Preserv. Effect. Testing

rkirsch2 at ix.netcom.com rkirsch2 at ix.netcom.com
Wed Apr 17 07:09:05 EST 1996


Does anyone have any expeience with refrigerated parenteral products 
and use of the USP or other Preservative Effectiveness Test.

	If the label specifies product refrigeration between 2 and 8 degC, 
must a standard PET be performed, seeing that many organisms that are 
usually of concern at room temp. cannot grow at the lower storage 
condition? The USP only seems to address materials stored at room 
temperature. If the test needs to be performed, how should it be done? 
Thanks.



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