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:
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.