NMR 850 Console Upgrade
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The Food and Drug Administration is seeking a console upgrade for its 850 NMR system to address sensitivity limitations caused by equipment degradation over the past eleven years. Currently, the system is restricted to studying high concentration drugs using only 1D or low resolution 2D NMR, which hinders the agency's analytical capabilities. This upgrade is essential for the characterization of biologic menotropin structures and oligonucleotides. By enhancing the sensitivity of the NMR console and probe, the agency aims to better support the assessment of complex generic Abbreviated New Drug Applications and biologic Biologics License Applications.
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USASet-Aside
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