Thermo Scientific Auto Trace 280 Solid Phase Extraction (SPE) System or Equivalent

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).