QA issues in radioisotope production for nuclear medicine
QA issues in radioisotope production for nuclear medicine
QA issues in radioisotope production for nuclear medicine
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LFMCong<br />
82701<br />
Measurement techniques of<br />
radioactive products<br />
<br />
<br />
<br />
<br />
Radioisotopic purity is determ<strong>in</strong>ed by gamma or beta<br />
spectroscopy [ we presently do not handle alpha emitters] us<strong>in</strong>g<br />
NIST traceable radioactivity standards and ANSI methodology<br />
guidel<strong>in</strong>es <strong>for</strong> measurement and calibration<br />
Chemical purity is determ<strong>in</strong>ed by standard analytical<br />
<strong>in</strong>strumentation (eg. optical emission or atomic absorption<br />
spectroscopy <strong>for</strong> elemental measurements, HPLC <strong>for</strong><br />
pharmaceutical content) and standard methodology. Calibrations<br />
with purchased analytical standards<br />
Note that the isotope mass is negligible and that what is be<strong>in</strong>g<br />
measured is trace metal content <strong>in</strong> the HCl f<strong>in</strong>al solution<br />
Sterility and pyrogenicity tests must be done <strong>in</strong> house if direct<br />
human use is <strong>in</strong>volved<br />
Brookhaven Science Associates<br />
U.S. Department of Energy
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