Back to the Top
Hello,
Can the diluted working standard (reference standard) be used to
prepare the CC and QC standards during the bioequivalence study?
Is there any specification regardind the potency/purity of the working
standard, like it should be minimum 90% pure etc.?
please provide valuable comments.
Regards,
Back to the Top
The following message was posted to: PharmPK
Hi debbie
Yes, you can use the working standard for the preparation of CC and QC
standard during bioequivalence study.
It is always better to use high grade purity standard.
Hope it will help you.
regards
laxman kaswan
Back to the Top
The following message was posted to: PharmPK
It is best to use a second preparation as a check against your first
preparation. Otherwise yo may get an unpleasant surprise when you do
finally make a second prepartion later in the life of the assay.
You should, must have an SOP describing this beforehand. 90% is a
good target, 95% is better, what has your manufacturing, regulatory
agreed to to get the expected/required efficacy?
Back to the Top
The following message was posted to: PharmPK
Hello,
Yes, you can use the diluted Reference Standard for CC and QC sample
for BE study but before that ypu should do stability testing for the
diluted RS from period of time.
Thx
Rgds,
Lovi
Back to the Top
The following message was posted to: PharmPK
What will you use for the stability sample if the QC and CC are prepared
from the same diluted reference? The easy way is not always the best
way
Want to post a follow-up message on this topic?
If this link does not work with your browser send a follow-up message to PharmPK@boomer.org with "Working standard" as the subject | Support PharmPK by using the |
Copyright 1995-2011 David W. A. Bourne (david@boomer.org)