Ofloxacin EP Impurity B

Use of various β-cyclodextrin derivatives as chiral selectors for the enantiomeric separation of ofloxacin and its five related substances by capillary electrophoresis
Bolin Zhu , Shuying Xu , Xingjie Guo , Lan Wei , Jia Yu , Tiejie Wang
J Sep Sci. 2017 Apr;40(8):1784-1795.
 
Stability Indicating Reversed-Phase High Performance Liquid Chromatography Method for Determination of Impurities in Ofloxacin Tablet Formulations
Bobba Venkateswara Reddy,1 Avvaru Praveen Kumar,2 Gosula Venkat Ram Reddy,1 Mohinish Sahai,1 Jadi Sreeramulu,1 and Jung Hag Park
Analytical Letters, 43: 2653–2662, 2010
 
Enantioseparation of ofloxacin and its four related substances with ligand exchange–micellar electrokinetic chromatography using copper(II)‐L‐isoleucine complex as chiral selector
Yongjing Liu  Xiaoying Wang
Chirality Volume29, Issue8 August 2017 Pages 422-429
 
Multiple Response Optimization of a HPLC Method for the Determination of Enantiomeric Purity of S-Ofloxacin
Valliappan Kannappan & Sai Sandeep Mannemala
Chromatographia volume 77, pages1203–1211(2014)

Ofloxacin EP Impurity B is chemically (3RS)-9-Fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazin-7-one (as per EP). It is also known as Ofloxacin Descarboxyl Impurity. Ofloxacin EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Ofloxacin EP Impurity B 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 Ofloxacin.

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.