Part of USDA requirements for in vitro bioequivalence testing is particle size distribution and agglomerate analysis of the budesonide suspension in the ampoules of both the generic product for submission and the reference listed drug. Automated optical microscopy with Raman characterization, and automated Scanning Electron Microscopy – Energy Dispersive Spectroscopy (SEM-EDS) methods were considered for the analysis of budesonide suspension, and the strengths and weaknesses of each was explored, as it relates to API-specific particle size data and agglomerate analysis.
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