Analytical methodologies for discovering and profiling degradation-related impurities

The analytical technologies currently in use for profiling degradation-related impurities (DRI’s) are powerful, but not without their limitations. This article critically assesses the technologies, their strengths and limitations, and recommends strategies for successful DRI profiling. Improvements in analytical separations and detection technologies are leading to strategies involving multiple orthogonal separations and detectors. Advances in knowledge of degradation chemistry and in computer-prediction tools are needed for the future.