Xenon Xe 127
» Xenon Xe 127 is a gas suitable for inhalation in diagnostic studies. Xenon 127 is a radioactive nuclide that may be prepared from the bombardment of a cesium 133 target with high-energy protons. It contains not less than 85.0 percent and not more than 115.0 percent of the labeled amount of 127Xe at the calibration date indicated on the labeling.
Packaging and storage—
Preserve in single-dose vials having leak-proof stoppers, at room temperature. The vials are enclosed in appropriate lead radiation shields. The vial content may be diluted with air and is packaged at atmospheric pressure.
Labeling—
Label it to include the following: the name of the preparation; the container volume, MBq (mCi) of 127Xe per container; the amount of 127Xe expressed as megabecquerels (millicuries) per mL; the intended route of administration; recommended storage conditions; the date of calibration; the expiration date; the name, address, and batch number of the manufacturer; the statement “Caution—Radioactive Material”; and a radioactive symbol. The labeling contains a statement of radionuclide purity, identifies probable radionuclidic impurities, and indicates permissible quantities of each impurity. 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 127Xe is 36.41 days.
Radionuclide identification (see Radioactivity
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Radionuclidic purity—
Using a suitable counting assembly (see Selection of a Counting Assembly under Radioactivity
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Assay for radioactivity—
Using a suitable counting assembly (see Selection of a Counting Assembly under Radioactivity
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
USP32–NF27 Page 3877
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