Search academic texts

Information × Registration Number 0221U102664, 0119U001610 , R & D reports Title Investigation of the bioequivalence of generic radiopharmaceutical sodium iodide (I-131), developed by the INR of NAS of Ukraine, and organization of its manufacturing popup.stage_title Head Trishin Vladimir V., Кандидат фізико-математичних наук Registration Date 08-02-2021 Organization Institute for Nuclear Research of NAS of Ukraine popup.description2  Works on reconstruction and preparation of technological premises for production of RFP of laboratory of radionuclides and RFP (I class of works with RR) and premises for carrying out of control of quality and safety (CQS) of RFP and a sanitary and hygienic mode at their manufacture (III class of works with RR) accordingly to the requirements of the State Service of Ukraine for Medicinal Products and the Good Quality of Production and Laboratory Practice of the WHO. The developed specifications and equipment for quality control of RFP in the framework of the International IAEA project of technological cooperation UKR6012 are coordinated. Based on tender proposals, the Agency purchased 18 pieces of equipment for determining the radiochemical and radionuclide purity of RFP. The equipment is being delivered. Standard operating procedures have been developed to determine the pharmaceutical properties of RFP sodium iodide (I-131). Determination of radionuclide, radiochemical, chemical purity and acidity of RFP sodium iodide solution (I-131). Drafts of scientific and technical documents have been developed to obtain permits for the right to carry out RFP production in the Institute of Nuclear Research (Regulations on the RFP CQS laboratory, Laboratory passports, Laboratory certification areas, Laboratory quality guidelines). A package of documents has been prepared to obtain a Sanitary Passport for work with radioactive substances in the laboratory of the RFP CQS (III class of work with PP). Product Description popup.authors Bezdrobna Larysa K Bozhok Olha V Odintsov Oleksii O Tryganok Tetiana V popup.nrat_date 2021-02-08 Close