Procurement and Installation of Mass Spectrometer
Closed Pre-Solicitation Posted
- Solicitation number
- CDER-2026-131687
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- Total Small Business
Opportunity facts
- NAICS code
- 334516 Analytical Laboratory Instrument Manufacturing
- PSC
- 6640 Laboratory Equipment And Supplies
- Place of performance
- Saint Louis, Missouri 63110, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Food and Drug Administration (FDA) Office of Acquisition and Grant Services, on behalf of the Center for Drug Evaluation and Research, is seeking to procure a high-resolution mass spectrometry system integrated with ultra-high-performance liquid chromatography (UHPLC) capability for pharmaceutical analysis and impurity characterization. The procurement references the Thermo Scientific Orbitrap Excedion Pro BioPharma MS as the benchmark product on a brand-name-or-equal basis, with acceptable alternatives required to meet or exceed specified salient characteristics including high-resolution accurate-mass detection, extended mass range up to m/z 12,000 for biomolecule analysis, and sensitivity sufficient for trace-level detection of pharmaceutical impurities such as nitrosamines. Key technical requirements include compatibility with integrated UHPLC systems, instrument control and data analysis software capable of supporting regulatory-grade analytical workflows, and fast, sensitive electron-based fragmentation capabilities. The evaluation will assess whether offered systems meet these minimum technical specifications for pharmaceutical quality evaluation and impurity characterization. The pre-solicitation notice was posted on April 1, 2026, with vendor responses due by April 6, 2026, to Reagan Davis, Contract Specialist, at Reagan.davis@fda.hhs.gov.
This procurement is designated as a Total Small Business set-aside, limiting competition to small business concerns. The contract encompasses delivery within 180 days of award, installation and qualification within 90 days of delivery, and training completion within 60 days of installation, establishing a full performance period of 12 months from award with an optional one-year annual preventive maintenance service agreement available following the warranty period for a total period of performance of two years. The NAICS code is 334516 (Analytical Laboratory Instrument Manufacturing) with a small business size standard, and the PSC code is 6640 (Laboratory Equipment and Supplies). While no specific award value or budget range is disclosed in the pre-solicitation notice, interested vendors should submit responses detailing company information, business size and socioeconomic status, current GSA Schedule or government-wide contracts, domestic manufacturing status, and technical specifications demonstrating compliance with the stated requirements. No reimbursement will be provided for response costs, and the government will not accept telephone calls or presentation appointments during this market survey phase.
Notice text
The Government intends to acquire a high-resolution mass spectrometry system with ultra-high-performance liquid chromatography capability to support the analysis of pharmaceutical drug substances and drug products, including detection and characterization of nitrosamine impurities, small molecules, peptides, and other biomolecules. The Thermo Scientific Orbitrap Excedion Pro BioPharma MS and UHPLC system is referenced as the brand-name product used to define the level of performance and functionality required.
This acquisition is conducted on a brand-name-or-equal basis. Products offered as an “equal” must meet or exceed the salient characteristics identified below in order to be considered technically acceptable.
The Government requires an integrated LC-MS analytical system capable of supporting regulatory-grade analytical workflows for pharmaceutical quality evaluation and impurity characterization. The system must provide high-resolution, accurate-mass detection across a wide mass range to support both small molecule and biomolecule applications, including trace-level impurity detection and characterization of peptide-based therapeutics.
At a minimum, the offered system shall meet the following salient characteristics:
• High-resolution accurate-mass (HRAM) mass spectrometry system capable of resolving complex mixtures and trace-level impurities in pharmaceutical samples
• Mass analyzer capable of achieving resolving power sufficient for high-confidence molecular identification and impurity characterization
• Extended mass range capability to analyze both small molecules and larger biomolecules (minimum mass range approximately up to m/z 12,000)
• Sensitivity sufficient for trace-level detection of pharmaceutical impurities, including nitrosamines
• Compatibility with an integrated ultra-high-performance liquid chromatography (UHPLC) system suitable for biocompatible analytical applications
• Integrated instrument control and data analysis software capable of supporting advanced analytical workflows for small molecule and peptide characterization
• Capability for automated data processing, spectral deconvolution, and identification workflows for complex pharmaceutical samples
• Centralized data management capability supporting secure instrument operation, workflow automation, and laboratory data integration
• Delivery, installation, and instrument qualification (IQ/OQ) services for the complete LC-MS system
• Vendor-provided instrument familiarization and operational training
The Government will evaluate quotations offering the referenced brand-name product or equal products that meet the above salient characteristics. Offerors proposing an equal product must clearly demonstrate in their quotation how the proposed equipment meets or exceeds each of the required salient characteristics.
Files
| File | Type | Posted |
|---|---|---|
| SSN_CDER-2025-131687.docx | DOCX document |
Notice history
| Notice | Type | Posted |
|---|---|---|
| This notice | Pre-Solicitation | |
| Procurement and Installation of Mass Spectrometer | Solicitation |
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