Description

Levofloxacin Impurity 18 is a high-purity chemical reference standard, specifically identified as a process-related impurity of the broad-spectrum fluoroquinolone antibiotic, Levofloxacin. This compound is critical for pharmaceutical research, development, and quality control, enabling the accurate identification, quantification, and monitoring of impurities to ensure drug safety and efficacy. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical industry, particularly those involved in method validation, stability studies, and regulatory compliance for antibiotic manufacturing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Levofloxacin drug substance and finished products.
• Method Development and Validation: Essential for developing and validating chromatographic methods (HPLC, UPLC) to separate and quantify impurities in compliance with ICH guidelines.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (light, heat, humidity) during drug shelf-life studies.
• Quality Control (QC) Testing: Serves as a system suitability standard and an impurity marker in the routine batch release testing of Levofloxacin APIs and formulations.
• Regulatory Submissions: Provides necessary impurity data for regulatory filings (e.g., ANDA, NDA, CMC documentation) to agencies like the US FDA and EMA.
• Research and Development: Used in synthetic chemistry research to study impurity formation pathways and to develop purification processes for the active pharmaceutical ingredient (API).

Basic Information

Product Name	Levofloxacin Impurity 18
CAS No.	138998-47-7
Molecular Formula	C18H20FN3O4
Molecular Weight	361.37 g/mol
Synonyms	Levofloxacin Related Compound 18; (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; 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic Acid Impurity; OFX Impurity; Levofloxacin EP Impurity G; Levofloxacin USP Related Compound G
EINECS	Contact for details

Quality Control

Our Levofloxacin Impurity 18 is manufactured and handled in a GMP-compliant environment. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency. Comprehensive characterization is performed using advanced techniques including HPLC, GC, NMR, and MS. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific results for all critical quality attributes. The material is suitable for use as a reference standard in regulated pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The product is light-sensitive and should be stored away from light. Keep the container tightly sealed in a dry, cool, and well-ventilated place.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
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.