USP Reference standards 11— USP Endotoxin RS.

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.

Expert Committee : (RMI05) Radiopharmaceuticals and Medical Imaging Agents 05

USP29–NF24 Page 2074

Phone Number : 1-301-816-8305