Sotax automated HPLC-dissolution platform

The purchase of the Sotax automated HPLC-dissolution platform is intended to replace the aging Waters Alliance dissolution platform and USP 2 apparatus, both of which are over fifteen years old and no longer supported by the vendor, making parts procurement increasingly difficult and unreliable. This modernized system is critical for maintaining the OPQ laboratory’s ability to perform dissolution studies that directly align with its mission to support the safety, efficacy, and quality of generic drugs. The new instrumentation will ensure uninterrupted analytical capability essential for ongoing research and regulatory compliance, particularly in support of the GDUFA program’s requirements for timely and accurate drug product testing. The acquisition is forecasted by the Food and Drug Administration, with the NAICS code 334516 indicating classification under laboratory analytical instrument manufacturing. The point of contact for program inquiries is the Cder Acquisition Liaison, reachable via cderacquisitions@fda.hhs.gov, while the contracting officer role is currently undetermined. The equipment will be deployed at an undisclosed location within the FDA’s operational infrastructure, and this procurement is part of a broader effort to modernize analytical infrastructure and maintain regulatory readiness in the face of aging legacy systems.