Empower dissolution option
Hi ,
I understand for dissolution option you need to set up sample set method and click dissolution (Bath A) (not ticking 2690D installed)
This then goes through bath A set up and input volumes , timepoints etc and then sample set has columns Bath , vessel and transfer time added along with function 'Compute Dissolution'
Can this dissolution option be used to calculate dissolution mass and volume correction ?
Volume correction (change dilution by amount removed) is simple enough but struggling to see how dissolution option works (is it only for reporting/ profiling dissolution Bath A and F1 f2 similarity factors ?
Thanks
0
Best Answer

Hi Thought I had posted this previously, but Yes, the Dissolution option does calculate either taking into account volume removed or it can be assumed you replaced the removed media. It summarizes by vessel, draws plots of % Dissolved etc as well as Q Factor calculations0
Answers
Thanks
Do how do I perform quantification of a dissolution using this option when formula :
Ri (%) = {Ci x (750 ((i 1)x 2))}+ Ệ(Sum of) {C_a.n)x2}}/LC
ie Bringing in concentration from previous timepoint
I have this working in excel for no correction , volume and mass and volume correction so assuming work required here on a custom field perhaps ?
Hi ,
I now have Empower calculating for Dissolution amount and dissolved % for mass and volume correction
I am assuming bath , vessel and transfer time are only for report and profiling?
Hi ,
Does the Dissolution function /option require in house validation ?
Is it GAMP software or can you use it 'from the box as it were?
Of course, Waters do testing to see it works as 'we' intend it to work, but we might be coming at it from different requirements to you.
Thanks
Is verifying results versus validated spreadsheet to a number of decimal places sufficient ?
Understood ,, though essentially checking versus excel spreadsheet the standard approach
For Empower set up do you have a specific folder for custom fields and test data ?
Can all custom fields be checked at the same time /protocol and close change control?
Thanks