Hitachi Refurbished ChromasterUltra Rs Ultra-High-Performance Liquid Chromatograph (UHPLC)

Overview

The Hitachi ChromasterUltra Rs is a rigorously refurbished ultra-high-performance liquid chromatograph (UHPLC) engineered for laboratories requiring exceptional resolution, speed, and sensitivity in small-molecule analysis. Built upon the foundational architecture of Hitachi’s flagship UHPLC platform, this instrument leverages high-pressure liquid chromatography (HPLC) principles—specifically gradient elution under pressures up to 140 MPa—to achieve sub-2 µm particle-packed column performance with minimal extra-column band broadening. Its design adheres to core separation science tenets: optimized dwell volume, low dispersion flow paths, thermally stabilized optical detection, and precise, pulseless solvent delivery. The system is routinely deployed in pharmaceutical R&D, impurity profiling per ICH Q3 guidelines, environmental contaminant screening (e.g., PAHs, pesticides), and synthetic chemistry QC—environments where reproducible retention time stability (1,200, and baseline noise <±0.25 × 10⁻⁵ AU are operationally mandated.

Key Features

• 140 MPa Maximum System Pressure: Enables use of sub-2 µm particles (e.g., LaChromUltra II ODS C18, 1.9 µm) at optimal linear velocities, delivering >50,000 theoretical plates per 250 mm column without pressure-induced degradation of peak shape or retention consistency.
• Low-Dispersion Binary Solvent Delivery: Dual-piston pump with variable-stroke actuation and Hitachi’s proprietary Low Back-Pressure Technology (LBT) ensures gradient accuracy <±0.2% and flow precision <±0.07% RSD across 0.001–5.000 mL/min—critical for method transfer between UHPLC and conventional HPLC platforms.
• Optimized Optical Detection: Standard DAD features a 10 mm total-reflection capillary flow cell; optional 65 mm high-sensitivity flow cell reduces detection limits by ~3× for trace-level analytes (e.g., genotoxic impurities at ≤10 ppm level). Noise is suppressed via dual-beam compensation and thermoelectrically stabilized optics.
• Autosampler with Residue Mitigation: 132-position tray supports 2 mL vials; integrated needle wash station with programmable solvent selection and default back-flush functionality achieves carryover <0.005% for high-concentration standards—validated per USP and ASTM E2982-20 protocols.
• Column Compartment Precision: Air-circulating oven maintains 4–85 °C at ±0.15 °C uniformity (measured at column midpoint), minimizing retention drift during multi-day sequence runs required for stability-indicating methods.

Sample Compatibility & Compliance

The ChromasterUltra Rs accommodates standard 1/16″ OD stainless steel and PEEK tubing, 2.1–4.6 mm ID analytical columns, and guard cartridges compatible with reversed-phase, HILIC, and ion-pairing chemistries. It supports mobile phases containing ≥95% acetonitrile or methanol, 0.1% formic acid, and volatile buffers (e.g., ammonium acetate, ammonium bicarbonate)—fully aligned with LC-MS interface requirements. From a regulatory standpoint, the system meets essential hardware prerequisites for GLP and GMP environments: audit-trail-capable software (via Chromaster Navigator), electronic signature support per FDA 21 CFR Part 11, and IQ/OQ documentation packages available upon request. All refurbished units undergo full mechanical recalibration, leak testing at 140 MPa, and detector wavelength accuracy verification against NIST-traceable holmium oxide filters.

Software & Data Management

Chromaster Navigator v3.x provides method development tools including gradient scouting, peak tracking algorithms, and automated system suitability assessment (SST) against user-defined criteria (e.g., tailing factor ≤2.0, resolution ≥2.0). Raw data is stored in vendor-neutral .CDF format (compatible with OpenLab CDS, Chromeleon, and Empower via conversion utilities). The software enforces role-based access control, records all parameter changes with timestamps and operator IDs, and generates PDF reports compliant with ISO/IEC 17025 clause 7.8.2. For laboratories operating under regulated workflows, optional 21 CFR Part 11 modules provide electronic signatures, secure audit trails, and locked archival of raw acquisition files—ensuring data integrity throughout the analytical lifecycle.

Applications

• Pharmaceutical impurity profiling per ICH Q3B(R3), including forced degradation studies and stability-indicating assay development.
• High-throughput screening of synthetic reaction mixtures for byproduct identification and yield quantification.
• Residual solvent analysis in APIs using headspace-GC coupling or direct UHPLC injection with volatile mobile phases.
• Environmental monitoring of polar micropollutants (e.g., pharmaceuticals in wastewater) via online SPE-UHPLC-DAD workflows.
• Food safety testing for mycotoxins, veterinary drug residues, and pesticide multiresidue methods validated per SANTE/11813/2017.

FAQ

Is this a factory-refurbished unit or dealer-refurbished?
All ChromasterUltra Rs systems are refurbished by Hitachi-certified service centers using OEM parts, followed by full functional validation against original factory specifications.
Does the system include a column oven and DAD detector as standard?
Yes—column compartment (4–85 °C) and diode array detector (190–800 nm) are integral components; the 65 mm high-sensitivity flow cell is an optional upgrade.
Can the autosampler handle 96-well plate formats?
The standard configuration supports only vial-based trays; 96-well plate capability requires optional plate-handling module (not included in base refurbishment package).
What documentation accompanies the instrument?
Each unit ships with Certificate of Refurbishment, calibration certificates for pump flow rate and detector wavelength accuracy, IQ/OQ test protocols, and a 12-month limited warranty covering parts and labor.
Is method transfer support available from Hitachi technical specialists?
Yes—refurbished systems qualify for paid remote method optimization services, including gradient translation, dwell volume adjustment, and system suitability troubleshooting.