Agricultural technical grade active ingredients may contain trace levels of impurities or degradants at various concentrations. When active ingredient synthetic routes are proposed to be changed and improved or new sources of raw materials are needed for manufacturing, the impurity profile must first be assessed. Components with a concentration at or above 0.1 weight percent must be identified and evaluated per regulatory guidelines. Isolation has proven to be a powerful tool to produce a relatively pure sample to facilitate the correct identification of compounds of interest prior to synthesis. This presentation will highlight examples of reverse phase semi-preparatory LC/MS method development and highlight problem-solving approaches required for a successful impurity isolation. After isolation, the sample of interest is evaluated with a variety of analytical technologies such as high resolution mass spectrometry and NMR to assign and confirm structural characterization.

Isolation of trace level impurities from agricultural technical grade active ingredients using semi-preparatory scale LC/MS

2019 Fall National Meeting

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