Recovery in Three Levels of the API A′
| Surface Area of Plates Sampled: 40 cm2 | |||
|---|---|---|---|
| Amount of standard 5.70 ppm C | TOC-VCSN (ppm C) | TOC-VWP (ppm C) | HPLC (ppm API A′) |
| Sample 1 | 6.336 | 5.884 | 7.680 |
| Sample 2 | 6.436 | 5.823 | 6.410 |
| Sample 3 | 6.916 | 6.455 | 7.440 |
| Blanc filtered swab | 1.315 | 1.245 | * |
| High-purity water blank | 0.237 | 0.287 | * |
| 5.7 ppmC real | 6.306 | 5.694 | 9.890 |
| Average | 6.563 | 6.054 | 7.180 |
| RSD (%) | 4.724 | 5.758 | 9.359 |
| % recovery | 86% | 89% | 73% |
| Amount of standard 2.87 ppm C | TOC-VCSN (ppm C) | TOC-VWP (ppm C) | HPLC (ppm API A′) |
|---|---|---|---|
| Sample 1 | 2.484 | 2.441 | 1.680 |
| Sample 2 | 3.562 | 2.074 | 3.073 |
| Sample 3 | 4.061 | 3.969 | 3.332 |
| Blank filtered swab | 1.315 | 1.245 | * |
| High-purity water blanc | 0.237 | 0.287 | * |
| 2.87 ppmC real | 3.353 | 2.404 | 5.059 |
| Average | 3.369 | 2.828 | 2.694 |
| RSD (%) | 23.925 | 35.538 | 32.612 |
| %recovery | 55% | 75% | 54% |
| Amount of standard 1, 43 ppm C | TOC-VCSN (ppm C) | TOC-VWP (ppm C) | HPLC (ppm API A′) |
|---|---|---|---|
| Sample 1 | 1.655 | 1.480 | 1.495 |
| Sample 2 | 1.596 | 1.493 | 1.606 |
| Sample 3 | 1.425 | 1.371 | 1.105 |
| Blanc filtered swab | 1.315 | 1.245 | * |
| High purity water blanc | 0.199 | 0.239 | * |
| 1.43 ppmC real | 1.698 | 1.527 | 2.472 |
| Average | 1.559 | 1.448 | 1.402 |
| RSD (%) | 7.664 | 4.627 | 18.320 |
| % recovery | 16% | 16% | 57% |
| Surface Area Sampled in the Equipment: 400 cm2 | |||
|---|---|---|---|
| Amount of standard 5, 34 ppm C | TOC-VCSN (ppm C) | TOC-VWP (ppm C) | HPLC (ppm API A′) |
| Sample 1 | 5.69 | 4.96 | 18.16 |
| Sample 2 | 4.74 | 4.99 | 14.97 |
| Sample 3 | 5.90 | 5.31 | 20.34 |
| Blanc filtered swab | 1.39 | 1.30 | * |
| High purity water blanc | 0.23 | 0.28 | * |
| Average | 5.44 | 5.09 | 17.83 |
| RSD (%) | 11.41 | 10.70 | 15.12 |
| % recovery | 75% | 71% | 70% |
↵* Does not apply.