Sodium Iodide I 123 Capsules

Sodium iodide (Na123I).
Sodium iodide (Na123I) [41927-88-2].
» Sodium Iodide I 123 Capsules contain radioactive iodine (123I) processed in the form of Sodium Iodide obtained from the bombardment of enriched tellurium 124 with protons or of enriched tellurium 122 with deuterons, or by proton irradiation of enriched xenon 124, or by the decay of xenon 123 in such manner that it is carrier-free. Capsules contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of 123I as iodide expressed in megabecquerels (microcuries or millicuries) at the time indicated in the labeling. Other chemical forms of radioactivity do not exceed 5 percent of the total radioactivity. The Capsules may contain a stabilizer.
Packaging and storage— Preserve in well-closed containers that are adequately shielded.
Labeling— Label the Capsules to include the following: the name of the Capsules; the name, address, and batch or lot number of the manufacturer; the time and date of calibration; the amount of 123I as iodide expressed in megabecquerels (microcuries or millicuries) per Capsule at the time of calibration; the name and quantity of any added preservative or stabilizer; a statement indicating that the Capsules are for oral use only; the expiration date and time; and the statement “Caution—Radioactive Material.” The labeling indicates that in making dosage calculations, correction is to be made for radioactive decay, and also indicates that the radioactive half-life of 123I is 13.2 hours.
Radionuclide identification— A solution or suspension of 1 or more Capsules in water responds to the test for Radionuclide identification under Sodium Iodide I 123 Solution.
Uniformity of dosage units 905: meet the requirements.
Procedure for content uniformity— Determine the instrument response of each of 20 Capsules by measurement in a suitable counting assembly and under identical geometric conditions. Calculate the mean radioactivity value per Capsule: the requirements of the test are met if not less than 19 of the Capsules are within the limits of 96.5% and 103.5% of the mean radioactivity value.
Radionuclidic purity— A solution or suspension of 1 or more Capsules in water responds to the test for Radionuclidic purity under Sodium Iodide I 123 Solution.
Radiochemical purity— Homogenize 1 Capsule in 3 mL of water, add 3 mL of methanol, and centrifuge: the supernatant so obtained meets the requirements of the test for Radiochemical purity under Sodium Iodide I 123 Solution.
Other requirements— A solution or suspension prepared by homogenizing 1 or more Capsules in water to yield a concentration of not less than 1 MBq (25 µCi) per mL meets the requirements of the Assay for radioactivity under Sodium Iodide I 123 Solution.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ian DeVeau, Ph.D.
Director, Veterinary Drugs and Radiopharmaceuticals
1-301-816-8178		 (RMI05) Radiopharmaceuticals and Medical Imaging Agents 05
USP32–NF27 Page 2654
Pharmacopeial Forum: Volume No. 31(6) Page 1642