Empower dissolution option

ydan1977

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

HeatherLongden

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

ydan1977

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 ?

Dan_Ramlose

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

ydan1977

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?

ydan1977

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?

HeatherLongden

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.

ydan1977

Thanks

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

Dan_Ramlose

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).

ydan1977

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

Empower2018

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. 

ydan1977

Hi .

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

Dan_Ramlose

double check that you have standard values and claim values in your component table (right click on sample set, alter sample, Amounts button), make sure that the component name spellings match in your component table and in your processing method. Also - (too late for this run) - all standard injections should say "inject standard" under function. Controls should say "inject control" under function. Your injection volumes appear to vary... seems odd.
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.

Empower2018

I think if you forget to assign a standard as Inject Standards or a sample as Inject Unknowns you can change this in Alter Sample under Sample Type field- change to standard or unknown or control as required. 

EmpAdm

Check your component name in three areas; processing method, amout table (component editor) and from alter sampe => edit => Dissolution...all names should match.

ydan1977

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

Dan_Ramlose

I don't think it will let you change function after data has been acquired.

ydan1977

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

Empower2018

Can you not change your run mode then to run and process or run and report? That way samples are acquired, processed and reported at the same time. That only works for some companies though. I wouldn't do it unless your molecule was very predictable with little changes between runs.

ydan1977

Not in GMP environment and current data integrity - unless as you say very confident of system and historically little change . Although standards, components weights multiplier etc required first. A lot of planning for run and report

ydan1977

Hi

Now figured out and checked dissolution option

How to calculate F1 and F2 for similarity determinations ? Custom filed or part of Dissolution option ?

Dan_Ramlose

Not part of the dissolution option. As this does not come up frequently for my work, I've always been inclined to do it in Excel, using the CDS output as a starting point.

ydan1977

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

EmpAdm

See screenshots, I'm not using them, on queue for testing.

Neil

Hello - F1 and F2 are calculated with custom fields provided within the Dissolution Default project. And there are nested custom fields in those calculations.　

ydan1977

Hi 
hi are you saying f1 and f2 are calculated in dissolution option installed in empower ?so no need for custom fields above ?

EmpAdm

No ydan1977, Neil is talking about the available custom fields on the Dissolution default project.

ydan1977

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

EmpAdm

See attached Custom Field Tab from the Dissolution Default Project.

ydan1977

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

Dan_Ramlose

My mistake. Thanks for showing me that! I never spotted a disso default project when I managed a system w/ that option.