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OtherPharmacy

Quality Control Validation for Exogenous Natural Surfactant Labeled with 99mTc

Gabriela P. Calmanovici, María J. Salgueiro, Natalia M. Leonardi, Cinthia G. Goldman, Jorge O. Nicolini, Jose R. Boccio, Ricardo A. Caro, Patricia D. Zubata and Marcela B. Zubillaga
Journal of Nuclear Medicine Technology December 2005, 33 (4) 234-237;
Gabriela P. Calmanovici
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María J. Salgueiro
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Natalia M. Leonardi
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Cinthia G. Goldman
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Jorge O. Nicolini
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Jose R. Boccio
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Ricardo A. Caro
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Patricia D. Zubata
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Marcela B. Zubillaga
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  • FIGURE 1.
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    FIGURE 1.

    Linearity evaluation for chromatographic studies. AC = activity concentration of 99mTc-ENS; A origin = activity at origin of acetone/Whatman-1 paper chromatography.

  • FIGURE 2.
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    FIGURE 2.

    Linearity evaluation for biodistribution studies. AC = activity concentration of 99mTc-ENS; A lungs = activity in lungs in biodistribution studies.

Tables

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    TABLE 1

    Accuracy of Chromatographic Studies (n = 9)

    Added activity (kBq)Mean recovered activity (kBq)Mean recovery (%)SD
    2.392.3799.10.8
    3.012.9598.00.7
    3.523.5099.50.7
    • View popup
    TABLE 2

    Robustness of Chromatographic Studies

    Variable% origin*
    Cube saturation time (h)
        0.599.1
        199.0
    Chromatographic-strip drying time (h)
        0.2599.3
        199.4
    Solvent migration distance (cm)
        899.8
        1299.2
    • ↵* Percentage of radioactivity remaining at origin.

    • View popup
    TABLE 3

    Specificity of Biodistribution Studies

    TreatmentActivity (%)
    LungsGISHeartBloodLiverSpleenKidneys
    Acid hydrolysis33.509.644.1126.2510.238.437.84
    Base hydrolysis33.818.382.9328.878.618.888.52
    Oxidation30.287.912.1329.679.8210.669.53
    Heat treatment99.780.050.050.000.000.000.11
    Light exposure94.105.690.000.020.030.000.16
    Control98.631.250.000.020.030.000.07
    • GIS = gastrointestinal system and content.

    • View popup
    TABLE 4

    Accuracy of Biodistribution Studies (n = 9)

    Added activity (kBq)Mean recovered activity (kBq)Mean recovery (%)SD
    4.074.0298.70.9
    5.265.2599.90.8
    6.366.2998.90.6
    • View popup
    TABLE 5

    Robustness of Biodistribution Studies

    Variable% lungs*
    Age of animal (mo)
        399.62
        694.70
    Sex of animal
        M97.71
        F99.36
    Time of measurement after dissection (h)
        0.2599.11
        298.65
    Injected volume (mL)
        0.299.25
        0.498.32
    • ↵* Percentage of activity in lungs.

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Journal of Nuclear Medicine Technology: 33 (4)
Journal of Nuclear Medicine Technology
Vol. 33, Issue 4
December 1, 2005
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Quality Control Validation for Exogenous Natural Surfactant Labeled with 99mTc
Gabriela P. Calmanovici, María J. Salgueiro, Natalia M. Leonardi, Cinthia G. Goldman, Jorge O. Nicolini, Jose R. Boccio, Ricardo A. Caro, Patricia D. Zubata, Marcela B. Zubillaga
Journal of Nuclear Medicine Technology Dec 2005, 33 (4) 234-237;
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Quality Control Validation for Exogenous Natural Surfactant Labeled with 99mTc
Gabriela P. Calmanovici, María J. Salgueiro, Natalia M. Leonardi, Cinthia G. Goldman, Jorge O. Nicolini, Jose R. Boccio, Ricardo A. Caro, Patricia D. Zubata, Marcela B. Zubillaga
Journal of Nuclear Medicine Technology Dec 2005, 33 (4) 234-237;

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