Table 3.
Osmolality results obtained at the end of the stability study of the 10 mg/mL dobutamine solution diluted in 5% dextrose or normal saline solution and stored in either cyclic-oleofin-copolymer vials or polypropylene syringes stored at ambient (+25°C/60% relative humidity), refrigerated (+5°C) or frozen (−20°C) temperatures, throughout the 12-month study period.
| Condition | Diluent | D5W | NS | ||||
| Storage temperature | +25°C/60% RH | +5°C | −20°C | +25°C/60% RH | +5°C | −20°C | |
| Upright COC vials | Time of measurement | M12 | M12 | M12 | M12 | M12 | M12 |
| Osmolality values (mOsmol/kg) | 122±1 | 121±1 | 120±0 | 121±0 | 120±0 | 119±0 | |
| Upside-down COC vials | Time of measurement | M12 | M12 | M12 | M12 | M12 | M12 |
| Osmolality values (mOsmol/kg) | 121±0 | 121±1 | 120±1 | 121±0 | 120±1 | 120±1 | |
| PP syringes | Time of measurement | M2* | M12 | M1* | M2* | M12 | M4* |
| Osmolality values (mOsmol/kg) | 134±11 | 120±1 | 124±8 | 128±8 | 120±1 | 121±4 | |
*The study was stopped once the stability of the solution had deteriorated.
COC, cyclic-oleofin-copolymer; D5W, 5% dextrose; M, month; NS, normal saline solution; PP, polypropylene; RH, relative humidity.