Detecting Elemental Impurities by Inductively Coupled Plasma Mass Spectrometry in Russian Radiopharmaceuticals

INTRODUCTION. Radiopharmaceutical manufacturers should assess potential negative impact of elemental impurities on the quality of their products using real data of their elemental contamination. Accumulating knowledge about medicinal products and their manufacturing process should start from the development stage and continue throughout the implementation stage until production finally ends.

AIM. This study aimed to monitor elemental impurities content in Russian radiopharmaceuticals using inductively coupled plasma mass spectrometry.

MATERIALS AND METHODS. The samples included 127 Russian radiopharmaceuticals obtained by the Scientific Center for Expert Evaluation of Medicinal Products during its statutory activities: fluorodeoxyglucose (¹⁸F), PSMA-1007 (¹⁸F), sodium iodide (¹³¹I), sodium iodohippurate (¹³¹I), iobenguane (¹²³I), and sodium pertechnetate (^99mTc). The content of Ag, Al, As, Au, Ba, Be, Bi, Cd, Co, Cr, Cu, Fe, Ga, Ge, Hg, Ir, Li, Mn, Nb, Ni, Os, Pb, Pd, Pt, Rh, Ru, Sb, Se, Mo, Sn, Tl, V, W, and Zn was detected on the Agilent 7900 mass spectrometer.

RESULTS. Elemental impurities Ag, As, Au, Bi, Be, Cd, Co, Cr, Ga, Ge, Hg, Ir, Mo, Nb, Ni, Os, Pb, Pd, Pt, Rh, Ru, Sb, Se, Sn, Tl, V, and W were not detected in any of the tested radiopharmaceuticals. Al, Zn, and Cu mostly contributed to elemental contamination in almost all radiopharmaceuticals. Radiopharmaceuticals used for single-photon emission computed tomography (SPECT) contained significantly less elemental impurities compared to positron emission tomography (PET) radiopharmaceuticals.

CONCLUSIONS. The elements that mostly contaminate Russian radiopharmaceuticals are non-toxic or low-toxic (Al, Zn, Cu). These impurities should be monitored in case they negatively impact the quality of radiopharmaceuticals. In fluorodeoxyglucose (¹⁸F), elemental contamination heavily depends on the used buffer solution. In order to find out elemental contamination sources in the studied radiopharmaceuticals, an additional analysis of impurities in the raw materials, reagents and semi-products is indispensable at all technological stages.

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