Minn. R. agency 144, ch. 4731, MEDICAL USE OF RADIOACTIVE MATERIAL, pt. 4731.4435 - PERMISSIBLE MOLYBDENUM-99, STRONTIUM-82, AND STRONTIUM-85 CONCENTRATION
A. A licensee may
not administer to humans a radiopharmaceutical that contains:
(1) more than 0.15 microcurie of
molybdenum-99 per millicurie of technetium-99m (0.15 kilobecquerel of
molybdenum-99 per megabecquerel of technetium-99m);
(2) more than 0.02 microcuries of
strontium-82 per millicurie of rubidium-82 chloride injection (0.02 kBq of
strontium-82 per MBq of rubidium-82 chloride); or
(3) more than 0.2 microcuries of strontium-85
per millicurie of rubidium-82 chloride injection (0.2 kBq of strontium-85 per
MBq of rubidium-82).
B.
A licensee that uses molybdenum-99/technetium-99m generators for preparing a
technetium-99m radiopharmaceutical must measure the molybdenum-99 concentration
in each eluate from a generator to demonstrate compliance with item A.
C. A licensee that uses a
strontium-82/rubidium-82 generator for preparing a rubidium-82
radiopharmaceutical must, before the first patient use of the day, measure the
concentration of strontium-82 and strontium-85 radionuclides to demonstrate
compliance with item A.
D. If a
licensee is required to measure the molybdenum-99 concentration or strontium-82
and strontium-85 concentrations, the licensee must retain a record of each
measurement according to part 4731.4509.
E. The licensee must report any measurement
that exceeds the limits in item A at the time of generator elution, in
accordance with part 4731.4528.
Notes
Statutory Authority: MS s 144.1202; 144.1203
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