Table 1.
Recovery Study.
| Analyst | Assay | Instrument | Potency (×105 IU/mg) |
||||
|---|---|---|---|---|---|---|---|
| 130% | 115% | 100% | 85% | 70% | |||
| 1 | 1 | 1 | 7.7852 | 6.7764 | 5.5017 | 4.9011 | 4.0139 |
| 2 | 2 | 7.1465 | 6.2950 | 5.8276 | 4.7577 | 3.9402 | |
| 3 | 1 | 7.4216 | 6.5590 | 6.0203 | 4.9451 | 4.1253 | |
| 4 | 2 | 7.2003 | 6.4968 | 5.7958 | 4.7743 | 4.0228 | |
| 5 | 1 | 7.9173 | 6.5266 | 5.6373 | 4.7727 | 3.8350 | |
| 6 | 2 | 7.4679 | 6.5898 | 5.8274 | 4.9749 | 4.1294 | |
| 7 | 1 | 7.4625 | 6.6443 | 5.5970 | 4.9066 | 3.9890 | |
| 8 | 2 | 7.2515 | 6.4691 | 5.6157 | 4.7409 | 3.9496 | |
| 2 | 1 | 1 | 7.8943 | 6.7825 | 5.9011 | 4.9491 | 4.1017 |
| 2 | 2 | 7.4888 | 6.7419 | 5.7973 | 5.0416 | 4.2560 | |
| 3 | 1 | 7.5383 | 6.6131 | 5.7356 | 4.9065 | 4.2273 | |
| 4 | 2 | 7.2667 | 6.5035 | 5.6728 | 4.8413 | 3.9851 | |
| 5 | 1 | 7.3138 | 6.5463 | 5.5661 | 4.8144 | 3.8874 | |
| 6 | 2 | 7.3360 | 6.5947 | 5.7450 | 4.8699 | 4.1428 | |
| 7 | 1 | 7.3950 | 6.5971 | 5.5998 | 4.9234 | 4.0717 | |
| 8 | 2 | 7.3723 | 6.6256 | 5.4948 | 4.9459 | 4.0338 | |
| 3 | 1 | 1 | 7.8821 | 6.6256 | 5.6538 | 4.9285 | 3.9420 |
| 2 | 2 | 7.4389 | 6.4214 | 5.6608 | 4.8478 | 4.0973 | |
| 3 | 1 | 7.0796 | 6.3387 | 5.5095 | 4.7300 | 3.8839 | |
| 4 | 2 | 7.1578 | 6.2747 | 5.6356 | 4.8739 | 4.0319 | |
| 5 | 1 | 7.4217 | 6.6921 | 5.5307 | 4.7184 | 4.0109 | |
| 6 | 2 | 7.8395 | 6.9471 | 5.9129 | 5.0263 | 4.2174 | |
| 7 | 1 | 6.8343 | 6.4052 | 5.2345 | 4.4942 | 3.8723 | |
| 8 | 2 | 6.9902 | 6.4778 | 5.3741 | 4.6322 | 3.9826 | |
| Mean Potency | 7.41 | 6.56 | 5.66 | 4.85 | 4.03 | ||
| Expected Potency | 7.54 | 6.67 | 5.8 | 4.93 | 4.06 | ||
| Standard Deviation | 0.29 | 0.16 | 0.18 | 0.13 | 0.11 | ||
| Relative Standard Deviation (%) | 4 | 2 | 3 | 3 | 3 | ||
| Mean Recovery (%) | 98 | 98 | 98 | 98 | 99 | ||
The recovery study was performed by three analysts using two instruments over 8 independent assays. All results are reported from valid assays that passed all system suitability criteria.