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May 2011


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Connie Hillenbrand <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Mon, 2 May 2011 13:24:40 -0400
text/plain (59 lines)
Dear Forum Members,
Could you tell me if you know of any reason that the use of Letheen as a neutralizer would interfere with Suitability recovery in USP <62> Bile Tolerant Gram Negative Bacteria testing using E. coli as the indicator organism?
We have had difficulty with this test over the course of various product Suitabilities using dilutions up to 1:100 by Membrane Filtration, so it does not seem to be related to the material under test. The most confusing aspect for me is that we have no difficulty recovering E. coli under its specific test method. 
We do not do this testing in-house but utilize the services of a contract lab for Microbiological testing, so I am not familiar with every detail of the testing. If anyone else has had these difficulties or know of anything that might be inhibiting growth, could you please let me know?
Thank you for your assistance.
Connie Hillenbrand

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