KEZHE PuriSmart-100 Preparative Liquid Chromatography System
| Brand | KEZHE SHANGHAI |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Original Equipment Manufacturer (OEM) |
| Product Category | Domestic |
| Model | PuriSmart-100 |
| Application Level | Laboratory-Scale R&D |
| Instrument Type | High-Pressure Preparative HPLC System |
| Flow Rate Range | 0–50.00 mL/min (per pump) |
| Maximum Operating Pressure | 30 MPa |
| Wavelength Range | 190–850 nm |
| Wavelength Accuracy | ±1 nm |
| Baseline Noise | ±0.1 mAU (at 254 nm) |
| Baseline Drift | 0.2 mAU/h (at 254 nm) |
| Detection Modes | Dual-Wavelength UV-VIS, Online UV-VIS Spectral Scanning |
| Gradient Capability | Binary, Low-Delay Mixing |
| Fraction Collection | X-Y Robotic Fraction Collector |
| Software Compliance | Audit Trail, User Management, Data Integrity per FDA 21 CFR Part 11 & GLP Principles |
Overview
The KEZHE PuriSmart-100 Preparative Liquid Chromatography System is a laboratory-scale, high-pressure preparative HPLC platform engineered for reproducible, milligram-to-gram scale purification of natural products—particularly botanical extracts and traditional Chinese medicine (TCM) compounds. Built upon validated instrumentation architecture from China’s National Major Scientific Instrument Development Program, the system implements classical reversed-phase liquid chromatography principles under controlled gradient elution conditions. It operates with dual-pump binary solvent delivery, enabling precise control over mobile phase composition across extended run times. The integrated dual-wavelength UV-VIS detector leverages deuterium and tungsten-halogen lamp sources to support simultaneous monitoring at two user-selectable wavelengths within the 190–850 nm range—critical for tracking chromophores with disparate absorption maxima in complex herbal matrices. Designed for robustness and operational continuity, the PuriSmart-100 targets early-stage academic labs, contract research organizations (CROs), and TCM R&D units requiring scalable, GxP-aligned purification workflows without enterprise-grade infrastructure.
Key Features
- High-precision preparative HPLC pump delivering stable flow rates from 0 to 50.00 mL/min per channel, with pressure tolerance up to 30 MPa—suitable for C18 and other high-efficiency preparative columns.
- Low-dead-volume binary mixing chamber minimizing gradient delay and ensuring accurate solvent transition profiles during method development.
- High-cycle-life high-pressure six-port injection valve with interchangeable quantitative loops (standard 5 mL; optional volumes available) for consistent sample introduction under elevated backpressure.
- Dual-lamp UV-VIS detector featuring real-time dual-wavelength monitoring, built-in lamp life diagnostics, and automatic monochromator calibration to maintain wavelength accuracy within ±1 nm.
- Optical subsystem incorporating a 1200-line/mm holographic grating and imported photodiode array detector, delivering stable baseline performance (±0.1 mAU noise at 254 nm) and low drift (0.2 mAU/h).
- X-Y robotic fraction collector enabling spatially indexed collection across >100 vials—offering significantly higher throughput and flexibility than rotary multi-port valve-based alternatives.
- Modular software architecture supporting synchronized display of gradient profile, chromatogram, fraction map, and instrument status—all within a single time-aligned coordinate system.
Sample Compatibility & Compliance
The PuriSmart-100 accommodates a broad spectrum of semi-polar to non-polar analytes common in phytochemical isolation, including flavonoids, alkaloids, terpenoids, saponins, and phenolic glycosides. Its standard configuration includes a Φ10 × 250 mm C18 column packed with 10 µm spherical silica, optimized for loading capacities up to 100 mg per injection under isocratic or shallow-gradient conditions. Optional detectors—including ELSD-5000KS (evaporative light scattering), DAD, and RI—extend compatibility to non-chromophoric or low-UV-absorbing compounds. The system conforms to fundamental data integrity requirements outlined in FDA 21 CFR Part 11 through mandatory audit trail logging, role-based user authentication, electronic signature support, and immutable raw data storage. All hardware and firmware design aligns with ISO/IEC 17025 general requirements for testing laboratories and supports GLP-compliant documentation practices.
Software & Data Management
The PuriSmart Control Suite is a Windows-based, modular chromatography data system (CDS) developed for regulatory-ready operation. It provides native support for multi-detector chromatogram overlay (UV-VIS, ELSD, RI) on a shared retention time axis, facilitating cross-modal peak correlation. Real-time UV-VIS spectral scanning allows acquisition of full 190–850 nm spectra at user-defined intervals—enabling library matching and peak purity assessment. Integrated peak integration algorithms support Gaussian, valley-to-valley, and tangent skim methods, with customizable thresholding and baseline correction. All analytical sequences, method parameters, audit logs, and raw signal files are stored in a structured, encrypted database compliant with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available). Data export adheres to ASTM E1967 and CDISC SDTM standards for interoperability with LIMS and ELN platforms.
Applications
- Purification of active pharmaceutical ingredients (APIs) and intermediates from plant-derived crude extracts.
- Isolation of reference standards for herbal monograph development (e.g., USP-NF, ChP, EP).
- Method scouting and scale-up studies bridging analytical HPLC to pilot-scale purification.
- Supporting ICH Q5C stability-indicating assays through orthogonal detection strategies (e.g., UV + ELSD).
- Fragment-based screening workflows where compound libraries require rapid desalting and buffer exchange prior to bioassay.
- Academic natural product chemistry labs conducting dereplication, structural elucidation, and SAR studies.
FAQ
What column dimensions and packing materials are supported beyond the standard C18?
The system accommodates columns ranging from Φ8 mm to Φ30 mm ID and lengths up to 500 mm, compatible with silica, C8, phenyl-hexyl, cyano, and amino-bonded phases—subject to pressure and flow constraints.
Can the software generate 21 CFR Part 11-compliant reports?
Yes—the software generates PDF reports with embedded electronic signatures, timestamped audit trails, and version-controlled method files meeting FDA submission requirements.
Is remote monitoring or network deployment supported?
The workstation supports LAN-based client-server configuration, enabling centralized method deployment and distributed data acquisition across up to eight connected instruments.
What maintenance protocols are recommended for long-term detector stability?
Biannual lamp output verification, quarterly grating alignment checks, and routine flow cell cleaning with acetonitrile/water (90:10) are advised per the manufacturer’s maintenance schedule.
How does the X-Y collector handle overlapping peaks during automated fractionation?
Peak-triggered collection logic allows dynamic window definition based on UV threshold crossing, slope detection, or time-slice mapping—minimizing cross-contamination even in co-eluting regions.
