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Direct detection of a sulfonate ester genotoxic impurity by atmospheric-pressure thermal desorption−extractive electrospray−mass spectrometry
journal contributionposted on 10.07.2013 by Neil A. Devenport, Laura C. Sealey, Faisal H. Alruways, Daniel J. Weston, Jim Reynolds, Colin Creaser
Any type of content formally published in an academic journal, usually following a peer-review process.
A direct, ambient ionization method has been developed using atmospheric pressure thermal desorption−extractive electrospray−mass spectrometry (AP/TD-EESI-MS) for the detection of the genotoxic impurity (GTI) methyl p-toluenesulfonate (MTS) in a surrogate pharmaceutical matrix. A custom-made thermal desorption probe was used to the desorb and vaporize MTS from the solid state, by rapid heating to 200 °C then cooling to ambient temperature, with a cycle time of 6 min. The detection of MTS using EESI with a sodium acetate doped solvent to generate the [MTS+Na]+ adduct ion provided a significant sensitivity enhancement relative to the [M+H]+ ion generated using a 0.1% formic acid solvent modifier. The MTS detection limit is over an order of magnitude below the longterm daily threshold of toxicological concern (TTC) of 1.5 μg/g and the potential for quantitative analysis has been determined using starch as a surrogate active pharmaceutical ingredient (API).
This work was supported by the Biotechnology and Biological Sciences Research Council (BBSRC) and AstraZeneca [grant number BB/G017557/1].