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Technetium Tc 99m Radiopharmaceutical Monographs: Removal of Biological Distribution Tests

Type of Posting: Notice of Intent to Revise
Posting Date: 30-Jul-2021
Targeted Official Date: TBD
Expert Committee: Small Molecules 4

In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 4 Expert Committee intends to revise the following Technetium Tc 99m monographs:

  • Technetium Tc 99m (Pyro- and trimeta-) Phosphates Injection
  • Technetium Tc 99m Albumin Aggregated Injection
  • Technetium Tc 99m Disofenin Injection
  • Technetium Tc 99m Exametazime Injection
  • Technetium Tc 99m Mebrofenin Injection
  • Technetium Tc 99m Medronate Injection
  • Technetium Tc 99m Oxidronate Injection
  • Technetium Tc 99m Pentetate Injection
  • Technetium Tc 99m Pyrophosphate Injection
  • Technetium Tc 99m Succimer Injection
  • Technetium Tc 99m Sulfur Colloid Injection

Comments were received indicating that the test for Biological Distribution should be eliminated from multiple Technetium Tc 99m monographs as part of efforts to reduce animal testing. The Expert Committee proposes to revise the Technetium Tc 99m monographs listed above to remove the Biological Distribution tests. 

A Biological Distribution test (an animal test) was included in the earlier Technetium Tc 99m related monographs. When these monographs were first developed, the analytical test methods needed to ensure the identity, purity, and quality were not yet fully established and standardized. Current analytical test methods (e.g., chromatographic test methods used for Radiochemical Identity and Radiochemical Purity) in the monographs are suitable for establishing the identity, strength, purity, and quality of the drug products. Therefore, the Biological Distribution test is no longer needed in these monographs.

It is anticipated that the proposed revisions will be published as In-Process Revisions in a future Pharmacopeial Forum.

Should you have any questions, please contact Gerald Hsu, Principal Liaison (