An LC–HRMS approach for the simultaneous analysis of 15 N-nitrosamines in multiple APIs using a novel HILIC-based SPE clean-up step has been developed and tested.
In this article, we review some key considerations for chromatographic technique selection and method development across the full drug process—from early-stage active pharmaceutical ingredient (API) synthesis to routine commercial release activities.
Ronald Piervincenzi, chief executive officer of the United States Pharmacoepia, focused on how collaboration and component quality can improve worldwide pharmaceutical production standards during a lecture at the Eastern Analytical Symposium (EAS) last month.
Organic solvents are generally not compatible with ion chromatography (IC) systems. The approach presented here assists the use of organic solvents for sample preparation and provides a mechanism for the removal of the organic solvents from the chromatographic flow path.