Radionuclide purity test

Determination of radionuclide purity of radiopharmaceuticals

Verification of the radionuclidic purity of the radiopharmaceutical

The test of radionuclide purity of radiopharmaceuticals is performed to verify that the content of long half-life impurities present in the sample meets the acceptance criteria defined by the European Pharmacopoeia. In particular, the control is the identification and determination, by gamma spectrometry and based on appropriate libraries, of the nature and quantity of radionuclides other than those foreseen for the normal use.

The test is performed in the quality control chemical laboratories of ITELPHARMA, radiopharmaceutical division of ITEL Telecomunicazioni, through a gamma spectrometer based on a germanium detector.

The spectrometer undergoes a periodic calibration in Energy and Efficiency through certified sources.

The ITEL laboratory is also able to perform the isotopic characterization of aqueous solutions of small volume using appropriate isotopic libraries.

The test result is communicated to the customer by appropriate analytical certificate issued at the end of the activity measurement.

The radionuclidic purity test is non-destructive, and thus the same sample, at the end of the radionuclidic measurement, may be used if needed also to perform the sterility test, with an advantage deriving from the rationalization of the volumes of the samples.

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