Cefotaxime EP Impurity B

Development and validation of stability indicating UFLC method for the estimation of Cefotaxime sodium and Diclofenac sodium in bulk and pharmaceutical dosage forms
By Koganti, Venkata Sairam; Thejaswini, J. Channabasappa; Chandan, Ravandur Shivanna; Bannimath, Gurupadayya
From International Journal of Pharmaceutical Sciences Review and Research (2014), 25(1), 310-314, 5 pp..
 
Physical and chemical stability studies on cefotaxime and its dosage forms by stability indicating HPTLC method
By Behin, S.; Punitha, I. S. R.; Krishnan, S.
From International Journal of Pharmaceutical, Chemical and Biological Sciences (2012), 2(4), 517-523
 
Identification and characterization of new impurity in cefotaxime sodium drug substance
By Kumar, Vundavilli Jagadeesh; Gupta, Peruri Badarinadh; Pavan Kumar, K. S. R.; Prasada Rao, Korrapati V. V.; Prasanna, S. John; Siva Kumar, G. S.; Sharma, Hemant; Mukkanti, K.
From Pharma Chemica (2010), 2(3), 230-241

Cefotaxime EP Impurity B is chemically (6R,7R)-7-[[(2Z)-2-(2-Aminothiazol-4-yl)-2-(methoxyimino)acetyl]amino]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid (as per EP) ; (6R,7R)-7-[(Z)-2-(2-Aminothiazol-4-yl)-2-(methoxyimino)acetamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid (as per USP). It is also known as Deacetyl Cefotaxime (EP & USP). Cefotaxime EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Cefotaxime 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 Cefotaxime Sodium.

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.