Multiplatform Benchtop NMR Interlaboratory Study of Model Liquid Dosage Forms of Pharmaceutical Products
Katharine T. Briggs, Frank Delaglio, Marc B. Taraban, Robert G. Brinson, Luke Arbogast, Brendan Lichtenthal, Matteo Pennestri, Robert Espina, Hector Robert, Juan F. Araneda, Paul Hui, Susanne D. Riegel, Kevin Nott, Leonid Grunin, Innokenty Nikolaev, Thomas Reininger, Y. Bruce Yu
TL;DR
This study tests how consistently low-field NMR can measure pharmaceutical liquid samples across different benchtop instruments and protocols.
Contribution
The paper provides insights into harmonizing wNMR protocols to ensure reliable pharmaceutical analysis across diverse platforms.
Findings
wNMR measurements from different instruments showed high linearity in tracking sample concentrations.
Outlier samples were successfully detected using wNMR.
Measurement variance was more influenced by protocols than by hardware differences.
Abstract
Low-field NMR relaxometry uses water proton (1H2O) relaxation (wNMR) as a powerful and flexible tool to reveal deviations in critical quality attributes of liquid pharmaceuticals such as concentration or, in the case of proteins, aggregation. Measurements are fast and nondestructive, and many benchtop instruments can make measurements noninvasively, with an intact drug vial, prefilled syringe, or pen inserted directly into the probe. Because of the diversity of low-field instrument configurations and operating temperatures, the varying field strengths available, and the many possible protocols, pulse sequences, and parameters for conducting relaxation measurements, we sought to test the reproducibility of wNMR across platforms, and to identify the details of applying wNMR that impact reproducibility. To accomplish this, we piloted an interlaboratory study, in collaboration with benchtop…
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Taxonomy
TopicsNMR spectroscopy and applications · Metabolomics and Mass Spectrometry Studies · Drug Solubulity and Delivery Systems