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); or


§
(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 of the first eluate after receipt of a generator to demonstrate compliance with item A.


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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.


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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.