Investigation of Light Isomerization of Tropolone Using Liquid Chromatography and Orbitrap Mass Spectrometry

by Robert J. Duff, PhD and John L. Snyder, PhD
Volume 12, Issue 3 (Fall 2013)

This investigation into the light isomerization of tropolone was initiated after a method for determining residual tropolone in the bulk drug substance (BDS) of a therapeutic monoclonal antibody was developed and validated at our laboratory. This method, developed at a client’s request, required a detection limit of 50 parts per billion (ppb) in the BDS to meet their regulatory requirements. The method was developed using liquid chromatography and tandem mass spectrometry (LC/MS/MS) because of the selectivity and sensitivity of the technique when using selective reaction monitoring (SRM). During development, however, it was discovered that only after creating a photoisomer of tropolone could successful separation, detection, and quantitation of tropolone be achieved. During validation, the method showed good performance...

Citation:
Duff RJ, Snyder JL. Investigation of Light Isomerization of Tropolone Using Liquid Chromatography and Orbitrap Mass Spectrometry. BioProcess J, 2013; 12(3): 10-19.
http://dx.doi.org/10.12665/J123.DuffSnyder.

Posted online September 30, 2013.