Development and Application of a New High Performance Mass Spectrometer for Small Molecule and Biotheraputic Pharmaceutical Development Applications


As scientists in Pharmaceutical and Analytical Development groups are called upon to identify an ever varying and always increasing number of APIs and unknown or unexpected impurities, many researchers are looking for more high performance analytical tools to better deal with these complex problems. Many groups rely upon traditional HPLC detection methods for much of their work, with a Mass Spectrometer available to aid in accurate mass determinations of unknown degradants or impurities routinely found in drug substances and drug products during routine development operations. However, the latest generation of more complex and larger molecular weight therapeutics and biotherapeutics has greatly complicated the analytical challenges in developing these types of molecules and the methods and analytical tools of the past are becoming increasingly less well suited for efficient and effective use.