The demands on the analytical laboratory to qualitatively and quantitatively determine active pharmaceutical ingredients and degradants continues to increase. The FDA regulations require companies to develop methods for their analysis and characterization of the APIs, as well as for the impurities/degradants that could arise from the synthesis process, raw material provider, and/or storage conditions. The utilization of UV or PDA data alone for these analyses is often inadequate.
The importance of exact mass and MS fragmentation products to determine the structure of degradants/impurities provides a higher understanding of the relationship of the impurity/degradant origin. This poster demonstrates the utility of a UPLC/PDA/MS system and explains how this configuration will impact the identification of pharmaceuticals and their related substances.To best illustrate this concept, the pharmaceutical drug substance budesonide is analyzed. Using the ACQUITY UPLC System results in significant benefits in resolution, speed, and sensitivity.
This poster was shown at the HPLC 2006 tradeshow, Montreaux 2006, and Pittcon 2006.