KEZHE PuriMaster-5000 Binary Automated Preparative Liquid Chromatography System
| Brand | KEZHE / KEZHE SHANGHAI |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Direct Manufacturer |
| Product Category | Domestic (China-Made) |
| Model | PuriMaster-5000 |
| Application Level | Laboratory-Scale |
| Instrument Type | High-Pressure Preparative HPLC |
| Flow Rate Range | 0–100 mL/min |
| Flow Accuracy | RSD ≤ 0.5% |
| Flow Precision | RSD ≤ 0.5% |
| Maximum Pressure | 4000 PSI (27.6 MPa) |
| Wavelength Range | 190–850 nm (simultaneous quad-wavelength detection) |
| Wavelength Accuracy | ±2 nm |
| Wavelength Repeatability | 0.4 nm |
| Baseline Noise | 3 × 10⁻⁵ AU |
| Data Acquisition Rate | 5 Hz |
Overview
The KEZHE PuriMaster-5000 Binary Automated Preparative Liquid Chromatography System is a high-performance, laboratory-scale preparative HPLC platform engineered for reproducible, scalable purification of natural products, pharmaceutical intermediates, and synthetic compounds—particularly optimized for complex matrices such as traditional Chinese medicine (TCM) extracts. Built upon principles of high-pressure liquid chromatography (HPLC), the system employs binary gradient elution with active solvent mixing to deliver precise, low-lag mobile-phase composition control without requiring external degassing. Its dual-detector architecture—integrating a quad-wavelength UV-VIS detector and an evaporative light scattering detector (ELSD)—enables universal detection across analytes with or without chromophores, supporting method development and fraction-guided isolation under GLP-aligned workflows.
Key Features
- Binary high-pressure gradient pump system with flow range up to 100 mL/min and pressure capability up to 4000 PSI (27.6 MPa), delivering RSD ≤ 0.5% for both accuracy and repeatability;
- Quad-wavelength UV-VIS detector featuring a 1200-line/mm holographic grating, deuterium-tungsten dual-source illumination, and real-time wavelength self-calibration; supports simultaneous acquisition at four user-selectable wavelengths between 190–850 nm;
- Integrated ELSD module with 650 nm laser source and adjustable nebulizer gas flow (0–5 L/min), enabling robust detection of non-chromophoric compounds including carbohydrates, lipids, and saponins;
- Automated sample introduction via 42-position autosampler with sealed vial handling, needle wash function, and status monitoring for valve, syringe pump, and robotic arm;
- X-Y matrix-type fraction collector accommodating up to 160 tubes (15 × 150 mm), offering higher collection density and positional fidelity than rotary multi-port valves;
- Fully integrated modular software controlling all hardware modules—including pump, detector, autosampler, and collector—in a single interface with synchronized display of chromatograms, gradient profiles, fraction maps, and device status;
- Real-time UV spectral scanning capability for peak identification and purity assessment; supports on-the-fly library matching and spectral overlay;
- Advanced fraction triggering logic including time-based, threshold-based, peak apex, and manual override modes—enhanced by real-time fraction indexing that overlays collected tube positions directly onto the chromatogram;
- Comprehensive data governance features: audit trail compliant with FDA 21 CFR Part 11 requirements, role-based user management, electronic signatures, and secure data archiving;
- Modular workstation architecture allowing seamless integration of optional detectors (e.g., DAD, RID) and column formats (e.g., C18, silica, amino, phenyl-hexyl) up to Φ50 mm ID.
Sample Compatibility & Compliance
The PuriMaster-5000 is routinely deployed in natural product isolation labs, pharmaceutical R&D centers, and academic core facilities where regulatory traceability and analytical rigor are essential. It accommodates crude extracts, partially purified fractions, and synthetic mixtures with molecular weights ranging from small molecules (<500 Da) to mid-sized biomolecules (up to ~2000 Da). The system complies with key international standards relevant to preparative chromatography workflows, including ISO/IEC 17025 for testing laboratories, ASTM E2500 for instrument qualification, and USP guidelines for chromatographic system suitability. All software functions—including method saving, event logging, and report generation—support full ALCOA+ data integrity principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).
Software & Data Management
The embedded modular liquid chromatography workstation provides a unified, intuitive interface designed for multi-user laboratory environments. It supports method development, sequence scheduling, real-time monitoring, and post-run analysis—all within a single application. Key capabilities include: gradient programming with linear, stepwise, and point-to-point profiles; automatic peak detection and integration with customizable baseline algorithms; co-plotting of UV and ELSD signals in shared retention time axes; spectral library creation and matching; and export of raw data in open formats (e.g., .cdf, .csv) compatible with third-party chemometric tools. Audit trail records capture operator identity, timestamp, parameter changes, and critical events—retained for ≥36 months per configurable retention policy. Data backups are encrypted and stored locally or on network drives with checksum validation.
Applications
- Isolation of bioactive constituents from plant extracts (e.g., flavonoids, alkaloids, terpenoids);
- Purification of peptide intermediates and oligonucleotide synthesis by-products;
- Removal of residual catalysts and protecting groups in fine chemical synthesis;
- Preparative separation of enantiomers using chiral stationary phases;
- Fractionation of fermentation broths for secondary metabolite profiling;
- Method transfer from analytical to preparative scale under QbD (Quality-by-Design) frameworks;
- Supporting ICH Q5A/Q5B assessments for biopharmaceutical impurity characterization.
FAQ
What is the maximum column internal diameter supported by the PuriMaster-5000?
The standard configuration supports columns up to Φ20 mm ID; optional high-flow manifolds and fittings enable operation with columns up to Φ50 mm ID.
Does the system support method validation according to ICH guidelines?
Yes—the software includes system suitability test (SST) templates aligned with ICH Q2(R2), and hardware performance meets precision and linearity requirements for preparative method validation.
Can UV and ELSD signals be acquired and displayed simultaneously?
Yes—both detectors operate concurrently, and their chromatograms are overlaid in real time on a common time axis with independent scaling and annotation.
Is remote monitoring or control available?
Remote desktop access is supported via secure VPN; however, direct cloud-based instrument control is not implemented to maintain data sovereignty and cybersecurity compliance.
What documentation is provided for IQ/OQ/PQ qualification?
A complete qualification package—including URS, FDS, test protocols, and executed reports—is supplied with each system, fully editable and compliant with GAMP5 classification.
