Forecasted Ethanol/Water Simulants and Polarities of Drug Products
| Drug Matrix | Proportion | Measured DEHP Level (mg/L) | Ethanol/Water Simulant | Polarity |
|---|---|---|---|---|
| Lipid Emulsion | 5% | 1090 | 58/42 | 21.8 |
| 10% | 2493 | 63/37 | 21.2 | |
| 20% | 2697 | 64/36 | 21.1 | |
| Albumin1 | 5% | 16.3 | 38/62 | 23.8 |
| 20% | 35.3 | 41/59 | 23.6 | |
| 25% | 9.6 | 36/64 | 24.0 | |
| Polysorbate 80 | 0.2% | 9.6 | 36/64 | 24.0 |
| 1% | 210 | 49/51 | 22.8 | |
| 5% | 1910 | 61/39 | 21.4 | |
| Blood and Blood Fractions | N/A | 100 | 46/54 | 23.2 |
Note:
↵1 The mean ethanol/water stimulant for albumin in the range of 5% to 25% is 39/61 and the mean polarity is 23.8.