NMR 850 Probe Upgrade
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The Food and Drug Administration is seeking an upgrade for its 850 NMR console and probe to address sensitivity degradation occurring over the last eleven years. Current equipment limitations restrict the agency to studying high concentration drugs using only 1D or low resolution 2D NMR, which hinders the detailed characterization of biologic menotropin structures and oligonucleotides. This upgrade is essential for supporting complex generic ANDA and biologic BLA assessments. The project is currently listed as a forecast, with program inquiries directed to the CDER Acquisition Liaison.
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USASet-Aside
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