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March 2017

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Subject:
From:
Mike Koenig <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Fri, 24 Mar 2017 14:17:40 +0000
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John, 

Unless you have a strange dosage form that is affected by cool, but not freezing temperatures, your 25/60 should cover all temperatures up to 25C. There are no chemical degradation processes that happen faster at lower temperatures.  Your cycling data covers any degradation that may be caused by variation in temperature, and those studies cover far more than the range to 15C.  

You can also remind the inspector that " excursions permitted 15C to 30C" is part of the USP definition of controlled room temperature.  

Mike



-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of McGrath, John (QA)
Sent: Friday, March 24, 2017 8:57 AM
To: [log in to unmask]
Subject: [PSDGLIST] Stability data to support excursions to 15C

Hi Stabilitarians,
We have drug product labelled per CRT : "Store at 25C excursions permitted 15C to 30C".
An inspector requested to see our stability data to support 15C.
We have stability data at 30C but not at 15C.
Our thermal cycling data (-10C) has no aging.

Has anyone else faced questions supporting 15C on product label?
Based on our 25/60 data, does Mean Kinetic Temperature idea not support "excursions 15C to 30C" or is there other guidance?
Thank You
John




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BahnsonEnvironmental Specialties - http://www.eschambers.com/
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Cincinnati Sub-Zero - http://www.cszindustrial.com/
    Provides a large selection of environmental chambers from benchtop, reach in to walk-in
    rooms along with chambers for freeze/thaw, temperature cycling applications.
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The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PSDG, or the sponsors of the list.

------------------
The PSDGList (http://microbiol.org/psdglist.htm) is operated from The Microbiology Network (http://www.microbiol.org) and supported by our sponsors as a service to the scientific community.   Please take a second to visit our sponsors' web sites and say thank you for their support of this service.


Avista Pharma Solutions - http://www.avistapharma.com/
   Comprehensive testing and CMC services organization
   Analytical and Microbiology support to early stage API and drug product development and manufacturing.


BahnsonEnvironmental Specialties - http://www.eschambers.com/
   Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
   Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration

Cincinnati Sub-Zero - http://www.cszindustrial.com/
    Provides a large selection of environmental chambers from benchtop, reach in to walk-in
    rooms along with chambers for freeze/thaw, temperature cycling applications.

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