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April 2015

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Subject:
From:
"Forenzo, Patrick" <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Wed, 1 Apr 2015 11:47:52 +0000
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Can anyone share their program for in use test of solids in multiple use packs (ie HDPE bottles containing 30 units)- there is no clear guidance on how to perform the test and I am looking for some sort of industry standard companies are using- for example remove 1 tablet a day for 20 days (leaving 10 tablets in the bottle) , store for an additional 10 days opening the bottle once a day- (total test time 30 days) and then test the remaining samples or remove 1 tablet a day from bottle a and move into bottle b (empty) until all 30 units have been moved from bottle a to bottle b- perform the testing on the units in bottle b


Patrick Forenzo
Senior Fellow / Stability Expert
Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover, NJ 07936-1080
USA

Phone     +1  862 7786690
Cell        + 1  201 7047992
Fax         +1  973 7812019
[log in to unmask]<mailto:[log in to unmask]>
www.novartis.com<http://www.novartis.com/>



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