Table 6.

Potency of epoprostenol AM 6000–30,000 ng/mL after storage at 5°C following immediate dilution

Concentration of diluted solution	Diluent	Storage conditions	Potency, %
6000 ng/mL	SWI	24 hours at 5°C	92
		12 hours at 25°C
	SSI	24 hours at 5°C	92
		12 hours at 25°C
9000 ng/mL	SWI	7 days at 5°C	91
		12 hours at 25°C
	SSI	7 days at 5°C	87
		12 hours at 25°C
12,000 ng/mL	SWI	24 hours at 5°C	91a
		24 hours at 25°C
	SSI	24 hours at 5°C	92a
		24 hours at 25°C
30,000 ng/mL	SWI	7 days at 5°C	93
		24 hours at 25°C
	SSI	7 days at 5°C	90
		24 hours at 25°C

Notes:

^aExtrapolated data. Potency was extrapolated using data from 6,000 ng/mL.

Abbreviations: AM, arginine and mannitol; SWI, sterile water for injection; SSI, sterile saline (sodium chloride 0.9%) for injection.