According to the AQbD principles defined in ICH Q2(R2), ICH Q14 and USP<1220> the number of sample prep and injections replicates should already be defined during the development stage of an analytical procedure. USP <1210>…
Tag: FusionQbD
Best Practices in Peak Tracking One of the critical bootle necks for any chromatographic modelling is accurate peak tracking. Incorrect peak name assignments will consequentially lead to poor or even wrong predictions. Therefore, adequate care…
In previous blogs we have provided explanation about robustness simulation in Fusion QbD and setting suitable distances between the single study factor levels. As explained in these notes, for both topics we need to know…
When starting to adopt DOE in AQbD I noticed that even experienced chromatographers (or should I say especially this group?) often try to take over established routines when setting up their first experiments in Fusion…
Often some of our users miss an option in Fusion QbD® that allows them to shift the gradient in parallel around the setpoint, as this is the way they want to create a robustness design.…
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