Waters' Acquity UPLC H-Class Method Development System automates liquid-chromatography method development according to Quality-by-Design (QbD) guidelines.
The system integrates Acquity UPLC H-Class; Fusion Method Development Software; Empower 2 Chromatography Data Software; and Waters Method Development Chemistry Kits.
It uses QbD-based methodology for LC method development, allowing scientists to develop the best possible method much faster.
Fusion works with Empower 2 and Acquity UPLC to increase lab efficiency by designing statistically valid experiments and automatically reconstructing them in Empower 2 as fully ready-to-run sequences.
Fusion uses the resulting data to generate parameter-effects models, which establish the final design and operating spaces for truly optimised LC methods.
The Acquity UPLC H-Class includes new features, such as multi-solvent blending, versatile column-management options and reliable Method Development Kits, available in a variety of chemistries.
It also addresses regulatory recommendations to incorporate robustness into LC method development.
Utilising a patented approach built on sound statistical process-control techniques, the Fusion Software computes and models the impact of key chromatographic parameters on method robustness.
This enables identification of methods optimised for mean performance and robustness, without the need for any additional experiments.
Establishing the final design space for a method in this manner creates the basis for flexibility and continuous improvement (ICH Q8(R2) Pharmaceutical Development).
Pharmaceutical organisations can standardise their approach to LC with this common technology platform that makes the future transition from HPLC to efficient UPLC-based methods straightforward and practical - from discovery through to product release testing.
Additional tools such as Method Transfer and Method Validation Kits enable transfer from an HPLC to a UPLC.