# Orbitrap Excedion Pro BioPharma Mass Spectrometer and UHPLC

Canonical: https://abierto.us/opportunities/75f40126q00088

- Solicitation number: 75F40126Q00088
- Notice type: Combined synopsis and solicitation
- Status: Closed. Deadline was May 7, 2026 at 12:00 PM EDT
- Department: Department of Health and Human Services
- Agency: Food and Drug Administration
- Contracting office: FDA Office of Acq Grant SVCS (75F401)
- NAICS: 334516 Analytical Laboratory Instrument Manufacturing
- Product or service code: 6640 Laboratory Equipment and Supplies
- Set-aside: Total small business set-aside
- Place of performance: Saint Louis, Missouri
- County: City of St. Louis (FIPS 29510). https://abierto.us/counties/city-of-st-louis-mo-29510
- City: St. Louis. https://abierto.us/cities/st-louis-mo-2965000
- First posted: May 1, 2026
- Last posted: May 6, 2026
- SAM.gov: https://sam.gov/workspace/contract/opp/daa8b5446379478e9536342d5cd69982/view

## Description

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 • Minimum one (1) year manufacturer warranty covering parts, labor, travel, and OEM-certified service support, beginning upon Government acceptance of the system 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.

## Publications

- May 1, 2026: Combined synopsis and solicitation, due May 6, 2026 at 12:00 PM EDT. Notice cd2ff363de66495aa17b5ae4d474557e. https://sam.gov/workspace/contract/opp/cd2ff363de66495aa17b5ae4d474557e/view
- May 6, 2026: Combined synopsis and solicitation, due May 7, 2026 at 12:00 PM EDT. Notice daa8b5446379478e9536342d5cd69982. https://sam.gov/workspace/contract/opp/daa8b5446379478e9536342d5cd69982/view

## Points of contact

- Reagan Davis, reagan.davis@fda.hhs.gov, 3017960910

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Source: SAM.gov Contract Opportunities bulk extract. Confirm deadlines on SAM.gov before responding. Cite https://abierto.us/opportunities/75f40126q00088.
