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U.S. Department of Health and Human Services

Science & Research

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Volume IV - 12.5 Radiopharmaceutical Program

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Orientation and Training

Food and Drug Administration


Section 12 - Radioactivity

EFFECTIVE DATE: 10-01-03 REVISED: 02-14-13

A. Objectives

The trainer will provide the training, e.g. reading, demonstrations, self-study, on the job training. Assigned radiopharmaceuticals will be dependent on Center/CDER initiatives or requests.

B.  Assignment

The trainee will read the ORA Laboratory Manual, Volume IV, Section 3:  Drug Analysis.

The USP/NDA methods for radiopharmaceuticals include conventional pharmaceutical analyses and may include the following:

  1. assay for radioactivity,
  2. radiochemical purity,
  3. radionuclidic purity, and
  4. radionuclide identification.

C. Questions

  1. Define radiochemical purity and radionuclidic purity.
  2. Define the term “cold kit.”  Define precautions are to be taken when preparing a cold kit with Tc-99m?  What happens when air is inadvertently introduced into the cold kit?
  3. Discuss the theory of operation and use of Tc-99m/Mo-99 generator.

D. References

  1. United States pharmacopoeia and national formulary (current ed.).
  2. ORA Laboratory Manual, Volume IV, Section 3:  Drug Analysis.