Technetium Tc 99m (Pyro- and trimeta-) Phosphates Injection
» Technetium Tc 99m (Pyro- and trimeta-) Phosphates Injection is a sterile, aqueous solution, suitable for intravenous administration, composed of sodium pyrophosphate, sodium trimetaphosphate, and stannous chloride labeled with radioactive Tc 99m. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of 99mTc as phosphate expressed in megabecquerels (microcuries or millicuries) per mL at the time indicated in the labeling. Other chemical forms of radioactivity do not exceed 10.0 percent of the total radioactivity.
pH 791: between 4.0 and 7.0.
Radiochemical purity Place a measured volume of Injection, appropriately diluted, such that it provides a count rate of about 20,000 counts per minute, about 10 mm from one end of a 10- × 50-mm strip of chromatographic paper (see Chromatography 621), and immediately develop the chromatogram over a period of 3 to 5 minutes by ascending chromatography, using saline TS, and air-dry. Determine the radioactivity distribution by scanning with a suitable collimated radiation detector. Not more than 10.0% of the total radioactivity is found at the point of application. Similarly prepare a second strip, and thoroughly dry the spot with nitrogen. Develop the chromatogram over a period of 35 to 45 seconds by ascending chromatography, using freshly distilled methyl ethyl ketone, and allow to dry. Determine the radioactivity distribution as previously directed. Not less than 90.0% of the total radioactivity is found at the point of application.
Other requirements It meets the requirements of the tests for Radionuclide identification and Radionuclidic purity under Sodium Pertechnetate Tc 99m Injection, and the requirements of the tests for Packaging and storage, Labeling, Bacterial endotoxins, Biological distribution, and Assay for radioactivity under Technetium Tc 99m Pyrophosphate Injection. It meets the requirements under Injections 1, except that it may be distributed or dispensed prior to completion of the test for Sterility, the latter test being started on the day of manufacture, and except that it is not subject to the recommendation on Volume in Container.
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USP32NF27 Page 3670