Feasibility evaluation of Ion Mobility Spectrometry as process analytical technology (PAT) application for 2,4,6-Tribromoanisole (TBA) detection; Transition from wet to dry chemistry.

摘要

General principles about Ion Mobility Spectrometry (IMS) including recent advances in the instrumentation for the characterization of ion mobilities in air at ambient pressure were reviewed in order to proof instrument's feasibility as a process analytical technology (PAT) tool for 2,4,6-Tribromoanisole (TBA) detection in the regulated pharmaceutical industry. The intention was to support innovation and efficiency in pharmaceutical development, manufacturing, and quality assurance of their products through the use of IMS instead of conventional methodologies. Findings have shown that the current technology in use is Gas Chromatography (GC) columns using different types of sample pre-concentration techniques and detectors as Mass Spectrometry (MS), Electron Capture Detector (ECD) to analyze product samples and track TBA contamination in their end products.;Because Ion Mobility Spectrometry (IMS) has emerged as a fast and specific analytical instrument for verifying and monitoring organic compounds in different venues, this investigational research was developed with the purpose of gathering all available information related to wet chemistry methodologies and compare the information against IMS technology capabilities in order to evaluate its attributes, suitability, and feasibility as a potential PAT application for 2,4,6-Tribromoanisole determination.;This research shows that given high costs associated with manufacturing in pharmaceuticals, as well as the push for greater process understanding through PAT, the implementation of IMS applications as a fast, specific analytical technology for at-line measurements (Selectivity and Sensitivity) has the potential to provide substantial improvements in TBA analysis, portability, and its monitoring efficiency.