UHPLC

Sources Sought: High Resolution Ion Trap Mass Spectrometer with Ultra High Performance Liquid Chromatography System Reference number: 1251793 The Food and Drug Administration (FDA) is conducting a market survey to assess the availability and potential technical capability of all small businesses as defined by NAICS code 334516 to provide a High-Resolution Ion Trap Mass Spectrometer with Ultra High Performance Liquid Chromatography System. We encourage all small businesses, in all socioeconomic categories (including, 8(a) Business Development Program, Small Disadvantage Business, Historically Underutilized Business Zone, Service-Disabled Veteran-Owned, Women-Owned Small Business concerns), to identify their capabilities in meeting the requirement at a fair market price. Purpose/Objective The purchase of one (1) high resolution ion trap mass spectrometer with an ultra high performance liquid chromatography (UHPLC) system for the Pacific Southwest Medical Products Laboratory (PSMPL), 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 as well as performing chemical analyses such as identification and quantitation of opioid compounds. Requirements Provide a Orbitrap Exploris 120 mass spectrometer or equivalent. The 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 24 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 quadruple (Orbitrap, or equivalent) ion trap configuration. The mass spectrometer must have an S-lens for ion transmission from atmosphere The mass spectrometer must have a minimum resolution of 15,000 (FWHM) at m/z 200 for all scan modes and both polarities and a maximum resolution of at least 120,000 (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 40-3,000 The mass spectrometer shall utilize accelerated Higher 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 to full mass range. The mass spectrometer must only require nitrogen as an external gas. The mass spectrometer must have the following minimum sensitivity: MS/MS: 200 fg Reserpine on column yields S/N 100:1 RMS tSIM: 200 fg Reserpine on column yields S/N 250:1 RMS The mass spectrometer must have the following scan speed, at a minimum: Highest scan speed is 22 scans per second (R=15,000 at m/z 200) in Full MS Scan or SIM mode. 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 (max Top 4) 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 an atmospheric pressure chemical ionization (APCI) probe. 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. A compatible computer running Windows 10 OS and monitor shall be included to run software and instrument components to include the UHPLC system described in Part II. Software for instrument control and for data acquisition to include analysis software such as TraceFinder, Xcalibur or equivalent. An uninterruptible power supply equipped with at least five (5) 5-15R output receptacles, at least four (4) 6-20R output receptacles, a compatible power distribution unit (PDU) module that has at least four (4) 5-15R receptacles, two (2) 6-20R receptacles and two (2) L6-20R receptacles and any necessary power cords for the specified equipment. The mass spectrometer must be compatible with the ultra high performance liquid chromatography system described in Part II. The contractor shall provide a Vanquish Horizon Binary Ultra High Performance Liquid Chromatography (UHPLC) System or equivalent. The UHPLC system shall meet or exceed the following requirements: The UHPLC System must be compatible with the mass spectrometer system described above in Part I. The UHPLC shall equipped with a binary pump with a minimum flow range of 0-5 mL/minute. The UHPLC shall be equipped with an autosampler to allow for split loop injection with an injection volume range of at least 0.1 µl to 25µl and an accuracy of at least ±0.5%. The UHPLC shall be equipped with a sample compartment temperature range from 4°C to 40°C, minimally and a sample capacity of at least four racks of at least 54 vials each. The UHPLC shall be equipped with a column compartment thermostat capable of regulating the temperature minimally in the range of 5°C up to 120°C and the column compartment capacity allows for 2 column slots. The UHPLC shall be equipped with a pre-heater and post-column cooler for the column compartment. The UHPLC shall include necessary accessories to connect to a mass spectrometer and complete installation to include a column, syringe and syringe filters. The UHPLC shall be equipped with a diode array detector with at least 10 UV channels and a UV-Vis lamp. The UHPLC shall have a titanium flow cell with a 7mm light path length and 2.5µl volume compatible with the diode array detector described above. The information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Respondents shall specify and document that their NAICS 334516 code is and provide proof of your business size. This is a request for information and shall not be considered as a solicitation or as an obligation on the part of the Food and Drug Administration (FDA) for any future solicitation. Telephone inquiries will not be accepted. All interested parties shall submit their capability statement to Julia Savage, FDA contracting office via email to [email protected] by March 7, 2022, 5 pm Eastern time.