|
Results and Quality Control
|
|---|
|
Overall productions
|
243
|
|
Successful productions
|
240 (98.8%)
|
|
Failed productions
|
3* (1.2%)
|
|
Productions with minor deviation from specification
|
4** (1.6%)
|
|
Radiochemical Yield [%]
|
49.2 ± 8.6
|
|
Product Activity [GBq]
|
43.6 ± 9.3
|
|
Molar Activity [GBq/μmol]
|
290.9 ± 62.1
|
|
Volume [mL]
|
17.7 ± 1.2
|
|
Radioactive Concentration [MBq/mL]
|
2410.2 ± 472.9
|
|
Radiochemical Purity by HPLC [%]
|
99.94 ± 0.23
|
|
Radiochemical Purity by TLC [%]
|
97.84 ± 0.95
|
|
Residual Solvents
| |
|
Ethanol [mg/mL]
|
52.0 ± 10.0
|
|
Acetonitrile [μg/mL]
|
40.1 ± 21.6
|
|
DMSO [μg/mL]
|
130.7 ± 79.3
|
|
Kryptofix® (< 50 μg/mL)
|
below limit
|
|
Endotoxins [EU/mL]
|
< 2.5
|
|
Sterility
|
passed
|
- *RCP < 90% by radio-TLC (n = 2); technical problem of the dispenser (n = 1)
- **RCP = 93.1–94.3% by radio-TLC; specification: RCP ≥ 95.0%; batches were released
