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Radiochemical Purity

rcp

In short

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>
Where this term comes up
RadiopharmaPharmaceutical
How V5 handles it
eBMR / eDHR — the batch record fills in as the work is done.
When operators record their work at the step, the batch record no longer has to be assembled afterwards. People review it and decide release.
Related terms
Specific ActivityDecay CorrectionQP release
Software that covers Radiochemical Purity
V5 Ultimate Radiopharmaceutical Manufacturing
Time-stamped batch record for short production windows, QC results tracked as available or pending, human release review and Part…
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