KEZHE SHANGHAI Anters-1200V High-Performance Liquid Chromatograph

Overview

The KEZHE SHANGHAI Anters-1200V High-Performance Liquid Chromatograph is a modular, research-grade analytical HPLC system engineered for precision, reproducibility, and regulatory compliance in pharmaceutical, academic, and industrial quality control laboratories. Based on reversed-phase liquid chromatography principles, the system separates analytes via differential partitioning between a polar mobile phase and a non-polar stationary phase—typically C18 silica—under high-pressure gradient elution. Its design emphasizes robustness in routine operation while supporting method development, stability-indicating assays, and impurity profiling per ICH Q2(R2) and USP . The integrated dual-pump binary gradient system delivers precise solvent composition control across wide flow and pressure ranges, enabling compatibility with sub-2 µm particles and UHPLC-capable columns (up to 40 MPa). All fluidic pathways are constructed from biocompatible stainless steel and PEEK, minimizing metal ion leaching and ensuring long-term baseline stability.

Key Features

• High-accuracy binary gradient pump with flow precision <0.3% RSD and accuracy <±0.06%, validated across 0.001–5 mL/min at pressures up to 40 MPa
• Autosampler with 144-position 2 mL vial capacity, featuring vial presence detection, needle wash-in-loop functionality, and carryover <0.1% (measured with caffeine standard)
• UV-Vis detector equipped with dual light sources (deuterium and tungsten lamps), 1200-line holographic grating monochromator, and wavelength accuracy ±0.2 nm (NIST-traceable calibration)
• Column oven with active cooling capability (−20 °C to 100 °C), temperature stability ±0.15 °C, and resolution of 0.1 °C—enabling retention time reproducibility critical for GLP/GMP workflows
• Integrated vacuum degasser with real-time pressure monitoring to prevent bubble formation and baseline disturbance
• Modular architecture supporting optional detectors: fluorescence (FLD), evaporative light scattering (ELSD), refractive index (RID), and mass spectrometry interfaces (via analog/digital outputs and TTL triggers)

Sample Compatibility & Compliance

The Anters-1200V accommodates standard 4.6 mm × 150 mm analytical columns as well as narrow-bore (2.1 mm ID) and preparative formats (up to 21.2 mm ID). It accepts all commercially available reversed-phase, HILIC, ion-exchange, and size-exclusion media—including fully porous and superficially porous particles. The system complies with key regulatory expectations for analytical instrumentation: audit trail functionality with user-level permissions, electronic signature support, and data integrity controls aligned with FDA 21 CFR Part 11 Annex 11 requirements. All hardware modules meet IEC 61010-1 safety standards; column oven and detector electronics conform to electromagnetic compatibility (EMC) Class B specifications. Routine performance qualification (PQ) protocols—including system suitability testing per USP and ISO/IEC 17025—can be executed using built-in diagnostic tools and reference standards.

Software & Data Management

The Anters-1200V operates under KEZHE’s modular ChromaLink™ workstation software—a Windows-based platform designed for multi-user laboratory environments. The interface supports full instrument control (pump, autosampler, detector, column oven, degasser), real-time overlay of chromatograms, gradient profiles, and device status telemetry. Gradient programming includes linear, step, and “point-and-drag” curve definition with up to 20 segments. Quantitative analysis features peak integration (baseline correction, tangent skim, valley-to-valley), calibration curve fitting (linear, quadratic, weighted), and report generation compliant with ALM (Analytical Laboratory Management) templates. Audit trail logs capture operator ID, timestamp, parameter changes, and data modifications with immutable records. Data files are stored in vendor-neutral .cdf format (compatible with OpenChrom and ACD/Labs), and raw data archives support automated backup to network drives or LIMS integration via ODBC and RESTful API endpoints.

Applications

• Pharmaceutical QC: Assay, related substances, residual solvents, and dissolution testing per USP, EP, and JP monographs
• Biopharmaceutical characterization: Peptide mapping, monoclonal antibody purity assessment, and glycan profiling using hydrophilic interaction chromatography (HILIC)
• Environmental analysis: PAHs, pesticides, and pharmaceutical residues in water and soil extracts
• Food & beverage safety: Mycotoxins, preservatives, sweeteners, and vitamin quantification
• Academic research: Natural product isolation, metabolomics sample profiling, and method development for novel stationary phases

FAQ

Is the Anters-1200V compatible with third-party chromatography data systems (CDS)?

Yes—it supports ASCII, .cdf, and .dx binary export formats and provides OEM-level API access for integration with Thermo Chromeleon, Waters Empower, and Agilent OpenLab CDS.
Does the system meet FDA 21 CFR Part 11 requirements for electronic records?

The ChromaLink™ software includes role-based access control, electronic signatures, and tamper-evident audit trails—fully configurable to satisfy Part 11 Subpart B controls.
Can the column oven cool below ambient temperature without external chillers?

Yes—the Peltier-cooled oven achieves −20 °C using only internal thermoelectric modules, eliminating dependency on recirculating chillers.
What is the maximum injection volume accuracy across the full range?

Injection precision is ≤0.3% RSD at volumes ≥1 µL; for low-volume injections (0.1–0.5 µL), accuracy is maintained via calibrated syringe actuation and pressure-compensated metering.
Are method transfer protocols supported between Anters-1200V and other major HPLC platforms?

ChromaLink™ includes retention time prediction algorithms and gradient scaling tools that facilitate cross-platform method translation per ASTM E2638 and USP guidelines.