Article: PetRad QC Suite

A specialised utility package for radiopharmaceutical quality control: PET, SPECT, therapeutic radionuclides, generators and decay calculations.

Package
RadioPharma
Category
Radiopharmaceuticals
Utilities
28
Format
CSV → JSON

Why choose FUZKK Utilities?

✅ Replace Excel

No hidden formulas or accidental edits. Deterministic logic, version control and reproducible results.

🔍 Audit-ready (IQ/OQ)

Each utility is supplied with URS & FS templates. This accelerates validation preparation and inspections.

⏱ Save lab time

Automate activity calculations, radiochemical purity, elution yield and batch-release checks.

🚀 Fast deployment

CSV input and JSON output allow integration without building heavy custom LIMS modules from scratch.

Integration workflow

Synthesizer / detector -> FUZKK utility -> JSON/PDF report -> LIMS / batch record

The utilities read CSV input and generate structured JSON output suitable for automated batch release, QA/QC review and LIMS/ELN/MES integration.

Utilities in this package

#API / productUtilityKey checks
1Actinium225Actinium225QualityCheckerdecay correction, endotoxins, heavy metals, impurities, microbiology
2Copper67Copper67QualityCheckerdecay correction, endotoxins, heavy metals, impurities, microbiology
3DecayDecayCorrectordecay correction, endotoxins, PET, radionuclide purity, radiopharma
4Fluorine18 FDGFluorine18FDGQualityCheckerdecay correction, endotoxins, heavy metals, medical gases, microbiology
5Fluorine18 Na FFluorine18NaFQualityCheckerdecay correction, endotoxins, heavy metals, impurities, microbiology
6Fluorine18 PSMAFluorine18PSMAQualityCheckerdecay correction, endotoxins, heavy metals, microbiology, PET
7Gallium68 DOTATATEGallium68DOTATATEQualityCheckerdecay correction, endotoxins, heavy metals, impurities, microbiology
8Gallium68 FAPIGallium68FAPIQualityCheckerdecay correction, endotoxins, heavy metals, impurities, medical gases
9Gallium68 GeneratorGallium68GeneratorQualityCheckerdecay correction, endotoxins, impurities, microbiology, PET
10Gallium68 LNP TrackerGallium68LNPTrackerQualityCheckerdecay correction, endotoxins, impurities, PET, radionuclide purity
11Gallium68 PSMAGallium68PSMAQualityCheckerdecay correction, endotoxins, heavy metals, impurities, microbiology
12Generator Elution PredictorGeneratorElutionPredictordecay correction, endotoxins, PET, radionuclide purity, radiopharma
13I131 Volatility ExtendedI131VolatilityExtendedCheckercapsules, decay correction, endotoxins, medical gases, PET
14Iodine131 CapsulesIodine131CapsulesQualityCheckerbiologics, capsules, decay correction, endotoxins, heavy metals
15Lead212Lead212QualityCheckerdecay correction, endotoxins, heavy metals, impurities, microbiology
16Lu177 OxidationLu177OxidationCheckerdecay correction, endotoxins, impurities, medical gases, PET
17Lutetium177 DOTATATELutetium177DOTATATEQualityCheckerdecay correction, endotoxins, heavy metals, impurities, medical gases
18Lutetium177 PSMALutetium177PSMAQualityCheckerdecay correction, endotoxins, heavy metals, microbiology, PET
19Radiation Dose CalculatorRadiationDoseCalculatordecay correction, endotoxins, PET, radionuclide purity, radiopharma
20Radiochemical PurityRadiochemicalPurityCheckercapsules, decay correction, endotoxins, impurities, PET
21Radiolabeled NanoparticleRadiolabeledNanoparticleQualityCheckerdecay correction, endotoxins, heavy metals, impurities, PET
22Radionuclide ImpurityRadionuclideImpurityCheckerdecay correction, endotoxins, impurities, PET, radionuclide purity
23Radionuclide MixRadionuclideMixCheckerdecay correction, endotoxins, PET, radionuclide purity, radiopharma
24Radium223 DichlorideRadium223DichlorideQualityCheckerdecay correction, endotoxins, heavy metals, impurities, medical gases
25Strontium89 ChlorideStrontium89ChlorideQualityCheckerdecay correction, endotoxins, heavy metals, impurities, microbiology
26Tc99m ColloidTc99mColloidCheckercontrast media, decay correction, endotoxins, PET, radionuclide purity
27Technetium99m GeneratorTechnetium99mGeneratorQualityCheckerdecay correction, endotoxins, PET, radionuclide purity, radiopharma
28Yttrium90Yttrium90QualityCheckerdecay correction, endotoxins, heavy metals, impurities, microbiology

Package positioning

The package is a marketing and technical selection. It is suitable for the first discussion with QC, portfolio coverage assessment, pilot scoping and integration planning.
radiopharma PET SPECT radionuclide purity decay correction sterility endotoxins

Licensing & support

  • License is granted to one pharmaceutical company or manufacturing site, with no redistribution rights.
  • Utilities are provided “as is”; validation is performed by the client using URS & FS / IQ/OQ templates.
  • Integration support is available for LIMS/ELN/MES, pilot preparation and CSV/JSON workflow clarification.
  • No public price is shown: the commercial proposal depends on package scope, number of sites, delivery model and support level.
© 2026 FUZKK Pharma · For QC/GMP implementation discussion

Utilities and checked parameters

#API / productUtilityKey checks
1Actinium225actinium225Actinium-225 Quality Checker — Actinium-225 for targeted alpha therapy (TAT) ℹ️ Utility checks critical parameters of actinium-225: • Specific activity (≥500 MBq/μmol for conjugates) • Radiochemical purity (≥95%) • Free actinium (≤5% for co…
2Copper67copper67Copper-67 Quality Checker — Copper-67 for targeted radionuclide therapy ℹ️ Utility checks critical parameters of copper-67: • Specific activity (≥100 MBq/μmol for conjugates) • Radiochemical purity (≥95%) • Copper-64 impurity (≤0.
3Decaydecay correctorDecayCorrector — Radionuclide Decay Correction Utility (Ph.
4Fluorine18 FDGfluorine18 fdgquality checkerFluorine-18 FDG Quality Checker — ¹⁸F-FDG (fluorodeoxyglucose) for PET diagnostics (Ph.
5Fluorine18 Na Ffluorine18 na fquality checkerFluorine-18 NaF Quality Checker — Sodium [18F]fluoride for bone PET imaging (Ph.
6Fluorine18 PSMAfluorine18 psmaquality checkerFluorine-18 PSMA Quality Checker — ¹⁸F-PSMA-1007 for prostate cancer PET imaging (Ph.
7Gallium68 DOTATATEgallium68 dotatatequality checkerGallium-68 DOTATATE Quality Checker — ⁶⁸Ga-DOTATATE (NETSPOT®) for neuroendocrine tumor PET imaging (Ph.
8Gallium68 FAPIgallium68 fapiquality checkerGallium-68 FAPI Quality Checker — ⁶⁸Ga-FAPI for PET imaging of tumor stroma ℹ️ Utility checks quality of FAPI (Fibroblast Activation Protein Inhibitor) radiopharmaceutical: • Specific activity (≥50 GBq/μmol) • Radiochemical purity (≥95%) •…
9Gallium68 Generatorgallium68 generatorGallium-68 Generator Quality Checker — ⁶⁸Ge/⁶⁸Ga generator for PET diagnostics (Ph.
10Gallium68 LNP Trackergallium68 lnptracker⚠️ DEPRECATED UTILITY This utility has been REPLACED by the universal version: RadiolabeledNanoparticleQualityChecker.
11Gallium68 PSMAgallium68 psmaquality checkerGallium-68 PSMA Quality Checker — ⁶⁸Ga-PSMA-11 for prostate cancer PET imaging (Ph.
12Generator Elution Predictorgenerator elution predictorGenerator Elution Predictor — Generator elution activity predictor ℹ️ Utility calculates PREDICTED daughter nuclide activity in generator eluate: • Accounts for parent nuclide decay since calibration • Accounts for daughter nuclide ingrowth…
13I131 Volatility Extendedi131 volatility extended checkerI-131 Volatility Extended Checker — Extended volatile iodine control in iodine-131 capsules ℹ️ Utility performs DEEP analysis of volatile iodine with: • Current value check (≤5.
14Iodine131 Capsulesiodine131 capsulesIodine-131 Capsules Quality Checker — Iodine-131 Capsules (radiopharmaceutical for thyroid therapy) (Ph.
15Lead212lead212Lead-212 Quality Checker — Lead-212 for targeted alpha therapy (TAT) ℹ️ Utility checks critical parameters of lead-212: • Specific activity (≥100 MBq/μmol for conjugates) • Radiochemical purity (≥95%) • Daughter nuclides: bismuth-212 (≤5%),…
16Lu177 Oxidationlu177 oxidation checkerLu-177 Oxidation Checker — Lutetium-177 oxidation control (Lu-177m impurity) ℹ️ Utility performs DEEP analysis of lutetium-177 oxidation with: • Current Lu-177m impurity check (≤0.
17Lutetium177 DOTATATElutetium177 dotatatequality checkerLutetium-177 DOTATATE Quality Checker — Lutetium-177 DOTATATE solution (Lutathera®) (Ph.
18Lutetium177 PSMAlutetium177 psmaquality checkerLutetium-177 PSMA Quality Checker — Lutetium-177 PSMA-617 solution (targeted therapy for prostate cancer) (Ph.
19Radiation Dose Calculatorradiation dose calculatorRadiation Dose Calculator — Patient absorbed dose calculator ℹ️ Utility calculates ESTIMATED absorbed dose based on ICRP data (ICRP 106, 128): • Effective dose (mSv) for overall radiation burden assessment • Target organ and critical organ…
20Radiochemical Purityradiochemical purity checkerRadiochemical Purity Checker — Universal utility for radiochemical purity calculation (TLC / HPLC) ℹ️ Utility calculates radiochemical purity as (target peak area / total peak area) × 100% from chromatographic analysis data.
21Radiolabeled Nanoparticleradiolabeled nanoparticleRadiolabeled Nanoparticle Quality Checker — Universal QC for radiolabeled nanocarriers ℹ️ Utility checks quality of radiolabeled nanoparticles (liposomes, LNPs, polymer NPs) for research use: • Radionuclide quality: specific activity, radio…
22Radionuclide Impurityradionuclide impurity checkerRadionuclide Impurity Checker — Universal utility for radionuclide impurity calculation from gamma spectrometry data ℹ️ Utility automatically calculates radionuclide impurity percentage with half-life correction.
23Radionuclide Mixradionuclide mix checkerRadionuclide Mix Checker — Batch and radionuclide mix-up check during manual data entry ℹ️ Utility performs CRITICAL data verification to prevent catastrophic errors: • Batch number verification (entered vs expected) • Radionuclide verifica…
24Radium223 Dichlorideradium223 dichlorideRadium-223 Dichloride Quality Checker — Radium-223 dichloride solution (Xofigo®) (Ph.
25Strontium89 Chloridestrontium89 chlorideStrontium-89 Chloride Quality Checker — Strontium-89 chloride solution (Metastron®) (Ph.
26Tc99m Colloidtc99m colloid checkerTc-99m Colloid Checker — Colloid phase control in technetium-99m radiopharmaceuticals ℹ️ Utility performs DEEP colloid phase analysis with: • Current colloid percentage check (≤5% for most agents) • Stability prediction until end of shelf l…
27Technetium99m Generatortechnetium99m generatorTechnetium-99m Generator Quality Checker — Molybdenum-technetium generator (Ph.
28Yttrium90yttrium90Yttrium-90 Quality Checker — Yttrium-90 for radionuclide therapy ℹ️ Utility checks critical parameters of yttrium-90: • Specific activity (≥1000 MBq/μmol for conjugates) • Radiochemical purity (≥95%) • Yttrium-88 impurity (≤0.