When setting up a design in Fusion QbD we recommend to always to start the pump program with an isocratic hold time (IHT). Still many of our customers wonder why we do this.
Well one reason is of course, that one might identify better method conditions with IHT as additional study factor. But this shouldn’t be the topic today and doesn’t need further explanation for users who are familiar with Fusion QbD.
There is a different reason, especially if the development LC system is not the same as the machine where the final method will run during routine use. And this is a point many of our customers often have to struggle, as the method received from the development department or any contract lab still needs to be adapted to the LC systems used onsite in the QC labs.
I’m happy that we can now share a guidance that demonstrates how LC methods developed according to an AQbD approach can be used on different LC systems without the need of any adaptions taking into account different dwell volumes.
A good example showing the AQbD is not an additional burden, but can really facilitate the implementation and operation of analytical procedures.
Guidance: 2305_Dwell Volume
