Electrospray Ionization-Ion Mobility Spectrometry (ESI-IMS) for Rapid On-site Cleaning Validation (CV) in Pharmaceutical Manufacturing Abstract

A novel high resolution ion mobility spectrometer (HRIMS) equipped with an electrospray ionization (ESI) source was used to analyze the active pharmaceutical ingredients (APIs) that comprise many of the top selling drugs for use in cleaning validation (CV) of pharmaceutical manufacturing equipment. The ESI-HRIMS system allowed rapid analysis of pharmaceutical samples that were difficult to detect using conventional IMS systems while providing resolving powers, R, greater than 60 and good sensitivity over a greater linear dynamic response range. This research demonstrated analysis of high molecular weight and thermally labile compounds, allowing them to be detected as their intact molecular ions. The high performance IMS system provides a rapid, effective analytical tool that offers improved performance for IMS-based applications.