U.S. PHARMACOPEIA

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Iodinated I 131 Albumin Injection

Albumin labeled with iodine-131.
» Iodinated I 131 Albumin Injection is a sterile, buffered, isotonic solution containing normal human albumin adjusted to provide not more than 37 MBq (1 mCi) of radioactivity per mL. It is derived by mild iodination of normal human albumin with the use of radioactive iodine (131I) to introduce not more than one gram-atom of iodine for each gram-molecule (60,000 g) of albumin.
Iodinated I 131 Albumin Injection contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of 131I as iodinated albumin, expressed in megabecquerels (microcuries or in millicuries) per mL at the time indicated in the labeling. Other forms of radioactivity do not exceed 3 percent of the total radioactivity. Its production and distribution are subject to federal regulations (see Biologics 1041 and Radioactivity 821).
Labeling— Label it to include the following, in addition to the information specified for Labeling under Injections 1: the date of calibration; the amount of 131I as iodinated albumin, expressed as total megabecquerels (millicuries or microcuries), and concentration 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.
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.
Other requirements— It meets the requirements for Packaging and storage, Bacterial endotoxins, pH, Radiochemical purity, and Assay for radioactivity under Iodinated I 125 Albumin Injection. It meets also the requirements under Biologics 1041, and the requirements under Injections 1, except that it is not subject to the recommendation on Volume in Container. It meets all other applicable requirements of the FDA.
Auxiliary Information— Staff Liaison : Andrzej Wilk, Ph.D., Senior Scientific Associate
Expert Committee : (RMI05) Radiopharmaceuticals and Medical Imaging Agents 05
USP29–NF24 Page 1148
Phone Number : 1-301-816-8305