Sodium Iodide I123Capsules

Sodium iodide (Na123I).
Sodium iodide (Na123I) [41927-88-2].
»Sodium Iodide I123Capsules contain radioactive iodine (123I)processed in the form of Sodium Iodide obtained from the bombardment of enriched tellurium 124with protons or of enriched tellurium 122with deuterons or by the decay of xenon 123in such manner that it is carrier-free.Capsules contain not less than 90.0percent and not more than 110.0percent of the labeled amount of 123Ias iodide expressed in megabecquerels (microcuries or millicuries)at the time indicated in the labeling.Other chemical forms of radioactivity do not exceed 5percent 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 123Ias 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 123Iis 13.2hours.
Radionuclide identification— Asolution or suspension of 1or more Capsules in water responds to the test for Radionuclide identificationunder Sodium Iodide I123Solution.
Uniformity of dosage units á905ñ: meet the requirements.
Procedure for content uniformity— Determine the instrument response of each of 20Capsules 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 19of the Capsules are within the limits of 96.5%and 103.5%of the mean radioactivity value.
Radionuclidic purity— Asolution or suspension of 1or more Capsules in water responds to the test for Radionuclidic purityunder Sodium Iodide I123Solution.
Radiochemical purity— Homogenize 1Capsule in 3mLof water,add 3mLof methanol,and centrifuge:the supernatant so obtained meets the requirements of the test for Radiochemical purityunder Sodium Iodide I123Solution.
Other requirements— Asolution or suspension prepared by homogenizing 1or more Capsules in water to yield a concentration of not less than 1MBq (25µCi)per mLmeets the requirements of the Assay for radioactivityunder Sodium Iodide I123Solution.
Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents
USP28–NF23Page 1033
Phone Number:1-301-816-8305