Shimadzu Prominence UFLC System with ELSD-LT II Detector

Overview

The Shimadzu Prominence UFLC System with ELSD-LT II Detector is a fully refurbished ultra-fast liquid chromatography platform engineered for high-resolution, high-throughput separation of non-chromophoric, semi-volatile, and thermally labile compounds. Unlike UV-absorbing analytes, substances such as carbohydrates, lipids, surfactants, polymers, and natural product extracts often lack strong or consistent UV absorbance—making them unsuitable for conventional UV/VIS or DAD detection. The integrated ELSD-LT II detector provides universal, mass-sensitive detection by nebulizing the column effluent, evaporating the mobile phase under controlled temperature, and measuring the scattered light intensity of the resulting analyte particles. This principle ensures consistent response across compound classes independent of optical properties, while maintaining compatibility with gradient elution and volatile mobile phases (e.g., acetonitrile/water, methanol/water, or THF-based systems). The system’s UFLC architecture operates at pressures up to 60 MPa (8700 psi), enabling use of sub-2 µm particle-packed columns (e.g., Shim-pack XR-ODS) without compromising long-term mechanical stability or baseline integrity.

Key Features

• Dual LC-20AD high-precision solvent delivery units delivering flow rates from 0.001 to 10.000 mL/min with ≤0.1% RSD over 1–5 mL/min range
• SIL-20AC autosampler with 100-position tray capacity, 0.1–100 µL injection volume range, and ≤0.25% RSD for peak area (n = 6, 10 µL injection)
• CTO-20AC column oven supporting temperature control from 4 °C to 85 °C (±0.1 °C stability)
• SPD-M20A photodiode array detector with 190–800 nm spectral range, 1 nm resolution, and real-time peak purity assessment
• ELSD-LT II detector featuring low-noise photomultiplier tube, adjustable drift tube temperature (30–100 °C), and optimized nebulizer gas flow control for enhanced sensitivity and dynamic range (typically 0.1–100 µg on-column for sucrose standard)
• CBM-20A system controller with Ethernet interface, synchronized timing control, and hardware-level event logging
• DGU-20A5 online degasser with four-channel membrane-based vacuum degassing (residual O₂ < 0.5 ppm)

Sample Compatibility & Compliance

This refurbished Prominence UFLC-ELSD system is validated for routine analysis of small-molecule APIs, excipients, oligosaccharides, glycosides, fatty acids, phospholipids, and synthetic polymers. It supports method transfer from legacy HPLC platforms and meets critical regulatory expectations for QC laboratories operating under GLP or GMP frameworks. All refurbished units undergo full functional verification—including pump linearity, injector carryover (<0.01%), column oven thermal uniformity, DAD wavelength accuracy (±1 nm), and ELSD baseline noise (<5 mV RMS over 30 min). Documentation includes Certificate of Refurbishment, Performance Qualification (PQ) report, and traceable calibration records. Optional IQ/OQ documentation packages are available to support FDA, EMA, or PMDA submissions. The system complies with ISO 9001 quality management requirements and aligns with ASTM D7594 (ELSD performance testing) and USP chromatography guidelines.

Software & Data Management

Controlled via Shimadzu LabSolutions software (Ver. 5.9x or later), the system supports instrument method setup, sequence definition, real-time monitoring, peak integration, library search, and multi-channel data overlay. LabSolutions includes built-in tools for system suitability testing (SST), custom report generation, and electronic signature capability. Audit trail functionality logs all user actions—including method edits, sequence changes, and data reprocessing—with timestamps and operator ID. When deployed in 21 CFR Part 11–compliant environments, optional security modules enable role-based access control, electronic signatures, and immutable archive export (e.g., PDF/A-2b or .cdf format). Raw data files (.lcd) are stored in vendor-neutral hierarchical directory structures compatible with third-party chemometric platforms (e.g., Simca, Unscrambler).

Applications

• Quantitation of lactose, maltose, and fructose in dairy and infant formula products (AOAC 2012.03)
• Residual solvent analysis in pharmaceutical intermediates using ELSD-coupled gradient UFLC
• Profiling of saponins and triterpenoid glycosides in botanical extracts without derivatization
• Stability-indicating assays for non-UV-absorbing degradation products in lipid-based drug delivery systems
• QC release testing of heparin sodium and low-molecular-weight heparins per USP
• Method development for polymer molecular weight distribution using SEC-UFLC-ELSD

FAQ

Is this system supplied with original Shimadzu documentation and software licenses?
Yes — each unit includes original installation manuals, operation guides, and a valid LabSolutions software license (perpetual, node-locked to the included PC). Reinstallation media and activation keys are provided.
What validation documentation accompanies the instrument?
A comprehensive PQ report is issued, covering pressure calibration, flow accuracy, injection precision, column oven stability, DAD photometric linearity, and ELSD response linearity across three concentration levels.
Can the system be configured for 21 CFR Part 11 compliance?
Yes — optional 21 CFR Part 11 add-on module enables electronic signatures, audit trail export, and user permission management. Installation qualification (IQ) and operational qualification (OQ) protocols are available upon request.
Are spare parts and consumables available post-purchase?
We maintain inventory of critical spares including ELSD nebulizer tips, drift tubes, DAD flow cells, pump seals, and Shim-pack XR-ODS columns. Extended warranty and service contracts are offered.
How is system performance verified prior to shipment?
Each unit undergoes ≥72 hours of continuous operation under load, followed by chromatographic challenge tests using certified reference standards (e.g., USP Sucrose RS for ELSD, caffeine for DAD). Final test chromatograms and raw data files are delivered with the system.