KEZHE SHANGHAI Anters-1200F2 High-Performance Liquid Chromatograph

Overview

The KEZHE SHANGHAI Anters-1200F2 High-Performance Liquid Chromatograph is a modular, research-grade analytical HPLC system engineered for high reproducibility and regulatory compliance in pharmaceutical, biotechnological, and quality control laboratories. Built upon core principles of reversed-phase, normal-phase, and hydrophilic interaction liquid chromatography (HILIC), the system integrates a precision binary gradient pump, a high-capacity autosampler with wash-in-place functionality, a thermally stabilized column oven, and a full-spectrum fluorescence detector optimized for pharmacopoeial applications. Its architecture supports both isocratic and multi-step gradient elution, with pressure monitoring and real-time flow calibration to ensure retention time stability across extended unattended runs. Designed to meet the instrumental requirements specified in Chinese Pharmacopoeia (ChP) 2010 and 2015 editions for fluorescence-based HPLC analysis—particularly for assay of vitamins, antibiotics, and fluorescent metabolites—the Anters-1200F2 delivers trace-level sensitivity and spectral fidelity without requiring proprietary consumables or vendor-locked software environments.

Key Features

• Binary high-pressure gradient pumping system with flow accuracy <0.06% and precision <0.3% RSD, operating up to 40 MPa (5800 psi)
• Autosampler with 144-position 2 mL vial capacity, integrated needle wash station, and vial presence detection via optical sensor
• Column oven with programmable temperature range from −20 °C to +100 °C, ±0.15 °C thermal stability, and 0.1 °C resolution
• Full-spectrum fluorescence detector featuring dual monochromators (excitation/emission), 1200-line holographic grating, and selectable bandwidths (2/5/10/20 nm)
• Wavelength accuracy of ±0.2 nm and repeatability validated per ISO 17025 traceable protocols
• Modular solvent management with built-in vacuum degasser and low-dead-volume fluidic pathways
• Integrated hardware synchronization enabling simultaneous display of chromatogram, gradient profile, and instrument status on a single timeline
• Open communication architecture supporting RS-232, USB, and Ethernet interfaces for third-party detector and mass spectrometer integration

Sample Compatibility & Compliance

The Anters-1200F2 accommodates standard 3.0–5.0 µm particle-packed analytical columns (e.g., C18, C8, phenyl-hexyl, HILIC) up to 30 cm in length, with optional column-switching capability for multidimensional separations. It complies with fundamental performance criteria outlined in USP , EP 2.2.46, and ChP General Chapter 0512 for HPLC system suitability testing. The fluorescence detector satisfies ChP 2015 requirements for excitation/emission wavelength verification and signal-to-noise ratio validation under defined quinine sulfate conditions. Audit trail functionality—including user login/logout timestamps, method modification history, and raw data integrity logs—meets FDA 21 CFR Part 11 baseline requirements for electronic records and signatures when deployed in GxP environments. All firmware and driver components are version-controlled and support GLP/GMP-compliant installation qualification (IQ) and operational qualification (OQ) documentation packages.

Software & Data Management

The Anters-1200F2 is operated via a modular Windows-based workstation software suite featuring intuitive graphical workflow design. Core modules include method editor (supporting linear, stepwise, and point-and-drag gradient programming), sequence scheduler (with conditional pause/resume logic), peak integration engine (based on tangent skim and valley-to-valley algorithms), and quantitative report generator compliant with ICH Q2(R2) validation parameters. Data files are stored in vendor-neutral .CDF format (compatible with Open Chromatography Data Format standards), enabling cross-platform review in third-party tools such as Chromeleon, Empower, or open-source platforms like MZmine. User management supports role-based access control (RBAC) with three-tier permissions (Administrator, Analyst, Viewer), while audit trail entries record all critical events—including parameter changes, injection triggers, and calibration actions—with immutable timestamps and operator IDs. Optional 21 CFR Part 11 add-on enables electronic signature capture and digital certificate binding for regulated submissions.

Applications

• Pharmaceutical QC testing of active pharmaceutical ingredients (APIs) and finished dosage forms per ChP monographs requiring fluorescence detection (e.g., riboflavin, tetracyclines, fluoroquinolones)
• Stability-indicating assays for photodegradation and oxidation products in accelerated and long-term storage studies
• Quantitative analysis of amino acids, catecholamines, and polycyclic aromatic hydrocarbons (PAHs) in environmental and food safety testing
• Method development and transfer for HPLC-FLD methods used in bioequivalence and dissolution testing
• Support for preparative-scale method scouting when coupled with fraction collection modules

FAQ

Does the Anters-1200F2 support FDA 21 CFR Part 11 compliance out of the box?
The base software includes audit trail, electronic signature, and user access controls; however, full Part 11 compliance requires configuration validation, documented SOPs, and implementation of organizational security policies (e.g., password complexity, session timeout). A dedicated Part 11 readiness package is available upon request.

Can the fluorescence detector operate in synchronous scanning or 3D emission scan mode?
Yes—the detector supports excitation-emission matrix (EEM) acquisition with configurable step increments (1–5 nm) and dwell times, enabling spectral fingerprinting for compound identification and interference assessment.

Is column oven cooling below ambient temperature required for all applications?
Sub-ambient operation (down to −20 °C) is optional but recommended for thermally labile compounds, chiral separations using polysaccharide-based phases, and methods requiring precise retention time locking across seasonal ambient fluctuations.

What column switching configurations are supported?
The system accepts optional 6-port/2-position or 10-port/2-position switching valves, enabling heart-cutting, column backflushing, and online sample cleanup workflows—fully programmable within the method editor.

Are firmware updates provided free of charge during the warranty period?
Yes—KEZHE SHANGHAI provides no-cost firmware and software patches for bug fixes, regulatory alignment updates (e.g., ChP 2020 revisions), and minor feature enhancements for 24 months post-delivery.