This Combined Synopsis/Solicitation opportunity from Department Of Health And Human Services was posted on May 6, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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Orbitrap Excedion Pro BioPharma Mass Spectrometer and UHPLC

Closed

75F40126Q00088Federal

Submission Closed05/07/2026, 04:00:00 PM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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NAICS: 334516

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252-NETWORK Contract Office 12 (36C252)

POSTED

about 20 hours ago

DEADLINE

in 4 days

AI Contract Overview

The Government is seeking a high-resolution mass spectrometry system with ultra-high-performance liquid chromatography capability to support pharmaceutical analysis, specifically for the detection and characterization of nitrosamine impurities, small molecules, peptides, and other biomolecules. The acquisition is structured as a brand-name-or-equal procurement, with the Thermo Scientific Orbitrap Excedion Pro BioPharma MS and UHPLC system serving as the reference for performance requirements. All offered systems—whether the branded product or an equal—must meet or exceed a defined set of salient characteristics, including high-resolution accurate-mass detection, a mass range extending to at least m/z 12,000, sensitivity for trace-level impurity detection, integrated UHPLC compatibility, automated data processing and spectral deconvolution, centralized data management, and full instrument qualification (IQ/OQ) services. The system must also include integrated software such as BioPharma Finder and the Ardia Platform, both of which must be listed on the FDA’s Master Approved Technology list and compliant with OIMT requirements. Delivery, installation, and operator training for two to three scientists are mandatory, and a minimum one-year manufacturer warranty covering parts, labor, and travel is required, commencing upon Government acceptance. The contract is a Firm-Fixed-Price award under FAR Part 12 and Part 13, selected through a Lowest Price Technically Acceptable evaluation method, where technical acceptability is a pass/fail criterion based entirely on adherence to the salient characteristics. The solicitation is a Total Small Business Set-Aside under NAICS 334516, with a 1,000-employee size standard, and incorporates clauses addressing subcontracting limitations, whistleblower protections, electronic invoicing via the HHS Invoice Processing Platform, and compliance with the Trade Agreements Act. All proposals must be submitted electronically via SAM.gov by the May 7, 2026 deadline and must include a Unique Entity ID, proof of SAM.gov registration, lead time, country of origin, and, for equal products, a detailed compliance matrix demonstrating how each salient characteristic is met or exceeded. The system must be delivered and fully operational at the CDER/OPQ/OPQR facility in St. Louis, Missouri, with installation, IQ/OQ, and training completed within set time frames, and all documentation—including validation reports, configuration records, and software certifications—submitted electronically to the Government. Payment is exclusively through IPP, and optional one-year preventative

General Info

FDA seeks high-res MS/UHPLC system for nitrosamine testing, benchmarked to Thermo Orbitrap Excedion Pro, lowest price technically acceptable.

Agency

Department Of Health And Human Services → FDA Office Of Acq Grant SvcsView Agency

NAICS

334516 - Analytical Laboratory Instrument ManufacturingView NAICS

Place of Performance

Saint Louis, MO, 63110, USA

Set-Aside

SBA

Documents

(1)

Combined_Syn.docx

DOCX

AI Contract Breakdown

Uniform Contract Format

Timeline

1 update

PhaseClosed

PostedMay 1

Combined Synopsis

Amendment 1May 6

Contract was updated

Response DeadlineMay 7

Deadline has passed

Submission Closed

05/07/2026, 04:00:00 PM UTC

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Organization & Contact Information

AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs

Contacts1 person available

OfficeRockville, MD, 20852, USA

Organization / Agency

Department Of Health And Human Services → FDA Office Of Acq Grant Svcs

View Agency Profile

Office AddressRockville, MD, 20852, USA

Contacts

Reagan Davis

contact@example.gov

+1 (555) 000-0000

Full 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.