Lab
Radiochemical Purity
rcp
TL;DR
The percentage of total radioactivity present as the intended labelled species — a mandatory release attribute for radiopharmaceuticals.
Radiochemical Purity (RCP) measures the fraction of total radioactivity that is the desired radiolabelled species, usually by radio-TLC or radio-HPLC. RCP is a critical release attribute alongside identity, specific activity, and sterility, and must be met under 21 CFR 212 and USP <823>.
V5 binds RCP results to the synthesis batch and applies conditional release rules (release pending sterility) per Annex 3 / NRC limits.
Regulatory anchors
- 21 CFR 212
- USP <823>
Industries that live with this
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