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October 1999

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Subject:
From:
Anthony Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Mon, 11 Oct 1999 11:54:50 -0400
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During product development the robustness of the preservative is demonstrated at 100, 75 and 50% of label claim.

Batches on stability are subject to AET with in the shelf specification not at the highest concentration.

Tony Cundell
wyeth-ayerst

>>> <[log in to unmask]> 10/10 10:42 PM >>>
When conducting the B&F test, are folks typically using product with the
highest labeled concentration of the preservative or simply testing the
product at whatever preservative level it may have, e.g., midpoint of the
labeled range?  Has FDA told anyone that they must conduct the B&F test at
the highest labeled preservative concentration?

Richard Prince
[log in to unmask] 


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