Ampicillin EP Impurity E

Identification of the Related Substances in Ampicillin Capsule by Rapid Resolution Liquid Chromatography Coupled with Electrospray Ionization Tandem Mass Spectrometry
lei zhang,¹ xian long cheng,^1,2 yang liu,¹ miao liang,¹ honghuan dong,¹ beiran lv,¹ wenning yang,¹ zhiqiang luo,¹ and mingmin tang
Journal of Analytical Methods in Chemistry, vol. 2014, Article ID 397492, 15 pages, 2014.
 
Impurity Effects on the Crystallization Kinetics of Ampicillin
M. Ottens, B. Lebreton, M. Zomerdijk, M. P. W. M. Rijkers, O. S. L. Bruinsma, and L. A. M van der Wielen
Ind. Eng. Chem. Res. 2004, 43, 7932-7938
 
Ampicillin and Ceftriaxone Solution Stability at Different Temperatures in Outpatient Parenteral Antimicrobial Therapy
L. Herrera-Hidalgo, L. E. López-Cortes, R. Luque-Márquez, J. Gálvez-Acebal, A. de Alarcón, L. F. López-Cortes, A. Gutiérrez-Valencia, M. V. Gil-Navarro
Antimicrobial Agents and Chemotherapy Jun 2020, 64 (7) e00309-20

Ampicillin EP Impurity E is chemically (2R)-2-[[[(2S,5R,6R)-6-[[(2R)-2-Amino-2-phenylacetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]hept-2-yl]carbonyl]amino]-2-phenylacetic acid (as per EP); (R)-2-((2S,5R,6R)-6-((R)-2-Amino-2-phenylacetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxamido)-2-phenylacetic acid (as per USP). It is also known as Ampicillinyl-D-phenylglycine. Ampicillin EP Impurity E is supplied with detailed characterization data compliant with regulatory guideline. Ampicillin EP Impurity E 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 Ampicillin.

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.