Cefepime EP Impurity A

Method development and validation of cefepime by using RP-​HPLC along with its potency
By Rani, S. Joshna; Mounika, N.
From International Journal of Pharmaceutical Sciences and Research (2018), 9(6), 2530-2534
 
Determination of related substances in Cefepime hydrochloride by HPLC
By Guo, Yu-juan
From Huaxi Yaoxue Zazhi (2014), 29(6), 712-713
 
Stability studies of cefepime hydrochloride by stability indicating RP-​HPLC method
By Behin, S.; Punitha, I. S. R.; Krishnan, S.
From International Journal of Pharmaceutical Sciences and Nanotechnology (2013), 6(3), 2181-2186

Cefepime EP Impurity A is chemically (6R,7R)-7-[[(2E)-(2-Aminothiazol-4-yl)(methoxyimino)acetyl]amino]-3-[(1-methylpyrrolidinio)methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate (as per EP) ; 1-(((6R,7R)-7-((E)-2-(2-aminothiazol-4-yl)-2-(methoxyimino)acetamido)-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl)methyl)-1-methylpyrrolidin-1-ium (as per USP). It is also known as Cefepime USP Related Compound A ; anti-Cefepime (EP) ; (E)-Cefepime (USP) ; Cefepime trans-Isomer. Cefepime EP Impurity A is supplied with detailed characterization data compliant with regulatory guideline. Cefepime EP Impurity A 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 Cefepime.

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.