Description

Levofloxacin n-Oxide is a key pharmaceutical intermediate and impurity reference standard used in the synthesis and quality control of the fluoroquinolone antibiotic Levofloxacin. Its precise chemical structure makes it essential for analytical method development, stability studies, and ensuring the purity and safety of the final active pharmaceutical ingredient (API). This high-purity compound is primarily required by pharmaceutical manufacturers, research institutions, and quality control laboratories engaged in antibiotic development and production.

Application

• Primary use as a reference standard for the identification and quantification of Levofloxacin-related impurities in pharmaceutical quality control (QC) and quality assurance (QA).
• Critical pharmaceutical intermediate in the research and development of novel fluoroquinolone antibiotic derivatives.
• Essential material for conducting stability studies and forced degradation studies of Levofloxacin API and finished dosage forms.
• Used in analytical method development and validation, particularly for HPLC and LC-MS techniques, to establish impurity profiles.
• Serves as a starting material or building block in organic synthesis for specialized chemical research.
• Supports regulatory compliance and documentation for drug master files (DMFs) and new drug applications (NDAs).

Basic Information

Product Name	Levofloxacin n-Oxide
CAS No.	117678-37-2
Molecular Formula	C18H20F3N3O5
Molecular Weight	415.37 g/mol
Synonyms	(-)-(S)-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; Levofloxacin Impurity; Levofloxacin N-Oxide Impurity; (S)-(-)-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; Levofloxacin Related Compound; OFX N-Oxide
EINECS	Contact for details

Quality Control

Our Levofloxacin n-Oxide is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via IR and MS, to ensure it meets exacting standards for use as a reference material. A comprehensive Certificate of Analysis (COA) detailing purity, impurities, and analytical methods is provided with every shipment to support your regulatory and research requirements.

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)	≥ 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.