Hitachi Transgenomic High-Performance Liquid Chromatograph (HPLC) System

Overview

The Hitachi Transgenomic High-Performance Liquid Chromatograph (HPLC) is a fully integrated, refurbished analytical platform engineered for precision separation, identification, and quantification of thermally labile, polar, and high-molecular-weight compounds. Based on the classic Hitachi L-series architecture originally developed in the United States, this system employs low-dispersion dual-plunger reciprocating pump technology (L-2130), temperature-stabilized column compartment control (L-2310T), and high-sensitivity UV absorbance detection (L-2400) operating at fixed wavelengths (e.g., 214 nm, 254 nm, 280 nm). Designed for robust routine operation in QC laboratories, pharmaceutical stability studies, and academic research environments, the system adheres to core principles of isocratic and gradient elution chromatography under ISO 17025-aligned verification protocols. All modules undergo full functional validation—including flow accuracy (<±1% RSD), pressure stability (<0.5 MPa drift over 30 min), baseline noise (<±0.5 × 10⁻⁵ AU), and retention time reproducibility (<0.2% RSD)—prior to release.

Key Features

• Refurbished Hitachi L-series modular architecture with traceable service history and component-level calibration records
• L-2130 Quaternary solvent delivery system: flow range 0.001–10.000 mL/min, pressure limit up to 40 MPa, pulse dampening optimized for low-flow microbore applications
• L-2200U autosampler with 100-position vial capacity, injection volume programmable from 0.1–100 µL, carryover <0.01% via active needle wash
• L-2310T column oven: temperature control range 4–85 °C, stability ±0.1 °C, compatible with 100–250 mm analytical columns (ID 2.1–4.6 mm)
• L-2400 UV/VIS detector featuring deuterium lamp source, 190–700 nm spectral range, 1 nm bandwidth, and analog/digital dual-output interface
• Pre-installed chromatography workstation software supporting method development, peak integration (EMEA/ICH Q2(R2)-compliant algorithms), and raw data export in .raw/.cdf formats

Sample Compatibility & Compliance

This Hitachi Transgenomic HPLC system supports reversed-phase (C18, C8), hydrophilic interaction (HILIC), ion-exchange, and size-exclusion chromatographic modes. It accommodates standard 4.6 mm ID analytical columns as well as narrow-bore and capillary configurations. The platform meets baseline requirements for USP , EP 2.2.46, and ASTM E2688-21 verification standards. All refurbished units include documented IQ/OQ evidence packages—covering installation checks (electrical safety, module recognition), operational qualification (gradient accuracy, dwell volume measurement, detector linearity), and system suitability testing (theoretical plates, tailing factor, resolution per USP ). Full audit trails are enabled in the workstation software to support GLP and GMP environments compliant with FDA 21 CFR Part 11 when configured with electronic signatures.

Software & Data Management

The bundled chromatography workstation provides validated acquisition, processing, and reporting capabilities. It supports multi-channel data acquisition (UV, optional analog inputs), real-time chromatogram overlay, customizable report templates (PDF/Excel), and secure user access levels (administrator, analyst, reviewer). Raw data files are stored in vendor-neutral formats compatible with third-party chemometric tools (e.g., MATLAB, SIMCA). Audit trail functionality logs all method modifications, sequence changes, and reprocessing events with timestamps and operator IDs—enabling full traceability required under ISO/IEC 17025:2017 Clause 7.11 and EU Annex 11. Data backups are supported via network drive mapping or encrypted USB storage.

Applications

• Pharmaceutical quality control: assay, related substances, dissolution testing per USP monographs
• Biopharmaceutical analysis: monoclonal antibody purity assessment (SEC-HPLC), peptide mapping (RP-HPLC)
• Food and beverage testing: preservative quantification (sorbic acid, benzoic acid), vitamin profiling, mycotoxin screening
• Environmental monitoring: PAHs, PCBs, and pesticide residue analysis in water and soil extracts
• Academic research: natural product isolation, polymer molecular weight distribution (GPC), metabolite profiling

FAQ

Is this system eligible for extended warranty or service contracts?
Yes—optional 12- or 24-month comprehensive service agreements are available, including preventive maintenance, remote diagnostics, and priority parts dispatch.
Does the system include original Hitachi documentation and calibration certificates?
Yes—all units ship with scanned copies of original operation manuals, electrical schematics, and a Certificate of Functional Verification issued by our ISO 17025-accredited technical team.
Can this HPLC be upgraded to support mass spectrometry coupling?
The L-2400 detector features analog output and TTL trigger signals compatible with most LC-MS interfaces; however, direct API source integration requires additional hardware (e.g., splitter, make-up flow module) and is assessed case-by-case during pre-installation review.
What consumables and spare parts are recommended for initial operation?
We recommend ordering a starter kit including guard cartridges (L-2130-compatible), UV lamp (L-2400), fuses, pump seals, and certified reference standards for system suitability testing.
Is remote training provided after purchase?
Yes—two hours of live virtual training are included, covering instrument startup, method loading, basic troubleshooting, and data export workflows.