Evaluation of an alternative radiochemical purity testing method for technetium-99m sestamibi.

OBJECTIVE Our study evaluated the accuracy and reliability of 3 radiochemical purity (RCP) measurement methods of 99mTc-sestamibi. A regular-sized (1.0 cm x 9.0 cm) Whatman 31 ET Chr paper strip (regular 31 ET) also was included in our evaluation because of its ease in handling. METHODS The miniaturized and regular 31 ET methods were compared with the standard RCP testing method (aluminum oxide-coated plastic thin-layer chromatography [TLC] plate, with > or = 95% ethanol as the developing solvent). A total of 30 experimental runs were performed in triplicate (n = 90) over an RCP range of 82%-98%. The 99mTc-sestamibi preparations were reconstituted purposely to ensure that 50% of the tested samples had RCP values below the 90% limit. RESULTS The evaluated RCP ranges were 89.9% +/- 6.3%, 91.0% +/- 3.8%, and 91.4% +/- 4.3% for the TLC, miniature 31 ET, and regular 31 ET methods, respectively (n = 30 each). A strong correlation was found between the TLC and miniature 31 ET methods (r = 0.92), as well as between the TLC and regular 31 ET methods (r = 0.94). Both alternative methods tended to overestimate RCP value as determined by the TLC method, especially in an RCP range below 95%. This resulted in a false-positive rate of 27% for the miniature 31 ET method and 33% for the regular 31 ET method. The test/retest reliability was 99% for both the TLC and regular 31 ET methods, and 91% for the TLC and miniature 31 ET methods. CONCLUSION The miniature and regular 31 ET methods produced a high false-positive rate, which makes them unacceptable for the determination of RCP value of 99mTc-sestamibi.