Characterization Of Trace Impurities

Characterization of Trace Impurities Leaching from Pharmaceutical Packaging Systems

Author: Thomas N. Feinberg, Ph.D. Director, Structural Chemistry

Summary: As the use of “universal” HPLC detectors such as evaporative light scattering (ELSD), and charged aerosol detectors (CAD) become more common for pharmaceutical quality control, the number of chromatographically observed peaks has increased accordingly. While these new detectors offer flexibility in the types of non-UV active compounds that can be analyzed by HPLC, this same flexibility opens up the possibility for new impurities, contaminants, degradation products and leachables to be observed, too. Typical pharmaceutical analysis studies will incorporate impurity profiling and degradation stress testing, but only for certain “high concern” dosage forms will the interactions of packaging and the formulation (i.e. extractables and leachables) be investigated. Examples of structural characterization of leachables and other novel unknown peaks in pharmaceutical dosage forms will be presented.