kit for the preparation of technetium tc99m sestamibi - Generic Medications

Each 5 mL vial contains a sterile, non-pyrogenic, lyophilized mixture of: • Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetrafluoroborate - 1.0 mg • Sodium Citrate Dihydrate - 2.6 mg • L-Cysteine Hydrochloride Monohydrate - 1.0 mg • Mannitol - 20 mg • Stannous Chloride, Dihydrate, minimum (SnCl 2 •2H 2 O) - 0.025 mg • Stannous Chloride, Dihydrate (SnCl 2 •2H 2 O) - 0.075 mg • Tin Chloride (stannous and stannic) Dihydrate, maximum (as SnCl 2 •2H 2 O) - 0.086 mg Prior to lyophilization the pH is 5.3 to 5.9. The contents of the vial are lyophilized and stored under nitrogen. This drug is administered by intravenous injection for diagnostic use after reconstitution with sterile, non-pyrogenic, oxidant-free Sodium Pertechnetate Tc 99m Injection. The pH of the reconstituted product is 5.5 (5.0–6.0). No bacteriostatic preservative is present. The precise structure of the technetium complex is Tc 99m[MIBI] 6 + where MIBI is 2-methoxy isobutyl isonitrile. Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetrafluoroborate has the following structural formula: 11.1 Physical Characteristics Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours 2 . Photons that are useful for detection and imaging studies are listed below in Table 3 . Table 3 Principal Radiation Emission Data Radiation Mean %/Disintegration Mean Energy (KeV) Gamma -2 89.07 140.5 2 Kocher, David, C., Radioactive Decay Data Tables, DOE/TIC-11026, 108(1981). 11.2 External Radiation The specific gamma ray constant for Tc 99m is 5.4 microcoulombs/Kg-MBq-hr (0.78R/mCi-hr) at 1 cm. The first half value layer is 0.017 cm of Pb. 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 4 . To facilitate control of the radiation exposure from Megabequerel (millicurie) amounts of this radionuclide, the use of a 0.25 cm thickness of Pb will attenuate the radiation emitted by a factor of 1,000. Table 4 Radiation Attenuation by Lead Shielding Shield Thickness (Pb) cm Coefficient of Attenuation 0.017 0.5 0.08 10 –1 0.16 10 –2 0.25 10 –3 0.33 10 –4 To correct for physical decay of this radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 5 . Table 5 Physical Decay Chart; Tc 99m Half-Life 6.02 Hours Hours Fraction Remaining Hours Fraction Remaining 0 Calibration Time 1.000 7 0.447 1 0.891 8 0.398 2 0.794 9 0.355 3 0.708 10 0.316 4 0.631 11 0.282 5 0.562 12 0.251 6 0.501 Structural Formula