Description
The U.S. Food and Drug Administration (FDA) is seeking to acquire a high-resolution mass spectrometer system with ultra-high-performance liquid chromatography (UHPLC) capability to support the analysis of pharmaceutical drug substances and drug products. The system must meet specific salient characteristics, including high-resolution accurate-mass detection, extended mass range capability, and sensitivity sufficient for trace-level detection of pharmaceutical impurities. The contract period is 12 months from award, with an optional 1-year annual preventive maintenance service agreement. The contractor shall deliver, install, and qualify the instrument, and provide training and familiarization.
Key features of the required system include:
• High-resolution accurate-mass (HRAM) mass spectrometry system
• Mass analyzer with sufficient resolving power for high-confidence molecular identification and impurity characterization
• Extended mass range capability up to m/z 12,000
• Sensitivity for trace-level detection of pharmaceutical impurities
• Compatibility with an integrated UHPLC system
• Integrated instrument control and data analysis software
• 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