Printed on: Tue Aug 03 2021, 07:34:38 AM Official Status: No Longer Official on 03-Aug-2021
(EST)
Printed by: Le Tran Official Date: Omitted on 01-May-2019
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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
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https://online.uspnf.com/uspnf/document/1_GUID-73A0529B-B77C-4FC3-A28F-3221AC1EAE35_2_en-US
DocId: 1_GUID-73A0529B-B77C-4FC3-A28F-3221AC1EAE35_2_en-US
Document Type: USP @2021 USPC
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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
al
36.41 days.
Radionuclide identification (see Radioactivity á821ñ)—Its
gamma-ray spectrum is identical to that of a known specimen
of xenon 127 that exhibits major photopeaks at 202.8 keV,
and 172.1 keV, and 375.0 keV. Minor photopeaks from other
ci
xenon radioisotopes, namely Xe 129m (197 keV) and Xe
131m (164 keV) may also be present.
Radionuclidic purity—Using a suitable counting assembly,
determine the radioactivity of the Xe 127 in the gas by use of a
calibrated system as directed under Radioactivity á821ñ. Using
ffi
the gamma-ray spectrum, determine the energy of each
gamma photopeak. Identify each radionuclide present, and
using the established detector efficiency and known gamma
abundance, calculate the quantity of each radionuclide
present in the specimen in MBq (mCi). The amount of Xe 127
present in the specimen is not less than 80%; the quantity of
O
either Xe 131m or Xe 129m does not exceed 10%, and no
other radioisotope exceeds 1%.
Assay for radioactivity—Using a suitable counting
assembly, determine the radioactivity, in MBq (mCi), of Xe
127 in each container by use of a calibrated system as
directed under Radioactivity á821ñ.▲ (USP 1-May-2019)
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