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October 1998


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The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Fri, 2 Oct 1998 00:02:55 -0400
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We don't work with cyclosporins but ran into a similar problem with Bacillus
subtillis and a quinolone.  The R&D group had determined that MIC (Minimum
Inhibitory Concentration) was extremly low. We used that to justify using
another gram positive organism in our method validation. (this was before
the current changes to the USP).

At 01:16 PM 9/24/98 -0700, Ambrus_Kate wrote:
>I wanted to know if anyone has encountered problems doing growth
>promotion (for sterility testing) on cyclosporin and A. niger. And how
>did you handle it? We have observed in the past that A. niger cannot be
>recovered in low numbers in the presence of cyclosporin. But now that it
>has been added to the required growth promotion list of organisms, we
>need to do something to overcome it. We have tried dilutions of up to
>1:1000 in Thio and TSB, but obtained no growth.
>Thank you,
>Kate S. Ambrus
>The PMFList ( is operated from
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Betty Darner
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