Levetiracetam Impurity 16

Enantiomeric impurity determination of levetiracetam using capillary electrochromatography
Debby Mangelings1 Jan Saevels2 Yvan Vander Heyden
J. Sep. Sci. 2006, 29, 2827 – 2836
 
separation and estimation of process related impurities and degradation products of levetiracetam in solid pharmaceutical formulation using ion-pair chromatography
Navneet Kumar1,2 and D. Sangeetha
Journal of Liquid Chromatography & Related Technologies, 36:1835–1848, 2013
 
Simple GC-MS Method for Analysis of Levetiracetam and ProcessRelated Toxic Impurity
Hazim M. Ali1,2 , Mohammed Gamal* 3,4 , Nada S. Abdelwahab4 , Nehal F. Farid
Microchemical Journal Volume 146, May 2019, Pages 1236-1240

Levetiracetam Impurity 16 is chemically (S)-4-((1-Amino-1-oxobutan-2-yl)amino)butanoic acid. Levetiracetam Impurity 16 is supplied with detailed characterization data compliant with regulatory guideline. Levetiracetam Impurity 16 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 Levetiracetam.

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.