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May 2008

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Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Thu, 29 May 2008 06:54:55 -0500
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Good Morning,

May I ask for your thoughts on extending the shelf life on an API that is not in its original container. A little background, we package our finished product API in 500 kg supersacks. A stability study was conducted for only three years and we are looking to extend the shelf life to 5 years. The stability study was initially conducted 6 years ago. We do retain finished product samples, however they are not kept under chamber conditions.
So, we went back and tested the original finished product retain samples, produced 6 years ago and the results were well within specification and followed the trend of existing stability data. Therefore, my question is, would this data be sufficient to extend shelf life or not?
Our stability team is divided on the interpretation of ICHQ7.

I look forward to your comments.

Best Regards,

Stephanie Stegall
Project Chemist
Cargill Health & Nutrition
1 Cargill Dr.
Eddyville, IA 52553
641.969.3520 direct
641.969.7796 fax
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