How to Characterize a Non-Stoichiometric Hydrate?

Solid-state NMR is a highly sensitive and powerful analytical tool for the direct characterization of active pharmaceutical ingredients in a drug product without interference from excipients. 

This webinar will showcase how to identify the hydration state in a non-stochiometric hydrate in a 1 % drug load, employing 19F solid-state NMR alongside additional characterization techniques.

Assessing the water content in a non-stoichiometric hydrate (NSH) within a formulation is critical due to the potential physicochemical and content uniformity challenges that may arise from variations in lattice water content. These variations are influenced by changes in external relative humidity (RH).

ssNMR was employed to identify the hydration state in one such NSH (active) formulated as a 1 % drug load capsule, a process that can successfully bypass interference from formulation excipients. 

Leveraging the variations in peak shifts across the 0-100 % RH range, 19F ssNMR effectively measured the lattice water content, ranging from 0 to 0.85 moles, in the NSH within the drug product.

Key Learning Topics

  • Characterization of non-stoichiometric hydrates in low-dose formulation.
  • Solid-state NMR analysis of the state of hydration of an active in a 1 % drug-loaded capsule.
  • Correlation of peak shift changes in 19F ssNMR with changes in lattice water content as a function of RH.

What to Expect

This webinar will focus on the use of ssNMR in successfully determining the state of hydration in a non-stoichiometric hydrate formulated as a capsule with an extremely low drug load (1 %) in the 0-100 % RH range utilizing changes in peak shifts as a function of RH.

About the Speakers

Hau has dedicated 15 years to working at Genentech, Inc., initially in the Synthetic Molecule Pharmaceutics group and now in the Solid-state Chemistry group. Throughout his tenure, he has accumulated significant expertise in analyzing crystalline and amorphous drug substances, as well as in examining complex drug product formulations.

Martial Piotto earned his Ph.D. in NMR spectroscopy under Professor D. Gorenstein at Purdue University, USA. Following his academic achievements, he took a position at Bruker France as the head of NMR application, delving into various facets of NMR spectroscopy. His work notably included the development of innovative pulse sequences and HRMAS technology. Over the years, Piotto developed a keen interest in NMR applications within the pharmaceutical and medical industries. His current research is centered on the characterization of biologics, including monoclonal antibodies (mAb), vaccines, and therapeutic oligonucleotides, through the integration of NMR and multivariate statistical analysis.

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