Shimadzu Nexera X2 UHPLC System (Refurbished)

Overview

The Shimadzu Nexera X2 is a high-performance, modular ultra-high-performance liquid chromatography (UHPLC) system engineered for precision, robustness, and method scalability across pharmaceutical QC, biopharmaceutical characterization, environmental testing, and academic research laboratories. Built on Shimadzu’s proven dual-plunger parallel flow pump architecture with micro-volume piston design, the Nexera X2 delivers exceptional gradient accuracy (<0.1% RSD), low dwell volume (<120 µL), and pressure stability up to 130 MPa (18,900 psi). Its core measurement principle relies on high-pressure solvent delivery, precise sample introduction via cooled Peltier-controlled autosampling, temperature-regulated column elution, and real-time UV-Vis spectral detection using a 1024-pixel diode array detector (SPD-M30A) with 1–4 nm resolution and 100 Hz acquisition rate. This configuration ensures compliance with ICH Q2(R2) guidelines for method validation and supports fully traceable data acquisition under GLP/GMP environments when operated with LabSolutions LCMS software configured for 21 CFR Part 11 compliance.

Key Features

• 130 MPa maximum system pressure enables use of sub-2 µm particle columns (e.g., Shim-pack XR-ODS III, 1.6 µm or 2.2 µm) for ultra-fast separations with >200,000 theoretical plates/m efficiency
• SIL-30AC autosampler with 0.01–100 µL injection range, <0.25% RSD precision at 1 µL, and <0.005% carryover—validated per USP requirements
• CTO-30A column oven with -10 °C to 80 °C temperature control (±0.1 °C stability) supporting green LC applications through elevated temperature mobile phase optimization
• LC-30AD binary/quaternary pump with active check valve monitoring, pulse-free flow, and real-time pressure feedback loop for uninterrupted method execution
• SPD-M30A DAD featuring full-spectrum acquisition (190–800 nm), peak purity assessment, and multi-wavelength quantitation without re-injection
• CBM-20A system controller with embedded Ethernet interface, remote diagnostics, and seamless integration into enterprise LIMS via standard OPC UA protocol

Sample Compatibility & Compliance

The Nexera X2 accommodates diverse sample matrices including small-molecule APIs, peptides, oligonucleotides, natural product extracts, and environmental water/soil extracts. Its low-dead-volume fluidic path (≤2 µL from needle seat to column inlet) minimizes band broadening for narrow-bore and capillary columns. All hardware modules are certified to IEC 61010-1 for laboratory safety and EMC Directive 2014/30/EU. When deployed with LabSolutions LCMS v5.9x or later and properly configured audit trail, electronic signatures, and role-based access control, the system meets analytical data integrity requirements defined in FDA Guidance for Industry (Data Integrity and Compliance With CGMP, 2018) and EU Annex 11. Routine PQ verification includes pressure calibration (traceable to NIST standards), retention time repeatability (n=6, RSD <0.15%), and peak area precision (n=6, RSD <0.5% at 10 ng on-column).

Software & Data Management

LabSolutions LCMS provides validated instrument control, sequence management, peak integration (with baseline correction algorithms per USP ), and report generation compliant with ALCOA+ principles. Raw data files (.lcd) are stored in vendor-neutral format with embedded metadata (operator ID, timestamp, method parameters, hardware logs). Audit trail functionality records all critical events—including method edits, data reprocessing, and user logins—with immutable timestamps. Data export supports CSV, PDF, and .cdf formats for third-party statistical analysis (e.g., JMP, SIMCA). The system supports networked deployment with centralized license management and automated backup to NAS or cloud storage (AWS S3 or Azure Blob) via optional Data Manager DX module.

Applications

• Pharmaceutical QC: Dissolution testing, assay and related substances analysis per USP monographs (e.g., , )
• Biologics characterization: mAb charge variant profiling using cation-exchange UHPLC, glycan release and HILIC analysis
• Environmental labs: EPA Method 8330B (PAHs), 8082A (PCBs), and 541 (pesticides) with sub-5-minute run times
• Academic research: Metabolomics workflows requiring high-resolution peak capacity (>150,000) and reproducible retention indexing (RI)
• Green chemistry: Temperature-assisted reduction of acetonitrile consumption by 40–60% without sacrificing resolution

FAQ

Is this a factory-refurbished unit or dealer-certified refurbished?
This Nexera X2 system has undergone comprehensive refurbishment and performance validation by SpectraLab Scientific’s ISO/IEC 17025-accredited technical team—including leak testing, pressure calibration, gradient accuracy verification, and 72-hour continuous runtime stress testing.
What documentation is provided with the system?
You will receive a full Certificate of Performance Verification, as-delivered configuration report, LabSolutions software installation media and license certificate, and original Shimadzu operation manuals (English digital copies).
Can the system be integrated with our existing LIMS or ELN?
Yes—the CBM-20A controller supports standard communication protocols including TCP/IP, RS-232, and OPC UA. Custom API integration support is available upon request.
Does the 6-month warranty cover parts, labor, and on-site service?
The warranty includes all components, labor, and remote technical support. On-site service is available within North America and EU regions under extended service plan options.
Are consumables and spare parts included or available separately?
No consumables are included, but SpectraLab maintains an inventory of genuine Shimadzu columns (XR-ODS III, FC-ODS), frits, seal kits, and pump check valves with same-day shipping.