Frank Swanek

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A complete cold chain freeze-fracture methodology has been developed to test the feasibility of using time-of-flight secondary ion mass spectrometry (TOF-SIMS) imaging for the molecular analysis of frozen hydrated biological samples. Because the technique only samples the first few monolayers of a sample, water on the surface of a sample can be a major(More)
Regulatory guidances for drug stability testing during early development stages lack specifics. Consequently, companies either conduct more stability studies than necessary just to avoid regulatory questions or perform insufficient stability work resulting in regulatory questions and delays in drug development. Hence, there exist a pressing need and a great(More)
The combination of capillary electrophoresis (CE) with electrospray ionization (ESI) mass spectrometry has proven to be broadly applicable to a wide range of biologically important compounds. When combined with Fourier transform ion cyclotron resonance (FTICR) mass spectrometry, the combined method, in addition to high-resolution separations, affords(More)
Recent results with on-line capillary electrophoresis (CE) electrospray ionization (ESI) Fourier transform ion cyclotron resonance (FTICR) mass spectrometry suggest that CE/ESI-FTICR can provide a powerful technique for micro-sample analyses owing to the inherent sensitivity of the technique and the enhanced information content derived from high-performance(More)
During phase 1 and phase 2 drug development (early stage drug development), it is normal to continuously improve a manufacturing process, with changes made to the synthetic pathway, reagents, reaction conditions, crystallization parameters, drying conditions, or manufacturing equipment or scale or site. These manufacturing process changes (“process changes”(More)
A reversed-phase high-performance liquid chromatographic method (HPLC) with diode-array detection (DAD) has been evaluated for monitoring trace levels of impurities, such as 4-amino-2-ethoxy-cinnamic acid (impurity A), hydrochloride salt of 4-amino-2-ethoxy-ethyl cinnamate (impurity B), and 4-bromo-3-ethoxy-nitrobenzene (impurity C), in drug substance and 3(More)
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