Sodium Iodide I 123 Solution
Sodium iodide (Na123I).
Sodium iodide (Na123I) [41927-88-2].
» Sodium Iodide I 123 Solution is a solution, suitable for oral or for intravenous administration, containing 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.
Sodium Iodide I 123 Solution contains 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) per mL at the time indicated in the labeling. Other chemical forms of radioactivity do not exceed 5 percent of the total radioactivity. The Solution may contain a preservative or stabilizer.
Packaging and storage Preserve in single-dose or multiple-dose containers that previously have been treated to prevent adsorption, if necessary.
Labeling Label it to include the following: the time and date of calibration; the amount of 123I as iodide expressed as total megabecquerels (microcuries or millicuries) per mL at the time of calibration; the name and quantity of any added preservative or stabilizer; a statement to indicate whether the contents are intended for oral or for intravenous use; the expiration date and time; and the statement CautionRadioactive 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 (see Radioactivity 821) Its gamma-ray spectrum is identical to that of a specimen of 123I of known purity that exhibits a major photoelectric peak having an energy of 0.159 MeV.
Radionuclidic purity Using a suitable counting assembly (see Selection of a Counting Assembly under Radioactivity 821), determine the radionuclidic purity of the Solution: not less than 90% of the total radioactivity is present as I 123.
Bacterial endotoxins 85 Solution intended for intravenous use meets the requirements of the Bacterial Endotoxins Test 85; and the limit of endotoxin content is not more than 175/V USP Endotoxin Unit per mL of the Injection, when compared with USP Endotoxin RS, in which V is the maximum recommended total dose, in mL, at the expiration date or time.
pH 791: between 7.5 and 9.0 for solutions intended for intravenous administration; between 7.5 and 10.0 for solutions intended for oral administration.
Radiochemical purity Place a measured volume of a solution, containing 100 mg of potassium iodide, 200 mg of potassium iodate, and 1 g of sodium bicarbonate in each 100 mL, 25 mm from one end of a 25- × 300-mm strip of chromatographic paper (see Chromatography 621), and allow to dry. To the same area add a similar volume of appropriately diluted Solution such that it provides a count rate of about 20,000 counts per minute, and allow to dry. Develop the chromatogram over a period of about 4 hours by ascending chromatography, using dilute methanol (7 in 10). Dry the chromatogram in air, and determine the radioactivity distribution by scanning with a suitable collimated radiation detector: the radioactivity of the iodide 123I band is not less than 95.0% of the total radioactivity, and its RF value falls within ±5.0% of the value found for sodium iodide when determined under similar conditions. Confirmation of the identity of the iodide band is made by the addition to the suspected iodide band of 6 drops of acidified hydrogen peroxide solution (prepared by adding 6 drops of 1 N hydrochloric acid to 10 mL of hydrogen peroxide solution) followed by the dropwise addition of starch TS: the development of a blue color indicates the presence of iodide.
Other requirements Solution intended for intravenous use 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 final manufacture, and except that it is not subject to the recommendation on Volume in Container.
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USP32NF27 Page 2655Pharmacopeial Forum: Volume No. 31(6) Page 1642