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OPQR has a requirement to obtain an advanced dynamic light scattering detector to enhance characterization capabilities for emerging pharmaceutical products and complex biologics. For a quoter's detector to be deemed acceptable, the following salient characteristics shall be met: QELS Dynamic Light Scattering Detector: Real-time hydrodynamic radius measurement capability that operates inline with Field-Flow Fractionation separation to provide simultaneous size characterization as samples elute from the FFF system. Compatibility with Existing FFF System: Must be fully compatible with and integrate seamlessly into the existing FFF system, including hardware connections, software integration with chromatography software, and synchronized data acquisition with existing MALS detectors. High-Sensitivity Detection: Capable of measuring hydrodynamic radii across a wide dynamic range from approximately 10 nm to 1000 nm to accommodate diverse sample types including proteins, protein aggregates, liposomes, and lipid nanoparticles.
Orthogonal Size Validation: Provides diffusion-based size measurements that complement separation-based FFF analysis, enabling validation of particle size distributions and detection of sub-populations or aggregates that may not be fully resolved by separation alone. Data Correlation and Analysis: Integrated software functionality that enables direct correlation between molecular weight data from MALS detection and hydrodynamic size from DLS detection to provide comprehensive analysis of absolute molar mass, root-mean-square radius, and hydrodynamic radius. Data Output: Generates validated, audit-trail-compliant data files suitable for regulatory submissions and scientific publications, with full integration into existing software platform for unified da…
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