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The Department of Health and Human Services intends to procure an Orbitrap Excedion Pro BioPharma Mass Spectrometer and UHPLC system to support pharmaceutical analysis, including impurity characterization. The system must meet specific technical requirements for high-resolution mass detection and be compatible with regulatory-grade workflows.
The work involves the delivery and installation of a high-resolution mass spectrometry system with ultra-high-performance liquid chromatography capabilities, along with training and support services.
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.
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