DEVELOPMENT OF METHODOLOGY FOR THE DETERMINATION OF RESIDUAL ORGANIC SOLVENTS IN RADIOPHARMACEUTICAL DRUG 18-FLUORODEOXYGLUCOSE BY GAS CHROMATOGRAPHY METHOD

Radiopharmaceutical drugs (RPs) are widely used for radionuclide diagnostics and treatment using nuclear medicine methods. These diagnostic preparations contain gamma- or positron-emitting radionuclide, which is an information carrier and are widely used in positron emission tomography. This modern diagnostic technique is performed to detect malignant lesions at an early stage. Positron emission tomography is combined with X-ray computed tomography, and they are performed sequentially on the same tomograph. Positron emission tomography determines pathological changes, and computed tomography provides information about the part of the body in which these changes occur. The radionuclide diagnostic technique with 18F-fluorodeoxyglucose (18F-FDG) is now widely used. Compared to other drugs, RPs are produced in small quantities and their shelf life depends on the half-life of radionuclides (from a few minutes to several days). Globally, the safety and efficacy of RPs are given greater importance. In quality control of RPs, the world pharmacopeial practice pays special attention to the control of their purity, in particular, the determination of the amount of residual organic solvents used in the synthesis of drugs. The current OFS.1.1.0008 GF RF “Residual organic solvents” specifies general principles of their determination and regulatory requirements for the content of these solvents depending on the class of toxicity. This paper describes the development of a technique for the determination of residual acetonitrile and ethanol in 18F-FDG RP by gas chromatography with flame ionization detector. Validation studies have shown that the performance characteristics of the methodology for the determination of acetonitrile and ethanol content confirm its suitability for testing the 18F-FDG preparation for compliance with the requirements of regulatory documentation for the indicator “Residual organic solvents”.