KEZHE PrepChromaster-7000 High-Pressure Preparative Liquid Chromatography System

Overview

The KEZHE PrepChromaster-7000 is a modular, high-pressure preparative liquid chromatography (Prep-LC) system engineered for robust, scalable purification of small-molecule pharmaceuticals, natural product isolates, and synthetic intermediates. Designed at the intersection of flash chromatography throughput and analytical-grade HPLC resolution, it employs dual-gradient high-pressure pumping, real-time multi-wavelength UV-Vis detection, and intelligent fraction collection to support gram-scale isolation with high reproducibility. Its architecture follows core principles of liquid-phase mass transport and retention kinetics under controlled pressure gradients, enabling method translation from analytical screening to preparative execution without column re-optimization. The system operates within ISO/IEC 17025-aligned laboratory environments and supports GLP-compliant workflows through full audit trail functionality, user role management, and electronic signature readiness per FDA 21 CFR Part 11.

Key Features

• Modular dual-pump configuration delivering 0–500 mL/min total flow with <0.5% RSD flow accuracy and precision—validated across viscosity ranges typical of acetonitrile/water and THF/methanol mobile phases.
• Four-channel UV-Vis detector with simultaneous real-time monitoring at user-selectable wavelengths (190–850 nm); equipped with deuterium/tungsten lamp pairing, automatic lamp life tracking, and monochromator self-calibration.
• Integrated auto-sampler with 42-position vial tray and 5 mL quantitative loop; supports both liquid and solid sample loading to minimize solvent dilution and avoid loop overfilling artifacts.
• Intelligent fraction collector with 60-position rack (30 mm tube diameter standard), programmable by time, peak threshold, UV signal derivative, or manual trigger—enabling precise alignment between chromatographic elution profiles and collected fractions.
• Independent sample injection and fraction collection fluidic paths prevent cross-contamination during extended runs; high-speed switching valves reduce dead volume and maximize recovery (>95% typical for mid-polarity compounds).
• Full-spectrum scanning capability (190–850 nm) with spectral overlay and peak purity assessment tools; baseline noise ≤3 × 10⁻⁵ AU (254 nm, 1 s response) ensures reliable low-concentration detection in crude extract applications.
• Pressure monitoring with real-time display, audible alarm, and hardware-based overpressure cutoff at user-defined thresholds (up to 300 bar)—critical for safeguarding stainless-steel columns packed with sub-10 µm particles.

Sample Compatibility & Compliance

The PrepChromaster-7000 accommodates diverse sample matrices including crude botanical extracts, fermentation broths, reaction mixtures, and synthetic libraries. It supports column diameters from 10 mm to 100 mm and accepts both commercial flash cartridges (e.g., silica, C18, NH₂) and custom-packed stainless-steel columns rated up to 300 bar. Column chemistries include reversed-phase (C4, C8, C18), normal-phase (silica, diol), and specialized media (HILIC, ion exchange). All hardware and software modules comply with electromagnetic compatibility (EMC) standards IEC 61326-1 and safety standard IEC 61010-1. Data integrity features—including immutable audit trails, electronic signatures, and user-access tiering—align with FDA 21 CFR Part 11, EU Annex 11, and WHO TRS 992 requirements for regulated laboratories.

Software & Data Management

The PrepChromaster Control Suite is a Windows-based, modular workstation offering synchronized visualization of pump status, gradient profile, UV chromatograms, fraction collection map, and instrument health diagnostics. It supports gradient programming via linear, stepwise, or “point-and-drag” curve editing, with seamless method import/export in .xml format. Fraction indexing links each collected tube to its corresponding retention window and peak apex—enabling rapid post-run identification and re-injection. Quantitative analysis includes peak integration (tangent skim, valley-to-valley), purity evaluation (spectral homogeneity), and calibration curve generation. Raw data files are stored in vendor-neutral .cdf format compliant with ASTM E1947 and are compatible with third-party chemometric platforms (e.g., MATLAB, Simca). All user actions—including parameter changes, fraction triggers, and method saves—are timestamped and attributed in the audit log.

Applications

This system serves as a primary purification platform in pharmaceutical process development labs (API isolation), natural product discovery programs (alkaloid, flavonoid, terpenoid fractionation), and academic synthetic chemistry facilities (purification of asymmetric catalysis products). It enables rapid method scouting using gradient scouting tools, scales directly from analytical (4.6 mm ID) to preparative (50 mm ID) columns, and supports orthogonal purification strategies when coupled with optional detectors (e.g., ELSD, DAD). Users routinely isolate >1 g of pure compound per run from complex matrices such as *Panax ginseng* root extract or combinatorial library reaction mixtures—with recovery yields consistently exceeding 88% and purity >99% (by NMR and LC-MS confirmation).

FAQ

What column formats and dimensions are supported?
Standard compatibility includes stainless-steel columns (10–100 mm ID) rated to 300 bar and commercially available flash cartridges (15–80 g capacity). Custom column adapters and fittings are available upon request.
Can the system be integrated into an existing LIMS or ELN environment?
Yes—via configurable ODBC drivers and .csv/.xlsx export protocols. Audit trail logs and raw chromatograms can be pushed to network storage with metadata tagging for LIMS ingestion.
Is method transfer from analytical UHPLC possible?
Yes—using the built-in scaling calculator that adjusts flow rate, injection volume, and gradient slope based on column geometry and particle size, preserving k’ and α values.
What validation documentation is provided?
Factory acceptance test (FAT) reports, IQ/OQ protocols, and performance qualification templates aligned with USP and ICH Q2(R2) guidelines are included with shipment.
Does the software support 21 CFR Part 11 compliance out-of-the-box?
Yes—role-based access control, electronic signatures, and tamper-evident audit logs are enabled by default; no additional licensing required.