Table 3.

Preservative effectiveness testing for epoprostenol AM stored at 5°C (reduction in count^a)

Time (days)	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
	9000 ng/mL
4	>0.90 log	>0.70 log	>0.70 log	−0.12 log	0.48 log	0.00 log	>0.85 log	>0.30 log	>0.85 log	>0.70 log	0.00 log	0.00 log
7	>0.90 log	>0.70 log	>0.70 log	0.18 log	0.08 log	0.00 log	>0.85 log	>0.30 log	>0.85 log	>0.70 log	0.10 log	0.00 log
10	>0.90 log	>0.70 log	>0.70 log	>0.48 log	0.08 log	0.00 log	>0.85 log	>0.30 log	>0.85 log	>0.70 log	0.70 log	0.00 log
14	>0.90 log	>0.70 log	>0.70 log	>0.48 log	0.30 log	0.00 log	>0.85 log	>0.30 log	>0.85 log	>0.70 log	>0.70 log	0.00 log
	30,000 ng/mL
4	>0.90 log	>0.70 log	>0.70 log	0.18 log	0.78 log	0.00 log	>0.85 log	>0.30 log	>0.85 log	>0.70 log	0.40 log	0.00 log
7	>0.90 log	>0.70 log	>0.70 log	>0.48 log	0.18 log	−0.30 log	>0.85 log	>0.30 log	>0.85 log	>0.70 log	0.10 log	0.00 log
10	>0.90 log	>0.70 log	>0.70 log	>0.48 log	0.00 log	0.00 log	>0.85 log	>0.30 log	>0.85 log	>0.70 log	>0.70 log	0.00 log
14	>0.90 log	>0.70 log	>0.70 log	>0.48 log	0.08 log	0.00 log	>0.85 log	>0.30 log	>0.85 log	>0.70 log	>0.70 log	0.00 log

Notes:

^aReduction in the number of CFU relative to the initial inoculation. Negative numbers therefore 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.