Determination of major radionuclidic impurities in K99TcO4 pharmaceutical raw material

A rapid analytical method for sequential separation and determination of the most significant alpha- and beta-emitting radionuclidic impurities in Tc-99 radiopharmaceutical raw material is presented. Successive HTiO co-precipitation steps were first conducted for effective removal of Tc-99 to avoid its spectral interference on the determination of beta-emitting nuclides by liquid scintillation counting. A sequential chromatographic method was applied for simultaneous separation and purification of actinide and lanthanide isotopes. A series of (KTcO4)-Tc-99 solution spiked with known quantities of Pu-238, Pu-239, Pu-241, Np-237, Am-241, Cm-244 and Pm-147 were analyzed for method evaluation, demonstrating that the method would meet the analytical requirements for radionuclidic impurity evaluation of (KTcO4)-Tc-99 raw material.

Automated summary

A rapid analytical method for sequential separation and determination of alpha- and beta-emitting radionuclidic impurities in Tc-99 radiopharmaceutical raw material was presented. The method involves consecutive HTiO co-precipitation steps and sequential chromatographic method to effectively separate and purify the radionuclides. Method evaluation using spiked (KTcO4)-Tc-99 solutions demonstrated its capability to meet the analytical requirements for radionuclidic impurity evaluation of (KTcO4)-Tc-99 raw material.