Manufacturing
Specific Activity
radioactivity per mass
TL;DR
The radioactivity of a radiopharmaceutical per unit mass of the labelled compound (e.g., GBq/µmol), a key release attribute.
Specific activity expresses how much radioactivity is carried per unit mass of the labelled molecule (typically GBq/µmol). It directly affects receptor binding, imaging quality, and dosing safety. Specifications, calculations, and decay corrections are part of the release record under 21 CFR 212 / Annex 3.
V5 records the time-stamped activity, mass, and decay correction so the release record always reflects the activity at administration time.
Regulatory anchors
- 21 CFR 212
- USP <823>
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