Elite 3200 Dedicated HPLC System for Phthalate Analysis
| Brand | Elite |
|---|---|
| Origin | Jiangsu, China |
| Manufacturer Type | OEM Manufacturer |
| Product Origin | Domestic (China) |
| Model | 3200 Dedicated HPLC System |
| Price Range | USD 28,000–56,000 |
| Instrument Type | Conventional High-Performance Liquid Chromatograph |
| Application Profile | Dedicated Analytical System |
| Flow Rate Range | 0.001–10.000 mL/min |
| Maximum Operating Pressure | 90 MPa |
| Column Oven Temperature Range | 4–85 °C |
| UV-Vis Detector Wavelength Range | 190–800 nm |
Overview
The Elite 3200 Dedicated HPLC System is an engineered solution designed specifically for the quantitative and qualitative analysis of phthalate esters—including DEHP, DBP, BBP, DINP, DIDP, and DNOP—in consumer products, plastics, toys, food contact materials, and environmental samples. Built upon a robust high-pressure liquid chromatography architecture, the system employs gradient elution with dual high-precision piston pumps to deliver exceptional flow stability (<0.07% RSD), low pulsation (<0.1% peak-to-peak), and minimal gradient dwell volume (<120 µL). These performance attributes directly support compliance with internationally recognized analytical protocols such as ISO 17225-3, EN 14372, ASTM D7244, and US EPA Method 8061A—where reproducibility, retention time precision, and peak symmetry are critical for regulatory reporting.
Key Features
- High-accuracy binary gradient pump system with active solvent selection and integrated online degassing—enabling seamless, unattended mobile phase switching across up to four solvents
- Low-dwell-volume fluidic path (<120 µL) optimized for fast gradient methods and sharp peak resolution of structurally similar phthalates
- Thermostatically controlled column compartment (4–85 °C, ±0.1 °C stability) supporting method robustness across seasonal ambient fluctuations
- UV-Vis photodiode array detector (190–800 nm) with 1 nm wavelength accuracy and <0.001 AU noise level at 254 nm—capable of spectral confirmation and peak purity assessment
- Modular design compliant with CE and RoHS directives; all wetted parts constructed from stainless steel 316L and PEEK to ensure chemical inertness with acetonitrile, methanol, and acidic/basic mobile phases
- Front-accessible service architecture with tool-free pump head replacement and plug-and-play detector modules—reducing scheduled maintenance downtime
Sample Compatibility & Compliance
The Elite 3200 is validated for use with standard reversed-phase columns such as SinoPak C18 (5 µm, 4.6 × 150 mm), enabling baseline separation of 6–10 common phthalates within ≤15 min using gradient elution (e.g., water/acetonitrile or water/methanol). Sample introduction supports both manual injection (via Rheodyne 7725i-compatible valve) and optional autosampler integration (up to 120 vials). The system meets core requirements for GLP-compliant laboratories: audit trail logging (user actions, method changes, calibration events), electronic signature capability, and data integrity alignment with FDA 21 CFR Part 11 principles when operated with certified chromatography data system (CDS) software. It is routinely deployed in third-party testing labs accredited to ISO/IEC 17025 for phthalate screening in accordance with EU REACH Annex XVII and China’s GB/T 22048–2015.
Software & Data Management
The system operates with EliteChrom CDS v3.2—a 64-bit Windows-based chromatography data system supporting method development, sequence control, peak integration (with tangent skim, valley-to-valley, and exponential curve fitting), and report generation per ISO 17025 clause 7.8. Raw data files (.ecd) are stored in a structured, non-proprietary format compatible with long-term archival and secondary analysis. Audit trails record timestamps, operator IDs, instrument configuration changes, and calibration verifications—exportable as PDF or CSV for internal QA review or regulatory submission. Optional LIMS connectivity via ASTM E1467-compliant interface enables automated result transfer to enterprise quality databases.
Applications
- Regulatory testing of plasticized PVC, vinyl flooring, and children’s toys per CPSC guidelines and EN71-9
- Migration testing of food packaging materials under EU Commission Regulation (EU) No 10/2011
- Environmental monitoring of phthalates in indoor dust, wastewater, and sediment extracts
- QC release testing for polymer additives and medical device components
- Method transfer and validation support in contract research organizations (CROs) serving global chemical manufacturers
FAQ
Is the Elite 3200 compatible with UHPLC columns?
Yes—when operated below 60 MPa and with appropriate guard columns and system filters, it supports 2.7 µm and 3 µm particle-packed columns; however, full UHPLC performance (e.g., sub-2 µm) requires higher pressure ratings and lower dispersion tubing.
Does the system include pre-configured phthalate analysis methods?
Standard operating procedures (SOPs) for GB/T 22048–2015 and EN 14372 are available upon request and may be loaded directly into EliteChrom CDS.
Can the detector perform simultaneous multi-wavelength quantification?
Yes—the PDA detector captures full spectra (190–800 nm) at 20 Hz acquisition rate, allowing post-run extraction of optimal wavelengths for each analyte without re-injection.
What validation documentation is supplied?
Each system ships with Factory Acceptance Test (FAT) report, IQ/OQ documentation templates aligned with ISO/IEC 17025, and a Certificate of Conformance traceable to NIST standards.
Is remote diagnostics supported?
Remote access for troubleshooting is enabled via secure TLS-encrypted VNC connection, subject to customer IT policy approval and firewall configuration.
