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Kit for the Preparation of Sodium Iodide I 131 Capsules and Solution USP
Therapeutic – Oral
HICON™ is a kit which provides a solution of Sodium Iodide I-131 with a radioconcentration of 37 gigabecquerels/mL (1,000 millicuries/mL). Each mL of the concentrated solution contains 37 GBq of no-carrier-added Sodium Iodide I-131, < 2 mg of Disodium Edetate Dihydrate USP as a stabilizer, < 4.4 mg of Sodium Thiosulfate Pentahydrate USP as a reducing agent, and < 40 mg of Dibasic Sodium Phosphate Anhydrous USP. The pH of the solution is between 7.5 and 9.0.
The concentrated solution provided with HICON™ is intended for use in the preparation of capsules and solution of varying strengths for oral administration for therapy.
Sodium Iodide I 131 Solution USP is designated chemically as Na 131I (MW 153.99, CAS 7790-26-3).
Hard gelatin capsules provided for the preparation of the Sodium Iodide I-131 final dosage form contain approximately 300 mg of Dibasic Sodium Phosphate Anhydrous USP as the absorbing buffer.
Iodine I-131 decays by beta emission and associated gamma emission with a physical half-life of 8.04 days.1 Photons that are useful for detection and imaging are listed in Table 1.
Table 1 : Principal Radiation Emission Data
|Radiation||Mean % per Disintegration||Mean Energy (keV)|
1Kocher, David C., “Radioactive Decay Data Tables”, DOE/TIC-11026, (1981) p. 133.
The specific gamma-ray constant for iodine I-131 is 15.8 μC•kg-1•MBq-1•hr-1 (2.27 R/mCi-hr) at 1 cm. The first half-value thickness of lead (Pb) for iodine I-131 is 0.24 cm. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 2. For example, the use of 2.55 cm of Pb will decrease the external radiation exposure by a factor of about 1,000.
Table 2 : Radiation Attenuation by Lead Shielding
|Shield Thickness (Pb) cm||Coefficient of Attenuation|
To correct for physical decay of iodine I-131, the fractions that remain at selected intervals after the time of calibration are shown in Table 3.
Table 3 : Physical Decay Chart: Iodine I-131, Half-Life 8.04
|Days||Fraction Remaining||Days||Fraction Remaining||Days||Fraction Remaining|
Last reviewed on RxList: 10/6/2011
This monograph has been modified to include the generic and brand name in many instances.
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