The standards framework a compliant Tc-99m service audits against.

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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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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