# Content uniformity

how create a custom field to calculate content uniformity(

give me details about the formula and the parameters of the CF .

M=X̅ if 98.5%≤ X̅≥101.5%

M= 98.5% if X̅<98.5%

M= 101.5% if X̅>101.5%

for 10 tablets

**Acceptance value**) in EMPOWER3?give me details about the formula and the parameters of the CF .

M=X̅ if 98.5%≤ X̅≥101.5%

M= 98.5% if X̅<98.5%

M= 101.5% if X̅>101.5%

for 10 tablets

0

## Comments

You'll need a few different fields:

Field 1, sample field for data entry of label claim...let's call it "LabelClaim"

Field 2, "%LabelClaim" this is a calculated peak field with the formula: Amount/LabelClaim*100

Field 3, this becomes a messy field to do it all at once, so here goes without any testing to confirm:

ABS(98.5*LT(ROUND(SAME…AVE(%LabelClaim), -1), 98.5)+ 101.5* GT(ROUND(SAME…AVE(%LabelClaim), -1), 101.5)+ SAME…AVE(%LabelClaim)*GTE(ROUND(SAME…AVE(%LabelClaim), -1), 98.5)*LTE(ROUND(SAME…AVE(%LabelClaim), -1), 101.5)- SAME…AVE(%LabelClaim))+(2.4* %RSD(SAME…AVE(%LabelClaim))*SAME…AVE(%LabelClaim)/100)

I don't see a standard deviation summary function in Empower, so I've gotten around that with taking the %RSD and back-calculating the standard deviation.

where in this case n=10

If further evaluation required where n=30 CF does get complicated

If amount quantified in empower then CF required will be mean , stdev and CU for n=10, then create a CF for AV= CU_10+2.4*Std_Dev

with labels for sample are the same

mean = SAME.1..AVE(amount)

Std_dev = %rsd*mean (as above)

Above formula will work but breaking this down makes testing some what simpler

ie

ABS(98.5*LT(mean,98.5)+101.5*GT(mean,101.5)+mean*GTE(mean,98.5)*LTE(mean,101.5)-mean

check out Informs 2017 app . this also gives information on CF for 10 and 30 tablets

This is relatively easy to accomplish.

Break it down so you have a CF for every value you need to calculate.

Acceptance Value then becomes: ABS(M-Average_LC)+(K_Value*STDEV_LC)

Your n=10 or n=30 can then become: ENUM((EQ(Stage,1)<(Acceptance_Value,15.0)), (EQ(Stage,2)<(Acceptance_Value,15.0)&RANGE(Average_LC,0.75*M,1.25*M)), (EQ(Stage,1)>(Acceptance_Value,15.0)), (EQ(Stage,2)>(Acceptance_Value,15.0)), (EQ(Stage,2)<(Average_LC,0.75*M)|EQ(Stage,2)>(Average_LC,1.25*M)))

The translations on the ENUM field above are a simple pass / pass / fail. test 20 more / fail / fail.

Works like a treat

I've always taken the approach not to validate the logic, but verify the individual parameters and the end result.

When I developed the code I was able to find a stage 1 pass, stage 1 fail, stage 2 pass, and stage 2 fail. Historical data was able to help me find results that were borderline for stage 1 and 2 to use in testing.

The code I posted was written quite a while ago. There may be more elegant ways to tackle this now. However, if its not broken, then don't fix it!

shaunwat ,

indeed no need to refine this if CF works as is

on that note if n=10 fails (one sample set) then a further n=20 is tested (second sample set) I guess the only option is to 'process only sample set ' to evaluate AV for n=30 for L2 = 25.0 ?

Hi ydan,

Yes, that is correct. If you generate a failure at n=10 and need to test more, then the only option to generate the correct n=30 data is to combine the two sample sets into a process only sample set.

Yes, as I believe you can gather I used very little nested functions in my approach. I seen examples online in various forums where people have tried to do this using a single custom field. That is a recipe for disaster in my opinion.

However, it would have been good to have a short cut / cheat / example to follow when I originally did this. I believe I first developed this approach back in 2013-2014, which was around the same time that I tackled dissolution calculations without the dissolution option (that was a fun exercise!).

USP_AV: ABS(-1*Ave_PercentClaim+M)+k*SD

L2Range: GTE(PercentClaim,(0.75*M))<E(PercentClaim,(1.25*M))

this is a calculated boolean where 0 translates to Outside L2 (25) Range and 1 translates to Within L2 (25) Range (so it's telling you whether there's any point to trying 20 more units if AV>15)

M: GT(AVE_PercentClaim,101.5)*101.5+LT(AVE_PercentClaim,98.5)*98.5+RANGE(AVE_PercentClaim, 98.5, 101.5)*AVE_PercentClaim

SD: SAME.%..%RSD(PercentClaim)*Ave_PercentClaim/100

k: boolean function that defaults to 0 (which translates to 2.4, and 1 translates to 2)

I'll assume users of this will already have appropriate dependent CFs corresponding to PercentClaim, AVE_PercentClaim etc.

so for validation check AV value to say 14DP ?

then logic been Pass L1, Test 20 units ,Pass L2,Fail L2, failed

CU can be reduced to 6 CF and not 21 as shown in document

The main frustration here is that you have to process results to retrieve CF results

agreed , but to show comparison to excel Empower sample set (once dilution manipulated to achaive required mean result) needs to be processed

So to test all five logics (or 6 if n=10 or n=30 fo rsome reason) then 6 results sets are required (sample set as a cf test run)