The Influence of Different Measurement Methods and Carrier Specifications on Results of Radiochemical Purity Analysis
Objective To investigate the impact of different measurement methods and different specifications of carriers on results of radiochemical purity analysis.Methods Based on the radiochemical purity determination methods included in the Chinese Pharmacopoeia(ChP2020)and the instructions for the 99Tcm kit,the most commonly clinically used Na99 TcmO4 injection,99Tcm-DTPA injection,99Tcm-MAA injection,and 99Tcm-PHY injection solutions were selected as the research subjects.Two specifications(8 mm × 9 cm and 1cm×14cm)of carriers and two measurement methods(radioactive thin layer chromatography scanner and γ Compare)were used to analyze the radiochemical purity results measured by the counter.Results The radiochemical purity values of 99Tcm-DTPA injection,99Tcm-MAA injection,and 99Tcm-PHY injection measured with a 9cm carrier using a radioactive thin layer chromatography scanner were better than those measured with a 14cm carrier(P<0.05);The difference in radiochemical purity values between Na99TcmO4 injection with a 9cm carrier and a 14cm carrier measured using a radioactive thin layer chromatography scanner was not statistically significant(P>0.05).99Tcm-DTPA injection,99Tcm-MAA injection,and 99Tcm-PHY injection with a 14cm specification carrier γ showed a statistically significant difference(P<0.05)in the radiochemical purity values measured by a counter and a radioactive thin-layer chromatography scanner.There was no significant difference for Na99 TcmO4 injection with γ in the radiochemical purity values measured by the counter and the radioactive thin-layer chromatography scanner(P>0.05).Conclusion Na99TcmO4,99Tcm-DTPA,99Tcm-MAA,99Tcm-PHY γ counters and radioactive thin layer chromatography scanners are used to measure their radiochemical purity with a 9cm carrier,which is better than 14cm carrier.Radioactive thin layer chromatography scanners can be the preferred instrument,γ counter can serve as an auxiliary instrument.