Cefaclor EP Impurity D

Multidimensional evaluation of impurity profiles for generic cephalexin and cefaclor antibiotics
B.A. Olsen*, S.W. Baertschi and R.M. Riggin
Journal of Chromatography, 648 (1993) 165-173
 
Mass Spectral Profile for Rapid Differentiating Beta-Lactams from Their Ring-Opened Impurities
Hecheng Wang,1,2 Haiwei Huang,3 Jin Cao,3 Dehua Chui,2 and Shengyuan Xiao
Hindawi Publishing Corporation BioMed Research International Volume 2015, Article ID 697958, 13 pages
 
The Degradation Mechanism of an Oral Cephalosporin: Cefaclor
Bartolomê Vilanova  Josefa Donoso  Francisco Muñoz  Francisco García‐Blanco
helvetica chimica acta - vol. 79 (1996)

Cefaclor EP Impurity D is chemically (2R,6R,7R)- and (2S,6R,7R)-7-[[(2R)-2-amino-2-phenylacetyl]amino]-3-chloro-8-oxo-5-thia- 1-azabicyclo[4.2.0]oct-3-ene-2-carboxylic acid (as per EP); ((6R,7R)-7-{[(2R)-(Aminophenylacetyl)]amino}-3-chloro-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-3-ene-2-carboxylic acid) (as per USP). It is also known as Delta-3-cefaclor (EP) ; Cefaclor Delta-3 Isomer (USP). Cefaclor EP Impurity D is supplied with detailed characterization data compliant with regulatory guideline. Cefaclor EP Impurity D 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 Cefaclor.

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.