Research & Development: Serves as a key reference standard and intermediate in microbiological and pharmacological research.
• Antibacterial Drug Synthesis: Intermediate in the synthesis of newer, more complex fluoroquinolone derivatives.
• Clinical Studies: Employed in the production of batches for preclinical and clinical trial materials.

Basic Information

Product Name	Difluoxacin Hydrochloride
CAS No.	91296-86-5
Molecular Formula	C21H19F2N3O3 • HCl
Molecular Weight	435.85 g/mol
Synonyms	Difloxacin Hydrochloride; 6-Fluoro-1-(4-fluorophenyl)-1,4-dihydro-7-(4-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid hydrochloride; DL-8280 Hydrochloride; ICI-99000 Hydrochloride; Difluoxacin HCl; 1,4-Dihydro-6-fluoro-1-(p-fluorophenyl)-7-(4-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid hydrochloride
EINECS	Contact for details

Quality Control

Our Difluoxacin Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for pharmaceutical use, including identity, purity, and impurity profiles. Certificates of Analysis (COA) are provided, detailing results from HPLC, IR spectroscopy, and other pharmacopeial tests. We support compliance with cGMP, ICH Q7, and other relevant regulatory guidelines for API manufacturing.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after each use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%

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