Packaging and storage
Preserve in single-dose containers, and store in a refrigerator for not more than 8 hours. [NOTETranslucent protein particles may develop, which are removed by filtration prior to administration using a 0.22-µm low-protein-binding filter.]
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 Yttrium Y 90 ibritumomab tiuxetan as total MBq (or mCi) and concentration of yttrium 90
Y ibritumomab tiuxetan, in MBq (or mCi) per mL, at the time of calibration; the expiration date and time; the storage temperature; and the statement, CautionRadioactive 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 90
Y is 64.1 hours.
Radionuclide identification (see Radioactivy 821)
The beta radiation of the Injection shows a mass absorption coefficient within 5% of the value found for a known standard of the 90Y when tested under the same counting conditions.
The beta-ray spectrum, obtained on an energy calibrated beta spectrometer, is identical to that of the spectrum of 90Y of known purity, showing a maximum beta particle energy (Emax) at about 2280 keV. [NOTEBecause of the inherent difficulty in measuring beta radiation, a second comparative test should be performed.]
Bacterial endotoxins 85
The limit of endotoxin content is not more than 175/V
USP Endotoxin Units 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.
1- × 8-cm instant silica gel strip.
Developing solvent system:
0.9% sodium chloride solution.
Proceed as directed for Thin-Layer Chromatography
under Chromatography 621
by ascending chromatography. Determine the distribution of radioactivity on the chromatogram by scanning with a suitable collimated radiochromatogram strip scanner, and determine the percentage of radiochemical purity of the test specimen. Not less than 95% of the 90
Y activity is present as a band between the RF
values of 0.0 and 0.1.
Radionuclidic purity (Content of 90Sr in an yttrium Y 90 chloride solution)
Prepare a strontium/yttrium carrier solution containing 0.34 mg of yttrium chloride (YCl3
O) and 0.30 mg of strontium chloride (SrCl2
O) per mL of 0.1 N hydrochloric acid. Apply about 50 µL of this solution at the origin of a 2- × 19-cm cellulose phosphate chromatographic strip (see Chromatography 621
), and allow to dry. Apply about 5 µL of the yttrium Y 90 chloride radiolabeling solution at the origin, and develop the chromatogram by ascending chromatography over a period of about 1.25 hours, using 3 N hydrochloric acid as the developing solvent, until the solvent front migrates to the 15-cm mark. Allow to dry. Cut the strip at the 8-cm mark, and place the upper section (solvent front) in a suitable liquid scintillation solvent. Using a suitable counting assembly (see Beta-Emitting Radionuclides
in the Assay
section of Identification and Assay of Radionuclides
under Radioactivity 821
), determine the radioactivity, in KBq (or µCi) per mL of yttrium Y 90 chloride solution. The total radioactivity of 90
Sr is not greater than 740 KBq per 37 GBq (or 20 µCi per Ci) of 90
Y at the expiration date as stated on the labeling.
It meets the requirements under Injections 1
, except that the radioactive component may be distributed or dispensed prior to completion of the test for Sterility,
the latter test being started on the date of manufacture.
Assay for radioactivity 821
Using a suitable counting assembly (see Scintillation and Semiconductor Detectors
in Identification and Assay of Radionuclides
), determine the total radioactivity, in MBq (or µCi), of the unshielded Injection, using a calibrated system.