Table 2. Microbiological and endotoxin assessment of different formulations of 17-OHPC.
Sample No. | Sterility | Bacterial endotoxin, EU/mL(< 300IU/ml) |
---|---|---|
1 | Pass | NA* |
2 | Pass | 11.22 |
3 | Pass | <1 |
4 | Pass | 0.02 |
5 | NA* | NA* |
6 | Pass | 0.06 |
7 | Pass | <1 |
8 | Pass | <1 |
9 | Pass | 0.006 |
10 | Pass | <1 |
11 | Pass | 0.005 |
12 | Pass | <1 |
13 | Pass | 0.078 |
14 | Pass | <1 |
15 | Pass | 0.013 |
16 | Pass | <1 |
17 | Pass | <1 |
18 | Pass | <1 |
Testing not done because of limited sample volume (<1 mL).
Sterility testing carried out over 14 day time period