ROTOP Pharmaka: manufacturer profiles and specific FUZKK Utilities

Bilingual FUZKK Portal article: ROTOP Pharmaka as a radiopharma/CDMO manufacturer, product profiles, suitable FUZKK suites and specific utilities for pilot QC mapping.

ROTOP Pharmaka: manufacturer profile and FUZKK Utility fit map

ROTOP Pharmaka GmbH is a major radiopharma/CDMO manufacturer based in Dresden-Rossendorf. This article maps ROTOP’s public product profile to typical QC workflows and specific FUZKK Utilities for radiopharma, laboratory control and GMP/CDMO operations.

Manufacturer
Radiopharmaceuticals, cold kits, ready-to-use patient doses, CDMO
Public profile
Diagnostics, SPECT/PET, theranostics, therapy, GMP/CDMO
Key QC streams
Tc-99m, F-18, Ga-68, I-123, I-131, Lu-177, Ac-225, Pb-212
FUZKK fit
RPH + PetRad + PetRad2/3 + LabEx + Lumex

How to read the utility map

Open each profile block below to see not only the suitable suites, but also specific utilities. This helps move from broad interest to a pilot-ready set of checks for QC, release, stability, microbiology, cleanroom and integration workflows.

ROTOP profile → FUZKK map

ROTOP profileTypical QC workflowSuitesWhat to automate
Tc-99m cold kits / SPECTRadiolabelling, RCP, radionuclidic impurities, generator checksRPH, PetRad3, LabEx, Lumexrelease checks, CSV→JSON, audit trail
F-18 / Ga-68 PETShort-lived PET products, generator eluates, decay correctionRPH, PetRad, PetRad3generator/QC calculations, batch review
I-123 patient dosesHigh activity, hot cells, sterile filling, logistics windowRPH, PetRad3, LabExdose/release calculations, sterility/endotoxin blocks
I-131 / therapeutic radionuclidesTherapy release, dosimetry, radiolysis/stabilityRPH, PetRad2, PetRad3therapy isotope QC and stability logic
CDMO / precursors / lyophilisatesAnalytical method validation, microbiology, cleanroom monitoringLabEx, Lumex, RPHmethod checks and GMP utility layer

Manufacturer → profiles → packages → specific utilities

Tc-99m cold kits and SPECT kits RPH / PetRad3 / LabEx / Lumex

Profile: ROTOP manufactures sterile cold kits for Tc-99m radiolabelling and SPECT diagnostics, including TEKTROTYD, ROTOP-MDP, Tetrofosmin ROTOP, CardioTOP, MAG-3/NephroMAG/Mertioscan/IELMAG3, NanoHSA/Nanotop/NanoSPECT, ROTOP-DMSA, HSA microspheres B20 and related products from the portfolio.

FUZKK suites: RPH · PetRad3 · LabEx · Lumex

Why it fits: Primary fit: Tc-99m generator checks, radiochemical purity, radionuclidic impurities, decay correction, dose calculations and baseline GMP/QC for sterile lyophilisates and ready-to-use injectable products.

Specific utilities:

  • technetium99m-generator-quality-checker
  • tc99m-mdp-quality-checker
  • tc99m-tetrofosmin-quality-checker
  • tc99m-mag3-quality-checker
  • tc99m-sestamibi-quality-checker
  • tc99m-hmpao-quality-checker
  • tc99m-colloid-checker
  • radiochemical-purity-checker
  • radionuclide-impurity-checker
  • decay-corrector
  • radiation-dose-calculator
  • environmental-monitoring-cleanroom-quality-checker
  • sterility-test-membrane-filtration-quality-checker
  • bacterial-endotoxins-lalquality-checker
  • particle-count-injection-usp788-quality-checker
  • uvvis-identity-assay-quality-checker
  • ftiridentity-quality-checker
  • raman-identity-quality-checker
PET line: F-18 products and Ge-68/Ga-68 generator RPH / PetRad / PetRad3 / LabEx

Profile: ROTOP’s public portfolio lists F-18 FDG, DopaRos F-18 DOPA, NaFRos F-18-Fluoride and the GalliAd Ge-68/Ga-68 radionuclide generator. This creates a dedicated QC stream for PET products, generator eluates and short-lived radiopharmaceuticals.

FUZKK suites: RPH · PetRad · PetRad3 · LabEx

Why it fits: Primary fit: QC of short-lived PET products, Ge-68/Ga-68 generator controls, elution forecasting, breakthrough/ingrowth logic, decay correction and JSON output for LIMS/QA review.

Specific utilities:

  • fluorine18-fdgquality-checker
  • fluorine18-dopa-quality-checker
  • fluorine18-na-fquality-checker
  • gallium68-generator-quality-checker
  • gallium68-dotatatequality-checker
  • gallium68-psmaquality-checker
  • gallium68-fapiquality-checker
  • gallium68-hbedcc-quality-checker
  • generator-elution-predictor
  • daughter-nuclide-ingrowth-calculator
  • radionuclide-mix-checker
  • specific-activity-calculator
  • radiochemical-purity-checker
  • radionuclide-impurity-checker
  • decay-corrector
  • radiation-dose-calculator
  • stability-condition-monitoring-quality-checker
  • tocwater-quality-checker
  • p-hconductivity-water-quality-checker
I-123 and ready-to-use patient doses RPH / PetRad3 / Radiology QC / LabEx

Profile: ROTOP Radiopharmacy describes ready-to-use diagnostic radiopharmaceutical manufacturing, including I-123 processing, an on-site cyclotron, hot cells, automated filling, Type-A packaging and time-critical European distribution.

FUZKK suites: RPH · PetRad3 · Radiology QC · LabEx

Why it fits: Primary fit: identity/purity controls for I-123 products, activity and decay-window calculations, sterility/endotoxin checks, integrity testing and traceable patient-dose batch release.

Specific utilities:

  • iodine123-ioflupane-quality-checker
  • iodine123-fpct-quality-checker
  • iodine123-mibg-quality-checker
  • iodine123-na-i-quality-checker
  • i131-volatility-extended-checker
  • radionuclide-impurity-checker
  • radiochemical-purity-checker
  • radiation-dose-calculator
  • decay-corrector
  • package-integrity-leak-test-quality-checker
  • filter-integrity-test-quality-checker
  • sterility-test-membrane-filtration-quality-checker
  • bacterial-endotoxins-lalquality-checker
  • environmental-monitoring-cleanroom-quality-checker
  • particle-count-injection-usp788-quality-checker
  • density-refractive-index-quality-checker
Therapy and theranostics: I-131, Lu-177, Ac-225, Pb-212 and others RPH / PetRad2 / PetRad3 / LabEx

Profile: The public product portfolio includes ThyroTop I-131 capsules for therapy. The CDMO page also lists support for Ac-225, Cu-64, Cu-67, Ga-68, I-123, In-111, Lu-177, Mo-99/Tc-99m, Pb-212 and other radionuclides for clinical and commercial batch manufacturing.

FUZKK suites: RPH · PetRad2 · PetRad3 · LabEx

Why it fits: Primary fit: therapeutic radionuclides, high-activity batches, dosimetry pre-calculations, stability/radiolysis, radionuclidic impurity profiles and batch-release workflow.

Specific utilities:

  • iodine131-capsules-quality-checker
  • i131-volatility-extended-checker
  • lutetium177-psmaquality-checker
  • lutetium177-dotatatequality-checker
  • lutetium177-dotatoc-quality-checker
  • lu177-oxidation-checker
  • actinium225-quality-checker
  • lead212-quality-checker
  • copper67-quality-checker
  • yttrium90-quality-checker
  • bismuth213-quality-checker
  • thorium227-quality-checker
  • radionuclide-impurity-checker
  • radiochemical-purity-checker
  • radiation-dose-calculator
  • dosimetry-pre-calculator
  • specific-activity-calculator
  • radiolysis-stability-checker
  • stability-condition-monitoring-quality-checker
CDMO, precursors, sterile lyophilisates and method validation LabEx / Lumex / RPH / PetRad2

Profile: ROTOP positions itself as a full-service CDMO: precursor/API synthesis, lyophilized cold kit development, process scale-up, clinical and commercial GMP manufacturing, integrated QC, stability testing and regulatory support. This is not only radiopharma release; it also requires lab analytics, microbiology, cleanroom monitoring, packaging and stability controls.

FUZKK suites: LabEx · Lumex · RPH · PetRad2

Why it fits: Primary fit: a broader QC/CDMO layer for precursors, lyophilisates, analytical method validation, microbiology, cleanroom monitoring and stability.

Specific utilities:

  • assay-impurity-hplcquality-checker
  • lcmsconfirmation-quality-checker
  • residual-solvents-gcquality-checker
  • elemental-impurities-icpquality-checker
  • water-content-kfquality-checker
  • uvvis-identity-assay-quality-checker
  • ftiridentity-quality-checker
  • raman-identity-quality-checker
  • nmrstructure-quality-checker
  • xrpdpolymorph-quality-checker
  • sterility-test-membrane-filtration-quality-checker
  • bacterial-endotoxins-lalquality-checker
  • microbial-enumeration-tamctymcquality-checker
  • specified-microorganisms-quality-checker
  • environmental-monitoring-cleanroom-quality-checker
  • stability-condition-monitoring-quality-checker
  • package-integrity-leak-test-quality-checker
  • filter-integrity-test-quality-checker
  • rapid-micro-alternative-method-quality-checker
  • preparative-lcfraction-quality-checker

Sources and interpretation note

This article is not a supplier qualification and does not claim that ROTOP uses FUZKK Utilities. It is a commercial and technical applicability map: ROTOP’s public profile is mapped to typical QC workflows and available FUZKK packages.

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 QC time

Automate checks, calculations and reporting. The team focuses on deviations and scientific assessment rather than formatting.

🚀 Fast deployment

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

Integration workflow

LIMS / ELN / CSV export → FUZKK utility → output.json → QMS / eDMS / batch release

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

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…
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 imp…
3Decaydecay correctorDecayCorrector — Radionuclide Decay Correction Utility (Ph. Eur. 0125, USP , IAEA TRS-468) ℹ️ The utility calculates decay-corrected radionuclide activity from calibration time to measurement or administration time. ℹ️ D…
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) • Radiochemi…
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 daugh…
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…
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…
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 d…
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: spec…
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) • R…
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…
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 impurit…
29Astatine-211astatine211Utility description: Astatine-211 Astatine-211 Quality Checker — Astatine-211 for targeted alpha therapy ℹ️ Utility checks critical parameters of astatine-211: • Radionuclidic purity (≥99.
30Bismuth-213bismuth213Utility description: Bismuth-213 Bismuth-213 Quality Checker — Bismuth-213 for targeted alpha therapy ℹ️ Utility checks critical parameters of bismuth-213: • Radionuclidic purity (≥99.
31Copper-64copper64Utility description: Copper-64 Copper-64 Quality Checker — Radiopharmaceutical (Ph.
32Dosimetry Pre Calculatordosimetry pre calculatorUtility description: Dosimetry Pre Calculator Dosimetry Pre-Calculator — Radiopharmaceutical Activity and Dose Calculation ℹ️ Calculates activity at injection time, effective dose, and critical organ load.
33Erbium-169erbium169Utility description: Erbium-169 Erbium-169 Quality Checker — Radiocolloid for Synovectomy (Ph.
34Holmium-166holmium166Utility description: Holmium-166 Holmium-166 Quality Checker — Radiopharmaceutical (SIRT/Therapy) (Ph.
35Radiolysis Stability Checkerradiolysis stability checkerUtility description: Radiolysis Stability Checker Radiolysis Stability Checker — Radiopharmaceutical Stability Assessment ℹ️ Predicts RCP drop due to autoradiolysis based on activity, volume, and time.
36Rhenium-186rhenium186Utility description: Rhenium-186 Rhenium-186 Quality Checker — Radiopharmaceutical (Therapy) (Ph.
37Rhenium-188rhenium188Utility description: Rhenium-188 Rhenium-188 Quality Checker — Radiopharmaceutical (Generator-based) (Ph.
38Scandium-47scandium47Utility description: Scandium-47 Scandium-47 Quality Checker — Theranostic Radiopharmaceutical (Ph.
39Specific Activity Calculatorspecific activity calculatorUtility description: Specific Activity Calculator Specific Activity Calculator — Radiopharmaceutical Specific Activity Calculation ℹ️ Calculates specific activity (MBq/nmol) with decay correction.
40Terbium-149terbium149Utility description: Terbium-149 Terbium-149 Quality Checker — Alpha Theranostics (Ph.
41Terbium-152terbium152Utility description: Terbium-152 Terbium-152 Quality Checker — PET Diagnostics (Ph.
42Terbium-155terbium155Utility description: Terbium-155 Terbium-155 Quality Checker — SPECT Diagnostics (Ph.
43Terbium-161terbium161Utility description: Terbium-161 Terbium-161 Quality Checker — Terbium-161 for targeted radionuclide therapy ℹ️ Utility checks critical parameters of terbium-161: • Radionuclidic purity (≥99.
44Thorium-227thorium227Utility description: Thorium-227 Thorium-227 Quality Checker — Alpha Therapy (Ph.
45[18F]AlFaluminum fluoride18 f[18F]AlF Quality Checker — PET Diagnostics (AlF method) (Ph. Eur., USP) ℹ️ The utility checks RCP, free fluoride, residual aluminum, sterility, endotoxins. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRI…
46[11C]Cholinecarbon11 choline[11C]Choline Quality Checker — PET Diagnostics (Ph. Eur., USP) ℹ️ The utility checks RCP, residual DMAE, methyl iodide, sterility, endotoxins. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICAL! RCP ≥9…
47[11C]Methioninecarbon11 methionine[11C]Methionine Quality Checker — PET Diagnostics (Ph. Eur., USP) ℹ️ The utility checks RCP, residual precursor, methyl iodide, sterility, endotoxins. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICAL…
48Chromium-51 EDTAchromium51 edta checkerChromium-51 EDTA Quality Checker — Chromium-51 EDTA for GFR assessment ℹ️ Utility checks critical parameters of chromium-51 EDTA: • Radiochemical purity (≥95%) — fraction of Cr-51 bound to EDTA • Free chromium-51 (≤5%) —…
49Cobalt-57cobalt57Cobalt-57 Quality Checker — Cobalt-57 for diagnostics and equipment calibration ℹ️ Utility checks critical parameters of cobalt-57: • Radionuclidic purity (≥99.
50Cobalt58cobalt58Cobalt58 Quality Checker — radiopharmaceutical QC utility. Limited source description was provided. The utility shall read input.csv, validate declared fields, apply deterministic acceptance rules defined in the executab…
51Copper-64 ATSMcopper64 atsmCopper-64 ATSM Quality Checker — Copper-64 ATSM for PET Hypoxia Imaging ℹ️ Utility checks critical parameters of [64Cu]Cu-ATSM: • Radionuclidic purity (≥99.
52Copper-64 DOTATATEcopper64 dotatateCopper-64 DOTATATE Quality Checker — Copper-64 DOTATATE for PET Imaging of Neuroendocrine Tumors ℹ️ Utility checks critical parameters of [64Cu]Cu-DOTATATE: • Radionuclidic purity (≥99.
53Copper-64 Sarcophaginecopper64 sarcophagineCopper-64 Sarcophagine Quality Checker — Copper-64 Sarcophagine for Stable PET Imaging ℹ️ Utility checks critical parameters of [64Cu]Cu-Sarcophagine: • Radionuclidic purity (≥99.
54Daughter Nuclide Ingrowth Calculatordaughter nuclide ingrowth calculatorDaughter Nuclide Ingrowth Calculator — Calculator for Daughter Nuclide Accumulation ℹ️ Utility calculates theoretical activity of daughter isotopes in radiopharmaceutical generators: • Supported pairs: Mo-99/Tc-99m, Sr-8…
55Fluorine-18 Amyloidfluorine18 amyloidFluorine-18 Amyloid Quality Checker — Fluorine-18 Amyloid Tracers for Alzheimer's Disease PET Imaging ℹ️ Utility checks critical parameters of F-18 amyloid imaging agents (Florbetapir, Flutemetamol, Florbetaben): • Radio…
56Fluorine-18 Cholinefluorine18 cholineFluorine-18 Choline Quality Checker — Fluorine-18 Choline for PET Oncology ℹ️ Utility checks critical parameters of [18F]Fluorocholine: • Radionuclidic purity (≥99.
57Fluorine-18 DOPAfluorine18 dopaFluorine-18 DOPA Quality Checker — Fluorine-18 DOPA for PET Diagnostics ℹ️ Utility checks critical parameters of [18F]FDOPA: • Radionuclidic purity (≥99.
58Fluorine-18 FESfluorine18 fesFluorine-18 FES Quality Checker — Fluorine-18 FES for PET Imaging of Estrogen Receptors ℹ️ Utility checks critical parameters of [18F]Fluoroestradiol (FES): • Radionuclidic purity (≥99.
59Fluorine-18 FLTfluorine18 fltFluorine-18 FLT Quality Checker — Fluorine-18 FLT for PET Proliferation Imaging ℹ️ Utility checks critical parameters of [18F]FLT (3'-deoxy-3'-[18F]fluorothymidine): • Radionuclidic purity (≥99.
60Fluorine-18 FMISOfluorine18 fmisoFluorine-18 FMISO Quality Checker — Fluorine-18 FMISO for PET Hypoxia Imaging ℹ️ Utility checks critical parameters of [18F]FMISO (Fluoromisonidazole): • Radionuclidic purity (≥99.
61Gallium-68 HBED-CCgallium68 hbedccGallium-68 HBED-CC Quality Checker — Gallium-68 PSMA (HBED-CC) for PET Prostate Cancer Imaging ℹ️ Utility checks critical parameters of [68Ga]Ga-PSMA-11 (HBED-CC): • Radionuclidic purity (≥99.
62Indium-111 Capromab Pendetideindium111 capromab pendetide checkerIndium-111 Capromab Pendetide Quality Checker — Indium-111 Capromab Pendetide (ProstaScint®) ℹ️ Utility checks critical parameters of the monoclonal antibody-based radiopharmaceutical: • Radiochemical purity (≥90%) • Fre…
63Indium-111 Pentetreotideindium111 pentetreotideIndium-111 Pentetreotide Quality Checker — Indium-111 Pentetreotide (OctreoScan®) ℹ️ Utility checks critical parameters of the somatostatin analog radiopharmaceutical: • Radiochemical purity (≥90%) • Free Indium-111 impu…
64Indium-111 WBC Labelingindium111 wbc labeling checkerIndium-111 WBC Labeling Checker — Indium-111 Labeled Leukocytes ℹ️ Utility checks critical parameters of autologous leukocytes labeled with Indium-111: • Labeling efficiency (≥80%) • Free Indium-111 impurity (≤20%) • Cel…
65Iodine-123 FP-CITiodine123 fpctIodine-123 FP-CIT Quality Checker — Ioflupane I-123 (DaTscan®) ℹ️ Utility checks critical parameters of the radiopharmaceutical for dopamine transporter imaging: • Radiochemical purity (≥95%) • Free Iodine-123 impurity (…
66Iodine-123 Ioflupaneiodine123 ioflupaneIodine-123 Ioflupane Quality Checker — Ioflupane I-123 (DaTscan®) ℹ️ Utility checks critical parameters of the radiopharmaceutical for dopamine transporter imaging: • Radiochemical purity (≥95%) • Free Iodine-123 impurit…
67Iodine-123 MIBGiodine123 mibgIodine-123 MIBG Quality Checker — Iodine-123 Metaiodobenzylguanidine ℹ️ Utility checks critical parameters of Iodine-123 MIBG radiopharmaceutical: • Radiochemical purity (≥95%) • Free Iodine-123 impurity (≤5%) • Radionuc…
68Iodine-123 NaIiodine123 na iIodine-123 NaI Quality Checker — Sodium Iodide I-123 ℹ️ Utility checks critical parameters of Sodium Iodide I-123: • Radionuclidic purity (≥99% I-123) • Iodine-124 impurity (≤0.
69Iodine-124 MAbiodine124 mabIodine-124 MAb Quality Checker — Iodine-124 Monoclonal Antibodies (ImmunoPET) ℹ️ Utility checks critical parameters of Iodine-124 labeled monoclonal antibodies: • Radiochemical purity (≥90%) • Free Iodine-124 impurity (≤…
70Iodine-131 Hippuraniodine131 hippuranIodine131 Hippuran Quality Checker — radiopharmaceutical QC utility.
71Iodine-131 Lipiodoliodine131 lipiodolIodine-131 Lipiodol Quality Checker — Iodine-131 Lipiodol for radioembolization and therapy ℹ️ Utility checks critical parameters of Iodine-131 Lipiodol: • Radionuclidic purity (≥99.
72Iodine-131 MIBGiodine131 mibgIodine-131 MIBG Quality Checker — Iodine-131 MIBG for neuroendocrine tumor therapy ℹ️ Utility checks critical parameters of Iodine-131 MIBG: • Radionuclidic purity (≥99.
73Lutetium-177 DOTATOClutetium177 dotatocLutetium-177 DOTATOC Quality Checker — Lutetium-177 DOTATOC for Peptide Receptor Radionuclide Therapy (PRRT) ℹ️ Utility checks critical parameters of Lutetium-177 DOTATOC: • Radionuclidic purity (≥99.
74Lutetium-177 J591lutetium177 j591Lutetium-177 J591 Quality Checker — Lutetium-177 J591 (Anti-PSMA mAb) for prostate cancer therapy ℹ️ Utility checks critical parameters of Lutetium-177 J591: • Radionuclidic purity (≥99.
75Manganese-52manganese52Manganese-52 Quality Checker — Manganese-52 for PET Imaging and Research ℹ️ Utility checks critical parameters of Manganese-52: • Radionuclidic purity (≥99.
76Mercury-197mercury197Mercury-197 Quality Checker — Mercury-197 for Renal Imaging ℹ️ Utility checks critical parameters of Mercury-197: • Radionuclidic purity (≥99.
77Nitrogen-13 Ammonianitrogen13 ammoniaNitrogen-13 Ammonia Quality Checker — Nitrogen-13 Ammonia for Cardiac PET Imaging ℹ️ Utility checks critical parameters of [13N]Ammonia: • Radionuclidic purity (≥99.
78Oxygen-15 Wateroxygen15 waterOxygen-15 Water Quality Checker — Oxygen-15 Water for PET Perfusion ℹ️ Utility checks critical parameters of [15O]Water: • Radionuclidic purity (≥99.
79Palladium-103palladium103Palladium-103 Quality Checker — Palladium-103 for Brachytherapy ℹ️ Utility checks critical parameters of Palladium-103: • Radionuclidic purity (≥99.
80Phosphorus-32 Chromic Phosphatephosphorus32 chromic phosphate checkerPhosphorus-32 Chromic Phosphate Quality Checker — P-32 Colloid for Radiosynovectomy ℹ️ Utility checks critical parameters of colloidal Phosphorus-32: • Radionuclidic purity (≥99.
81Phosphorus-32 Orthophosphatephosphorus32 orthophosphate checkerPhosphorus-32 Orthophosphate Quality Checker — P-32 Orthophosphate Solution for Systemic Therapy ℹ️ Utility checks critical parameters of Phosphorus-32 solution: • Radionuclidic purity (≥99.
82Platinum-195mplatinum195mPlatinum-195m Quality Checker — Platinum-195m for Theranostics and Research ℹ️ Utility checks critical parameters of Platinum-195m: • Radionuclidic purity (≥99.
83Recoil Effectrecoil effect checkerRecoil Effect Checker — Recoil Effect Analyzer in Alpha Therapy ℹ️ Utility assesses consequences of bond rupture during alpha decay: • Calculation of Recoil Energy • Comparison with chemical bond energy • Assessment of f…
84Rubidium-82 Chloriderubidium82 chlorideRubidium-82 Chloride Quality Checker — Rubidium-82 Chloride for Myocardial PET Perfusion ℹ️ Utility checks critical parameters of Sr-82/Rb-82 generator eluate: • Strontium-82 breakthrough (≤20 Bq/MBq Rb-82) — CRITICAL!
85Samarium-153 EDTMPsamarium153 edtmpSamarium-153 EDTMP Quality Checker — Samarium-153 EDTMP (Quadramet) for Palliative Therapy ℹ️ Utility checks critical parameters of Samarium-153 EDTMP: • Radionuclidic purity (≥99.
86Scandium-43scandium43Scandium-43 Quality Checker — Scandium-43 for PET Imaging (Theranostics) ℹ️ Utility checks critical parameters of Scandium-43: • Radionuclidic purity (≥99.
87Scandium-44scandium44Scandium-44 Quality Checker — Scandium-44 for PET Imaging (Long Kinetics) ℹ️ Utility checks critical parameters of Scandium-44: • Radionuclidic purity (≥99.
88Silver-105silver105Silver-105 Quality Checker — Silver-105 for Theranostics and PET ℹ️ Utility checks critical parameters of Silver-105: • Radionuclidic purity (≥99.
89Strontium-82 Breakthroughstrontium82 breakthrough checkerStrontium-82 Breakthrough Checker — Strontium-82 Breakthrough Analyzer (Rb-82 Generators) ℹ️ Utility checks strontium breakthrough compliance with USP : • Sr-82 Limit: ≤20 Bq per 1 MBq Rb-82 • Sr-85 Limit: ≤500 Bq per 1…
90Tc-99m HMPAOtc99m hmpaoTc-99m HMPAO Quality Checker — Technetium-99m HMPAO for Brain SPECT Perfusion ℹ️ Utility checks critical parameters of Tc-99m HMPAO: • Radiochemical purity of lipophilic complex (≥80%) • Secondary complex (≤15%) • Free p…
91Tc-99m MAG3tc99m mag3Tc-99m MAG3 Quality Checker — Technetium-99m Mercaptide (MAG3) for Dynamic Renal Scintigraphy ℹ️ Utility checks critical parameters of Tc-99m MAG3: • Radiochemical purity (≥90%) • Free pertechnetate (≤5%) • Colloidal tec…
92Tc-99m MDPtc99m mdpTc-99m MDP Quality Checker — Technetium-99m MDP for Bone Scintigraphy ℹ️ Utility checks critical parameters of Tc-99m MDP: • Radiochemical purity (≥95%) • Free pertechnetate (≤5%) • Colloidal technetium (≤5%) • Aluminum…
93Tc-99m Sestamibitc99m sestamibiTc-99m Sestamibi Quality Checker — Technetium-99m Sestamibi (MIBI) for Cardiology and Surgery ℹ️ Utility checks critical parameters of Tc-99m Sestamibi: • Radiochemical purity (≥90%) • Free pertechnetate (≤5%) • Colloida…
94Tc-99m Tetrofosmintc99m tetrofosminTc-99m Tetrofosmin Quality Checker — Technetium-99m Tetrofosmin for Myocardial Scintigraphy ℹ️ Utility checks critical parameters of Tc-99m Tetrofosmin: • Radiochemical purity (≥90%) • Free pertechnetate (≤5%) • Colloida…
95Tc-99m ECDtechnetium99m ecdTc-99m ECD Quality Checker — Technetium-99m Bicisate (ECD) for Brain SPECT Perfusion ℹ️ Utility checks critical parameters of Tc-99m ECD: • Radiochemical purity (≥95%) • Free pertechnetate (≤2%) • Colloidal technetium (≤…
96Tc-99m Exametazimetechnetium99m exametazimeTc-99m Exametazime Quality Checker — Technetium-99m Exametazime (HMPAO) for Brain and WBCs ℹ️ Utility checks critical parameters of Tc-99m HMPAO: • Radiochemical purity of lipophilic complex (≥80%) • Secondary complex (≤…
97Tc-99m Glucoheptonatetechnetium99m glucoheptonate checkerTc-99m Glucoheptonate Quality Checker — Technetium-99m Glucoheptonate for Brain and Kidneys ℹ️ Utility checks critical parameters of Tc-99m Glucoheptonate: • Radiochemical purity (≥90%) • Free pertechnetate (≤5%) • Collo…
98Tc-99m PYPtechnetium99m pyrophosphate checkerTc-99m PYP Quality Checker — Technetium-99m Pyrophosphate (PYP) for Bones and Heart ℹ️ Utility checks critical parameters of Tc-99m PYP: • Radiochemical purity (≥95%) • Free pertechnetate (≤5%) • Colloidal technetium (≤5…
99Tc-99m RBCtechnetium99m red blood cell checkerTc-99m RBC Quality Checker — Technetium-99m Labeled Red Blood Cells for Heart and GI Tract ℹ️ Utility checks critical parameters of Tc-99m RBC: • Labeling efficiency (≥95%) • Free pertechnetate (≤3%) • Colloidal techneti…
100Tc-99m Sulfur Colloidtechnetium99m sulfur colloid checkerTc-99m Sulfur Colloid Quality Checker — Technetium-99m Sulfur Colloid ℹ️ Utility checks critical parameters of Tc-99m Sulfur Colloid: • Radiochemical purity (≥92%) • Particle size (depends on application: liver/lymph) •…
101Thallium-201 Chloridethallium201 chlorideThallium-201 Chloride Quality Checker — Thallium-201 Chloride for Cardiology and Oncology ℹ️ Utility checks critical parameters of Thallium-201: • Radionuclidic purity (≥99.
102Thulium-170thulium170Thulium-170 Quality Checker — Thulium-170 for Synovitis Therapy and Palliative Care ℹ️ Utility checks critical parameters of Thulium-170: • Radionuclidic purity (≥99.
103Yttrium-86yttrium86Yttrium-86 Quality Checker — Yttrium-86 for PET Dosimetry (Theranostics with Y-90) ℹ️ Utility checks critical parameters of Yttrium-86: • Radionuclidic purity (≥99.
104Yttrium-90 Glass Microsphereyttrium90 glass microsphere checkerYttrium-90 Glass Microsphere Quality Checker — Yttrium-90 Glass Microspheres (TheraSphere) ℹ️ Utility checks critical parameters of Y-90 Glass Microspheres: • Particle size (20–30 μm) — strict!
105Yttrium-90 Resin Microsphereyttrium90 resin microsphere checkerYttrium-90 Resin Microsphere Quality Checker — Yttrium-90 Resin Microspheres (SIR-Spheres) ℹ️ Utility checks critical parameters of Y-90 Resin Microspheres: • Particle size (20–60 μm) • Number of particles (important for…
106Zirconium-89 DFOzirconium89 dfoZirconium-89 DFO Quality Checker — Zirconium-89 DFO for Immuno-PET ℹ️ Utility checks critical parameters of Zr-89-DFO: • Radionuclidic purity (≥99.
107Zirconium-89 Trastuzumabzirconium89 trastuzumabZirconium-89 Trastuzumab Quality Checker — Zirconium-89 Trastuzumab for HER2-PET ℹ️ Utility checks critical parameters of Zr-89-Trastuzumab: • Immunoreactivity (≥80%) — MAIN PARAMETER!

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.

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.

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