Rose Bengal Sodium I 131 Injection
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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].
» Rose Bengal Sodium I 131 Injection is a sterile solution containing rose bengal sodium in which a portion of the molecules contain radioactive iodine (131I) in the molecular structure. It may contain a suitable buffer.
Rose Bengal Sodium I 131 Injection contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of 131I as rose bengal sodium expressed in megabecquerels (microcuries or in millicuries) per mL at the time indicated in the labeling. The rose bengal sodium content is not less than 90.0 percent and not more than 110.0 percent of the labeled amount. Other chemical forms of radioactivity do not exceed 10.0 percent of the total radioactivity.
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:
0.004D(AU / AS)
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.
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Topic/Question Contact Expert Committee
Monograph Ravi Ravichandran, Ph.D.
Principal Scientific Liaison
(SM42010) Monographs - Small Molecules 4
Reference Standards RS Technical Services
85 Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison
(GCM2010) General Chapters - Microbiology
USP35–NF30 Page 3523