C9H7131INNaO3

Glycine, N-[2-(iodo-131I-benzoyl)-, monosodium salt.
Monosodium o-iodo-131I-hippurate [881-17-4].

Packaging and storage— Preserve in single-dose or in multiple-dose containers.

Labeling— Label it to include the following, in addition to the information specified for Labeling under Injections 1: the time and date of calibration; the amount of 131I as iodohippurate sodium expressed as total megabecquerels (microcuries or millicuries) and as megabecquerels (microcuries or millicuries) per mL at the time of calibration; 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— The limit of endotoxin content is not more than 175/V USP Endotoxin Unit per mL of the Injection, 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 7.0 and 8.5.

Radiochemical purity— Place 1 drop of a solution containing 0.2 percent potassium iodide, 1.0 percent sodium bicarbonate, and 1.0 percent sodium thiosulfate, about 45 mm from one end of each of two 25- × 300-mm strips of chromatographic paper (see Chromatography 621), and allow to dry. Superimpose on one of the spots a measured volume of Injection, appropriately diluted, such that it provides a count rate of about 20,000 counts per minute, on this point of application, and allow to air-dry. Superimpose on the second spot 100 µL of a solution prepared by dissolving 50 mg of non-radioactive iodohippurate sodium in 10 mL of alcohol, and allow to air-dry. Develop the chromatogram over a period of about 2½ hours by descending chromatography, using the upper layer obtained by shaking together 2 volumes of benzene, 2 volumes of glacial acetic acid, and 1 volume of water. Use the aqueous layer to equilibrate the apparatus prior to the start of development. Dry the chromatogram in air, and determine the radioactivity distribution by scanning the chromatogram with a suitable collimated radiation detector. Locate the position of the non-radioactive spot by viewing the chromatogram under short-wavelength UV light. The radioactivity under the iodohippuric acid band is not less than 97.0% of the total radioactivity, and its RF value is within ±10% of that of the non-radioactive spot.

Other requirements— It meets the requirements under Injections 1, except that the Injection may be distributed or dispensed prior to the 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 Injection by use of a calibrated system as directed under Radioactivity 821.

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

USP29–NF24 Page 1149

Phone Number : 1-301-816-8305