{"entity":{"id":"cold-kit-formulation","kind":"technology","name":"Cold kit formulation","aka":["technetium cold kit","lyophilised radiopharmaceutical kit"],"tldr":"Many everyday radioactive scan drugs come as a freeze-dried powder in a sealed vial; the hospital pharmacy just adds the freshly produced radioactive solution and the finished injectable drug forms in minutes, no chemistry lab required.","summary":"A 'cold kit' is a sterile, pyrogen-free, freeze-dried (lyophilised) vial containing a non-radioactive ligand together with a reducing agent (commonly stannous/tin(II) chloride for technetium chemistry), buffer to set the correct pH for labelling, and stabilisers or fillers. Reconstituting the kit with freshly eluted radionuclide, most often sodium [99mTc]pertechnetate from a molybdenum-99/technetium-99m generator, or 68Ga chloride from a germanium-68/gallium-68 generator, drives rapid complex formation, sometimes at room temperature, sometimes with brief heating (for example 20 minutes in a boiling water bath for some 99mTc-HYNIC peptide kits), yielding an injectable radiopharmaceutical without dedicated radiochemistry infrastructure. Because the cold components are pre-sterilised and sealed, the entire process is a closed, aseptic operation that can be performed safely within a standard hospital nuclear medicine pharmacy rather than a full synthesis laboratory.\n\nCold kits typically have long, refrigerated shelf lives (commonly 3-12 months at 2-8°C) prior to radiolabelling, but the reconstituted, radiolabelled product itself is usually stable and usable for only a few hours at room temperature. Established 99mTc cold kits cover bone (MDP/HDP), myocardial perfusion (MIBI, tetrofosmin), renal (DTPA, MAG3-type, DMSA), hepatobiliary (mebrofenin), lung perfusion (MAA), lymphoscintigraphy (tilmanocept, nanocolloid), and neuroendocrine (HYNIC-TOC/TATE) imaging. The same general approach, sometimes called 'cold kit labelling', has since been extended to 68Ga-radiopharmaceuticals (for example the FDA/EMA-approved Illuccix and Locametz PSMA-11 kits), reducing the specialised equipment needed for routine PET tracer production. In the US, compounding radiopharmaceuticals, including kit reconstitution outside licensed manufacturing, is governed by USP General Chapter <825>, which sets minimum standards for preparation, dispensing and repackaging and defines beyond-use dating that accounts for radionuclide half-life and radiolytic decomposition.","asOf":"2026-09-22","links":[{"label":"IAEA Technical Reports Series 466: Technetium-99m radiopharmaceuticals - manufacture of kits","url":"https://www-pub.iaea.org/MTCD/Publications/PDF/trs466_web.pdf"},{"label":"Cold kit labeling: the future of 68Ga radiopharmaceuticals? (PMC 2022)","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC8869247/"},{"label":"USP fact sheet: decisions on appeals to General Chapter <825> Radiopharmaceuticals","url":"https://www.usp.org/sites/default/files/usp/document/health-quality-safety/usp-decision-on-appeals-825-factsheet.pdf"}],"tags":["manufacturing","cold kit","technetium"],"related":["mo99-tc99m-generators","ge68-ga68-generators","radionuclide-generators-kits","sterile-fill-finish","illuccix","locametz","ga-68","tc-99m","mo-99","ge-68"],"indications":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":["mo99-tc99m-generators","ge68-ga68-generators"],"notes":[],"principle":"A vial of freeze-dried, sterile, non-radioactive ligand, reducing agent and buffer is reconstituted at the point of use simply by adding the freshly eluted radionuclide solution; the labelling chemistry then proceeds inside the sealed, closed vial without any dedicated synthesis equipment, yielding an injectable dose within minutes.","strengths":[],"limitations":[],"since":"99mTc cold kits in routine use since the 1970s; 68Ga cold kits (Illuccix, Locametz) FDA/EMA approved 2021"},"route":"/technologies/cold-kit-formulation/","neighbours":{"technology":[{"id":"ge68-ga68-generators","kind":"technology","name":"Germanium-68/gallium-68 generators","route":"/technologies/ge68-ga68-generators/"},{"id":"mo99-tc99m-generators","kind":"technology","name":"Molybdenum-99/technetium-99m generators","route":"/technologies/mo99-tc99m-generators/"},{"id":"radiolabelling-quality-control","kind":"technology","name":"Radiolabelling quality control","route":"/technologies/radiolabelling-quality-control/"},{"id":"radionuclide-generators-kits","kind":"technology","name":"Radionuclide generators and cold kits","route":"/technologies/radionuclide-generators-kits/"},{"id":"sterile-fill-finish","kind":"technology","name":"Sterile fill-finish and lyophilisation","route":"/technologies/sterile-fill-finish/"}],"drug":[{"id":"illuccix","kind":"drug","name":"Illuccix (kit for Ga-68 gozetotide)","route":"/drugs/illuccix/"},{"id":"locametz","kind":"drug","name":"Locametz (kit for Ga-68 gozetotide)","route":"/drugs/locametz/"}],"isotope":[{"id":"ga-68","kind":"isotope","name":"Gallium-68","route":"/isotopes/ga-68/"},{"id":"ge-68","kind":"isotope","name":"Germanium-68","route":"/isotopes/ge-68/"},{"id":"mo-99","kind":"isotope","name":"Molybdenum-99","route":"/isotopes/mo-99/"},{"id":"tc-99m","kind":"isotope","name":"Technetium-99m","route":"/isotopes/tc-99m/"}]}}