HOGON STI5000 High-Performance Liquid Chromatograph

Overview

The HOGON STI5000 High-Performance Liquid Chromatograph is a robust, modular benchtop HPLC system engineered for precision, long-term operational stability, and method transfer compatibility in regulated and research laboratory environments. It operates on the principle of reversed-phase liquid chromatography (RPLC), where analytes are separated based on differential partitioning between a polar mobile phase and a non-polar stationary phase under high-pressure gradient or isocratic elution conditions. Designed with an emphasis on mechanical integrity and hydraulic consistency, the STI5000 integrates a dual-pump gradient architecture (P5000 series) and a high-sensitivity UV-Vis detector (UV5000), enabling reproducible retention time control (<0.05% RSD) and quantitative peak area precision (<0.5% RSD) across extended run sequences. Its pressure-rated fluidic path (up to 5400 psi) supports use with sub-2 µm particle-packed columns, facilitating higher resolution and faster separations without compromising baseline stability.

Key Features

• High-stability dual high-pressure constant-flow pumps (P5000) featuring patented “floating dual-piston rod and seal ring” design, minimizing pulsation (<10 psi pressure ripple) and accommodating solvent compressibility correction.
• ASI self-priming check valves integrated into pump heads—demonstrated in inter-laboratory comparative studies to deliver superior flow accuracy and cycle-to-cycle reproducibility versus conventional sapphire or ceramic valve assemblies.
• UV-Vis detector (UV5000) with spectral range from 190 nm to 700 nm (expandable to 850 nm via optional grating), 20 Hz data acquisition rate, and low-noise optical design optimized for trace-level quantitation (LOD < 0.5 ng injected for caffeine standard).
• Column compartment with precise ambient-to-60 °C temperature control (±0.2 °C), supporting method robustness validation per ICH Q2(R2) guidelines.
• Modular expandability: compatible with third-party electrochemical, fluorescence, or mass spectrometric detectors; supports future integration of autosamplers (e.g., HOGON AS-5000 series) and column switching modules.
• Pre-configured gradient mixing system with low-dead-volume mixer and real-time solvent composition monitoring, compliant with ASTM D7485 and ISO 17025 method validation requirements.

Sample Compatibility & Compliance

The STI5000 accommodates a broad spectrum of sample matrices—including small-molecule pharmaceuticals, agrochemical residues, organic acids, nucleotides, and synthetic intermediates—when paired with C18, phenyl-hexyl, or HILIC stationary phases. Its manual injection configuration (Reodyne 7725i, 20 µL loop) ensures operator-controlled sampling integrity, suitable for GLP-compliant routine QC testing where audit trail documentation is maintained externally. The system meets mechanical and electrical safety standards per IEC 61010-1 and electromagnetic compatibility (EMC) requirements per EN 61326-1. While not pre-certified for FDA 21 CFR Part 11, its data acquisition software supports user-defined electronic signatures, audit trail logging, and secure file export (CSV, PDF, .hcd) — fully configurable to align with internal SOPs for regulated environments.

Software & Data Management

The included dual-channel chromatography data system (CDS) provides real-time signal visualization, peak integration using tangent skim and valley-to-valley algorithms, calibration curve generation (linear, quadratic, weighted), and report templating compliant with ISO/IEC 17025 reporting clauses. Raw data files are stored in vendor-neutral formats with embedded metadata (date/time stamp, instrument ID, method parameters, detector settings). Software supports batch processing, system suitability assessment (tailing factor, plate count, resolution), and export to LIMS via ODBC connectivity. All method files and sequence logs are digitally signed and timestamped, enabling full traceability for internal audits or regulatory inspections.

Applications

• Pharmaceutical QC: Assay and related substances analysis per USP and EP 2.2.46 monographs.
• Pesticide residue screening in food matrices (AOAC 2007.01 and SANTE/11813/2017 workflows).
• Chemical purity verification in fine chemical synthesis and polymer additive characterization.
• Environmental analysis of PAHs, phenols, and endocrine disruptors in water extracts (EPA Method 8330B).
• Academic research requiring method development flexibility, including pH-gradient and multi-step gradient elution protocols.

FAQ

Is the STI5000 compliant with 21 CFR Part 11?
The base software supports audit trail generation and user access controls; however, full Part 11 compliance requires site-specific configuration, electronic signature implementation, and validation documentation—services available through HOGON’s GxP Support Package.
Can I upgrade from single-pump to dual-pump configuration post-purchase?
Yes—the STI5000 chassis and electronics architecture support field-upgrade to dual-pump gradient operation using certified P5000 modules and firmware revision v3.2 or later.
What column dimensions and particle sizes are validated for use at maximum pressure?
The system has been verified with 150–250 mm × 4.6 mm ID columns packed with 3–5 µm particles; sub-2 µm columns require careful dwell volume compensation and may necessitate low-dispersion tubing upgrades.
Does the UV5000 detector support wavelength scanning during runs?
Yes—full-spectrum scanning (190–700 nm) is supported at up to 5 spectra/sec; simultaneous dual-wavelength quantitation is enabled for ratio-based assays.
Is preventive maintenance training available for laboratory staff?
HOGON offers on-site or virtual technician certification programs covering pump seal replacement, detector lamp alignment, leak diagnostics, and system suitability test execution.