RT Journal Article
SR Electronic
T1 The Efficacy of Antimicrobial Agents in Parenteral Products Assessed by the USP XIX Method Compared to the USP XVIII Method
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 431
OP 435
VO 34
IS 6
A1 Tan, Tjeng Giok
A1 Wilson, Raymond Charles
YR 1980
UL http://journal.pda.org/content/34/6/431.abstract
AB 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.