Description

Nadifloxacin CAS NO 124858-35-1 is a synthetic fluoroquinolone antibiotic known for its potent antibacterial activity against a broad spectrum of Gram-positive and Gram-negative bacteria. Its primary value lies in its topical efficacy, offering a targeted therapeutic approach with minimal systemic absorption. This makes it a critical active pharmaceutical ingredient (API) for manufacturers in the pharmaceutical and dermatological sectors, particularly for developing anti-acne and other topical skin infection treatments.

Application

• Primary use as an Active Pharmaceutical Ingredient (API) in topical antibiotic creams, ointments, and gels.
• Formulation of prescription dermatological products for the treatment of acne vulgaris, including inflammatory and bacterial types.
• Key component in medications targeting skin and soft tissue infections caused by susceptible organisms.
• Used in veterinary pharmaceutical preparations for topical antibacterial applications.
• Intermediate in the synthesis and research of novel fluoroquinolone derivatives.
• Reference standard in analytical laboratories for quality control and method development.

Basic Information

Product Name	Nadifloxacin
CAS No.	124858-35-1
Molecular Formula	C19H21FN2O4
Molecular Weight	360.38 g/mol
Synonyms	OPC-7251; Acuatim; Nadixa; 9-Fluoro-6,7-dihydro-8-(4-hydroxy-1-piperidyl)-5-methyl-1-oxo-1H,5H-benzo[i,j]quinolizine-2-carboxylic acid; (RS)-9-Fluoro-8-(4-hydroxypiperidin-1-yl)-5-methyl-1-oxo-2,3-dihydro-1H,5H-pyrido[3,2,1-ij]quinoline-6-carboxylic acid; 1-Ethyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid (related structural analog); Nadifloxacino; Nadifloxacine
EINECS	Contact for details

Quality Control

Our Nadifloxacin is manufactured under strict quality management systems, targeting specifications suitable for pharmaceutical applications. Each batch undergoes comprehensive analytical testing, including HPLC for assay and impurity profiling, to ensure identity, purity, and consistency. Certificates of Analysis (COA) documenting compliance with agreed specifications are provided with every shipment. We support customer audits and can tailor quality parameters to meet specific pharmacopeial standards (e.g., USP, EP, JP) upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. The container should be kept tightly sealed after each use to minimize exposure to 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)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Microbial Limits	Meets standard requirements for non-sterile API

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