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. 2012 Mar 28;6:61–70. doi: 10.2147/DDDT.S29916

Table 2.

Preservative effectiveness testing for epoprostenol AM stored at 25°C (reduction in counta)

Time (hours) Sterile water for injection Sterile saline (sodium chloride 0.9%) for injection


S. aureus P. aeruginosa E. coli C. albicans A. niger C. sporogenes S. aureus P. aeruginosa E. coli C. albicans A. niger C. sporogenes
3000 ng/mL
12 0.48 log >0.60 log 0.55 log −0.25 log −0.18 log >0.30 log >0.60 log >0.48 log >0.90 log 0.18 log −0.40 log 0.30 log
24 >0.48 log >0.60 log 0.85 log −0.10 log −0.40 log 0.30 log >0.60 log >0.48 log >0.90 log 0.18 log −0.40 log >0.30 log
36 >0.48 log >0.60 log 0.85 log 0.60 log 0.00 log 0.30 log >0.60 log >0.48 log >0.90 log 0.48 log 0.30 log −0.18 log
48 >0.48 log >0.60 log 0.85 log 0.00 log −0.30 log 0.30 log >0.60 log >0.48 log >0.90 log 0.48 log 0.30 log 0.30 log
6000 ng/mL
12 >0.48 log >0.60 log 0.85 log 0.12 log −0.18 log >0.30 log >0.60 log >0.48 log >0.90 log 0.18 log 0.30 log −0.18 log
24 >0.48 log >0.60 log >0.85 log 0.12 log 0.30 log 0.00 log >0.60 log >0.48 log >0.90 log 0.18 log 0.30 log 0.30 log
36 >0.48 log >0.60 log >0.85 log >0.60 log 0.30 log 0.30 log >0.60 log >0.48 log >0.90 log 0.18 log >0.30 log 0.30 log
48 >0.48 log >0.60 log >0.85 log 0.12 log 0.00 log >0.30 log >0.60 log >0.48 log >0.90 log 0.48 log >0.30 log 0.30 log
15,000 ng/mL
24 0.3 log 1.3 log 0.6 log 0.1 log 0.00 log nd >0.9 log >1 log >1 log 0.2 log 0.00 log nd
48 1.0 log >1 log 1.0 log 0.7 log 0.00 log nd >1 log >1 log >1 log 0.2 log 0.00 log nd
72 >1 log >1 log >1 log >1 log 0.00 log nd >1 log >1 log >1 log 0.5 log 0.00 log nd
96 >1 log >1 log >1 log >1 log 0.00 log nd >1 log >1 log >1 log 0.8 log 0.00 log nd
30,000 ng/mL
24 >0.48 log >0.60 log >0.85 log >0.60 log 0.00 log 0.30 log >0.60 log >0.48 log >0.90 log 0.48 log 0.00 log 0.30 log
48 >0.48 log >0.60 log >0.85 log >0.60 log 0.00 log 0.30 log >0.60 log >0.48 log >0.90 log >0.48 log 0.30 log >0.30 log
72 >0.48 log >0.60 log >0.85 log >0.60 log −0.30 log >0.30 log >0.60 log >0.48 log >0.90 log >0.48 log 0.00 log >0.30 log
96 >0.48 log >0.60 log >0.85 log >0.60 log −0.18 log >0.30 log >0.60 log >0.48 log >0.90 log >0.48 log −0.18 log >0.30 log

Notes:

a

Reduction in the number of CFU relative to the initial inoculation. Negative numbers indicate an increase in CFU over the initial inoculum. ‘No increase’ was defined as no increase in CFU > 0.5 log10.

Abbreviations: AM, arginine and mannitol; CFU, colony-forming units; nd, not done.