The FDA's San Juan Medical Products Laboratory (SJNLMP) requires a new UHPLC with an Ultra High-Field Triple Quadrupole Mass Spectrometer and comprehensive workstation/software. This system is crucial for analyzing and quantifying samples, supporting projects like b-lactam, nitrosamine, and health fraud investigations, and ensuring sensitive detection of adulterants in complex matrices. The system must comply with cGMP/cGLP, ISO/IEC 17025-2017, ISO 9001:2008, and 21 CFR 11 standards. Key requirements include specific performance specifications for the UHPLC, Diode Array Detector, Triple Quadrupole, integrated syringe pump, UPS, vacuum system, nitrogen generator, and controller software. The contractor is responsible for delivery, on-site installation within 90 days, demonstrating performance, providing a minimum 3-year warranty, and offering on-site training for 3-5 users. All equipment must be newly manufactured. Deliverables are expected within 6-8 weeks of award.

The Food and Drug Administration’s Irvine Medical Products Laboratory (IRVLMP) requires a triple quadrupole inductively coupled plasma mass spectrometer with a high-performance liquid chromatography (HPLC) system (HPLC-QQQ-ICP-MS). This system will replace an aging unit and be used to detect trace levels of toxic elements and perform speciation of specific elements like arsenic, supporting the FDA’s Elemental Analysis Manual (EAM) methods and the Closer to Zero Action Plan. The solicitation details extensive technical requirements for both the QQQ-ICP-MS and HPLC systems, including general parameters, performance specifications, and integration capabilities for automated speciation analysis. The contractor must provide a new, turnkey system, including all necessary supplies, accessories, software, and training. Key trade and service specifications include a 90-day installation timeline, a 12-month warranty, method transfer from an existing Agilent 8800 system, and on-site demonstration of performance specifications. The system is to be delivered to the FDA/IRVLMP in Irvine, CA, with all requirements completed within 120 days of contract award.

The Food and Drug Administration (FDA) requires the purchase of one High Resolution Quadrupole Ion Trap Mass Spectrometer with an Ultra High Performance Liquid Chromatography (UHPLC) System and Accessories for its Irvine Medical Products Laboratory (IRVLMP) in Irvine, CA. This equipment is crucial for the timely analysis of dietary supplements to detect undeclared active pharmaceutical ingredients, including GLP-1 receptor agonists. The solicitation specifies detailed technical requirements for both the mass spectrometer (Orbitrap Exploris 480 or equivalent) and the UHPLC system (Vanquish Flex Binary or equivalent), covering aspects like resolution, mass accuracy, sensitivity, flow range, and temperature control. The contractor must provide a new, turn-key solution with a minimum 12-month warranty, installation by a certified engineer, operator training for two users, and access to a technical support call center. Deliverables include the system, installation, training, and the manufacturer's warranty, with all requirements to be completed within 120 days of contract award.

The National Forensic Chemistry Center (NFCC) requires one (1) Liquid Chromatography with Mass Spectrometer (LC-MS) system, specifically a hybrid quadrupole/linear ion trap mass spectrometer with an ultra-high performance liquid chromatograph (LC-MS/MS). This system will enhance capabilities for detecting and quantifying drugs of abuse, synthetic opioids, and other small molecules in various products, supporting criminal and regulatory investigations. The system must be new, include installation and service manuals, preloaded software, and a one-year warranty. Key technical requirements for the LC include a binary pump, flow rate range of 0.001-5 mL/min, pressure range of 50-600 bar, and specific accuracy/precision. The MS must have an atmospheric pressure ionization (API) source with x, y, z probe positioning, HESI, interchangeable APCI, and an integrated calibrant source. It needs linear ion trap mass analyzers with a scan range of m/z 50-1500 or greater, resonant collision induced dissociation (rCID) or tandem-in-time MSn, and data-dependent MSn where n > 3. The instrument must also be capable of multiplexing multiple precursor ions and polarity switching. The contractor must provide field service reports and monthly summaries of maintenance activities. The LC-MS/MS system is to be delivered within 90 days of award, with familiarization training for up to six users provided within two weeks of government acceptance. The period of performance begins on the contract award date and lasts one year from government acceptance. The instrument will be shipped to the National Forensic Chemistry Center in Cincinnati, OH.