C20H2Cl4131I4Na2O5

Spiro[isobenzofuran-1(3H),9¢-[9H]-xanthene]-3-one, 4,5,6,7-tetrachloro-3¢,6¢-dihydroxy-2¢,4¢,5¢,7¢-tetraiodo-, disodium salt, labeled with iodine-131.
4,5,6,7-Tetrachloro-2¢,4¢,5¢,7¢-tetraiodofluorescein disodium salt-131I [24916-55-0; 50291-21-9; 15251-14-6].

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 rose bengal sodium expressed as total megabecquerels (microcuries or millicuries) and as megabecquerels (microcuries or millicuries) per mL on the date 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 131I 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 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 about 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 Injection 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 2 hours by ascending chromatography, using 1 N acetic acid. Dry the chromatogram in air, and determine the radioactivity distribution by scanning the chromatogram with a suitable collimated radiation detector. The radioactivity under the rose bengal band is not less than 90.0% of the total radioactivity. The rose bengal band is at the point of application.

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 rose bengal sodium— Determine the absorbance of Injection, appropriately diluted, in a 1-cm cell at 550 nm, with a suitable spectrophotometer, using a sodium bicarbonate solution adjusted to a pH of 8.0 as the blank. Calculate the quantity, in mg, of rose bengal sodium per mL of the Injection taken by the formula: in which D is the dilution factor; AU is the absorbance of the solution; and AS is the absorbance, similarly determined, of a solution of rose bengal sodium adjusted to a pH of 8.0 by the addition of sodium bicarbonate and containing 4 µg of rose bengal sodium per mL.

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 1150

Phone Number : 1-301-816-8305