Description

Ofloxacin n-Oxide (Mixture Of Diastereomers) is a key synthetic intermediate and impurity standard in the production of fluoroquinolone antibiotics. This compound matters for ensuring the purity, safety, and regulatory compliance of critical pharmaceutical products. It is primarily needed by pharmaceutical R&D laboratories, quality control (QC) departments, and manufacturers specializing in active pharmaceutical ingredients (APIs) and analytical reference standards.

Application

• As a critical impurity reference standard for the quality control and validation of Ofloxacin and related fluoroquinolone APIs.
• In pharmaceutical research and development for studying the metabolism, degradation pathways, and stability of quinolone antibiotics.
• For use in analytical method development and calibration in HPLC, LC-MS, and other chromatographic systems.
• As a chemical intermediate in the synthesis and process optimization of advanced antibiotic compounds.
• In regulatory compliance and documentation, providing essential data for drug master files (DMFs) and regulatory submissions.

Basic Information

Product Name	Ofloxacin n-Oxide (Mixture Of Diastereomers)
CAS No.	104721-52-0
Molecular Formula	C18H20FN3O5
Molecular Weight	377.37 g/mol
Synonyms	9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic Acid n-Oxide; Ofloxacin N-Oxide; Ofloxacin Impurity G (EP); Ofloxacin Related Compound G (USP); (±)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic Acid N-Oxide; Ofloxacin N-Oxide Diastereomers
EINECS	Contact for details

Quality Control

Our Ofloxacin n-Oxide is produced and handled under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, meeting the requirements for use as a pharmaceutical reference standard. Certificates of Analysis (COA) with detailed chromatographic data (HPLC) are provided to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment 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)	≥ 95.0% (sum of diastereomers)
Purity (HPLC, Area %)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%

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