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spectrum of a pure Rb 82 specimen (generator eluate
Rubidium Chloride Rb 82 Injection containing 82 Rb taken within 10 minutes of elution). Sr 85
exhibits a major photopeak at 514 keV and decays with a
» Rubidium Chloride Rb 82 Injection is a sterile radioactive half-life of 64.8 days. Sr 85 may be determined by
subtraction of the 511 and 777 keV peaks in the pure Rb 82,
solution, suitable for intravenous administration. It from the 511–514 keV and 777 keV peaks in the hour-old
contains not less than 90.0 percent and not more eluate. The activity level of Sr 85 is not more than 0.2 kBq per
than 110.0 percent of the labeled amount of 82 Rb MBq (0.2 µCi per mCi) of Rb 82 at the end of elution.
expressed in megabecquerels (or in millicuries) per Other gamma-ray emitters—The total of other gamma-ray
mL at the time indicated in the labeling. It is emitting radionuclidic impurities does not exceed 0.005 kBq
per MBq (0.005 µCi per mCi) of Rb 82 at the end of elution.
obtained by elution from a strontium 82-rubidium
82 generator system. 82 Rb, with a half-life of 76 Chemical purity—
seconds, is a short-lived positron-emitting Electrolyte solution—Transfer 107 g of ammonium chloride,
25 g of gelatin, and 42 mL of hydrochloric acid to a 500-mL
radionuclide formed by the radioactive decay of volumetric flask. Add about 450 mL of water, and sonicate
the parent nuclide 82 Sr. Strontium Sr 82 with a until a clear solution is obtained. Dilute with water to volume,
half-life of 25.5 days is produced by the proton and mix.
irradiation of rubidium or spallation of Tin stock standard solution—Dissolve 100 mg of metallic tin
(Sn), accurately weighed, in 10 mL of dilute hydrochloric acid
molybdenum. The chemical form of the Injection (1 in 2), and dilute with water to 100 mL.
is 82 RbCl. [NOTE—Elute with additive-free Sodium Tin standard solution A—Transfer 0.5 mL of Tin stock
Chloride Injection only. Discard the first 50 mL of standard solution to a 50-mL volumetric flask and dilute with
al
the eluate each day the generator is eluted.] 0.1 N hydrochloric acid to volume.
Tin standard solution B—Transfer 1.0 mL of Tin standard
Packaging, storage, and labeling—Requirements for solution A to a 50-mL volumetric flask. Add 10.0 mL of 0.9%
packaging, storage, and labeling do not apply; Rubidium sodium chloride solution, dilute with Electrolyte solution to
Chloride Rb 82 Injection is obtained by elution from the
ci volume, and mix.
generator and is administered by direct infusion. Test solution—Obtain a 50-mL eluate from the generator,
Bacterial Endotoxins Test á85ñ—It contains not more than and allow to stand for at least 1 hour to allow for the complete
175/V USP Endotoxin Unit per mL of the Injection, when decay of 82 Rb. Transfer 10.0 mL of the eluate to a 50-mL
compared with the USP Endotoxin RS, in which V is the volumetric flask, dilute with the Electrolyte solution to volume,
maximum recommended total dose, in mL, at the expiration and mix.
ffi
date or time. Procedure—Transfer a portion of the Test solution to a
Radionuclide identification (see Radioactivity á821ñ)— polarographic cell, and deaerate by bubbling nitrogen
[NOTE—Perform this test quickly, because of the rapid decay through the solution for 5 minutes. Insert the dropping
of the 82 Rb.] The gamma-ray spectrum of eluted 82 Rb exhibits mercury electrode of a suitable polarograph, and obtain the
photopeaks at 511 and 777 keV. differential pulse polarogram from −0.15 to −0.75 volts, at a
pH á791ñ: between 4.0 and 8.0. current range of 0.5 µA, using a saturated calomel electrode
O
Radionuclidic purity—Using a suitable counting assembly, as the reference electrode and a platinum wire as the auxiliary
determine the radioactivity of each radionuclidic impurity, in electrode (see Polarography á801ñ). Similarly, transfer a portion
kBq per MBq (or µCi per mCi), of Rb 82 in the generator eluate of the Tin standard solution B to a polarographic cell and obtain
by use of a calibrated system as directed under Radioactivity the polarogram. A peak at −0.52 volts indicates the presence
á821ñ. [NOTE—For the following tests, use the generator eluate of tin. The peak height of the Test solution is not greater than
containing 82 Rb that has been allowed to decay for 1 hour that of the Tin standard solution B (1 µg per mL).
after the end of elution.] Other requirements—It meets the requirements under
Sr 82 and Rb 83—Obtain a gamma-ray spectrum of the Injections and Implanted Drug Products á1ñ, except that the
hour-old eluate, and measure the activities of the radionuclidic Injection may be distributed or dispensed prior to completion
impurities directly from the spectrum. Sr 82 exhibits of the test for Sterility, the latter test being started on the day
photopeaks at 511 and 777 keV and decays with a radioactive of final manufacture, and except that it is not subject to the
half-life of 25.5 days. Rb 83 exhibits a photopeak at 530 keV recommendation for Container Content á697ñ.
and decays with a radioactive half-life of 86.2 days. The activity Assay for radioactivity—Using a suitable counting
levels of Sr 82 and Rb 83 are not more than 0.02 kBq per MBq assembly , determine the radioactivity, in MBq (or in µCi) per
(0.02 µCi per mCi) and not more than 0.05 kBq per MBq (0.05 mL, of the Injection by use of a calibrated system as directed
µCi per mCi) of Rb 82 at the end of elution, respectively. under Radioactivity á821ñ.
Sr 85—Obtain a gamma spectrum of the hour-old eluate,
and, using the same system and geometry, obtain a gamma
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