Cefuroxime Axetil EP Impurity B

Liquid chromatography-​tandem mass spectrometry method for the determination of cefuroxime axetil diastereoisomers: application to stability-​indicating method
By Sharaf El-Din, Mohie M. K.; Nassar, Mohamed W. I.; Attia, Khalid A. M.; El Demellawy, Maha A.; Kaddah, Mohamed M. Y.
From Journal of the Iranian Chemical Society (2021), 18(9), 2505-2515
 
Content determination of cefuroxime in peritoneal dialysis solution by HPLC and compatible stability of the mixture
By Li, Cheng; Wu, Xiao-juan; Feng, Lian-jie; Mai, Jia-hui; Zhang, Kai-li
From Zhongguo Yaofang (2012), 23(25), 2378-2379

Specific stability indicating assay method for the determination of cefuroxime sodium in pharmaceutical formulation by UV-​Vis Spectrophotometer
By Devkhile, A. B.; Shaikh, K. A.
From International Journal of Pharmacy and Technology (2011), 3(1), 1609-1622

Cefuroxime Axetil EP Impurity B is chemically (1RS)-1-(Acetyloxy)ethyl (6R,7R)-3-[(carbamoyloxy)-methyl]-7-[[(E)-2-(furan-2-yl)-2-(methoxyimino)acetyl]-amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2carboxylate (as per EP);(1RS,6R,7R)-1-Acetoxyethyl 3-[(carbamoyloxy)methyl]-7-[(E)-2-(furan-2-yl)-2-(methoxyimino)acetamido]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate) (as per USP). It is also known as Cefuroxime Axetil trans-Isomer ; Cefuroxime Axetil E-isomers (USP). Cefuroxime Axetil EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Cefuroxime Axetil 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 Cefuroxime.

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.