Sotax automated HPLC-dissolution platform

This contract involves the acquisition of a Sotax automated HPLC-dissolution platform to upgrade the OPQ laboratory’s dissolution testing capabilities for generic drugs. It is intended to replace the outdated Waters Alliance dissolution system and the USP 2 apparatus, which have been in use for over 15 years and are no longer supported by the vendor, making parts difficult to obtain. The new equipment is critical for maintaining the OPQR laboratory's operational effectiveness in conducting dissolution studies that are integral to the FDA's Office of Pharmaceutical Quality's mission and research goals. The upgraded platform will ensure continued analytical capacity for drug product testing, directly supporting the objectives of the Generic Drug User Fee Amendments (GDUFA) program. This purchase reflects the FDA’s commitment to maintaining state-of-the-art testing infrastructure to meet evolving regulatory and scientific needs. The solicitation details are managed by the Food and Drug Administration, with the program point of contact provided, while the contracting officer is yet to be determined. The contract falls under NAICS code 334516, indicating it pertains to manufacturing and testing equipment in the analytical instrumentation sector.