Bérenger L
99mTc-NephroMAG™ is a radiopharmaceutical which is used for dynamic renal imaging. The summary of product characteristics (SPC) specifies that the determination of radiochemical purity must be achieved via high pressure liquid chromatography or Sep-Pak™ C18 cartridge methods. To minimize the time required to test radiochemical purity, a method with radio-thin-layer chromatography (r-TLC) was used in radiopharmacy unit of Tours CHRU. However, this method on Whatman™ 3mm was too long and offered no optimized resolving parameters.
Methods: For each preparation (n=5), two strips r-TLC with Tec-Control™ #150-005 has been achieved, first with hydrophilic mobile phase (hMP) in order to highlight colloidal technetium (99mTcO2), second with lipophilic mobile (lMP) to separate 99mTcO4
Results: The method with two kinds of mobile phase offers a better resolving power for both impurities searched and was more rapid to perform.
Conclusion: The simplified method is a reasonable alternative to the registered SPC methods and to the method with Whatman™ 3 mm chromatographic paper.
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