Levofloxacin EP Impurity I 

In silico and in vitro genotoxicity evaluation of levofloxacin n-oxide, an impurity in levofloxacin
Qingfen Zhu1,2, Tao Li2 , Jun Li2 , Ming Guo2 , Weijian Wang2 , and Xiumei Zhang
Toxicology Mechanisms and Methods, 2012; 22(3): 225–230
 
Identification, Isolation and Characterization of New Process-related Impurities in Levofloxacin
Kishor More* , Leena Gupta, Brajesh Sharma, Prashant Patil, Dattatray Govare
Der Pharma Chemica, 2017, 9(12):7-13
 
An integrated approach for detection and characterization of the trace impurities in levofloxacin using liquid chromatography– tandem mass spectrometry
Ya-Jie Zheng1 , Jiu-Ming He1 , Rui-Ping Zhang1 , Yu-Cheng Wang2 , Ju-Xian Wang2 , Hui-Qing Wang1 , Yan Wu1 , Wen-Yi He1 and Zeper Abliz
Rapid Commun. Mass Spectrom. 2014, 28, 1164–1174
 
Analyses of Levofloxacin Adsorption on Pretreated Barley Straw with Respect to Temperature: Kinetics, π–π Electron-Donor–Acceptor Interaction and Site Energy Distribution
Bei Yan, Catherine Hui Niu, and Jian Wang
Environ. Sci. Technol. 2017, 51, 14, 8048–8056
 
Rapid chiral separation and impurity determination of levofloxacin by ligand-exchange chromatography
Hongyuan Yan, Kyung Ho Row
Analytica Chimica Acta 584 (2007) 160–165

Levofloxacin EP Impurity I  is chemically (3S)-10-fluoro-3-methyl-9-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-carboxylic acid. It is also known as Levofloxacin 9-Piperazinyl Isomer ; 10-Fluoro Impurity. Levofloxacin EP Impurity I  is supplied with detailed characterization data compliant with regulatory guideline. Levofloxacin EP Impurity I  can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Levofloxacin.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.