Chromatographic methods are central to drug product characterization, especially for detecting impurities, but the decisions behind those methods are rarely straightforward. Molecular structure, column design, and the range of available chromatographic approaches all factor into method determination. If not properly aligned, these choices can lead to incomplete separation, co-elution, inaccurate quantification, and challenges in meeting regulatory expectations—particularly for impurities like nitrosamines, where allowable levels are extremely low and analytical selectivity is critical.
This compendium examines how chromatographic methodology underpins effective impurity and structural analysis, covering regulations and method development for nitrosamine detection, strategies to address co-elution, and considerations for column selection. Together, these resources help lab managers and analytical teams make more informed decisions that contribute to reliable drug product characterization.
Download this compendium to explore:
- Causes of co-elution and interference, and how they affect quantification
- FDA-shared methods for detecting nitrosamine impurities
- How a column’s dimensions, stationary phase, and particle design influence selectivity and separation
- Chromatographic considerations for characterizing complex biomolecules
