Four (4) Mass Spectrometers

STATEMENT OF WORK Four (4) Mass Spectrometers Background The regulatory laboratories of the Food and Drug Administration (FDA) Office of the Chief Scientist (OCS), conduct a range of chemical analyses on pharmaceutical products and dietary supplements to determine if they meet regulatory requirements. As such we require a wide range of unique types of mass spectrometers to complete our regulatory work. These instruments are needed for current projects involving β-lactam, nitrosamine, complex health fraud, and CRADA mass spectral data. Additionally, these systems will enhance capabilities for the detection and quantitation of drugs of abuse, such as synthetic opioids, the results of which would support criminal and regulatory investigations involving foods, drugs, dietary supplements, medical products. Purpose/Objective The purchase of one (1) high resolution quadrupole-ion trap mass spectrometer with an ultra-high performance liquid chromatography (UHPLC) system for the Irvine Medical Products Laboratory (IRVLMP), Irvine, CA is required to ensure the laboratory has sufficient instrumentation for the timely analysis of dietary supplements which are analyzed to detect the presence of undeclared active pharmaceutical ingredients to include GLP-1 receptor agonist ingredients. The purchase of one (1) UHPLC with Ultra High-Field Triple Quadrupole Mass Spectrometer for the San Juan Medical Products Laboratory (SJLMP) can perform targeted analysis with a high degree of sensitivity and specificity. Additionally, San Juan needs the ability to perform robust quantitative analyses with low detection limits in complex pharmaceutical analyses. The system in use needs to maintain cGMP/cGLP, ISO/IEC 17025-2017, ISO 9001:2008, and 21 CFR 11 standards for use as analytical equipment under the current accreditation. The system is used to analyze medical product samples using specific protocols and methods established by the FDA Laboratories, internal FDA programs, and the FCC program. The purchase of two (2) hybrid quadrupole/linear ion trap mass spectrometers with two (2) ultra-high performance liquid chromatographs (LC-MS/MS) for the National Forensic Chemistry Center (NFCC). The systems must offer data-dependent acquisition (DDA), data-independent acquisition (DIA), and MSn acquisition through use of the hybrid quadrupole/linear ion trap and will enhance capabilities for both targeted and non-targeted identification and quantitation of small molecules, particularly approved and counterfeit drugs, opioids, designer drug isomers and analogs, synthetic cannabinoids, misbranded/adulterated dietary supplements, and designer steroids in support of investigations involving foods, drugs, dietary supplements, medical products, tobacco products and vape products. Scope OCS requires one (1) high resolution quadrupole-ion trap mass spectrometer with an ultra-high-performance liquid chromatography (UHPLC), one (1) UHPLC with Ultra High-Field Triple Quadrupole Mass Spectrometer system and two (2) hybrid quadrupole/linear ion trap mass spectrometers with two (2) ultra-high performance liquid chromatographs (LC-MS/MS) and accessories as well as Nitrogen Generator(s) Power Conditioner(s), and Uninterruptible Power Supply (UPS) as well as delivery, installation, and training to FDA personnel that meets or exceeds the requirements below: Requirements High resolution quadrupole-ion trap mass spectrometer with an ultra-high performance liquid chromatography (UHPLC) The contractor shall provide an Orbitrap Exploris 480 mass spectrometer or equivalent. The quadrupole-ion trap mass spectrophotometer shall meet or exceed the following requirements: The mass spectrometer must be a high-resolution, high-field bench top system that can occupy a bench space of 36 x 36 x 36 inches (h x d x w) and can connect to existing utilities to include nitrogen gas and an exhaust outlet. The mass spectrometer must be a quadrupole-ion trap configuration. The mass spectrometer must have an electrodynamic ion funnel for ion transmission from atmosphere. The mass spectrometer must have a minimum resolution of 7500 (FWHM) at m/z 200 for all scan modes and both polarities and a maximum resolution of at least 480,000 (FWHM) at m/z 200 for all scan modes and both polarities. The mass spectrometer must operate in the m/z range of at least 40-8,000. The mass spectrometer shall utilize accelerated Higher-Energy Collisional Dissociation (HCD) cell for generating fragment spectra. The mass spectrometer must be equivalent to a LC-MS/MS system utilizing a Quadrupole Mass Filter consisting of segmented mass filter, providing variable and step-less precursor isolation width selection from 0.4 Da up to 2000 Da. The mass spectrometer must only require nitrogen as an external gas. The mass spectrometer must have the following minimum sensitivity: MS/MS: 50 fg Reserpine on column yields S/N 100:1 SIM: 50 fg Reserpine on column yields S/N 150:1 The mass spectrometer must have the following scan speed, at a minimum: Highest scan rate of at least 35 Hz at resolution setting at 7,500. Scan speed for MS/MS is up to 22 MS/MS scans per second at resolution (R=15,000 at m/z 200) in targeted or data dependent mode The mass spectrometer must have the following mass accuracy, at a minimum: < 3 ppm RMS – with external calibration over 24 h and without any kind of mass recalibration  < 1 ppm RMS – with internal calibration (used-defined lock mass)  < 1 ppm RMS – with internal calibration for up to 5 consecutive days  The mass spectrometer must be equipped with a two position RoHS valve or equivalent, to allow for solvents coming from the UHPLC to be diverted to waste. Software Package: Software for instrument control data acquisition, data processing, and analysis shall be included. The software shall have seamless control of both the mass spectrometer and liquid chromatography system. Software for instrument cont…