Table 5 Specifications for quality control of a novel RP: exemplified acceptance criteria and methods
Test | Acceptance criteria | Method reference |
|---|---|---|
Appearance | Free from particle | Visual |
pH | 4.5–8 | pH indicator paper |
Radiochemical identity | Co-elution with unlabelled reference | LC |
Radiochemical purity | > 95% | LC with radio detector |
Radionuclide purity | > 99.9% | Gamma spectrometry |
Chemical amount of UV-absorbing impurities a | The mass does not exceed 10 µg per injected dose | LC |
Residual solvents DMSO | Not more than 5000 ppm | LC |
Acetonitrile | Not more than 410 ppm | GC |
Ethanol content | Not more than 10% | GC |
Sterility | Sterile | Ph Eur |