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Iobenguane I 131 Injection
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[[3-(Iodo-131I)-phenyl]methyl]guanidine sulfate (2:1).
[(m-Iodo-131I)-benzyl]guanidine sulfate (2:1).
» Iobenguane I 131 Injection is a sterile solution containing iobenguane sulfate in which a portion of the molecules contain radioactive iodine (131I) in the molecular structure. Iobenguane I 131 Injection contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of 131I as iobenguane sulfate expressed in megabecquerels (or in millicuries) per mL at the time indicated in the labeling. It may contain preservatives or stabilizers.
Packaging and storage— Preserve in single-dose or in multiple-dose containers that are adequately shielded. Store in a freezer.
Labeling— Label it to include the following: the date of calibration; the amount of 131I as iobenguane sulfate expressed as total megabecquerels (or millicuries) per mL at the time of calibration; the name and quantity of any added preservative or stabilizer; 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 8.04 days.
Radionuclidic 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 It contains 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 4.5 and 7.5.
Radionuclidic purity— Using a suitable counting assembly (see Selection of a Counting Assembly under Radioactivity 821), determine the radionuclidic purity of the Injection: not less than 99% of the total radioactivity is present as 131I.
Radiochemical purity—
Mobile phase— Prepare a filtered and degassed mixture of water and acetonitrile (900:100). Add 3.04 g of triethylamine per liter, and adjust with phosphoric acid to a pH of 4.0 ± 0.4. Make adjustments if necessary (see System Suitability under Chromatography 621).
Standard preparation— Dissolve an accurately weighed quantity of iobenguane sulfate in water to obtain a solution having a known concentration of about 1 mg per mL.
Test preparation— Use Iobenguane I 131 Injection.
Chromatographic system (see Chromatography 621)—The liquid chromatograph is equipped with a 229-nm detector, a collimated radiation detector (see Radioactivity 821), and a 3.9-mm × 3-cm column that contains 10-µm packing L1. The flow rate is about 1.5 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed under Procedure: the column efficiency is not less than 1000 theoretical plates, the tailing factor is not more than 1.2, and the relative standard deviation for replicate injections is not more than 1.5%.
Procedure— Inject a volume (about 20 µL) of Injection, equivalent to between 1.6 and 2.7 MBq (or between 44 and 64 µCi) into the chromatograph, record the chromatograms, and measure the areas for the major peaks. The radioactivity of the iobenguane 131I peak is not less than 90% of the total radioactivity measured, and its retention time is within 10% of that of the Standard preparation, similarly chromatographed. The retention time of the iobenguane 131I peak obtained from the Injection is also within 10% of that obtained from the Standard preparation.
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 71, the latter test being started on the day of final manufacture, and except that it is not subject to the recommendation for Volume in Container.
Assay for radioactivity— Using a counting assembly (see Selection of a Counting Assembly under Radioactivity 821), determine the radioactivity, in MBq (or µCi), per mL, of Injection by use of a calibrated system as directed under Radioactivity 821.
Auxiliary Information— Staff Liaison : Andrzej Wilk, Ph.D., Senior Scientific Associate
Expert Committee : (RMI05) Radiopharmaceuticals and Medical Imaging Agents 05
USP29–NF24 Page 1145
Phone Number : 1-301-816-8305