Omeprazole Impurity 53

Elemental impurities analysis in name-brand and generic omeprazole drug samples
Fernanda C. Pinheiro, Ariane I.Barros, Joaquim A.Nóbrega
Heliyon Volume 6, Issue 2, February 2020, e03359
 
Development of a validated RP-HPLC method for separation and determination of process-related impurities of omeprazole in bulk drugs
cristina iuga, marius bojiţă, sorin e. leucuţa
farmacia, 2009, vol. 57, 5
 
Low Level Quantification of Potential Genotoxic Impurity in Omeprazole Drug Substance by UPLC
Vinay Kumar Patcha , Susheela Bhai Gajbhiye , Vundavilli Jagadeesh Kumar , Ray UK ,Pavan Kumar KSR , Sreenivas N
Der Pharma Chemica, 2017, 9(15):72-76

Omeprazole Impurity 53 is chemically 5-(hydroxymethyl)-4-methoxy-1-(6-methoxy-1H-benzo[d]imidazol-2-yl)-2,3-dimethylpyridin-1-ium. Omeprazole Impurity 53 is supplied with detailed characterization data compliant with regulatory guideline. Omeprazole Impurity 53 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 Omeprazole.

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.