The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality Research – St. Louis (OPQR–St. Louis), requires the acquisition of a Thermo Scientific AutoTrace 280 Solid Phase Extraction (SPE) System or equivalent, including delivery, installation, qualification (IQ/OQ), training, and warranty. The system will support the FDA’s nitrosamine testing program by automating pre-concentration of contaminants such as NDBA, NDMA, NMOR, and NDEA from large-volume intravenous (IV) drug products to ensure reproducible and accurate results.
Interested vendors are advised to carefully read the attached Combined Synopsis/Solicitation (CSS 75F40125Q00404) in its entirety for full details, submission instructions, and applicable provisions/clauses.
Questions are due no later than September 2, 2025, at 10:30 AM Eastern Time (ET).
Quotations are due no later than September 4, 2025, at 4:00 PM Eastern Time (ET).
