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May 2008

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Subject:
From:
Bill Sherman <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Thu, 29 May 2008 08:39:36 -0700
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I'm looking for an interpretation/discussion of the label storage conditions as found in USP "PRESERVATION, PACKAGING, STORAGE, AND LABELING" and USP &lt;1150&gt;.&nbsp; Does anyone have a reference?&nbsp; 
&nbsp;
For instance, in the EU a product meant to be stored at room temperature did not require a label.&nbsp; Does "Do not store above 25C" mean the same as "store at controlled room temperature [25C (77F) with excursions permitted from 15 to 30C (59 to 86F)"?
&nbsp;Can I apply the USP concept of 25C +/- 2C to the "Do not store above 25C"?&nbsp; &nbsp;Etc.
&nbsp;
Regards,
Bill Sherman



      

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