Description
The U.S. Food and Drug Administration (FDA) is seeking to acquire a high-resolution mass spectrometry system with ultra-high-performance liquid chromatography capability. The system must be capable of supporting regulatory-grade analytical workflows for pharmaceutical quality evaluation and impurity characterization. The requirements include high-resolution accurate-mass detection, extended mass range capability, sensitivity sufficient for trace-level detection of pharmaceutical impurities, and compatibility with an integrated UHPLC system. The acquisition is conducted on a brand-name-or-equal basis, with the Thermo Scientific Orbitrap Excedion Pro BioPharma MS and UHPLC system as the referenced brand-name product.
• High-resolution accurate-mass (HRAM) mass spectrometry system
• 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
• Sensitivity sufficient for trace-level detection of pharmaceutical impurities
• Compatibility with an integrated ultra-high-performance liquid chromatography (UHPLC) system
• Integrated instrument control and data analysis software
• Capability for automated data processing, spectral deconvolution, and identification workflows
• Centralized data management capability
• Delivery, installation, and instrument qualification (IQ/OQ) services
• Vendor-provided instrument familiarization and operational training