Description

Levofloxacin Tetrafluoro Impurity 1 is a key process-related impurity and analytical reference standard used in the pharmaceutical development and quality control of the antibiotic Levofloxacin. This compound is critical for ensuring the purity, safety, and efficacy of the final active pharmaceutical ingredient (API) by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance testing.

Application

• Primary use as a certified reference standard for the quantitative and qualitative analysis of Levofloxacin API and related formulations.
• Critical component in impurity profiling and method development for HPLC and LC-MS systems in QC laboratories.
• Essential for conducting stability studies and forced degradation studies to monitor impurity formation over time.
• Used in pharmaceutical research and development to understand the synthesis pathway and degradation profile of Levofloxacin.
• Serves as a system suitability standard for regulatory submissions (e.g., to FDA, EMA) to demonstrate analytical control.
• Supports pharmacopoeial testing to ensure compliance with monographs from USP, EP, or other international standards.

Basic Information

Product Name	Levofloxacin Tetrafluoro Impurity 1
CAS No.	110548-02-2
Molecular Formula	C18H20F4N3O4
Molecular Weight	418.37 g/mol
Synonyms	Levofloxacin Impurity 1; Levofloxacin Tetrafluoro Impurity; (3S)-9-Fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic Acid Tetrafluoro Impurity; Levofloxacin Related Compound 1; Levofloxacin EP Impurity 1; Levofloxacin USP Impurity 1; (-)-(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 Tetrafluoro Impurity
EINECS	Contact for details

Quality Control

Our Levofloxacin Tetrafluoro Impurity 1 is manufactured under strict quality management systems. Each batch is characterized and tested using advanced analytical techniques, including HPLC, LC-MS, and NMR, to ensure high purity and accurate identification. Certificates of Analysis (COA) are provided with each shipment, detailing batch-specific results for identity, purity, and related substances. Our quality commitment aligns with the standards required for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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