Sodium Iodide I131Capsules

Sodium iodide (Na131I).
Sodium iodide (Na131I) [7790-26-3].
»Sodium Iodide I131Capsules contain radioactive iodine (131I)processed in the form of Sodium Iodide from products of uranium fission or the neutron bombardment of tellurium in such a manner that it is essentially carrier-free and contains only minute amounts of naturally occurring iodine 127.Capsules contain not less than 90.0percent and not more than 110.0percent of the labeled amount of 131Ias 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 stabilizing agent.
Packaging and storage— Preserve in well-closed containers.
Labeling— Label the Capsules to include the following:the date of calibration;the amount of 131Ias iodide expressed in megabecquerels (microcuries or millicuries)per Capsule at the time of calibration;a statement of whether the contents are intended for diagnostic or therapeutic use;the expiration date;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 131Iis 8.08days.
Radionuclide identification— Asolution or suspension of 1or more Capsules in water responds to the test for Radionuclide identificationunder Sodium Iodide I131Solution.
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 are met if not less than 19of the Capsules are within the limits of 96.5%and 103.5%of the mean radioactivity value.
Radiochemical purity— Homogenize 1Capsule in 3mLof water,add 3mLof methanol,and centrifuge.The supernatant meets the requirements of the test for Radiochemical purityunder Sodium Iodide I131Solution.
Other requirements— Asolution or suspension prepared by homogenizing 1or more Capsules in sufficient water to yield a concentration of not less than 1MBq (25µCi)per mLmeets the requirements of the Assay for radioactivityunder Sodium Iodide I131Solution.
Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents
USP28–NF23Page 1037
Phone Number:1-301-816-8305
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