Table 5.
Potency of epoprostenol AM 3000–30,000 ng/mL stored at 30°C following immediate dilution
| Epoprostenol AM, ng/mL | Diluent | Potency over time (hours), % | ||||
|---|---|---|---|---|---|---|
|
| ||||||
| 0 | 8 | 12 | 24 | 72 | ||
| 3000 | SWI | 100 | 86 | 79 | 58 | nd |
| SSI | 100 | 84 | 76 | 55 | nd | |
| 6000 | SWI | 100 | 92 | 88 | 77 | nd |
| SSI | 100 | 92 | 88 | 76 | nd | |
| 9000 | SWI | 100 | nd | nd | 83 | nd |
| SSI | 100 | nd | nd | 82 | nd | |
| 12,000 | SWI | 100 | nd | nd | 86 | nd |
| SSI | 100 | nd | nd | 87 | nd | |
| 30,000 | SWI | 100 | nd | nd | 93 | 81 |
| SSI | 100 | nd | nd | 92 | 79 | |
Abbreviations: AM, arginine and mannitol; SWI, sterile water for injection; SSI, saline (sodium chloride 0.9%) for injection; nd, not done.