SCIEX API4000 Triple Quadrupole LC-MS/MS System (Refurbished)

Overview

The SCIEX API4000 Triple Quadrupole LC-MS/MS System is a rigorously refurbished, production-proven platform engineered for high-sensitivity quantitative analysis and structural confirmation in regulated and discovery laboratory environments. Based on the proven triple quadrupole mass filter architecture—Q1 (mass selection), Q2 (collision-induced dissociation cell), and Q3 (mass analysis)—the system operates under electrospray ionization (ESI) or atmospheric pressure chemical ionization (APCI) to deliver robust, reproducible multiple reaction monitoring (MRM) performance. Its core design emphasizes signal stability, low chemical noise, and efficient ion transmission across wide dynamic ranges—critical for pharmacokinetic (PK), toxicokinetic (TK), and biomarker quantification in biological matrices such as plasma, serum, urine, and tissue homogenates. The API4000 remains widely deployed in pharmaceutical CMC, contract research organizations (CROs), and academic translational labs due to its documented reliability, extensive method transfer history, and compatibility with legacy regulatory submissions.

Key Features

• Refurbished and fully requalified per SCIEX-recommended protocols: includes detector recalibration, vacuum system integrity verification, ion optics cleaning and alignment, and source replacement where warranted.
• Turbo V™ ion source architecture: optimized gas flow dynamics and heated nebulizer design enable stable ionization from 5 µL/min to 2 mL/min LC flow rates—supporting both microbore and conventional HPLC configurations.
• Dual-mode ionization flexibility: factory-integrated TurboIonSpray® and APCI capabilities; optional field-upgradable DuoSpray™ source allows concurrent ESI/APCI method screening without hardware swapping.
• Linear accelerator (LINAC™) collision cell: provides uniform collision energy distribution and reduced cross-talk between MRM transitions—enhancing selectivity and quantitative accuracy in complex biological extracts.
• Embedded hardware diagnostics and real-time system health monitoring via Analyst® software interface—facilitating proactive maintenance scheduling and minimizing unplanned downtime.

Sample Compatibility & Compliance

The API4000 accommodates diverse sample types including small-molecule pharmaceuticals, peptides, metabolites, endogenous biomarkers, and degradation products. It supports direct injection, protein precipitation, solid-phase extraction (SPE), and online SPE-LC workflows. All refurbished units are validated against ASTM E2637–22 (Standard Guide for Validation of LC-MS/MS Systems) and meet baseline requirements for USP , ICH M10, and ISO/IEC 17025:2017 method validation frameworks. Software configurations include full audit trail logging, electronic signature support, and user access controls aligned with FDA 21 CFR Part 11 compliance—enabling use in GLP and GMP-regulated studies when deployed with appropriate SOPs.

Software & Data Management

Controlled exclusively by SCIEX Analyst® 1.7.2 or later (licensed separately), the system supports automated acquisition of full-scan MS, product ion scans, enhanced MS/MS, and scheduled MRM. Data files (.wiff) are natively compatible with MultiQuant™ for PK/PD quantitation, PeakView® for qualitative review, and MasterView™ for cross-study trending. Raw data integrity is preserved through immutable file structures, time-stamped acquisition logs, and configurable retention policies. All refurbished systems ship with verified software installation media and documentation packages—including IQ/OQ templates, calibration reports, and instrument-specific performance verification records.

Applications

• Quantitative bioanalysis of drug candidates and metabolites in preclinical and clinical studies (e.g., plasma PK profiling, tissue distribution).
• DMPK assay development and validation per FDA Guidance for Industry (2022) and EMA CHMP Reflection Paper (2021).
• Impurity identification and quantification in stability-indicating methods per ICH Q3B(R3).
• Endogenous compound measurement (e.g., steroids, vitamins, neurotransmitters) using stable isotope-labeled internal standards.
• Support for regulated environmental and food safety testing—particularly pesticide residue analysis per EU SANTE/11312/2021 guidelines.

FAQ

Is this unit covered by original SCIEX factory warranty?
No. This is a professionally refurbished system backed by a 12-month comprehensive parts-and-labor warranty administered by our ISO 9001-certified service team—not SCIEX directly.
What documentation accompanies the instrument?
Each shipment includes a full refurbishment report, post-calibration verification data, IQ/OQ execution templates, electrical safety test certificate, and a traceable serial-numbered log of all replaced components.
Can this system be integrated into an existing LIMS environment?
Yes. Analyst software supports standard ASCII export formats and ODBC connectivity for seamless integration with major LIMS platforms—including LabVantage, Thermo Fisher SampleManager, and Waters Empower.
Are consumables and spare parts still available?
All critical consumables—including Turbo V source components, curtain gas orifices, and detector dynodes—are actively stocked by authorized SCIEX distributors globally; no obsolescence risk exists for this platform.
Does the system include a liquid chromatograph?
No. The API4000 is a standalone mass spectrometer requiring external LC instrumentation (e.g., Shimadzu Nexera, Waters ACQUITY UPLC, or Thermo Vanquish). LC compatibility is confirmed during pre-delivery system integration testing.