Fast Method for the Determination of Residual Solvents in Radiopharmaceutical Products

• DOI: 10.37358/rc.17.4.5526
• Publication Date: 2020-02-21T09:29:38Z
• Authors: Mirela Mihon; Catalin Stelian Tuta; Alina Catrinel Ion; Dana Niculae; Vasile Lavric
• Keywords: PET Imaging

The aim of this work was the development and validation a fast analytical method to determine residual solvents content in radiopharmaceuticals such as: 18F-Fluorodeoxyglucose (18F-FDG), 18F-Fluoroestradiol (18F-FES), 18F-Fluorothymidine (18F-FLT),18F-Fluoromisonidazole (18F-FMISO). Radiopharmaceuticals are radioactive preparations for medical purposes used nuclear medicine as tracers diagnostic imaging treatment certain diseases. Positron Emission Tomography (PET) is technique that consists introducing into body small amount biologically active chemical compound labelled with short lived positron-emitting radioisotope (18F, 11C, 68Ga). Residual critical impurities can affect labelling, stability physicochemical properties drugs. Therefore, determination these essential quality control radiopharmaceuticals. Validation by gas chromatography referred European Pharmacopoeia using special injection (head space). parameters method, which comply International Conference on Harmonization guidelines, are: accuracy, precision, linearity, limit detection, quantification robustness. proposed (direct injection) proved be linear, precise, accurate robust. Good linearity achieved all correlation coefficients (R2) each solvent were found more than 0.99.