IMPACT ON DRUG IMPURITY PROFILING WITH SUB 3 μM HPLC COLUMN PACKINGS

One key analytical area where column loadability is a major concern is drug impurity profiling assays, where a large amount of the main component must be loaded onto the column in order to increase the detectability of trace contaminants. Typically it is necessary to quantitate the impurities at the 0.05 - 0.1% level compared to the main peak area. In this paper, we examine the loadability of commercially available sub 3 μm stationary phases, and investigate the role that media surface area has on loadability and how this impacts impurity-profiling assays.