Sodium iodide (Na131I).
Sodium iodide (Na131I) [7790-26-3].

Packaging and storage— Preserve in single-dose or in multiple-dose containers that previously have been treated to prevent adsorption.

Labeling— Label it to include the following: the time and date of calibration; the amount of 131I as iodide expressed as total megabecquerels (microcuries or millicuries) and as megabecquerels (microcuries or millicuries) per mL at the time of calibration; the name and quantity of any added preservative or stabilizer; a statement of the intended use, whether oral or intravenous; 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 131I is 8.08 days.

USP Reference standards 11— USP Endotoxin RS.

Radionuclide identification (see Radioactivity 821)— Its gamma-ray spectrum is identical to that of a specimen of iodine 131 of known purity that exhibits a major photopeak having an energy of 0.364 MeV.

Bacterial endotoxins 85— Solution intended for intravenous use meets the requirements of the Bacterial Endotoxins Test 85, the limit of endotoxin content being not more than 175/V USP Endotoxin Unit per mL of the Solution, when compared with the 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.

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 (7.0 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 131I band is not less than 95% of the total radioactivity, and its RF value falls within ±5% of the value found for sodium iodide when determined under parallel 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 presence of iodide.

Other requirements— Solution intended for intravenous use meets the requirements under Injections 1, except that the Solution 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.

Assay for radioactivity— Using a suitable counting assembly (see Selection of a Counting Assembly under Radioactivity 821), determine the radioactivity, in MBq (µCi) per mL, of Solution by use of a calibrated system as directed under Radioactivity 821.

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

USP29–NF24 Page 1151

Phone Number : 1-301-816-8305