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NMR 850 Probe Upgrade

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Federal

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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.

General Info

FDA seeks 850 NMR console and probe upgrades for biologic and generic assessments.

NAICS

334516 - Analytical Laboratory Instrument Manufacturing

Place of Performance

USA

Set-Aside

NONE

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Organization & Contact Information

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AgencyFood and Drug Administration → Food And Drug Administration
Contacts2 people available
OfficeN/A
Office AddressN/A
Contacts
Cder Acquisition Liaison
To Be Determined To Be DeterminedContracting Officer

Full Description

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NMR console and probe degrade over time (11 years), and currently we are limiited to study of high concentration drugs using 1D or low resolution 2D NMR. The 850 NMR needs upgrade for senstivity to characterize oligonucleotide and biologic menotropin structure, supporting complex generic ANDA and biologic BLA assessment.

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