KEZHE SHANGHAI Anters-1200F1 High-Performance Liquid Chromatograph

Overview

The KEZHE SHANGHAI Anters-1200F1 High-Performance Liquid Chromatograph is a modular, research-grade analytical HPLC system engineered for precision, reproducibility, and regulatory compliance in pharmaceutical, natural product, and quality control laboratories. Based on classical reversed-phase liquid chromatography principles, the system employs high-pressure gradient elution, precise solvent delivery, thermally stabilized column environments, and fluorescence-based detection optimized for low-abundance analytes—particularly mycotoxins such as aflatoxins B₁, B₂, G₁, and G₂. Its architecture conforms to fundamental chromatographic performance criteria defined in USP , EP 2.2.46, and Chinese Pharmacopoeia (ChP) 2015 Edition monographs for aflatoxin analysis in traditional Chinese medicinal materials. Designed for method robustness under GLP/GMP-aligned workflows, the Anters-1200F1 integrates hardware-level traceability features—including pump pressure logging, lamp usage counters, and wavelength calibration logs—to support audit-ready documentation.

Key Features

• Binary high-pressure gradient pumping system with flow accuracy ≤ ±0.06% and precision ≤ 0.3% RSD across 0.001–5 mL/min range
• Autosampler with 144-position 2 mL vial capacity, integrated vial presence sensing, needle wash station, and carryover < 0.1% (measured via blank injection after high-concentration standard)
• Column oven supporting temperature control from −20 °C to +100 °C at ±0.15 °C stability and ±0.5 °C absolute accuracy; accommodates up to three 30 cm columns (six optional)
• Single-wavelength fluorescence detector featuring 190–800 nm excitation/emission tunability, 0.2 nm wavelength accuracy, and 1200-line holographic grating optics
• Self-diagnostic UV-Vis light source monitoring with predictive lamp life estimation and automated replacement alerts
• Onboard monochromator auto-calibration routine ensuring long-term spectral fidelity without external reference standards
• Full system control via modular software with real-time overlay of chromatogram, gradient profile, autosampler status, and instrument pressure/temperature telemetry

Sample Compatibility & Compliance

The Anters-1200F1 supports universal compatibility with commercially available analytical columns (e.g., C18, C8, phenyl-hexyl, HILIC), including those certified for ChP-compliant aflatoxin testing. Its autosampler accepts standard 2 mL screw-thread vials, 10 mL vials, and 96-well microplates (350 µL or 2 mL format). The system meets baseline requirements for regulated environments: audit trail functionality (user login, method change history, result modification log), electronic signature support per FDA 21 CFR Part 11 (when deployed with validated software configuration), and data integrity safeguards aligned with ALCOA+ principles. It has been verified for compliance with ChP 2015 General Chapter 2351 “Determination of Aflatoxins in Medicinal Materials” and supports validation protocols per ICH Q2(R2) for specificity, linearity, accuracy, precision, and robustness.

Software & Data Management

• Modular LC workstation software with fully localized English interface and intuitive workflow-driven navigation
• Gradient programming engine supporting linear, stepwise, and “point-and-drag” custom profiles with up to 20 segments
• Integrated peak integration, calibration curve generation (linear, quadratic, weighted), and multi-level quantitation with internal standard correction
• Comprehensive user management: role-based access control (administrator, analyst, reviewer), password policy enforcement, and session timeout
• Automated data archiving with timestamped raw files (.raw), processed reports (.pdf/.xlsx), and audit trail export in CSV format
• Open API architecture enabling bidirectional communication with LIMS platforms and third-party MS data systems (e.g., Thermo Xcalibur, Waters MassLynx)

Applications

The Anters-1200F1 is routinely deployed in herbal medicine QC labs for quantitative determination of aflatoxins in dried fungi, seeds, and root extracts. Its low detection limits (sub-ng/mL range for aflatoxin B₁ using post-column photochemical derivatization), thermal stability for temperature-sensitive separations (e.g., glycosides, alkaloids), and gradient flexibility make it suitable for complex matrix analysis in food safety, environmental monitoring (e.g., ochratoxin A in cereals), and natural product profiling. The system also serves as a platform for method development in academic and contract research settings—particularly where cost-effective, CE- or ChP-aligned instrumentation is required without compromising chromatographic resolution or data traceability.

FAQ

Does the Anters-1200F1 comply with FDA 21 CFR Part 11?
Yes—when configured with enabled audit trail, electronic signatures, and secure user authentication, the system satisfies core technical requirements for electronic records and signatures in regulated environments. Full compliance requires site-specific validation per internal SOPs.

Can the fluorescence detector operate in both excitation and emission scanning modes?
No—the Anters-1200F1 is equipped with a single-wavelength fluorescence detector optimized for fixed-excitation/fixed-emission applications (e.g., 365 nm excitation / 425 nm emission for aflatoxins). Full-spectrum scanning requires optional full-range fluorescence detector upgrade.

Is column switching supported out-of-the-box?
Column switching functionality is available as an optional hardware module (valve manifold + controller); it is not included in the base Anters-1200F1 configuration but can be retrofitted and software-enabled.

What is the minimum detectable injection volume?
The autosampler achieves reliable precision down to 0.1 µL using the standard 100 µL loop; sub-microliter injections require optional nano-loop configurations and are subject to method-specific validation.

Are maintenance logs and service history tracked within the software?
Yes—the workstation maintains a time-stamped service log including lamp operating hours, pump seal replacement events, and firmware update history, accessible via administrator-level reporting tools.