Printed on: Tue Aug 03 2021, 07:34:45 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 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.
Labeling—Label it to include the following, in addition to the
information specified for Labeling á7ñ, Labels and Labeling for
Injectable Products: 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
er
time of calibration; the expiration date; the name and amount
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https://online.uspnf.com/uspnf/document/1_GUID-6432BF0F-1A82-4562-B28E-F0A4387DA1C0_4_en-US
DocId: 1_GUID-6432BF0F-1A82-4562-B28E-F0A4387DA1C0_4_en-US
Document Type: USP @2021 USPC
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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 á821ñ)—Its
al
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 Test á85ñ—It contains not more than
175/V USP Endotoxin Unit per mL of the Injection, when
ci
compared with the USP Endotoxin RS, in which V is the
maximum recommended total dose, in mL, at the expiration
date or time.
pH á791ñ: between 4.5 and 8.0.
Radionuclidic purity—Using a suitable counting assembly,
ffi
determine the radioactivity of Xe 133 in the Injection by use
of a calibrated system as directed under Radioactivity á821ñ.
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 and Implanted Drug Products á1ñ, except that the
O
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 Container Content.
Assay for radioactivity—Using a suitable counting
assembly, determine the radioactivity, in MBq (mCi) per mL,
of Injection by use of a calibrated system as directed under
Radioactivity á821ñ.▲ (USP 1-May-2019)
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