Knowledge Hub · Mo-99/Tc-99m Generator
The standards framework a compliant Tc-99m service audits against.
Every weekly generator delivery lands into a paperwork chain — EU-GMP release Certificate of Analysis, AERB import + storage records, USP <825> preparation documentation, IAEA TECDOC-1592 dose-calibrator constancy log. Below are the six anchor documents that define the chain, plus the methodology reviews the procurement + RSO team cite when sizing weekly deliveries.
Standards framework
Six anchors covering manufacture, dispensing, regulation, methodology and clinical practice.
Manufacture of Radiopharmaceuticals
The EU-GMP annex that governs the manufacture and release of Mo-99/Tc-99m generators before shipment. Sets the QC-release framework (radiochemical purity, radionuclidic purity, sterility, endotoxin, breakthrough limits) that a compliant generator ships with a Certificate of Analysis against.
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Radiopharmaceuticals for Positron Emission Tomography (823) & Radiopharmaceuticals — Preparation, Compounding, Dispensing, Repackaging (825)
The US Pharmacopeia chapters governing radiopharmaceutical preparation and dispensing. USP <825> in particular is the reference for the elution + kit-labelling workflow the generator feeds — beyond-use dating, environmental controls, per-batch documentation.
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Operational Guidance on Hospital Radiopharmacy
The IAEA operational guide for hospital radiopharmacies — the reference most Indian teaching hospitals cite when writing their SOPs around Tc-99m elution, kit formulation, and dispensing to the hot lab.
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Safety Code for Nuclear Medicine Facilities
India's regulatory framework for a nuclear-medicine facility receiving Mo-99/Tc-99m generators — RSO responsibilities, receipt-and-storage requirements, weekly waste-handling and the audit-record obligations around every elution.
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Quality Assurance for Radioactivity Measurements in Nuclear Medicine
The QA guide for the dose-calibrator + elution-check chain — daily constancy, weekly linearity, quarterly geometry, annual accuracy — that turns the generator's eluate into a validated administered activity.
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Society of Nuclear Medicine and Molecular Imaging — General Procedure Guidelines
The SNMMI general procedure guidelines applied by nuclear-medicine departments worldwide for Tc-99m-based imaging protocols. Anchors dose-per-kg, injection-to-imaging timing and radiation-safety practice around Tc-99m administration.
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Review literature
Three references the procurement + RSO teams cite when sizing supply.
The supply of medical radioisotopes: Review of potential Molybdenum-99 / Technetium-99m production technologies
OECD Nuclear Energy Agency
OECD/NEA review of Mo-99 supply chains, generator manufacturing pipelines and long-term supply resilience — the reference for procurement teams sizing multi-source supply contracts.
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Tc-99m generators: essentials for a stable, secure supply for nuclear medicine
Ballinger JR
Short, practical review of generator supply factors and eluate quality checks. Cited by procurement + RSO teams when planning weekly generator schedules.
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Comparison of two commercial fission-based Mo-99/Tc-99m generators: Yield, radiochemical purity and radionuclidic purity
Various — reviewed in Journal of Nuclear Medicine Technology
Peer-reviewed methodology work characterising the two commercial fission-based generator formats — the head-to-head reference used when a department switches supplier.
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Literature Radar · auto-updated daily
Latest radiopharmacy QC research
Peer-reviewed papers on radiopharmaceutical QC + generator elution, auto-updated from Europe PMC + OpenAlex.
- Peer-ReviewedPubMedApplied radiation and isotopes · 2026
Quality assurance planning for Actinium-225: Layering current good manufacturing practice requirements onto US department of energy/nuclear safety quality systems to support medical isotope production suitable for clinical trial use.
Cato TL, Singer JM.
- Peer-ReviewedPubMedNuclear medicine and biology · 2026
Production of 135La via the 136Ba(p,2n)135La reaction and its DNA-damaging properties as a low-energy Auger electron emitter.
Brühlmann SA, Zarschler K, Kenkadze M et al.
- Peer-ReviewedPubMedMolecules (Basel, Switzerland) · 2026
Multibatch Analysis of Process Sensitivity Across Stages in 100 g Scale Mannose Triflate Synthesis.
Özokan G.
- Peer-ReviewedPubMedNuclear medicine and biology · 2026
cGMP production of radiometal solutions from solid targets at a university-scale facility.
Bender A, Mower B, Buckway B et al.
- Peer-ReviewedPubMedApplied radiation and isotopes · 2026
Advancing infection imaging: A one-step radioformulation strategy using antimicrobial peptide cold kit.
Sachdeva A, Mitra JB, Pati B et al.