Procurement and Installation of Mass Spectrometer CDER-2026-131687

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 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.