Assay and purity evaluation of 5-chlorooxindole by liquid chromatography.
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.
Colgan
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Pfizer Central Research, Groton, CT 06340, USA.
Haggan
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Reed
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D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000138:chemical synthesis; D002853:Chromatography, Liquid; D015195:Drug Design; D007211:Indoles / Q000032:analysis / Q000138:chemical synthesis / Q000737:chemistry / Q000302:isolation & purification*; D000078183:Oxindoles; D012015:Reference Standards; D015203:Reproducibility of Results; D013237:Stereoisomerism
D000894:Anti-Inflammatory Agents, Non-Steroidal; D007211:Indoles; D000078183:Oxindoles; C102691:5-chlorooxindole; C062866:tenidap