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Quality Control Validation for Exogenous Natural Surfactant Labeled with ^sup 99m^Tc

Objective: Exogenous natural surfactant (ENS) labeled with ^sup 99m^Tc shows an elevated lung specificity allowing the acquisition of high-quality images for ventilation scintigraphy.

Methods: The methods for ^sup 99m^Tc-ENS quality control (physical properties, pH determination, radiochemical studies, and biologic studies) were evaluated and validated.

Results: The physical properties of the nonradioactive precursor and of the radiopharmaceutical were analyzed as general descriptors of the product. The pH of the radiopharmaceutical was determined by using pH test papers, a method described and validated in the United States Pharmacopeia. Chromatographic studies performed using the ...

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