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.
