1. A. Maximum concentrations. A licensee may not administer to humans a radiopharmaceutical containing:

   1. (1) more than 0.15 microcurie of molybdenum-99 per each millicurie of technetium-99m (0.15 kilobecquerel of molybdenum-99 per each megabecquerel of technetium-99m); or
   2. (2) more than 0.02 microcurie of strontium-82 per millicurie of rubidium-82 chloride injection (0.02 kilobecquerel of strontium-82 per megabecquerel of rubidium-82 chloride); or more than 0.2 microcurie of strontium-85 per millicurie of rubidium-82 chloride injection (0.2 kilobecquerel of strontium-85 per megabecquerel of rubidium-82).

2. B. Measurement.

   1. (1) A licensee preparing technetium-99m radiopharmaceutical from molybdenum-99/technetium-99m generators shall measure the molybdenum-99 concentration in each eluate from a generator to demonstrate compliance with Subsection A of this section.
   2. (2) A licensee that uses a strontium-82/rubidium-82 generator for preparing a rubidium-82 radiopharmaceutical shall, before the first patient use of the day, measure the concentration of radionuclides strontium-82 and strontium-85 to demonstrate compliance with Subsection A of this section.
3. C. Record keeping. If a licensee is required to measure the molybdenum-99 concentration or strontium-85 and strontium-85 concentrations, the licensee shall retain a record of each measurement in accordance with Subsection M of 20.3.7.715 NMAC.
4. D. Reporting. The licensee shall report any measurement that exceeds the limits in Subsection A of this section at the time of generator elution, in accordance with subsection D of 20.3.7.716 NMAC and 10 CFR § 35.3204.

[20.3.7.706 NMAC - Rp, 20 NMAC 3.1.7.706, 04/30/2009, A, 02/14/2023]