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| Orientation and Training Food and Drug Administration |
| DOCUMENT NO.: IV-12 | VERSION NO.:1.1 | Section 12 - Radioactivity | EFFECTIVE DATE: 10/01/2003 | REVISED: 06/27/2008 |
12.5 Radiopharmaceutical Program
A. Objectives The trainer will provide reading and reference materials pertinent to pharmaceutical and radiopharmaceutical testing, methodology, and on the job training for radiopharmaceutical analyses. 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 procedures for measuring radioactivity: - assay for radioactivity,
- radiochemical purity,
- radionuclidic purity, and
- radionuclide identification.
The trainee will analyze the simpler technetium cold kits. Samples reserved from previous radiopharmaceutical surveillance studies may serve as training samples (e.g. technetium 99m medronate kit, technetium 99m gluceptate kit). More difficult radiopharmaceuticals, (e.g. Cyanocobalamin Co-57 cobalt tablets, Sodium Chromate Cr-51 solution for injection) will be introduced as the trainee progresses. C. Questions - Define radiochemical purity and radionuclidic purity.
- Define the term “cold kit.” What precautions are to be taken when preparing a cold kit with Tc-99m? What happens when air is inadvertently introduced into the cold kit?
- Discuss the theory of operation and use of Tc-99m/Mo-99 generator.
D. References - United States pharmacopoeia and national formulary (current ed.).
- ORA Laboratory Manual, Volume IV, Section 3: Drug Analysis.
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