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July 2010

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Subject:
From:
Mark Schreiber <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Wed, 14 Jul 2010 12:20:18 +0200
Content-Type:
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Dear Stabilitarians,

It is quite clear in the USP how to handle temperature excursions for 
Controlled Room Temperature, as an example.
However, I have found no mention any place about humidity excursions.  I 
would like to know if anyone out there has justified humidity excursions 
for their products.  If so, what has been used for extent of the excursion 
(%RH and time).  What data was used to justify this?

Many thanks.

Mark A. Schreiber, Ph.D.
Sr. Manager Pharma Analytics
===============================================================
BIOTRONIK AG
Ackerstr. 6 
8180 Bülach, Switzerland
Phone: +41 44 864 5306
Mobile: +41 79 786 0602
Fax:     +41 44 864 5353
Mail: [log in to unmask]
 

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