Application Note: Pharmaceutical Impurity Profiling

Screen complementary selectivity

Start with a robust C18 phase, then compare an alternative family when impurities co-elute with the active ingredient or with one another. ODS-UG-5 supports conventional methods, while FireFlex C18 and Fusion C18 provide modern configuration options.

Control ionization

Mobile-phase pH has a major effect on retention and peak shape for ionizable compounds. Select a buffer range appropriate to the analyte and stationary phase, and keep buffer concentration consistent during method development.

Stress-sample evaluation

Use representative stressed samples to confirm that degradants are separated from the main component and from each other. Examine peak purity with an appropriate detector where available.

Robustness

Study small deliberate changes in pH, organic composition, temperature, flow and column lot. Confirm that critical resolution remains acceptable throughout the intended operating range.

Develosil ODS-UG-5

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FireFlex C18

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Fusion C18

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Develosil SR Columns

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