THE RATIONALE FOR THE SELECTION OF QUALITY INDICATORS IN THE STANDARDIZATION OF RADIOPHARMACEUTICAL PREPARATION "SODIUM PERTECHNETATE [99mТс], EXTRACTIONAL, SOLUTION FOR INJECTION"

Technetium-99m has optimal characteristics for use in nuclear medicine and is a priority in the selection of radiopharmaceuticals for the diagnosis of oncological diseases. An important stage in the complex of scientific and research works on the creation of the radiopharmaceutical preparation «Sodium pertechnetate [99mTc], extractional, solution for injection» is standardization, which includes the establishment of requirements for the quality of the drug. When developing the specification for the drug, a set of quality indicators was determined, taking into account the type of dosage form. Acceptance criteria and testing methods were established. Sections of the specification were compiled, which will be used to control the quality of the drug and included in section P of the registration dossier of the common technical document (CTD) format during drug registration.