Fuli LC5090Plus Ultra-High Performance Liquid Chromatograph

Overview

The Fuli LC5090Plus Ultra-High Performance Liquid Chromatograph is an integrated UHPLC system engineered for precision, robustness, and regulatory compliance in modern analytical laboratories. Built upon proven liquid chromatographic principles—namely high-pressure gradient elution, column-based solute separation, and UV-Vis or optional multi-wavelength detection—the LC5090Plus delivers consistent retention time reproducibility, low baseline noise, and high-resolution peak separation across diverse sample matrices. Its architecture adheres to fundamental chromatographic performance criteria including pressure stability up to 130 MPa (1300 bar), flow rate accuracy ≤ ±0.1%, and gradient composition precision ≤ ±0.15% RSD. Designed for routine QC/QA, method development, and research-grade applications, the system supports both isocratic and multi-step gradient methods with real-time dwell volume compensation and active solvent compressibility correction.

Key Features

• High-stability dual-plunger parallel reciprocating pump with patented pressure-balancing compensation and integrated pulse-dampening buffer—ensuring <0.05% RSD pressure fluctuation and sub-0.5 mAU baseline noise under standard 254 nm detection conditions.
• Autosampler with low-cross-contamination injection mechanism (<0.005% carryover), temperature-controlled sample compartment (4–40 °C), and programmable needle wash protocols compliant with ICH Q2(R2) validation requirements.
• Column oven with rapid thermal equilibration (±0.1 °C uniformity over 20–80 °C range) and pre-heater module for mobile phase conditioning—minimizing retention time drift and enhancing quantitative repeatability (RSD <0.2% for retention time, <0.5% for peak area over 24 h).
• Modular detector options including variable-wavelength UV-Vis (190–700 nm, 1 nm resolution), PDA, and compatibility with third-party mass spectrometers via standard analog/digital interfaces.
• EMC-hardened electronics architecture meeting IEC 61326-1 Class A emission and immunity standards—validated for stable operation in shared laboratory environments with RF-emitting instrumentation.

Sample Compatibility & Compliance

The LC5090Plus accommodates a broad spectrum of sample types—including small-molecule pharmaceuticals, natural product extracts, environmental contaminants, food additives, and polymer degradation products—when paired with reversed-phase (C18, C8), HILIC, ion-exchange, or size-exclusion columns (2.1–4.6 mm ID, 50–250 mm length). System hardware and firmware comply with ISO/IEC 17025:2017 general requirements for testing laboratories, and its embedded chromatography data system (CDS) supports 21 CFR Part 11-compliant user authentication, role-based access control, electronic signatures, and immutable audit trails for all acquisition, processing, and reporting events. Full traceability is maintained per GLP/GMP Annex 11 and EU GMP Chapter 4 guidelines.

Software & Data Management

Fuli ChromaLink™ CDS v3.2 provides intuitive method building, real-time chromatogram visualization, peak integration with customizable baselines and threshold logic, and automated report generation in PDF/A-1b or CSV formats. The software includes built-in system suitability test (SST) templates aligned with USP , EP 2.2.46, and JP 6.05; supports IQ/OQ/PQ documentation packages; and enables secure network deployment via TLS 1.2 encrypted client-server architecture. Raw data files adhere to ANDI/MSD format standards and are stored with SHA-256 hash verification to ensure integrity during archival or regulatory submission.

Applications

The LC5090Plus serves as a primary analytical platform in pharmaceutical quality control (assay, related substances, dissolution testing), clinical toxicology (therapeutic drug monitoring, metabolite profiling), environmental analysis (PAHs, pesticides, PFAS), and food safety (mycotoxins, preservatives, adulterants). Its scalability supports method transfer from HPLC to UHPLC without revalidation overhead, while its linear dynamic range (>10⁴) and LOD/LOQ performance (sub-ng on-column for typical UV-active compounds) meet stringent regulatory thresholds across FDA, EMA, and NMPA submissions.

FAQ

Does the LC5090Plus support method transfer from legacy HPLC systems?

Yes—its gradient delay volume calibration, dwell volume compensation algorithm, and scalable flow/pressure parameters enable seamless backward compatibility with validated HPLC methods.
Is the system qualified for GMP-regulated environments?

Yes—hardware design, firmware validation documentation, and ChromaLink™ CDS v3.2 collectively fulfill 21 CFR Part 11, EU Annex 11, and ISO 13485 requirements for regulated manufacturing and testing labs.
Can third-party detectors or mass spectrometers be integrated?

Yes—standard analog voltage output (0–1 V), digital TTL trigger signals, and RS-232/USB device control interfaces allow interoperability with most commercial MS and fluorescence detectors.
What column dimensions and chemistries are recommended for optimal UHPLC performance?

For maximum efficiency, use 2.1 mm × 50–100 mm columns packed with sub-2 µm particles (e.g., C18, phenyl-hexyl); system backpressure management ensures stable operation even with 1.7 µm BEH or core-shell phases.
How is data integrity ensured during long-term unattended operation?

Real-time disk write verification, automatic backup to redundant storage paths, and SHA-256 checksum logging prevent data corruption and support forensic reconstruction during audit investigations.