Assessment of chemical purity of [13N]ammonia injection: Identification of aluminium ion concentration

$[^{13}N]$Ammonia or $[^{13}N]NH_3$ is one of the most widely used PET tracer for the measurement of MBF. To produce $[^{13}N]NH_3$, devarda's alloy which contains aluminum, copper and zinc is used for the purpose of reduction from $^{13}N$-nitrate/nitrite to $[^{13}N]NH_3$. Since aluminum has neurotoxicity and renal toxicity, the amount of it should be carefully limited for the administration to the human body. Although USP and EP provide a way to identify the aluminum ion concentration, there are some difficulties to perform. Therefore, we tried to develop the modified method for verifying aluminum concentration of test solution. We compared color between test and standard solutions using chrome azurol S in pH 4.6 acetate buffer. We also tested color change of test and standard solutions according to pH, amounts and the order of reagent and time difference These results demonstrated that the color change of the solution can reflect quantitatively measure aluminum ion concentration. We hope the method is to be used effectively and practically in many sites where $[^{13}N]NH_3$ is produced.