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
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Best Answer
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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
Tried dissolution function but I am not getting a result for dissolved amount or % dissolved
I am getting an Amount calculated
Used and ticked Bath A
If you're getting an Amount, you're really close to getting %Dissolved too. Make sure your report is pulling in the correct field, isn't filtering stuff out or something like that. Best way to hunt down "working" fields is probably to review your way to a sample result and then right click on the table, show all and see if something resembling a % Dissolved shows up there.
If not, there's an issue w/ either naming something or not having included a claim value in sample set or processing method. Find/Correct that, reprocess and you should be good.
Hi
Thanks for comments
So before processing :
peak name of main active should be entered into component table of Bath A components exactly as in component Editor table
In this case bracket standard are named 'standards' after acquisition
Function set as inject samples at time of acquisition does not matter until you process
inj vols changed as this was a test sample set to mimic a dissolution and test dissolution option
Not got as far as looking at report yet
indeed , function type cannot be changed once data acquired but sample type can be for quantification purposes
I find the process of processing to obtain, hopefully, some results rather frustrating.. Only so many times you can click calibrate, quantitate etc to confirm result correct before hitting process otherwise reprocess and produce replicate data multiple times,, whereas ideally want see results instantaneously
Hi
Now figured out and checked dissolution option
How to calculate F1 and F2 for similarity determinations ? Custom filed or part of Dissolution option ?
Thanks ,
Was hoping was part of option
So F1and F2 require to be custom fields ? although what if dissolutions ran in different sample sets ?
I have an excel spreadsheet just wanted to avoid this process
hi are you saying f1 and f2 are calculated in dissolution option installed in empower ?so no need for custom fields above ?
Hi
Sorry , what dissolution default project ? you only have a project folder for dissolutions?
The dissolution option comes into play when creating a sample set from wizard and 'compute dissolution function at the end of sample set when ready to process,,, , no a default project ,,sorry if I'm missing something here
thanks for info
how would samples be labelled for quantification
AU0101 - AU0106 say for bath A (Timepoint 1 for example)
BU0101 - BU0106 say for bath B (Timepoint 1 for example)
Calibrate S01* S02* Quantitate AU01* BU01* (if by timepoint)
And compute dissolution at the end of sample set containing both dissolution baths A and B