Fusion QbD HPLC Method Development software is the Analytical Quality by Design toolset, extending the realm of Design of Experiments (DOE) beyond that of the statistician, to that of the chromatographer.
100% aligned with ICH Q8, Q9, Q10, and Q14 regulatory guidelines, Fusion QbD is the premier Analytical Quality by Design HPLC Method Development platform.
Fusion QbD is a true DOE package, with all predictions based on empirical models generated from multi-variate experimental raw data and never theoretical equations or proprietary algorithms. This means Fusion QbD can be applied to any separation mechanism, including mixed mode columns as well as:
- Ion Exchange
- Normal Phase
- Reverse Phase
- Size Exclusion/Gel Permeation
- Supercritical Fluid
Fusion QbD can also be applied to difficult sample matrix such as biologicals and other large molecules where classical baseline resolution is not achieved. This is due to Fusion’s ability to extract and model any peak property from your data system.
Integration with your chromatography data system (CDS) turns your HPLC into a rapid method development machine, with your defined experimental region translated directly into instrument methods and ready to run sequences.
Support for column and solvent switching valves enables rapid multi-column and multi-solvent screening for maximum instrument utilization and efficiency, while dynamic preparation of aqueous solutions (e.g. for pH screening) is available with quaternary pumps, saving analyst time and materials.
Fusion’s patented PeakTracker can use UV Spectra, Mass Spectra, and classical peak properties to track peaks and aid peak identifications, doing away with the need to identify peaks in your data system.
No MS? No Problem! Trend Responses may be used to holistically evaluate chromatograms and do away with the need to track peaks altogether during chemistry screening experiments where tracking peaks within the CDS can prove challenging.
Contact us for more information or to arrange a demonstration.