Per-isotope SOP · miniGITA Dual
For each isotope the hot lab handles, this page lists the radiochemical-purity threshold and the nuclide-identity check that go onto the paired release record. The instrument carries both methods in the library; the operator runs the paired check, the audit trail captures both results per release.
Per-isotope paired-check methods
Radiochemical purity
%RCP ≥ 95 % per Eur.Ph. kit monograph
Nuclide-identity check
140 keV photopeak; ratio against shoulder energies confirms Tc-99m identity (vs Tc-99 / Mo-99 breakthrough)
Notes: Routine paired check on every cold-kit release. Mo-99 breakthrough on generator eluate is the failure mode the gamma spectrum catches.
Radiochemical purity
%RCP ≥ 95 % per Eur.Ph. monograph 1325 / 2100
Nuclide-identity check
511 keV annihilation photopeak + Compton continuum profile confirms F-18 identity
Notes: Cyclotron-produced F-18 is rarely contaminated, but the paired check anchors the release record for the AERB inspector.
Radiochemical purity
%RCP ≥ 95 % per Eur.Ph. monograph 2482 / site SOP
Nuclide-identity check
511 keV annihilation + 1077 keV pair-line check + delayed-spectrum Ge-68 breakthrough check (< 0.001 % at expiry)
Notes: Generator-fed Ga-68 carries a real Ge-68 breakthrough risk. The delayed-spectrum check is what the Eur.Ph. monograph requires.
Radiochemical purity
%RCP ≥ 95 % (NETTER / VISION protocols target ≥ 99 %)
Nuclide-identity check
113 / 208 keV doublet ratio confirms Lu-177; check for 228 keV Lu-177m peak (n.c.a. should not show it)
Notes: The nuclide-identity check is what distinguishes n.c.a. supply from carrier-added Lu-177. For NETTER / VISION-grade therapy, the absence of Lu-177m matters.
Radiochemical purity
%RCP per investigator-protocol acceptance criteria
Nuclide-identity check
511 keV annihilation + 1346 keV gamma line confirms Cu-64; check for Cu-67 / Co-58 / Co-60 cyclotron-by-product contamination
Notes: Investigator-initiated Cu-64 labelling — paired check is part of the ethics-committee + CDSCO investigational protocol.
Radiochemical purity
%RCP ≥ 95 % per Eur.Ph. monograph 0281 / 0282
Nuclide-identity check
364 keV photopeak confirms I-131 identity; check for I-132 / I-133 generator-product contamination
Notes: Routine paired check on each capsule batch and bulk solution. Generator-produced I-131 occasionally carries short-lived iodine contaminants.
Per-isotope thresholds are carried in the QC software method library. Site IQ / OQ / PQ verifies the latest Eur.Ph. / USP <823> monograph values; per-protocol acceptance criteria for investigational tracers are configured during site PQ.
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