Understanding and Applying USP Chapter 621 for Generic Pharmaceutical Applications

This executive summary explores how revisions to USP <621> have introduced greater flexibility in chromatographic method adjustments while reinforcing system suitability as the definitive standard for method acceptance. Heiko Behr, senior business development manager at Phenomenex, walks through key principles governing column substitution, flow rate scaling, mobile phase control, and dwell volume management during method transfer. A practical Nifedipine case study demonstrates how these allowances can be applied to reduce run times tenfold without compromising monograph-defined selectivity or compliance.