Quality control
Which release tests apply to which tracer, and what equipment each test needs. Monograph numbers are references only — the texts are copyrighted and are not reproduced. How the derived entries work
Of 309 entries, 15 rest on a monograph and 279 carry at least one preliminary mark.
Taken from a pharmacopoeial monograph, cited by number
Derived from what the published synthesis states
Preliminary — inferred from compound class and isotope, not yet from data
Rows with an amber edge carry at least one preliminary mark: the test set was inferred from the compound class and isotope, not from a monograph or from what a paper states about the synthesis. Treat those as a starting point for scoping, never as a release specification.
What each test needs
| Test | What it establishes | Equipment |
|---|---|---|
| Appearance / clarity and colour | Visual conformity of the solution | Visual inspection against a lit background |
| pH | pH within the specified range Strips accepted in many monographs for small volumes | pH meter |
| Radiochemical purity by HPLC | Fraction of activity present as the intended chemical form Only HPLC resolves radiolysis products; radio-TLC alone may miss them | HPLC with radiometric detector |
| Radiochemical purity by radio-TLC | Same as above, faster, no recovery issues | Radio-TLC scanner |
| UV detection on HPLC | Identity and chemical impurities of UV-active species | HPLC with UV or PDA detector |
| Electrochemical detection on HPLC | Chemical impurities of species with poor UV response Needed for catecholamine-type compounds | HPLC with electrochemical detector |
| Conductometric detection on HPLC | Ionic species not detected by UV | HPLC with conductivity detector |
| Chemical purity / limit of impurities | Non-radioactive impurities within limits | HPLC |
| Residual solvents | Acetonitrile, ethanol, ether and similar within limits Almost universal for F-18 tracers made with acetonitrile | Gas chromatograph with FID or headspace |
| Kryptofix 2.2.2 / phase transfer catalyst | Residual cryptand within limits Applies where K222 is used in the synthesis | TLC spot test (iodoplatinate) |
| Radionuclidic purity | Correct radionuclide, gamma impurities within limits Ph. Eur. commonly requires >99.9%; F-18 samples are held ~24 h to allow decay before measurement | Gamma spectrometer (HPGe) |
| Half-life determination | Identity of the radionuclide by decay | Dose calibrator with timer |
| Radioactivity concentration | Activity at reference time Requires validated geometry | Dose calibrator (activity meter) |
| Bacterial endotoxins | Endotoxin level below limit Released before result in most cases; retrospective for short-lived tracers | LAL tester (kinetic or gel clot) |
| Sterility | Absence of viable micro-organisms Always retrospective | Sterility testing (media fill / membrane filtration) |
| Filter integrity (bubble point) | Integrity of the sterilising filter Substitutes for pre-release sterility | Filter integrity tester |
| Osmolality | Isotonicity of the final formulation More often required for therapeutic and large-volume preparations | Osmometer |
| Molar activity | Activity per mole of compound Critical for receptor-targeted tracers with saturable targets | HPLC with UV and radiometric detection |
| Metal impurities | Fe, Zn, Cu and similar within limits Relevant for radiometal preparations | ICP-MS |
| Ge-68 breakthrough | Parent radionuclide from the generator within limits Generator-produced Ga-68 only | Gamma spectrometer after Ga-68 decay |
| Lu-177m content | Long-lived isomer within limits Lu-177 preparations; matters for waste handling | Gamma spectrometer |
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