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Sotax automated HPLC-dissolution platform

Forecast

Federal

Contract Overview

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The Food and Drug Administration is seeking a Sotax automated HPLC-dissolution platform to enhance lab testing capabilities for generic drugs. This acquisition serves as a critical replacement for the existing Waters Alliance dissolution platform and USP 2 apparatus, which are over 15 years old and no longer supported by the vendor, leading to significant challenges in parts procurement. This equipment is essential for OPQR laboratory operations to conduct dissolution studies that support OPQ mission objectives, research goals, and GDUFA program needs. By ensuring continued analytical capability for drug product testing, the new platform will maintain the operational integrity of the laboratory's testing processes.

General Info

FDA seeks a Sotax automated HPLC-dissolution platform to replace outdated lab testing equipment.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

334516 - Analytical Laboratory Instrument Manufacturing

Place of Performance

USA

Set-Aside

NONE

Documents

0

No documents available

Documents will appear here when they are available.

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Organization & Contact Information

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AgencyFood and Drug Administration → Food And Drug Administration

Contacts2 people available

OfficeN/A

Organization / AgencyFood and Drug Administration → Food And Drug Administration

Office AddressN/A

Contacts

Cder Acquisition Liaison

contact@example.gov

To Be Determined To Be DeterminedContracting Officer

Full Description

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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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