Table 3. Specified impurity analysis of compounded 17-hydroxyprogesterone caproate (17-OHPC).
| No. | Conc. of CA (μg/mL) |
CA/17-OHPC ratio (%) |
Conc. of 17-OHP (μg/mL) |
17-OHP/17-OHPC ratio (%) |
|---|---|---|---|---|
| 1 | 30 | 0.012 | 242 | 0.10 |
| 2 | 0 | 0 | 99.8 | 0.04 |
| 3 | 0 | 0 | 99.0 | 0.04 |
| 4 | 0 | 0 | 107 | 0.04 |
| 5 | 30 | 0.012 | 179 | 0.07 |
| 6 | 0 | 0 | 49.5 | 0.02 |
| 7 | 0 | 0 | 52.0 | 0.02 |
| 8 | 50 | 0.020 | 53.2 | 0.02 |
| 9 | 0 | 0 | 0 | 0 |
| 10 | 0 | 0 | 0 | 0 |
| 11 | 30 | 0.012 | 47.3 | 0.02 |
| 12 | 0 | 0 | 96.2 | 0.04 |
| 13 | 0 | 0 | 152 | 0.06 |
| 14 | 0 | 0 | 51.9 | 0.02 |
| 15 | 0 | 0 | 52.4 | 0.02 |
| 16 | 0 | 0 | 48.4 | 0.02 |
| 17 | 0 | 0 | 0 | 0 |
| 18 | 0 | 0 | 0 | 0 |
| Mean ± SD | 7.8 ± 15.6 | 0.003 ± 0.006 | 73.8 ± 65.9 | 0.03 ± 0.03 |
| 90%CI | 1.4 – 14.2 | 0.001 – 0.005 | 46.8 – 101 | 0.02 – 0.04 |
CA= caproic acid, 17-OHP= 17 hydroxyprogesterone
Caproic acid (CA) measured at 208 nm and 17-OHP measured at 242 nm using standard curves generated with corresponding standards.