Topiramate EP Impurity A

Determination of topiramate and its degradation product in liquid oral solutions by high performance liquid chromatography with a chemiluminescent nitrogen detector
Maria Styslo-Zalasik, Weiyong Li
Journal of Pharmaceutical and Biomedical Analysis Volume 37, Issue 3, 9 March 2005, Pages 529-534
 
Topiramate: A Review of Analytical Approaches for the Drug Substance, Its Impurities and Pharmaceutical Formulations
Eduardo Costa Pinto, Maressa Danielli Dolzan, Lucio Mendes Cabral, Daniel W. Armstrong, Valéria Pereira de Sousa
Journal of Chromatographic Science, Volume 54, Issue 2, 1 February 2016, Pages 280–290
 
High-Performance Liquid Chromatographic Study of Topiramate and Its Impurities
A. Biró, É. Pergel, G. Árvai, I. Ilisz, G. Szepesi, A. Péter & F. Lukács
Chromatographia volume 63, pagesS137–S141(2006)
 
Development and validation of a stability‐indicating HPLC method for topiramate using a mixed‐mode column and charged aerosol detector
Eduardo Costa Pinto  Mariana da Silva Gonçalves  Lucio Mendes Cabral  Daniel W. Armstrong  Valéria Pereira de Sousa
Journal of Separation Science Volume41, Issue8 April 2018 Pages 1716-1725
 
Validation of liquid‐liquid extraction followed by flow‐injection negative ion electrospray mass spectrometry assay to Topiramate in human plasma
Su Chen , Paul M. Carvey
Rapid Communications in Mass Spectrometry Volume15, Issue2 30 January 2001 Pages 159-163

Topiramate EP Impurity A is chemically 2,3:4,5-bis-O-(propan-2,2-diyl)-beta-D-fructopyranose. It is also known as Topiramate USP Related Compound A. Topiramate EP Impurity A is supplied with detailed characterization data compliant with regulatory guideline. Topiramate 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 Topiramate.

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.