Waters Alliance 2690/2695 HPLC System (Refurbished)

Overview

The Waters Alliance 2690/2695 HPLC System is a benchtop high-performance liquid chromatography platform engineered for robustness, method transfer fidelity, and regulatory compliance in pharmaceutical, academic, and quality control laboratories. Based on the proven Alliance architecture, this system employs dual-piston reciprocating pumps with pulse-dampening technology, low-dead-volume flow cells, and precision solvent selection valves to deliver high reproducibility in gradient and isocratic elution modes. Its modular design supports integration of multiple detectors—including the included Waters 2996 Photodiode Array Detector—enabling full-spectrum acquisition (190–800 nm), peak purity assessment, and quantitative analysis across diverse compound classes. As one of the first HPLC systems formally recognized by the U.S. FDA and referenced in United States Pharmacopeia (USP) monographs, the 2690/2695 remains a benchmark for system suitability testing, column qualification, and stability-indicating assay development under GLP and GMP environments.

Key Features

• Modular Alliance architecture with integrated solvent manager, sample manager, column heater, and detector interface
• High-precision binary or quaternary gradient pump delivering flow rates from 0.001 to 10.000 mL/min with ≤0.1% RSD at 1 mL/min
• Waters 2996 PDA detector featuring 1024-element diode array, 1.2 nm optical resolution, and real-time spectral deconvolution capability
• Autosampler with 100-position vial capacity, programmable injection volume (0.1–100 µL), and temperature-controlled sample compartment (4–40 °C)
• Column oven supporting temperature range of 5–80 °C with ±0.5 °C stability for retention time reproducibility
• Fully refurbished and functionally validated per Waters-recommended maintenance protocols; all fluidic paths replaced or certified leak-free
• Pre-installed Empower™ 2 or Empower 3 software (version-dependent on hardware compatibility); licensed for standalone operation with audit trail enabled

Sample Compatibility & Compliance

The system accommodates standard 4.6 mm × 150 mm analytical columns and is compatible with reversed-phase (C18, C8), HILIC, ion-exchange, and size-exclusion chemistries. It meets critical performance criteria outlined in USP , EP 2.2.46, and ISO 17025 for chromatographic system verification—including baseline noise (<±0.5 mAU), drift (<1.0 mAU/h), and wavelength accuracy (±1 nm). All refurbished units undergo comprehensive system suitability testing using caffeine, uracil, and naphthalene reference standards prior to shipment. Documentation includes Certificate of Operational Verification, preventive maintenance log, and calibration summary—all traceable to NIST-traceable standards. The configuration satisfies data integrity requirements under FDA 21 CFR Part 11 when operated with Empower’s electronic signature and audit trail features enabled.

Software & Data Management

Empower Chromatography Data System (CDS) provides full method development, acquisition, processing, reporting, and archival capabilities. The included installation supports raw data storage in .raw format, PDF report generation with embedded chromatograms and spectra, and export to CSV, Excel, or LIMS-compatible formats. Audit trail functionality records all user actions—including method edits, reprocessing events, and result approvals—with immutable timestamps and operator identification. Data backups are supported via network share or external NAS; no cloud storage is preconfigured. License transfer is subject to Waters’ End User License Agreement (EULA) and requires formal registration post-installation.

Applications

• Pharmaceutical QC release testing (assay, related substances, dissolution)
• Stability-indicating method validation per ICH Q2(R2)
• Natural product fingerprinting and quantification (e.g., flavonoids, alkaloids)
• Environmental contaminant analysis (PAHs, pesticides, pharmaceutical residues)
• Food safety testing (mycotoxins, preservatives, additives)
• Academic research requiring high-resolution separation and spectral confirmation

FAQ

Is this system compliant with 21 CFR Part 11?
Yes—when operated with Empower 2 or 3 configured with electronic signatures, audit trail, and secure user authentication.
What documentation is provided with the instrument?
Certificate of Operational Verification, refurbishment checklist, system suitability test report, and maintenance history log.
Can I add other Waters detectors post-purchase?
Yes—the Alliance platform supports hot-swappable detector modules including 2487 UV/Vis, 2475 FLR, and 2414 RID, subject to interface compatibility and firmware version.
Is column oven included in the base configuration?
Yes—a thermostatically controlled column compartment (5–80 °C) is integrated into the Alliance module.
What is the expected lifetime of refurbished components?
All critical wear parts—including pump seals, check valves, and autosampler rotor seals—have been replaced with genuine Waters OEM components; mean time between failures exceeds 12,000 hours under typical QC usage.