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Subject:
From:
"Cuk, Petra" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 22 May 2018 11:12:28 +0000
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Fiducial limits are basically confidence limits of your test, which are included in your calculation of potency.

For example:

Your potency calculated (average potency) is 1000 IU/vial
Confidence limits of assay: 96 - 103 % (criteria 95-105°)

Your fiducial limits (an interval in which exact potency results is) are:
0,96 x 1000 = 960 IU/vial
1,03 x 1000 = 1030 IU/vial

This whole interval needs to be within your specification limit. 

L

ep pozdrav/Kind regards

Petra Čuk
QC Manager





-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of vasu surepalli
Sent: Tuesday, May 22, 2018 7:25 AM
To: [log in to unmask]
Subject: [PMFLIST] Fiducial limits

Dear PMF members,

Last week  performing antibiotic assay , i have doubt on Fiducial limits.
what is the use of fiducial limits and how we calculate the fiducial https://urldefense.proofpoint.com/v2/url?u=http-3A__limits.is&d=DwIBaQ&c=ZbgFmJjg4pdtrnL2HUJUDw&r=UH-ymPWODQAXUuVVTLYKe4Prs2RIjrsVyknF_2VFFLk&m=gP1qkhako7CijJZ0k2bT_S6YqadiaWZAHk0lbwUZpAA&s=gqWkJeUBvIilfT0GvYbG26JLXAw0J-TdR6Z_QD1F9I8&e= there any reference documents please share it.
thank you for your feed back.

S vasu

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MilliporeSigma  https://urldefense.proofpoint.com/v2/url?u=http-3A__www.emdmillipore.com_&d=DwIBaQ&c=ZbgFmJjg4pdtrnL2HUJUDw&r=UH-ymPWODQAXUuVVTLYKe4Prs2RIjrsVyknF_2VFFLk&m=gP1qkhako7CijJZ0k2bT_S6YqadiaWZAHk0lbwUZpAA&s=KCcaZAYhk3ROeDgQzeDslW00kRxZrSsW-p6ds5noXYw&e=

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Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
If your company would be interested in sponsoring this community, please contact [log in to unmask]

Sartorius https://promotions.sartorius.com/real-heroes

Steris - http://www.sterislifesciences.com/

Avista Pharma Solutions  http://www.avistapharma.com

MilliporeSigma  http://www.emdmillipore.com/

Charles River Laboratories - http://www.criver.com/

Veltek Associates, Inc - http://www.sterile.com

Microbiologics, Inc. - http://www.microbiologics.com

Nelson Labs - http://www.nelsonlabs.com

BD Diagnostic Systems - http://www.bd.com/ds/

Boston Analytical http://www.bostonanalytical.com/

Associates of Cape Cod, Inc. - http://www.acciusa.com/


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The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PMF, or the sponsors of the list.

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