From: Good practices for the automated production of 18F-SiFA radiopharmaceuticals
Test | Specifications | Results | Method |
---|---|---|---|
Appearance | Clear, colorless, no particles | Pass | Visual inspection |
Radiochemical purity | ≥ 95% | 97 ± 0.9% | HPLCa |
Chemical purity | ≤ 5.7 µg/ml | 2.1 ± 1.6 µg/ml | HPLCa |
Identity | 0.93–1.07 RRTb | 0.97 ± 0.01 | HPLCa |
Residual solvents | ≤ 10% (v/v) EtOH ≤ 410 ppm MeCN | 5.8 ± 0.7% 29 ± 6 ppm | GCc |
Half life | 99–120 min | 110 ± 1.32 min | Dose calibrator |
Radionuclide identity | 511 keV | Pass | Gamma spectrometry |
Radionuclide purity | ≥ 99.9% | Pass | Gamma spectrometry |
pH | 5–7 | 6.2 ± 0.2 | pH meter |
Kryptofix K222 | ≤ 733 µg/ml | Pass | Colorimetric spot test |
Endotoxins | ≤ 10 EU/ml | Pass | LAL testd |
Sterility | Sterile | Sterile | Membrane filtration |
Filter integrity | ≥ 3.3 bar | Pass | Bubble point test |