USP Microbial Limits Prep Test

Enigl enigl at aol.com
Tue Nov 28 09:13:17 EST 1995

In article <49f014$gef at newsbf02.news.aol.com>, dprince225 at aol.com
(DPrince225) writes:

>You have descibed a hostile product which is not supportive of microibial
>growth. In this circumstance ML testing is not required. I believe that
>this is covered in the USP ML chapter <58>? in a small paragraph

Where?  Somewhere?  There is no chapter <58>.  Do you mean if a product
passes the antimicrobial effectiveness test, chapter  <51>?

A "hostile" product?  How hostile is hostile?  Without preparatory testing
you have no scientific valid evidence and can not "prove" hostility. 
Anything required to be tested by MLT in the USP _monographs_ must be
tested. The monogra[phs are written for a reason (sometimes I wonder ;-)).
 The Prep test provides a means for  scientific validity. 

The chapter you describe <58?>?  Are you thinking of <51>?  There is
<51>(preservative testing), <61> (MLT), and <71> (sterility testing).  
Hostility must be _proven_ .  Without proof ,not running the MLT, is not
acceptable to our FDA inspectors.
Even the USP does not 100% guarantee FDA compliance because the USP is
very weak in some places. This is in many of FDA's written statements and
I agree to some extent.  Take the antimicrobial effectiveness test,Chapter
<51>  the acceptance criterium to pass is equivalent to a D-value of 112
hours for even pathogens.  Most products I've tested have a  D-value of
only 4 hours, a much more stringent criterium than the USP.  Another
example is the microbiological assay for some antibiotics that could be
tested for potency using HPLC.  But, HPLC is not approved by USP, (yet).


Dynamically Optimistic!
Davin C. Enigl
Send Internet e-mail to: enigl at aol.com
Send AOL e-mail to:  Enigl

November 28, 1995
6:58 am

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