Iodinated I 131 Albumin Aggregated Injection

Albumin labeled with iodine-131.
» Iodinated I 131 Albumin Aggregated Injection is a sterile aqueous suspension of Albumin Human that has been iodinated with 131I and denatured to produce aggregates of controlled particle size. Each mL of the suspension contains not less than 300 µg and not more than 3.0 mg of aggregated albumin with a specific activity of not less than 7.4 megabecquerels (200 microcuries) per mg and not more than 44.4 megabecquerels (1.2 millicuries) per mg of aggregated albumin. Iodinated I 131 Albumin Aggregated Injection contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of 131I, as aggregated albumin, expressed in megabecquerels (microcuries) per mL or megabecquerels (millicuries) per mL at the time indicated in the labeling. Other chemical forms of radioactivity do not exceed 6 percent of the total radioactivity. Its production and distribution are subject to federal regulations (see Biologics 1041 and Radioactivity 821).
Packaging and storage— Preserve in single-dose or in multiple-dose containers, at a temperature between 2 and 8.
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 aggregated albumin expressed as total megabecquerels (microcuries or millicuries) and as aggregated albumin in mg 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; in addition, the labeling states that it is not to be used if clumping of the albumin is observed and directs that the container be agitated before the contents are withdrawn into a syringe.
USP Reference standards 11
USP Endotoxin RS
Radionuclide identification— 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.
pH 791: between 5.0 and 6.0.
Other requirements— It meets the requirements under Biologics 1041 and under Injections 1, except that it is not subject to the recommendation on Volume in Container. It meets also the requirements for Particle size, Bacterial endotoxins, and Radiochemical purity under Technetium Tc 99m Albumin Aggregated Injection, except that in the test for Radiochemical purity, not more than 6% of the radioactivity is found in the supernatant following centrifugation.
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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Monograph Ravi Ravichandran, Ph.D.
Principal Scientific Liaison
(SM42010) Monographs - Small Molecules 4
Reference Standards RS Technical Services
USP35–NF30 Page 3522