10 C.F.R. § 35.204   Permissible molybdenum-99 concentration.


Title 10 - Energy


Title 10: Energy
PART 35—MEDICAL USE OF BYPRODUCT MATERIAL
Subpart D—Unsealed Byproduct Material—Written Directive Not Required

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§ 35.204   Permissible molybdenum-99 concentration.

(a) A licensee may not administer to humans a radiopharmaceutical that contains more than 0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (0.15 microcurie of molybdenum-99 per millicurie of technetium-99m).

(b) A licensee that uses molybdenum-99/technetium-99m generators for preparing a technetium-99m radiopharmaceutical shall measure the molybdenum-99 concentration of the first eluate after receipt of a generator to demonstrate compliance with paragraph (a) of this section.

(c) If a licensee is required to measure the molybdenum-99 concentration, the licensee shall retain a record of each measurement in accordance with §35.2204.

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