Shimadzu Essentia LC-16 Modular High-Performance Liquid Chromatograph
| Brand | Shimadzu |
|---|---|
| Origin | Jiangsu, China |
| Manufacturer Status | Authorized Distributor |
| Origin Category | Domestic |
| Model | LC-16 |
| Instrument Type | Conventional HPLC System |
| Flow Rate Range | 0.001–10.000 mL/min |
| Maximum Pressure | 36 MPa |
| Sample Tray Capacity | 108 positions for 1.5 mL vials + support for 4.0 mL vials |
| Injection Volume Range | 0.1–100 µL (expandable to 2000 µL with optional syringe) |
| Column Oven Temperature Range | 14–60 °C |
| UV-Vis Wavelength Range | 190–700 nm |
| Data Acquisition Frequency | 100 Hz |
Overview
The Shimadzu Essentia LC-16 is a modular, entry-level high-performance liquid chromatography (HPLC) system engineered for precision, reliability, and regulatory compliance in routine QC/QA laboratories. Designed as the foundational platform of the Essentia series—named after the Latin word for “essence”—this system distills the core engineering principles of Shimadzu’s globally validated Prominence architecture into a compact, cost-optimized configuration. It employs classical reversed-phase and normal-phase HPLC methodologies, utilizing gradient or isocratic elution with solvent delivery governed by dual-plunger reciprocating pumps. The system operates on the principle of differential partitioning of analytes between a stationary phase (typically silica-based C18 columns) and a mobile phase, with detection based on UV-Vis absorbance at user-selectable wavelengths. Its design targets laboratories in pharmaceutical, food & beverage, environmental, and academic sectors requiring consistent, auditable performance under GLP and GMP frameworks.
Key Features
- LC-16 Solvent Delivery Unit: Enhanced piston seal geometry and pressure feedback control deliver long-term flow accuracy ≤ ±0.2% RSD and precision ≤ ±0.07% RSD across the full 0.001–10.000 mL/min range, supporting both low-flow micro-applications and standard analytical workflows.
- SPD-16 UV-Vis Dual-Wavelength Detector: Features a low-noise optical path and optimized deuterium/tungsten lamp configuration, achieving baseline noise 2.5 AU, and simultaneous dual-wavelength monitoring for peak purity assessment or reference channel correction.
- SIL-16 Autosampler: Implements full-loop injection with wash-in-place (WIP) technology, delivering quantitative reproducibility ≤ ±0.2% RSD and carryover < 0.005% for typical small-molecule applications. Injection cycle time ≤ 10 seconds enables high-throughput batch processing without compromising robustness.
- CTO-16 Column Compartment: Integrates column oven and solvent reservoir tray in a single unit; accommodates one 25 cm column with ±0.1 °C temperature stability over 14–60 °C; supports up to three 1 L or five 500 mL solvent bottles with integrated degassing ports.
- Intuitive Chinese-language front-panel interface: Enables standalone operation of all modules (up to two LC-16 units, one SPD-16, one SIL-16, one CTO-16) without PC dependency—ideal for training, troubleshooting, or walk-up analysis.
Sample Compatibility & Compliance
The LC-16 system supports standard 1.5 mL and 4.0 mL screw-thread vials, compatible with widely adopted autosampler racks (e.g., ANSI/SLAS format). Its hardware and software architecture are explicitly validated for compliance with international quality standards: data integrity features—including role-based user authentication, electronic signatures, and immutable audit trails—meet FDA 21 CFR Part 11 requirements. System suitability testing (SST) parameters (e.g., resolution, tailing factor, theoretical plates) are automatically calculated per USP , EP 2.2.46, and JP 6.01 guidelines. IQ/OQ protocols are prequalified using LabSolutions LC-compatible templates, facilitating rapid validation in regulated environments.
Software & Data Management
LabSolutions Essentia is a Windows-based chromatography data system (CDS) built on the same kernel as Shimadzu’s flagship LabSolutions platform. It provides instrument control, real-time data acquisition, post-run reprocessing, calibration curve generation (linear, quadratic, weighted), and automated pass/fail evaluation against user-defined SST criteria. All user actions—including method edits, sequence modifications, and result approvals—are timestamped and logged in a tamper-evident audit trail. LabSolutions Direct extends remote oversight via iOS/Android devices: users can monitor pump pressure, detector signal, oven temperature, and run status in real time; initiate/pause sequences; and receive push notifications for completion or error conditions—all without accessing the host PC. Data files adhere to AIA/ANDI standards and export seamlessly to LIMS or ELN platforms.
Applications
- Pharmaceutical QC: Assay quantification of active pharmaceutical ingredients (APIs), related substances testing per ICH Q2(R2), dissolution profile analysis, and cleaning validation swab extract analysis.
- Food Safety: Pesticide residue screening (e.g., organophosphates, carbamates), mycotoxin detection (aflatoxins, ochratoxin A), preservative quantitation (sorbic acid, benzoic acid), and vitamin profiling (B-complex, C, E).
- Environmental Monitoring: Analysis of PAHs, phenols, endocrine disruptors (bisphenol A, nonylphenol), and anionic surfactants in water and soil extracts.
- Academic Research: Method development for natural product isolation, polymer additive characterization, and synthetic reaction monitoring under controlled isocratic or gradient conditions.
FAQ
Is the LC-16 compliant with FDA 21 CFR Part 11?
Yes—the system implements electronic signatures, audit trail logging, and role-based access control through LabSolutions Essentia, satisfying all technical and procedural requirements for Part 11 compliance in regulated laboratories.
Can the LC-16 perform gradient elution?
Yes—it supports binary gradient mixing with active proportioning valves and real-time composition verification via pressure monitoring, enabling robust method transfer from Prominence or Nexera platforms.
What is the maximum injection volume without optional hardware?
The standard configuration supports 0.1–100 µL; expansion to 2000 µL requires installation of the high-volume syringe option (SIL-16-HV) and corresponding needle seat.
Does the CTO-16 support column switching or multi-column configurations?
No—the CTO-16 is designed exclusively for single-column thermal management; column switching functionality requires integration with a separate switching valve module (e.g., FCV-16 or similar) and corresponding LabSolutions method programming.
Is LabSolutions Essentia compatible with networked LIMS environments?
Yes—it supports secure data export in .csv, .pdf, and AIA/ANDI formats, and integrates with common LIMS via ODBC or RESTful API extensions provided through Shimadzu’s LabSolutions Connect add-on package.
