NeoTect^® (Kit for the Preparation of Technetium Tc 99m Depreotide Injection) is intended for use in the preparation of Technetium Tc 99m Depreotide, a diagnostic radiopharmaceutical to be used by intravenous injection. Each vial contains a sterile, non-pyrogenic lyophilized mixture of 50 µg of Depreotide, 5 mg of sodium glucoheptonate dihydrate, 50 µg of stannous chloride dihydrate (with a minimum stannous tin content of 15 µg), 100 µg edetate disodium dihydrate, and sufficient sodium hydroxide or hydrochloric acid for adjustment to pH 7.4 prior to lyophilization. The lyophilized powder is sealed under a nitrogen atmosphere with a rubber closure. The product contains no antimicrobial preservative.

Cyclo (L-homocysteinyl-N-methyl-L-phenylalanyl-L-tyrosyl-D-tryptophyl-L-lysyl-L-valyl), (1‡1´)-sulfide with 3-[(mercaptoacetyl)amino]-L-alanyl-L-lysyl-L-cysteinyl-L-lysinamide

When sterile, non-pyrogenic Sodium Pertechnetate Tc 99m Injection, in 0.9% Sodium Chloride Injection, U.S.P., is added to the vial, a Technetium Tc 99m complex of Depreotide is formed.

PHYSICAL CHARACTERISTICS

Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours.The photon that is useful for imaging studies is listed in Table 1.

External radiation

The specific gamma-ray constant for Technetium Tc 99m is 5.4 microcoulombs/kg·MBq·hour (0.78 R/mCi·hour) at 1 cm. The first half-value thickness of lead for Technetium Tc 99m is 0.17mm. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from the interposition of various thicknesses of lead is shown in Table 2. For example, the use of a 0.25 cm thickness of lead will decrease the external radiation exposure by a factor of 1,000.

To correct for physical decay of this radionuclide, the fractions that remain at selected intervals relative to the time of calibration are shown in Table 3.

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