Xenon Xe 133 Injection
» Xenon Xe 133 Injection is a sterile, isotonic solution of Xenon 133 in Sodium Chloride Injection suitable for intravenous administration. Xenon 133 is a radioactive nuclide prepared from the fission of uranium 235. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of Xenon 133 at the date and time stated on the label.
Packaging and storage—
Preserve in single-dose containers that are totally filled, so that any air present occupies not more than 0.5% of the total volume of the container. Store at a temperature between 2
and 8. If there is free space above the solution, a significant amount of the xenon 133 is present in the gaseous phase. Glass containers may darken under the effects of radiation.
and 8. If there is free space above the solution, a significant amount of the xenon 133 is present in the gaseous phase. Glass containers may darken under the effects of radiation.
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 xenon 133 expressed as total megabecquerels (microcuries or millicuries), and concentration as megabecquerels (microcuries or millicuries), per mL at the time of calibration; the expiration date; the name and amount of any added bacteriostatic agent; 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 133Xe is 5.24 days.
1: the time and date of calibration; the amount of xenon 133 expressed as total megabecquerels (microcuries or millicuries), and concentration as megabecquerels (microcuries or millicuries), per mL at the time of calibration; the expiration date; the name and amount of any added bacteriostatic agent; 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 133Xe is 5.24 days.
Radionuclide identification (see Radioactivity 821)—
Its gamma-ray and X-ray spectra are identical to those of a known specimen of xenon 133 that exhibits two major photopeaks having energies of 0.081 MeV and 0.031 MeV (X-ray peak).
821)—
Its gamma-ray and X-ray spectra are identical to those of a known specimen of xenon 133 that exhibits two major photopeaks having energies of 0.081 MeV and 0.031 MeV (X-ray peak).
Bacterial endotoxins 85—
It contains 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.
85—
It contains 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 4.5 and 8.0.
791:
between 4.5 and 8.0.
Radionuclidic purity—
Using a suitable counting assembly (see Selection of a Counting Assembly under Radioactivity 821), determine the radioactivity of Xe 133 in the Injection by use of a calibrated system as directed under Radioactivity 821. The radioactivity exhibited at 0.081 MeV and 0.031 MeV is not less than 95.0% of the total radioactivity of the specimen.
821), determine the radioactivity of Xe 133 in the Injection by use of a calibrated system as directed under Radioactivity 821. The radioactivity exhibited at 0.081 MeV and 0.031 MeV is not less than 95.0% of the total radioactivity of the specimen.
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 manufacture, and except that it is not subject to the recommendation on Volume in Container.
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 manufacture, and except that it is not subject to the recommendation on Volume in Container.
Assay for radioactivity—
Using a suitable counting assembly (see Selection of a Counting Assembly under Radioactivity 821), determine the radioactivity, in MBq (mCi) per mL, of Injection by use of a calibrated system as directed under Radioactivity 821.
821), determine the radioactivity, in MBq (mCi) per mL, of Injection by use of a calibrated system as directed under Radioactivity 821.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
| Monograph | Ian DeVeau, Ph.D.
Director, Veterinary Drugs and Radiopharmaceuticals 1-301-816-8178 |
(RMI05) Radiopharmaceuticals and Medical Imaging Agents 05 |
| Reference Standards | Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org |
|
| 85 |
Radhakrishna S Tirumalai, Ph.D.
Senior Scientist 1-301-816-8339 |
(MSA05) Microbiology and Sterility Assurance |
USP32–NF27 Page 3878