WAYEAL LC3400 Ultra-High-Performance Liquid Chromatograph

Overview

The WAYEAL LC3400 Ultra-High-Performance Liquid Chromatograph is an engineered solution for laboratories requiring robust, scalable, and regulatory-ready liquid chromatography performance. Built on the fundamental principles of high-pressure gradient elution and precise retention-time control, the LC3400 operates within a pressure range up to 75 MPa—enabling full compatibility with sub-3 µm fully porous and superficially porous (core-shell) columns. This pressure capability places the system firmly in the UHPLC class, supporting separations at flow rates up to 2.0 mL/min with minimal extra-column band broadening. The instrument architecture integrates modular fluidic design, thermally stabilized optical detection pathways, and low-dispersion flow paths to ensure baseline stability, peak symmetry, and reproducible retention time (RSD < 0.15% over 24 h, typical). It is intended for use in analytical development, quality control, and routine testing environments where method transfer between HPLC and UHPLC platforms must be seamless.

Key Features

• High-Pressure Binary Gradient Pump with Dual-Suspension Drive Technology: Delivers pulse-free flow across 0.001–2.000 mL/min with ≤0.07% RSD (measured at 1.0 mL/min, methanol/water); pressure accuracy ±0.2 MPa up to 75 MPa.
• Flow-Path Integrated Autosampler with Needle-in-Loop Injection: 0.1–100 µL injection volume range (0.1 µL increments), carryover < 0.005%, sample cooling (4–40 °C) and temperature-controlled tray (±0.5 °C).
• Bidirectional Column Oven with Active Air Circulation: Temperature range 5–85 °C (±0.1 °C stability), dual-zone heating/cooling for independent control of column and detector cell compartments.
• Low-Dispersion UV-Vis Detector (Standard): Wavelength range 190–800 nm, photodiode array option available; noise ≤ ±0.5 × 10⁻⁵ AU, drift < 1.0 × 10⁻⁴ AU/h.
• Modular I/O Architecture: Supports RS-232, USB 2.0, and Ethernet (TCP/IP) connectivity; compatible with third-party CDS platforms via ASTM E1384 and AIA/Chromatography Data Exchange (CDX) protocols.

Sample Compatibility & Compliance

The LC3400 accommodates standard 1/16″ stainless steel and PEEK capillary tubing, 4.6 mm × 150 mm to 2.1 mm × 50 mm column formats, and all commercially available reversed-phase, HILIC, and ion-exchange media. Its hardware and firmware are designed to support GLP/GMP workflows per FDA 21 CFR Part 11 requirements—including electronic signature enforcement, audit trail logging (user actions, method changes, sequence edits), and data integrity controls (write-protection, immutable raw data storage). System suitability tests (SST) are programmable and reportable per USP , EP 2.2.46, and ISO 17025 Clause 7.7. The instrument meets CE marking requirements under the EU Machinery Directive 2006/42/EC and Electromagnetic Compatibility Directive 2014/30/EU.

Software & Data Management

Control and data acquisition are managed via WAYEAL ChromNav v3.x—a Windows-based chromatography data system compliant with ALCOA+ data governance principles. The software supports multi-user role-based access (Administrator, Analyst, Reviewer), method versioning with timestamped change logs, and automated generation of PDF reports with embedded chromatograms, calibration curves, and integration tables. Raw data files (.WYD) are stored in vendor-neutral HDF5 format with embedded metadata (instrument ID, operator, date/time, method parameters, SST results). Optional integration with LIMS (e.g., Thermo Fisher SampleManager, LabVantage) is supported through ODBC and RESTful API interfaces. All audit trails are exportable as CSV or XML for internal QA review or regulatory inspection.

Applications

The LC3400 is validated for quantitative and qualitative analysis across pharmaceutical, environmental, food safety, and clinical research domains. Typical use cases include: assay of active pharmaceutical ingredients (APIs) and related substances per ICH Q2(R2); residual solvent analysis by headspace-GC/LC coupling; pesticide multiresidue screening in fruits and vegetables (EN 15662:2018); organic acid profiling in fermentation broths; and oligonucleotide purity assessment using ion-pairing RP-LC. Its pressure resilience and low dwell volume (< 120 µL) allow rapid method development and transfer from legacy HPLC methods without re-optimization—reducing validation effort and accelerating time-to-result.

FAQ

Does the LC3400 support method transfer from conventional HPLC systems?

Yes—its gradient delay volume, dwell time consistency, and pressure-rated flow path enable direct translation of isocratic and gradient methods from 400-bar HPLC platforms, with retention time shifts typically < 0.2 min.
Is the autosampler compatible with 96-well and 384-well microtiter plates?

Standard configuration supports 96-well plates (SBS format); 384-well compatibility requires optional high-density sampling module (P/N LC3400-ASM384).
Can the system be operated under 21 CFR Part 11-compliant conditions out-of-the-box?

Yes—when deployed with ChromNav v3.x in “Compliance Mode”, all required controls (electronic signatures, audit trail, data encryption) are activated and configurable per site-specific SOPs.
What column dimensions and particle sizes are certified for use at maximum pressure?

Columns with inner diameters 2.1 mm or larger and particle sizes ≥ 1.7 µm (e.g., Waters ACQUITY UPLC BEH C18, Phenomenex Kinetex EVO C18) are validated for continuous operation at 75 MPa.
Is remote monitoring and diagnostic support available?

Yes—via integrated Ethernet port and WAYEAL Remote Assist (WRA) service, which enables secure technician access for real-time diagnostics, firmware updates, and preventive maintenance scheduling.