Description

Levofloxacin n-Oxide is a key pharmaceutical intermediate and impurity reference standard in the synthesis and quality control of the fluoroquinolone antibiotic, Levofloxacin. This compound is critical for ensuring the purity, safety, and efficacy of the final active pharmaceutical ingredient (API) by serving as a marker for specific oxidative degradation pathways. It is primarily required by pharmaceutical manufacturers, research institutions, and analytical laboratories engaged in API development, regulatory compliance, and advanced chemical research.

Application

• Pharmaceutical Impurity Standard: Used as a certified reference material (CRM) for the identification and quantification of Levofloxacin n-Oxide impurity in Levofloxacin API and finished drug products, per ICH guidelines.
• API Synthesis & Process Control: Serves as an intermediate and a critical marker in the research, development, and optimization of Levofloxacin manufacturing processes.
• Analytical Method Development: Essential for developing and validating stability-indicating analytical methods, such as HPLC and LC-MS, for Levofloxacin.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity profiles and stability data for drug master files (DMFs).
• Quality Assurance/Quality Control (QA/QC): Employed in routine batch release testing and stability studies to monitor impurity levels throughout the product lifecycle.
• Academic & Contract Research: Utilized in pharmacological and metabolic studies to understand the degradation pathways and stability of fluoroquinolone antibiotics.

Basic Information

Product Name	Levofloxacin n-Oxide
CAS No.	328936-18-1
Molecular Formula	C18H20FN3O5
Molecular Weight	377.37 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 N-Oxide Impurity; Levofloxacin Impurity G (EP); Levofloxacin Related Compound G; (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 EP Impurity G; Levofloxacin Oxidative Degradant
EINECS	Contact for details

Quality Control

Our Levofloxacin n-Oxide is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing to ensure high purity and consistency, meeting the stringent requirements for use as a reference standard. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, including HPLC purity and impurity profiles. The product is suitable for use in compliance with ICH Q3A(R2), Q3B(R2), and relevant pharmacopoeial standards (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to minimize further oxidative 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.