Purchaser
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Country
United States
Published
1 Apr 2026
Closing date
6 Apr 2026
Source ID
Docs found
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Tender summary
<p>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 <strong>Thermo Scientific Orbitrap Excedion Pro BioPharma MS and UHPLC system</strong> is referenced as the <strong>brand-name product</strong> used to define the level of performance and functionality required.</p> <p>This acquisition is conducted on a <strong>brand-name-or-equal basis</strong>. Products offered as an “equal” must meet or exceed the <strong>salient characteristics</strong> identified below in order to be considered technically acceptable.</p> <p>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.</p> <p>At a minimum, the offered system shall meet the following <strong>salient characteristics</strong>:</p> <p>• High-resolution accurate-mass (HRAM) mass spectrometry system capable of resolving complex mixtures and trace-level impurities in pharmaceutical samples<br /> • Mass analyzer capable of achieving resolving power sufficient for high-confidence molecular identification and impurity characterization<br /> • Extended mass range capability to analyze both small molecules and larger biomolecules (minimum mass range approximately up to m/z 12,000)<br /> • Sensitivity sufficient for trace-level detection of pharmaceutical impurities, including nitrosamines<br /> • Compatibility with an integrated ultra-high-performance liquid chromatography (UHPLC) system suitable for biocompatible analytical applications<br /> • Integrated instrument control and data analysis software capable of supporting advanced analytical workflows for small molecule and peptide characterization<br /> • Capability for automated data processing, spectral deconvolution, and identification workflows for complex pharmaceutical samples<br /> • Centralized data management capability supporting secure instrument operation, workflow automation, and laboratory data integration<br /> • Delivery, installation, and instrument qualification (IQ/OQ) services for the complete LC-MS system<br /> • Vendor-provided instrument familiarization and operational training</p> <p>The Government will evaluate quotations offering the referenced brand-name product or <strong>equal products</strong> 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.</p>
What to check before bidding
- Located in United States.
- Deadline listed as 6 Apr 2026.
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