Shine CLC-3200 High-Performance Liquid Chromatography System

Overview

The Shine CLC-3200 High-Performance Liquid Chromatography (HPLC) System is an engineered platform designed for robust, reproducible, and compliant separation of small- to medium-molecular-weight analytes in complex matrices. Based on the principles of reversed-phase, normal-phase, ion-exchange, and size-exclusion chromatography, the CLC-3200 employs high-pressure solvent delivery, precise temperature-controlled column management, and high-sensitivity UV-Vis detection to deliver consistent retention time stability, peak symmetry, and quantitative accuracy across routine analytical workflows. Developed by Qingdao Shine Chromatography Co., Ltd.—a manufacturer with over two decades of specialization in ion chromatography—the system integrates design rigor from ion analysis into general-purpose HPLC architecture, resulting in a platform optimized for method transfer, long-term operational reliability, and regulatory readiness in QC, environmental, pharmaceutical, and food safety laboratories.

Key Features

• Dual High-Pressure Binary Pump System: Delivers gradient elution with ≤0.06% RSD flow precision (per ASTM D7507), low dwell volume (<150 µL), and seamless solvent switching across two independent mobile phase channels per pump—enabling rapid method development and multi-solvent compatibility without hardware reconfiguration.
• Thermostatically Controlled Column Compartment: Maintains column temperature from ambient +5°C to 65°C with ±0.1°C stability, minimizing retention time drift and improving inter-run reproducibility—critical for pharmacopeial methods (e.g., USP , EP 2.2.46) and long-sequence unattended operation.
• 120-Position Autosampler: Supports programmable injection volumes (10–500 µL), needle wash cycles, and vial agitation; compatible with standard 1.5 mL and 4 mL screw-cap vials. Optional manual injector (Rheodyne-type) available for cost-sensitive or low-throughput applications.
• Broad-Spectrum UV-Vis Detector: Equipped with a deuterium/tungsten dual-lamp source covering 190–800 nm, enabling simultaneous wavelength monitoring, peak purity assessment, and method flexibility for diverse compound classes—including flavonoids, azo dyes, PAHs, and alkaloids—without detector replacement.
• Modular Detector Interface: Standard RS-232 and analog output ports support integration with third-party detectors—including fluorescence (FLD), conductivity (for ion chromatography coupling), electrochemical (ECD), and mass spectrometry interfaces (via LC-MS adapter kits)—ensuring future scalability and application adaptability.

Sample Compatibility & Compliance

The CLC-3200 accommodates a wide range of sample types—from aqueous extracts of herbal matrices (e.g., Evodiae Fructus) and ethanolic food homogenates (e.g., chili powder for Sudan dye screening) to acetonitrile-based environmental extracts (e.g., soil or water samples for PAH quantification). Its pressure rating of 42 MPa supports sub-2 µm particle-packed columns, facilitating UHPLC-compatible separations when paired with appropriate hardware upgrades. The system meets core performance criteria outlined in ISO 17025:2017 for testing laboratories and aligns with instrument qualification requirements under FDA 21 CFR Part 11 when operated with audit-trail-enabled software. All thermal and fluidic modules undergo factory calibration traceable to NIST-certified standards.

Software & Data Management

The CLC-3200 operates with Shine’s unified Chromatography Data System (CDS) workstation—designed for GLP/GMP environments and validated per IQ/OQ protocols. The software provides real-time chromatogram display, automated peak integration (with customizable baseline algorithms), calibration curve generation (linear, quadratic, weighted), and report templates compliant with ISO/IEC 17025 Annex A. Audit trail functionality records all user actions—including method edits, data reprocessing, and instrument parameter changes—with timestamped, non-erasable entries. Raw data files (.shd) are stored in vendor-neutral formats compatible with third-party review tools (e.g., OpenLab CDS, Chromeleon). Electronic signatures and role-based access control (RBAC) are configurable to meet 21 CFR Part 11 compliance requirements.

Applications

• Phytochemical Analysis: Quantification of evodiamine, rutaecarpine, and evocarpine in Evodia rutaecarpa using RP-HPLC with C18 columns and gradient elution (MeCN/H₂O + 0.1% formic acid); LODs < 0.5 ng on-column.
• Food Contaminant Screening: Simultaneous determination of Sudan I–IV in spice matrices via isocratic elution on a phenyl-hexyl column, with UV detection at 520 nm—validated per AOAC Official Method 2005.03.
• Environmental Monitoring: Analysis of 16 priority PAHs (EPA Method 8310) in sediment extracts using programmed temperature gradient and fluorescence detection post-column; recoveries >92% across spiked concentration ranges (1–100 ng/g).
• Quality Control in Chemical Manufacturing: Assay of active pharmaceutical ingredients (APIs) and related substances per ICH Q2(R2) guidelines, including system suitability testing (tailing factor ≤2.0, resolution ≥2.0, RSD ≤1.0% for replicate injections).

FAQ

Is the CLC-3200 compatible with UHPLC columns?
Yes—when operated within its 42 MPa pressure limit and with appropriate low-dwell-volume configuration, the system supports columns packed with sub-2 µm particles. Gradient delay and extra-column volume should be minimized for optimal efficiency.

Does the autosampler support needle-in-vial or needle-over-vial injection modes?
The standard 120-position autosampler offers both modes, with programmable penetration depth and syringe draw speed to accommodate viscous or volatile samples.

Can the UV-Vis detector perform spectral scanning during a run?
Yes—the detector supports full-spectrum acquisition (190–800 nm) at up to 100 Hz, enabling real-time peak purity evaluation and library matching against reference spectra.

What validation documentation is provided with the system?
Each shipment includes Factory Acceptance Test (FAT) reports, calibration certificates for pump flow, column oven temperature, and UV wavelength accuracy, plus IQ/OQ protocol templates aligned with ASTM E2500 and EU GMP Annex 15.

Is remote monitoring supported?
The CDS workstation supports secure remote access via TLS-encrypted VNC or RDP connections, with session logging and concurrent user restrictions enforced through Windows Active Directory integration.