Indiclor
Generic name: Indium Chloride In-111
Dosage form: Sterile Solution
Drug class:Diagnostic radiopharmaceuticals
Medically reviewed by Drugs.com. Last updated on Apr 21, 2022.
Diagnostic - For Use in Radiolabeling ProstaScint™, and Zevalin™
(see package insert for indications)
For single dose, single use only
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Indiclor Description
Indiclor Indium In-111 Chloride is a diagnostic radiopharmaceutical intended for radiolabeling ProstaScint (capromab pendetide) used for in vivo diagnostic imaging procedures and for radiolabeling Zevalin (ibritumomab tiuxetan) in preparations used for radioimmunotherapy procedures. It is supplied as a sterile, pyrogen-free solution of Indium (111In) Chloride in 0.04M HCl. Each milliliter is supplied at a radioactive concentration of 370 MBq, 10 mCi of Indium In-111 Chloride at time of calibration (no carrier added, with specific activity of > 1.85 GBq/µg Indium, > 50 mCi/µg Indium at time of calibration). The pH of the solution is about 1.4.
RADIONUCLIDIC PURITY
A Cadmium Cd-112 enriched target is bombarded in a cyclotron to produce Indium In-111 by the (p,2n) reaction. The bombardment conditions, the energy of the proton beam and the length of the bombardment are chosen to ensure an Indium In-111 yield of high radionuclidic purity. Radionuclidic purity is checked at release particularly for the presence of Indium In-114. The relative proportion of this impurity increases, after release of the batch, as a result of its longer half-life. Because of its beta-emitting component and its potentially high organ dose contribution, Indium In-114m is particularly important if present above carefully controlled levels.
Release specifications:
- < 0.08% Indium In-114m at calibration time
- < 0.16% Indium In-114m at expiration time
RADIOCHEMICAL PURITY
Release specification: Not less than 95% Indium present as ionic In3+.
PHYSICAL CHARACTERISTICS
Indium In-111 decays by electron capture with a physical half-life of 67.2 hours (2.8 days). The energies of the photons that are useful for detection and imaging studies are listed in Table 1.
