Procurement Summary
Country: USA
Summary: Procurement and Installation of Mass Spectrometer
Deadline: 06 Apr 2026
Posting Date: 02 Apr 2026
Other Information
Notice Type: Tender
TOT Ref.No.: 138871628
Document Ref. No.: CDER-2026-131687
Competition: ICB
Financier: Self Financed
Purchaser Ownership: Public
Tender Value: Refer Document
Purchaser's Detail
Name: Login to see tender_details
Address: Login to see tender_details
Email: Login to see tender_details
Login to see detailsTender Details
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 analy...
Notice ID: cder-2026-131687
Department/Ind. Agency: health and human services, department of
Original Set Aside: total small business set-aside (far 19.5)
Sub-tier: food and drug administration
Office: fda office of acq grant svcs
Product Service Code: 6640 - laboratory equipment and supplies
NAICS Code: 334516 - Analytical Laboratory Instrument Manufacturing
Inactive Dates: apr 07, 2026
Inactive Policy: manual
Documents
Tender Notice
Documents.zip