Indium In 111 Pentetate Injection
» Indium In 111 Pentetate Injection is a sterile, isotonic solution suitable for intrathecal administration, containing radioactive indium (111In) in the form of a chelate of pentetic acid. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of 111In as the pentetic acid complex expressed in megabecquerels (microcuries or millicuries) per mL at the time indicated in the labeling. It may contain sodium chloride and buffers. Other chemical forms of radioactivity do not exceed 10.0 percent of the total radioactivity.
Packaging and storage Preserve in single-dose containers.
Labeling 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 111In as labeled pentetic acid complex expressed as total megabecquerels (millicuries or microcuries) and concentration as megabecquerels (microcuries or millicuries) per mL on the date and time of calibration; the expiration date; 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 111In is 2.83 days.
Bacterial endotoxins 85 It contains not more than 14/V USP Endotoxin Unit 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.
pH 791: between 7.0 and 8.0.
Radionuclide identification (see Radioactivity 821)Its gamma-ray spectrum is identical to that of a specimen of 111In that exhibits major photopeaks having energies of 0.173 and 0.247 MeV.
Radiochemical purity Place 2 µL to 5 µL of Injection about 17 mm from one end of a 65- × 97-mm piece of silica gel-impregnated glass microfiber sheet (see under Reagents in the section Reagents, Indicators, and Solutions) (see also Chromatography 621), and allow to dry. Repeat applications may be made to obtain a suitable count rate. Develop the chromatogram over a suitable period of time by ascending chromatography, using dilute methanol (8.5 in 10), and dry in an oven at 105 ± 5 for 5 minutes. Determine the radioactivity distribution by scanning the chromatogram with a suitable collimated radiation detector. The radioactivity of the indium pentetic acid complex band is not less than 90.0% of the total radioactivity, and the RF value is between 0.8 and 1.0.
Radionuclidic purity Using a suitable counting assembly (see Selection of a Counting Assembly under Radioactivity 821), determine the radioactivity of each radionuclidic impurity, in kBq per MBq (µCi per mCi) of 111In, in the Injection by use of a calibrated system as directed under Radioactivity 821.
Indium 114mThe presence of 114mIn in the Injection is demonstrated by a characteristic gamma-ray spectrum with prominent photopeaks having energies of 0.192, 0.558, and 0.724 MeV. 114mIn decays with a radioactive half-life of 49.5 days. The amount of 114mIn is not greater than 3 kBq per MBq (3 µCi per mCi) of 111In.
Zinc 65The presence of 65Zn in the Injection is demonstrated by a characteristic gamma-ray spectrum with a prominent photopeak at 1.115 MeV. 65Zn decays with a radioactive half-life of 243.9 days. The amount of 65Zn is not greater than 3 kBq per MBq (3 µCi per mCi) of 111In.
Other requirements It meets the requirements under Injections 1, except that the Injection may be distributed or dispensed prior to the completion of the test for Sterility, the latter test being started on the day of final manufacture, and except that it is not subject to the recommendation on Volume in Container.
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USP32NF27 Page 2630