Table 13.
Results of quality control tests of a 99mTcO4− saline solution and 99mTc-radiopharmaceuticals along with USP specifications
| Parameter | USP | Exp. 1 | Exp. 2 | Exp. 3 | Exp. 4 |
|---|---|---|---|---|---|
| pH | 4.5 to 7.5 | 7.23 | 7.16 | 6.66 | 6.58 |
| Endotoxins | <175 EU/V | <0.03 EU/mL | >0.03 EU/mL | <0.03 EU/mL | <0.03 EU/mL |
| Radionuclidic purity - non fission | 99Mo/99mTc < 0.015% | <0.015% | <0.015% | <0.015% | <0.015% |
| Other gammas/99mTc < 0.05% | <0.05% | <0.05% | <0.05% | <0.05% | |
| Aluminium | <10 ppm | <10 ppm | <10 ppm | <10 ppm | <10 ppm |
| Molybdenum | Not specified | — | 0.138 ppm | 0.020 ppm | 0.034 ppm |
| Radiochemical purity of 99mTcO4− | >95% | 99.80% | 99.90% | 99.59% | 99.52% |
| Radiochemical yield of 99mTc-radiopharmaceuticals | >90% | 99mTc-MIBI | 99mTc-ECD | 99mTc-MAG3 | 99mTc-MDP |
| 99.98% | 98.27% | 97.23% | 99.95% |