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.
In this seventh part of " Conversations with Michael Dong," a series on fundamentals of HPLC in pharmaceutical analysis, LCGC International’s "Perspectives in HPLC" column editor explains why 2.1-mm i.d. columns are less preferred for pharmaceutical quality control.
Ultrahigh-performance liquid chromatography–quadrupole time-of-flight mass spectrometry (UHPLC–QTOF-MS) shows how soaking and cooking break down soybean fats.
Nicolai Zederkopff explores chromatography’s role to help implement the maximum tolerable level (MTL) framework for food adulteration to translate analytical results into compliance decisions.
Franz Berthiller (BOKU University, Austria) discusses a multilaboratory study that used retention index markers to align mycotoxin liquid chromatography–mass spectrometry (LC–MS) data.
A QuEChERS/ultrahigh-performance liquid chromatography and high-resolution mass spectrometry (UHPLC-HRMS) method tracks 23 plant toxins in cereals and spices. Michele Suman discusses the method with LCGC International.
