Description

Ofloxacin n-Oxide CAS NO 90318-77-7 is a key pharmaceutical intermediate and metabolite of the fluoroquinolone antibiotic ofloxacin. This compound is of significant importance in the research, development, and quality control of antibacterial agents. It serves as a critical reference standard and building block for pharmaceutical manufacturers, analytical laboratories, and research institutions focused on antimicrobial drug development and metabolite studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification, assay, and impurity profiling of ofloxacin in drug substances and finished products.
• Active Pharmaceutical Ingredient (API) Intermediate: A crucial synthetic precursor in the manufacturing pathway of ofloxacin and related fluoroquinolone antibiotics.
• Metabolite Studies: Employed in pharmacokinetic and pharmacodynamic research to study the metabolism, distribution, and activity of ofloxacin.
• Analytical Method Development: Essential for developing and validating high-performance liquid chromatography (HPLC), LC-MS, and other analytical methods in quality control labs.
• Impurity Standard: Used to quantify and control the n-Oxide impurity as per ICH guidelines in ofloxacin API and formulation specifications.
• Biochemical Research: Utilized in microbiological and enzymatic studies to investigate the mechanism of action and resistance patterns of fluoroquinolones.

Basic Information

Product Name	Ofloxacin n-Oxide
CAS No.	90318-77-7
Molecular Formula	C18H20FN3O5
Molecular Weight	377.37 g/mol
Synonyms	Ofloxacin N-Oxide; 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 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 Impurity; OFX N-Oxide
EINECS	Contact for details

Quality Control

Our Ofloxacin n-Oxide is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC for purity and identity confirmation via IR and MS, to ensure it meets stringent specifications for use as a reference standard. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary standards. Production can adhere to relevant pharmacopeial guidelines (USP, EP) for impurity standards 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). 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 individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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