Quality control validation for exogenous natural surfactant labeled with 99mTc.
J Nucl Med Technol
; 33(4): 234-7, 2005 Dec.
Article
en En
| MEDLINE
| ID: mdl-16322125
ABSTRACT
OBJECTIVE:
Exogenous natural surfactant (ENS) labeled with 99mTc shows an elevated lung specificity allowing the acquisition of high-quality images for ventilation scintigraphy.METHODS:
The methods for 99mTc-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 acetone/Whatman-1 paper system were validated as a method to evaluate the radiochemical purity of the 99mTc-ENS. Biodistribution studies on rats after intratracheal administration were validated as a method to estimate the radiopharmaceutical biodistribution in humans.CONCLUSION:
The proposed method for 99mTc-ENS quality control studies and stability studies was evaluated and validated following international standards.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Surfactantes Pulmonares
/
Tecnecio
/
Marcaje Isotópico
/
Pulmón
Límite:
Animals
Idioma:
En
Revista:
J Nucl Med Technol
Año:
2005
Tipo del documento:
Article
País de afiliación:
Argentina