Situation: A client company had indications that their existing manufacturing process was promoting oxidation in a protein commercial drug product.  Improvements in the analytical methodology were necessary to assess the...

Situation: A new API for injectable application showed nine different impurities when analyzed by HPLC/UV methodology.  The identification of these unknown peaks was critical for the continuation of the project in the...

Situation: The use of this lipid based excipient system in injectable formulations required a full characterization of its composition.   Lipids are complex multi-component mixtures with very complicated oxidation...