Sotax automated HPLC-dissolution platform
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $250,000 to $700,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- 334516 Analytical Laboratory Instrument Manufacturing
- Points of contact
-
- Christopher Scott christopher.scott@fda.hhs.gov
- tbd@fda.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Food and Drug Administration (FDA) is forecasting the procurement of a Sotax automated HPLC-dissolution platform to replace an aging Waters Alliance dissolution platform and USP 2 apparatus. This new instrument is critical for enhancing the Office of Pharmaceutical Quality (OPQ) laboratory testing capabilities for generic drugs, supporting the Generic Drug User Fee Amendments (GDUFA) program objectives. The estimated solicitation release is scheduled for November 1, 2025, with an anticipated contract award date of January 1, 2026.
While specific award value details are not provided, the contract falls under NAICS code 334516 for Analytical Laboratory Instrument Manufacturing. The primary point of contact is Christopher Scott (christopher.scott@fda.hhs.gov) from the Food and Drug Administration, who can provide additional information about the procurement. The instrument will be used to conduct dissolution studies essential for drug product testing, with the procurement aimed at ensuring continued analytical capability for the OPQ laboratory operations.
Forecast text
The purrchase of this instrument enhances OPQ lab testing capability for generic drugs. Replacement of the current Waters Alliance dissolution platform as well as the USP 2 apparatus, which is over 15 years old and no longer supported by the vendor with increasingly difficult parts procurement. This equipment is essential for OPQR laboratory operations to conduct dissolution studies that directly support OPQ mission objectives and research goals, ensuring continued analytical capability for drug product testing. The work performed with this instrument will support GDUFA program needs.
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