Table 1:
Quality Control Results
| QUALITY CONTROL TEST | REQUIREMENT FOR PASS | QUAL RUN 1 | QUAL RUN 2 | QUAL RUN 3 |
|---|---|---|---|---|
| Appearance | Clear, colorless, no particulates | Clear, colorless, no particulates | Clear, colorless, no particulates | Clear, colorless, no particulates |
| Filter Integrity | Pass | Pass | Pass | Pass |
| pH | 4 – 7 | 5.0 | 5.0 | 5.0 |
| Molar Activity | ≥ 18.5 GBq/μmol (≥ 500 Ci/mmol) | 409.7 GBq/μmol (11073 Ci/mmol) | 375.3 GBq/μmol (10144 Ci/mmol) | 299.0 GBq/μmol (8081 Ci/mmol) |
| Radiochemical Purity (%) (HPLC) | ≥ 90% | 99.70 % | 99.71 % | 99.74 % |
| Maximum Dose Volume based on Chemical Impurities | ≤ 50 μg Total Chemical Impurities | > 11 mL (Whole dose may be injected) | > 11 mL (Whole dose may be injected) | > 11 mL (Whole dose may be injected) |
| Maximum Dose Volume based on MH.MZ Cold Mass | ≤10 μg of MH.MZ | > 11 mL (Whole dose may be injected) | 10.66 mL | 9.04 mL |
| Radiochemical Identity Relative Retention Time from Reference Std) by HPLC | 0.9 – 1.1 | 0.9588 | 0.9765 | 0.9834 |
| Residual Acetonitrile Level | ≤ 410 ppm | 151.43 ppm | 124.21 ppm | 139.45 ppm |
| Residual DMSO Level, ppm | ≤ 5000 ppm | 0.00 ppm | 0.00 ppm | 0.00 ppm |
| Residual Methanol Level | ≤ 3000 ppm | 0.00 ppm | 0.00 ppm | 0.00 ppm |
| Kryptofix-222 Level | < 50 μg/mL | < 50 μg/mL | < 50 μg/mL | < 50 μg/mL |
| Bacterial Endotoxin Levels (EU/mL) | < 8.75 EU/mL | <1.00 EU/mL | <1.00 EU/mL | <1.35 EU/mL |
| Radionuclidic Identity (t1/2) | 105 – 115 min | 111.35 min | 105.07 min | 109.90 min |
| Sterility (Observed growth after 14 d) | No Growth | No Growth | No Growth | No Growth |
| Starting Activity | Not Specified | 102.7 GBq (2775 mCi) |
120.7 GBq (3262 mCi) |
103.6 GBq (2801 mCi) |
| Amount of Product | Not Specified | 6416 MBq (173.4 mCi) |
8261 MBq (223.3 mCi) |
8214 MBq (222.0 mCi) |
| Activity Yield (Non-corrected) | Not Specified | 6.25 % | 6.85 % | 7.93 % |