Abstract
In 1975 the USP test for assessing the efficacy of preservatives was modified. Of major significance was the change in the temperature at which the killing rate was assessed (from 32 °C to the storage temperature specified on the label, or at 20 to 25 °C if no storage temperature is specified). For most of Connaught’s products the specified storage temperature is 2–8 °C. After July 1, 1975 all microbiological efficacy testing was performed on inoculated samples that were stored at about 4 °C. The results are presented as days required to attain at least 99.9% reduction in the number of viable lest organisms in the inoculated samples and indicate that preservative efficacy decreases when storage temperature is lowered from 32 to 4 °C. In two products the preservative was found not satisfactory when tested by the USP XIX method and a change of preservative was recommended.
- Received April 14, 1980.
- Accepted August 1, 1980.
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