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UltraTag RBC
  • Professionals
  • FDA PI

UltraTag RBC

Generic name: technetium tc 99m-labeled red blood cells
Dosage form: kit, injection

UltraTag RBC Description

Ultratag™ RBC (kit for the preparation of technetium Tc 99m-labeled red blood cells) is a sterile, nonpyrogenic, diagnostic kit for the in vitro preparation of technetium Tc 99m-labeled red blood cells.

Each kit consists of three separate nonradioactive components:

  1. A 10 milliliter reaction vial containing:

    Stannous Chloride, Dihydrate (SnCl2•2H2O) – 50 ug minimum
    Stannous Chloride, Dihydrate (SnCl2•2H2O) – 96 ug theoretical
    Tin Chloride (Stannous and Stannic), Dihydrate (as SnCl2•2H2O) – 105 ug maximum
    Sodium Citrate, Dihydrate – 3.67 mg
    Dextrose, Anhydrous – 5.50 mg

    Prior to lyophilization, the pH is adjusted to 7.1 to 7.2 with sodium hydroxide. The contents of the vial are lyophilized and stored under argon.

  2. Syringe I contains:

    Sodium Hypochlorite – 0.6 mg in Sterile Water for InjectionThe total volume of this syringe is 0.6 mL. Sodium hydroxide may have been added for pH adjustment. The pH of this solution is 11 to 13. The syringe must be protected from light to prevent degradation of the light-sensitive sodium hypochlorite.

  3. Syringe II contains:

    Citric Acid, Monohydrate – 8.7 mg
    Sodium Citrate, Dihydrate – 32.5 mg
    Dextrose, Anhydrous – 12.0 mg in Sterile Water for Injection

The total volume of this syringe is 1.0 mL. The pH range of this solution is adjusted to 4.5 to 5.5 with sodium citrate or citric acid.

PHYSICAL CHARACTERISTICS

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

Table 1. Principal Radiation Emission Data*
*
Kocher, David C., “Radioactive Decay Tables,” DOE/TIC 11026, 108 (1981).
Radiation Mean % /
Disintegration
Energy (keV)