Abstract

Radionuclide impurities of radiopharmaceuticals do not provide any diagnostic information, but contribute to the radiation dose to the patient. For 99mTc, even small amounts of long lived radionuclide impurities may contribute significantly to the dose from 99mTc itself. In this preliminary study, estimates have been made for the radiation dose to specific organs and for the effective dose equivalent from impurities in 99mTc-sodium pertechnetate prepared from fission product 99Mo. In addition to 99Mo, 131I, 103Ru, 89Sr and 90Sr at maximum permissible levels as stipulated in the European Pharmacopoeia, 110mAg and 239Pu were taken as representative nuclides for beta-gamma emitters and alpha emitters. Using all of these radionuclides at such maximum permissible levels of impurity as stated in the European Pharmacopoeia, the total contribution from the impurities to the effective dose equivalent is approximately 30% of the effective dose equivalent from 99mTc-pertechnetate. In terms of specific organs, the liver and kidneys can receive doses of 3-4 times and 1-3 times the dose from 99mTc-pertechnetate itself. Although these are worst case calculations, a consistent approach should be reconsidered to limit the additional effective dose equivalent from impurities to e.g. 10% of the effective dose equivalent from 99mTc itself.

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