S. Colgan, G. Haggan, R. Reed
May 1, 1996
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0
Influential Citations
8
Citations
Journal
Journal of pharmaceutical and biomedical analysis
Abstract
5-Chlorooxindole (5-CO) is a starting material for tenidap sodium, a pharmaceutical drug candidate produced by Pfizer. To insure potency and purity of the drug substance, it is necessary to demonstrate that commercial supplies of 5-CO are free from elevated levels of chemical analogs that could be carried through the synthetic scheme. This is accomplished using a single highly specific normal-phase chromatographic system that allows the quantitation of 5-CO concomitantly with all of its potential positional isomers. This paper describes the chromatographic system and its supportive validation data.