March 2017


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"Capucao, Jing [MCCUS]" <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Fri, 17 Mar 2017 14:46:03 +0000
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Dear Folks,
This should be an easy one so please let me know your thoughts!

If you have acceptance criteria or specifications that are not indicated as either "for release only" or "for stability only", for example:

Active Assay: 90.0-110.0%
Unspecified Degradation Products: Not More Than 0.2%
Moisture: Maximum 5%

Do the specifications apply:

A: for both release and stability?
B: for stability only?
C: other, please specify...

Thank you in advance for your responses!

Jing Capucao, Ph. D.
R&D Stability Manager
Johnson & Johnson Consumer Inc.
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