Structural Elucidation of a Novel Degradation Product in Norepinephrine Bitartrate Drug Product Formulation Utilizing UPLC and High Resolution MS/MS

摘要

ICH Guidelines dictate allowable levels of impurities and at what level an impurity ordegradation product needs to beidentified. During the reformulation of current products and qualification of new suppliers of active pharmaceutical ingredients (APIs), new methods are often required to meet ICH guidelines, and new impurities are observed atlevels that warrant identification. High-resolution mass spectrometry is an in dispensable tool in the identification of these new impuritiesin pharmaceutical products.