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

Best Answer

  • Accepted 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 calculations

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 ?


  • Compute dissolution algorithm - try entering that into Empower's help dialog to see how it's done (disso option not required).
  • 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?

  • edited March 8
    Just like any Empower calculation, you need to see it it works as you hope it will work. I call that "validation".

    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 ?

  • ydan1977 said:

    Thanks

    Is verifying results versus validated spreadsheet to a number of decimal places sufficient ?

    That is a function of your internal SOPs and validation protocol(s).
  • 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


  • You don't have to use Excel to check that Empower calculates a custom field correctly. I use an online calculator set to the max precision of the Empower calculation eg A.%..AVE(Area) I would plug in the FULL value of each area from the samples labelled as A and divide by the total number of injections to get the exact same value as Empower. There is no reason not to test multiple CFs with the same result or result set, it depends on your own internal SOPs for this though. 
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