Hitachi ChromasterUltra Rs Ultra-High-Performance Liquid Chromatograph

Overview

The Hitachi ChromasterUltra Rs is an ultra-high-performance liquid chromatograph engineered for demanding analytical laboratories requiring exceptional resolution, sensitivity, and method robustness. Built upon a modular architecture and leveraging advanced fluidic design principles—including low-dispersion flow paths, minimized extra-column volume, and high-pressure-stable components—the system operates under the fundamental principles of reversed-phase HPLC with gradient elution capability. Its 140 MPa maximum pressure rating enables utilization of sub-2 µm particle-packed columns (e.g., LaChromUltra II ODS C18, 1.9 µm, 250 mm), delivering theoretical plate counts exceeding 50,000 and significantly enhanced peak capacity. This performance envelope supports critical applications in pharmaceutical development, impurity profiling, peptide mapping, environmental contaminant screening, and quality control workflows where regulatory compliance, reproducibility, and data integrity are non-negotiable.

Key Features

• High-Pressure Binary Solvent Delivery: Dual-piston reciprocating pumps with variable stroke control and Hitachi’s proprietary Liquid Buffer Technology (LBT) ensure precise, pulse-free gradient formation and long-term flow stability—critical for retention time reproducibility across multi-day sequences.
• Low-Dispersion Optical Detection: Standard DAD detector equipped with a 10 mm total-reflection capillary flow cell minimizes band broadening; optional 65 mm high-sensitivity flow cell improves detection limits for trace-level analytes without sacrificing linearity or dynamic range.
• Advanced Autosampling Architecture: 120-position tray capacity with programmable injection volumes (0.1–20 µL), integrated needle wash station featuring multiple solvent options, and standard back-flush functionality at the injection port reduce carryover to <0.005%—validated per ICH Q2(R2) guidelines.
• Thermally Stable Column Compartment: Precise temperature control from (ambient −15 °C) to 90 °C ensures retention time consistency and facilitates method transfer between instruments and laboratories.
• UV-Vis Spectral Fidelity: Broad 100–900 nm wavelength coverage with 100 Hz acquisition rate supports comprehensive spectral library matching, peak purity assessment, and multi-wavelength quantitation in a single run.

Sample Compatibility & Compliance

The ChromasterUltra Rs accommodates a wide range of sample matrices—including biological fluids, purified proteins, synthetic organic compounds, environmental extracts, and formulated pharmaceuticals—without modification to core hardware. Its fluidic path is chemically resistant to common mobile phases (aqueous/organic mixtures, low-pH TFA buffers, high-pH ammonium bicarbonate). The system meets essential regulatory requirements for GxP environments: it supports audit trail generation, electronic signature implementation, and user access level management in accordance with FDA 21 CFR Part 11 and EU Annex 11 when operated with compliant chromatography data systems (CDS). Method validation parameters—including precision, accuracy, linearity, LOD/LOQ, and robustness—are routinely demonstrated using USP , ISO 17025, and ICH Q2(R2) protocols.

Software & Data Management

Controlled via Hitachi’s ChromasterNavigator software, the system provides intuitive method building, real-time monitoring, and automated report generation. The software architecture supports secure network deployment, role-based permissions, and full electronic record retention. Raw data files adhere to open-standard formats (e.g., ANDI/NetCDF), ensuring long-term accessibility and third-party processing compatibility. Integrated sequence scheduling, calibration curve management, and peak integration algorithms comply with GLP/GMP documentation standards. Audit trails capture all user actions—including parameter changes, reprocessing events, and instrument status transitions—with immutable timestamps and operator identification.

Applications

• Peptide mapping of hydrolyzed proteins using extended-length, sub-2 µm columns—achieving 1.4× higher peak capacity versus conventional 5 µm columns while reducing analysis time by 50%.
• Impurity profiling in active pharmaceutical ingredients (APIs), including structurally similar degradants and synthetic intermediates, under ICH Q3B-compliant conditions.
• Multi-residue pesticide analysis in food matrices with simultaneous UV and photodiode array spectral confirmation.
• Stability-indicating assays for biologics, where baseline resolution of charge variants and glycoforms is required.
• High-throughput screening of reaction mixtures in medicinal chemistry, enabled by rapid gradient methods and low carryover autosampling.

FAQ

What column dimensions and particle sizes are supported at full system pressure?
The ChromasterUltra Rs is validated for use with columns up to 250 mm in length and sub-2 µm particles (e.g., 1.9 µm), operating continuously at 140 MPa. Columns with internal diameters from 2.1 mm to 4.6 mm are fully compatible.
Does the system support method transfer from legacy HPLC platforms?
Yes—through scalable gradient delay volume compensation, dwell time adjustment tools, and column dimension normalization functions in ChromasterNavigator, enabling seamless migration of isocratic and gradient methods from conventional HPLC systems.
Is the DAD detector compliant with pharmacopeial requirements for peak purity assessment?
Yes—the detector provides full-spectrum acquisition at 100 Hz with photometric accuracy traceable to NIST standards, satisfying USP , EP 2.2.46, and JP 6.03 criteria for spectral overlay and homogeneity evaluation.
Can the autosampler be configured for unattended operation over weekends?
Yes—sequence-based scheduling, automatic tray recognition, and integrated cooling (optional Peltier module) allow continuous 7-day operation with validated carryover performance and temperature-stable sample integrity.
What cybersecurity features are implemented in the control software?
ChromasterNavigator includes TLS 1.2 encryption for remote access, Windows Active Directory integration, password complexity enforcement, session timeout controls, and tamper-evident audit log hashing—aligned with IEC 62443-3-3 industrial security standards.