59 research outputs found
The main issues of quality assurance of radiopharmaceuticals
One of the prerequisites for successful application of nuclear medicine technologies is the production and clinical use of radiopharmaceuticals (RPs) of a reliably high quality. The aim of the review is to discuss specific properties of RPs, which stipulate specific approaches to their production (or preparation) and quality control. The decisive requirement for the management of RPs at all stages of their life cycle is the observance of the radiation safety rules and regulations. The paper considers the main approaches to assessing the risks of medical radiation exposure to patients and radiation protection of nuclear medicine staff. The choice of a particular quality parameter and the corresponding analytical procedure should be made taking into account the duration of the test, which, like the production time, should be comparable with the radionuclide half-life. The feasibility of the analytical procedure should also be taken into account, given the high radioactivity of the samples tested. Now that theranostics has caught on, new approaches are being developed all over the world concerning regulatory aspects of transition from preclinical studies of RPs to clinical trials, because, according to experts, this is becoming a key condition for rapid implementation of nuclear medicine achievements. The results and conclusions of the present study can be used in the development and expert review of monographs and other specifications required for RP marketing and use. The results of the analysis suggest that it is necessary to develop specific requirements and guidelines for RP testing and evaluation for their successful promotion on the EAEU market
ΠΡΠ½ΠΎΠ²Π½ΡΠ΅ ΠΏΡΠΎΠ±Π»Π΅ΠΌΡ ΠΎΠ±Π΅ΡΠΏΠ΅ΡΠ΅Π½ΠΈΡ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° ΡΠ°Π΄ΠΈΠΎΡΠ°ΡΠΌΠ°ΡΠ΅Π²ΡΠΈΡΠ΅ΡΠΊΠΈΡ Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½Π½ΡΡ ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ²
One of the prerequisites for successful application of nuclear medicine technologies is the production and clinical use of radiopharmaceuticals (RPs) of a reliably high quality. The aim of the review is to discuss specific properties of RPs, which stipulate specific approaches to their production (or preparation) and quality control. The decisive requirement for the management of RPs at all stages of their life cycle is the observance of the radiation safety rules and regulations. The paper considers the main approaches to assessing the risks of medical radiation exposure to patients and radiation protection of nuclear medicine staff. The choice of a particular quality parameter and the corresponding analytical procedure should be made taking into account the duration of the test, which, like the production time, should be comparable with the radionuclide half-life. The feasibility of the analytical procedure should also be taken into account, given the high radioactivity of the samples tested. Now that theranostics has caught on, new approaches are being developed all over the world concerning regulatory aspects of transition from preclinical studies of RPs to clinical trials, because, according to experts, this is becoming a key condition for rapid implementation of nuclear medicine achievements. The results and conclusions of the present study can be used in the development and expert review of monographs and other specifications required for RP marketing and use. The results of the analysis suggest that it is necessary to develop specific requirements and guidelines for RP testing and evaluation for their successful promotion on the EAEU market.ΠΠ΄Π½ΠΈΠΌ ΠΈΠ· ΠΎΡΠ½ΠΎΠ²Π½ΡΡ
ΡΡΠ»ΠΎΠ²ΠΈΠΉ, ΠΎΠΏΡΠ΅Π΄Π΅Π»ΡΡΡΠΈΡ
ΡΡΠΏΠ΅ΡΠ½ΠΎΠ΅ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΠ΅ ΡΠ΅Ρ
Π½ΠΎΠ»ΠΎΠ³ΠΈΠΉ ΡΠ΄Π΅ΡΠ½ΠΎΠΉ ΠΌΠ΅Π΄ΠΈΡΠΈΠ½Ρ, ΡΠ²Π»ΡΠ΅ΡΡΡ ΠΏΠΎΠ»ΡΡΠ΅Π½ΠΈΠ΅ ΠΈ Π²Π²Π΅Π΄Π΅Π½ΠΈΠ΅ ΠΏΠ°ΡΠΈΠ΅Π½ΡΡ ΡΠ°Π΄ΠΈΠΎΡΠ°ΡΠΌΠ°ΡΠ΅Π²ΡΠΈΡΠ΅ΡΠΊΠΎΠ³ΠΎ Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½Π½ΠΎΠ³ΠΎ ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠ° (Π Π€ΠΠ) Π³Π°ΡΠ°Π½ΡΠΈΡΠΎΠ²Π°Π½Π½ΠΎ Π²ΡΡΠΎΠΊΠΎΠ³ΠΎ ΠΊΠ°ΡΠ΅ΡΡΠ²Π°. Π¦Π΅Π»Ρ ΠΎΠ±Π·ΠΎΡΠ° β ΠΎΠ±ΡΡΠΆΠ΄Π΅Π½ΠΈΠ΅ ΡΠΏΠ΅ΡΠΈΡΠΈΡΠ΅ΡΠΊΠΈΡ
ΡΠ²ΠΎΠΉΡΡΠ² Π Π€ΠΠ, ΠΎΠ±ΡΡΠ»ΠΎΠ²Π»ΠΈΠ²Π°ΡΡΠΈΡ
ΡΠΏΠ΅ΡΠΈΠ°Π»ΡΠ½ΡΠ΅ ΠΏΠΎΠ΄Ρ
ΠΎΠ΄Ρ ΠΊ ΠΈΡ
ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΡΡΠ²Ρ (ΠΈΠ»ΠΈ ΠΈΠ·Π³ΠΎΡΠΎΠ²Π»Π΅Π½ΠΈΡ) ΠΈ ΠΊΠΎΠ½ΡΡΠΎΠ»Ρ ΠΊΠ°ΡΠ΅ΡΡΠ²Π°. ΠΠΏΡΠ΅Π΄Π΅Π»ΡΡΡΠΈΠΌ ΡΡΠ΅Π±ΠΎΠ²Π°Π½ΠΈΠ΅ΠΌ ΠΊ ΠΎΠ±ΡΠ°ΡΠ΅Π½ΠΈΡ Π Π€ΠΠ Π½Π° Π²ΡΠ΅Ρ
ΡΡΠ°Π΄ΠΈΡΡ
ΠΈΡ
ΠΆΠΈΠ·Π½Π΅Π½Π½ΠΎΠ³ΠΎ ΡΠΈΠΊΠ»Π° ΡΠ²Π»ΡΠ΅ΡΡΡ ΡΠΎΠ±Π»ΡΠ΄Π΅Π½ΠΈΠ΅ Π½ΠΎΡΠΌ ΠΈ ΠΏΡΠ°Π²ΠΈΠ» ΡΠ°Π΄ΠΈΠ°ΡΠΈΠΎΠ½Π½ΠΎΠΉ Π±Π΅Π·ΠΎΠΏΠ°ΡΠ½ΠΎΡΡΠΈ. Π Π°ΡΡΠΌΠΎΡΡΠ΅Π½Ρ ΠΎΡΠ½ΠΎΠ²Π½ΡΠ΅ ΠΏΠΎΠ΄Ρ
ΠΎΠ΄Ρ ΠΊ ΠΎΡΠ΅Π½ΠΊΠ΅ ΡΠΈΡΠΊΠΎΠ² ΠΌΠ΅Π΄ΠΈΡΠΈΠ½ΡΠΊΠΎΠ³ΠΎ ΠΎΠ±Π»ΡΡΠ΅Π½ΠΈΡ ΠΏΠ°ΡΠΈΠ΅Π½ΡΠΎΠ² ΠΈ ΡΠ°Π΄ΠΈΠ°ΡΠΈΠΎΠ½Π½ΠΎΠΉ Π·Π°ΡΠΈΡΠ΅ ΠΏΠ΅ΡΡΠΎΠ½Π°Π»Π°, ΡΠ°Π±ΠΎΡΠ°ΡΡΠ΅Π³ΠΎ Π² ΠΎΠ±Π»Π°ΡΡΠΈ ΡΠ΄Π΅ΡΠ½ΠΎΠΉ ΠΌΠ΅Π΄ΠΈΡΠΈΠ½Ρ. ΠΡΠ±ΠΎΡ ΡΠΎΠ³ΠΎ ΠΈΠ»ΠΈ ΠΈΠ½ΠΎΠ³ΠΎ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Ρ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° ΠΈ ΡΠΎΠΎΡΠ²Π΅ΡΡΡΠ²ΡΡΡΠ΅ΠΉ Π°Π½Π°Π»ΠΈΡΠΈΡΠ΅ΡΠΊΠΎΠΉ ΠΌΠ΅ΡΠΎΠ΄ΠΈΠΊΠΈ Π΄ΠΎΠ»ΠΆΠ΅Π½ ΠΎΠΏΡΠ΅Π΄Π΅Π»ΡΡΡΡΡ Π² ΡΠΎΠΎΡΠ²Π΅ΡΡΡΠ²ΠΈΠΈ ΡΠΎ Π²ΡΠ΅ΠΌΠ΅Π½Π΅ΠΌ ΠΏΡΠΎΠ²Π΅Π΄Π΅Π½ΠΈΡ Π°Π½Π°Π»ΠΈΠ·Π°, ΠΊΠΎΡΠΎΡΠΎΠ΅ ΡΠ°ΠΊ ΠΆΠ΅, ΠΊΠ°ΠΊ ΠΈ Π²ΡΠ΅ΠΌΡ ΡΠΈΠ½ΡΠ΅Π·Π°, Π΄ΠΎΠ»ΠΆΠ½ΠΎ Π±ΡΡΡ ΡΠΎΠΈΠ·ΠΌΠ΅ΡΠΈΠΌΠΎ Ρ ΠΏΠ΅ΡΠΈΠΎΠ΄ΠΎΠΌ ΠΏΠΎΠ»ΡΡΠ°ΡΠΏΠ°Π΄Π° ΡΠ°Π΄ΠΈΠΎΠ½ΡΠΊΠ»ΠΈΠ΄Π°, Π° ΡΠ°ΠΊΠΆΠ΅ Ρ Π²ΠΎΠ·ΠΌΠΎΠΆΠ½ΠΎΡΡΡΡ ΡΠ΅Π°Π»ΠΈΠ·Π°ΡΠΈΠΈ Π°Π½Π°Π»ΠΈΡΠΈΡΠ΅ΡΠΊΠΎΠ³ΠΎ ΠΎΠΏΡΠ΅Π΄Π΅Π»Π΅Π½ΠΈΡ Π² ΡΡΠ»ΠΎΠ²ΠΈΡΡ
ΡΠ°Π±ΠΎΡΡ Ρ Π²ΡΡΠΎΠΊΠΎΡΠ°Π΄ΠΈΠΎΠ°ΠΊΡΠΈΠ²Π½ΡΠΌΠΈ ΠΎΠ±ΡΠ°Π·ΡΠ°ΠΌΠΈ. Π‘ ΡΠ°Π·Π²ΠΈΡΠΈΠ΅ΠΌ ΡΠ΅ΡΠ°Π½ΠΎΡΡΠΈΠΊΠΈ Π² ΠΌΠΈΡΠΎΠ²ΠΎΠΉ ΠΏΡΠ°ΠΊΡΠΈΠΊΠ΅ Π²ΡΡΠ°Π±Π°ΡΡΠ²Π°ΡΡΡΡ Π½ΠΎΠ²ΡΠ΅ ΠΏΠΎΠ΄Ρ
ΠΎΠ΄Ρ ΠΊ ΡΠ΅Π³ΡΠ»ΡΡΠΎΡΠ½ΡΠΌ Π²ΠΎΠΏΡΠΎΡΠ°ΠΌ ΠΏΠ΅ΡΠ΅Ρ
ΠΎΠ΄Π° ΠΎΡ Π΄ΠΎΠΊΠ»ΠΈΠ½ΠΈΡΠ΅ΡΠΊΠΈΡ
ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΠΉ ΡΠ°Π΄ΠΈΠΎΡΠ°ΡΠΌΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ² ΠΊ ΠΊΠ»ΠΈΠ½ΠΈΡΠ΅ΡΠΊΠΈΠΌ, ΠΏΠΎΡΠΊΠΎΠ»ΡΠΊΡ, ΠΏΠΎ ΠΌΠ½Π΅Π½ΠΈΡ ΡΠΊΡΠΏΠ΅ΡΡΠΎΠ², ΡΡΠΎ ΡΡΠ°Π½ΠΎΠ²ΠΈΡΡΡ ΠΎΠΏΡΠ΅Π΄Π΅Π»ΡΡΡΠΈΠΌ Π΄Π»Ρ Π±ΡΡΡΡΠΎΠ³ΠΎ Π²Π½Π΅Π΄ΡΠ΅Π½ΠΈΡ Π΄ΠΎΡΡΠΈΠΆΠ΅Π½ΠΈΠΉ ΡΠ΄Π΅ΡΠ½ΠΎΠΉ ΠΌΠ΅Π΄ΠΈΡΠΈΠ½Ρ. Π Π΅Π·ΡΠ»ΡΡΠ°ΡΡ ΠΈ Π²ΡΠ²ΠΎΠ΄Ρ ΡΠ°Π±ΠΎΡΡ ΠΌΠΎΠ³ΡΡ Π±ΡΡΡ ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π½Ρ ΠΏΡΠΈ ΡΠ°Π·ΡΠ°Π±ΠΎΡΠΊΠ΅ ΠΈ ΡΠΊΡΠΏΠ΅ΡΡΠΈΠ·Π΅ ΡΠ°ΡΠΌΠ°ΠΊΠΎΠΏΠ΅ΠΉΠ½ΡΡ
ΡΡΠ°ΡΠ΅ΠΉ ΠΈ Π΄ΡΡΠ³ΠΎΠΉ Π½ΠΎΡΠΌΠ°ΡΠΈΠ²Π½ΠΎΠΉ Π΄ΠΎΠΊΡΠΌΠ΅Π½ΡΠ°ΡΠΈΠΈ, ΡΠΎΠΏΡΠΎΠ²ΠΎΠΆΠ΄Π°ΡΡΠ΅ΠΉ ΠΎΠ±ΡΠ°ΡΠ΅Π½ΠΈΠ΅ Π Π€ΠΠ. ΠΡΠΎΠ²Π΅Π΄Π΅Π½Π½ΡΠΉ Π°Π½Π°Π»ΠΈΠ· ΠΏΠΎΠΊΠ°Π·Π°Π», ΡΡΠΎ Π½Π΅ΠΎΠ±Ρ
ΠΎΠ΄ΠΈΠΌΠ° ΡΠ°Π·ΡΠ°Π±ΠΎΡΠΊΠ° ΠΎΡΠ΄Π΅Π»ΡΠ½ΡΡ
ΡΡΠ΅Π±ΠΎΠ²Π°Π½ΠΈΠΉ ΠΈ ΡΡΠΊΠΎΠ²ΠΎΠ΄ΡΡΠ² ΠΏΠΎ ΠΈΡΠΏΡΡΠ°Π½ΠΈΡΠΌ ΠΈ ΡΠΊΡΠΏΠ΅ΡΡΠΈΠ·Π΅ Π Π€ΠΠ Π΄Π»Ρ ΡΡΠΏΠ΅ΡΠ½ΠΎΠ³ΠΎ ΠΏΡΠΎΠ΄Π²ΠΈΠΆΠ΅Π½ΠΈΡ ΠΈΡ
Π½Π° ΡΡΠ½ΠΎΠΊ ΠΠΠΠ‘
Possible Impurities in Radiopharmaceuticals and Corresponding Test Methods
The main quality attributes of radiopharmaceuticals that ensure their effectiveness and safety and are unique to their specifications are activity, radionuclide identity, radionuclide purity, and radiochemical purity. The aim of this study was to analyse the possibility of formation and methods for determination of various impurities in radiopharmaceuticals based on radionuclides of several groups: technetium-99m and rhenium-188; iodine and fluorine-18 isotopes; and gallium-68 and some other metallic radionuclides used in theranostic schemes combining radionuclide diagnostics and radionuclide therapy. The article analyses the sources for the formation of radionuclide, radiochemical, and chemical impurities; the influence of these impurities on visualisation quality and dosimetric characteristics of radiopharmaceuticals; various approaches to the methods of impurity detection and quantification; compendial requirements to the quality of radiopharmaceuticals; and research results reported in publications. The article demonstrates the need for the development and certification of Russian reference standards for testing quality attributes of radiopharmaceuticals as part of harmonisation of the State Pharmacopoeia of the Russian Federation with the Pharmacopoeia of the Eurasian Economic Union and the European Pharmacopoeia
ΠΡΠΈΡΡΡΡΡΠ²ΠΈΠ΅ Π²ΠΎΠ·ΠΌΠΎΠΆΠ½ΡΡ ΠΏΡΠΈΠΌΠ΅ΡΠ΅ΠΉ Π² ΡΠ°Π΄ΠΈΠΎΡΠ°ΡΠΌΠ°ΡΠ΅Π²ΡΠΈΡΠ΅ΡΠΊΠΈΡ Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½Π½ΡΡ ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠ°Ρ ΠΈ ΠΌΠ΅ΡΠΎΠ΄Ρ ΠΈΡ ΠΎΠΏΡΠ΅Π΄Π΅Π»Π΅Π½ΠΈΡ
The main quality attributes of radiopharmaceuticals that ensure their effectiveness and safety and are unique to their specifications are activity, radionuclide identity, radionuclide purity, and radiochemical purity. The aim of this study was to analyse the possibility of formation and methods for determination of various impurities in radiopharmaceuticals based on radionuclides of several groups: technetium-99m and rhenium-188; iodine and fluorine-18 isotopes; and gallium-68 and some other metallic radionuclides used in theranostic schemes combining radionuclide diagnostics and radionuclide therapy. The article analyses the sources for the formation of radionuclide, radiochemical, and chemical impurities; the influence of these impurities on visualisation quality and dosimetric characteristics of radiopharmaceuticals; various approaches to the methods of impurity detection and quantification; compendial requirements to the quality of radiopharmaceuticals; and research results reported in publications. The article demonstrates the need for the development and certification of Russian reference standards for testing quality attributes of radiopharmaceuticals as part of harmonisation of the State Pharmacopoeia of the Russian Federation with the Pharmacopoeia of the Eurasian Economic Union and the European Pharmacopoeia.ΠΡΠ½ΠΎΠ²Π½ΡΠΌΠΈ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»ΡΠΌΠΈ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° Π»ΡΠ±ΠΎΠ³ΠΎ ΡΠ°Π΄ΠΈΠΎΡΠ°ΡΠΌΠ°ΡΠ΅Π²ΡΠΈΡΠ΅ΡΠΊΠΎΠ³ΠΎ Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½Π½ΠΎΠ³ΠΎ ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠ°, ΠΊΠΎΡΠΎΡΡΠ΅ ΠΎΠ±Π΅ΡΠΏΠ΅ΡΠΈΠ²Π°ΡΡ Π΅Π³ΠΎ ΡΡΡΠ΅ΠΊΡΠΈΠ²Π½ΠΎΡΡΡ ΠΈ Π±Π΅Π·ΠΎΠΏΠ°ΡΠ½ΠΎΡΡΡ, ΠΈ ΠΏΡΠΈ ΡΡΠΎΠΌ ΠΎΡΡΡΡΡΡΠ²ΡΡΡ Π² ΡΠΏΠ΅ΡΠΈΡΠΈΠΊΠ°ΡΠΈΡΡ
Π΄ΡΡΠ³ΠΈΡ
Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½Π½ΡΡ
ΡΡΠ΅Π΄ΡΡΠ², ΡΠ²Π»ΡΡΡΡΡ ΠΏΠΎΠ΄Π»ΠΈΠ½Π½ΠΎΡΡΡ ΠΏΠΎ ΡΠ°Π΄ΠΈΠΎΠ½ΡΠΊΠ»ΠΈΠ΄Ρ, Π°ΠΊΡΠΈΠ²Π½ΠΎΡΡΡ, ΡΠ°Π΄ΠΈΠΎΠ½ΡΠΊΠ»ΠΈΠ΄Π½Π°Ρ ΡΠΈΡΡΠΎΡΠ° ΠΈ ΡΠ°Π΄ΠΈΠΎΡ
ΠΈΠΌΠΈΡΠ΅ΡΠΊΠ°Ρ ΡΠΈΡΡΠΎΡΠ°. Π¦Π΅Π»Ρ ΡΠ°Π±ΠΎΡΡ β Π°Π½Π°Π»ΠΈΠ· Π²ΠΎΠ·ΠΌΠΎΠΆΠ½ΠΎΡΡΠΈ ΠΎΠ±ΡΠ°Π·ΠΎΠ²Π°Π½ΠΈΡ ΡΠ°Π·Π»ΠΈΡΠ½ΡΡ
Π²ΠΈΠ΄ΠΎΠ² ΠΏΡΠΈΠΌΠ΅ΡΠ΅ΠΉ Π² ΡΠ°Π΄ΠΈΠΎΡΠ°ΡΠΌΠ°ΡΠ΅Π²ΡΠΈΡΠ΅ΡΠΊΠΈΡ
Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½Π½ΡΡ
ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠ°Ρ
ΠΈ ΠΌΠ΅ΡΠΎΠ΄ΠΎΠ² ΠΎΠΏΡΠ΅Π΄Π΅Π»Π΅Π½ΠΈΡ ΡΡΠΈΡ
ΠΏΡΠΈΠΌΠ΅ΡΠ΅ΠΉ. Π Π°ΡΡΠΌΠΎΡΡΠ΅Π½Ρ ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΡ Π½Π° ΠΎΡΠ½ΠΎΠ²Π΅ ΡΠ°Π΄ΠΈΠΎΠ½ΡΠΊΠ»ΠΈΠ΄ΠΎΠ² ΡΠ°Π·Π»ΠΈΡΠ½ΡΡ
Π³ΡΡΠΏΠΏ: ΡΠ΅Ρ
Π½Π΅ΡΠΈΡ-99ΠΌ ΠΈ ΡΠ΅Π½ΠΈΡ-188; ΠΈΠ·ΠΎΡΠΎΠΏΠΎΠ² ΠΉΠΎΠ΄Π° ΠΈ ΡΡΠΎΡΠ°-18; Π³Π°Π»Π»ΠΈΡ-68 ΠΈ Π½Π΅ΠΊΠΎΡΠΎΡΡΡ
Π΄ΡΡΠ³ΠΈΡ
ΡΠ°Π΄ΠΈΠΎΠ½ΡΠΊΠ»ΠΈΠ΄ΠΎΠ²-ΠΌΠ΅ΡΠ°Π»Π»ΠΎΠ², ΠΏΡΠΈΠΌΠ΅Π½ΡΠ΅ΠΌΡΡ
Π² ΡΠ΅ΡΠ°Π½ΠΎΡΡΠΈΡΠ΅ΡΠΊΠΈΡ
ΡΡ
Π΅ΠΌΠ°Ρ
Β«ΡΠ°Π΄ΠΈΠΎΠ½ΡΠΊΠ»ΠΈΠ΄Π½Π°Ρ Π΄ΠΈΠ°Π³Π½ΠΎΡΡΠΈΠΊΠ°/ΡΠ°Π΄ΠΈΠΎΠ½ΡΠΊΠ»ΠΈΠ΄Π½Π°Ρ ΡΠ΅ΡΠ°ΠΏΠΈΡΒ». ΠΡΠΎΠ°Π½Π°Π»ΠΈΠ·ΠΈΡΠΎΠ²Π°Π½Ρ ΠΈΡΡΠΎΡΠ½ΠΈΠΊΠΈ ΠΎΠ±ΡΠ°Π·ΠΎΠ²Π°Π½ΠΈΡ ΡΠ°Π΄ΠΈΠΎΠ½ΡΠΊΠ»ΠΈΠ΄Π½ΡΡ
, ΡΠ°Π΄ΠΈΠΎΡ
ΠΈΠΌΠΈΡΠ΅ΡΠΊΠΈΡ
ΠΈ Ρ
ΠΈΠΌΠΈΡΠ΅ΡΠΊΠΈΡ
ΠΏΡΠΈΠΌΠ΅ΡΠ΅ΠΉ, ΠΈΡ
Π²Π»ΠΈΡΠ½ΠΈΠ΅ Π½Π° ΠΊΠ°ΡΠ΅ΡΡΠ²ΠΎ Π²ΠΈΠ·ΡΠ°Π»ΠΈΠ·Π°ΡΠΈΠΈ ΠΈ Π΄ΠΎΠ·ΠΈΠΌΠ΅ΡΡΠΈΡΠ΅ΡΠΊΠΈΠ΅ Ρ
Π°ΡΠ°ΠΊΡΠ΅ΡΠΈΡΡΠΈΠΊΠΈ ΡΠ°Π΄ΠΈΠΎΡΠ°ΡΠΌΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ², ΡΠ°Π·Π»ΠΈΡΠ½ΡΠ΅ ΠΏΠΎΠ΄Ρ
ΠΎΠ΄Ρ ΠΊ ΠΌΠ΅ΡΠΎΠ΄Π°ΠΌ ΠΎΠ±Π½Π°ΡΡΠΆΠ΅Π½ΠΈΡ ΠΈ ΠΊΠΎΠ»ΠΈΡΠ΅ΡΡΠ²Π΅Π½Π½ΠΎΠ³ΠΎ ΠΎΠΏΡΠ΅Π΄Π΅Π»Π΅Π½ΠΈΡ ΠΏΡΠΈΠΌΠ΅ΡΠ΅ΠΉ,Β ΡΠ°ΡΠΌΠ°ΠΊΠΎΠΏΠ΅ΠΉΠ½ΡΠ΅ ΡΡΠ΅Π±ΠΎΠ²Π°Π½ΠΈΡ ΠΊ ΠΊΠ°ΡΠ΅ΡΡΠ²Ρ ΡΠ°Π΄ΠΈΠΎΡΠ°ΡΠΌΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ² ΠΈ ΡΠ΅Π·ΡΠ»ΡΡΠ°ΡΡ ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΠΉ, ΠΎΠΏΡΠ±Π»ΠΈΠΊΠΎΠ²Π°Π½Π½ΡΠ΅ Π² Π½Π°ΡΡΠ½ΠΎΠΉ Π»ΠΈΡΠ΅ΡΠ°ΡΡΡΠ΅. ΠΠΎΠΊΠ°Π·Π°Π½Π° Π½Π΅ΠΎΠ±Ρ
ΠΎΠ΄ΠΈΠΌΠΎΡΡΡ ΡΠ°Π·ΡΠ°Π±ΠΎΡΠΊΠΈ ΠΈ Π°ΡΡΠ΅ΡΡΠ°ΡΠΈΠΈ ΠΎΡΠ΅ΡΠ΅ΡΡΠ²Π΅Π½Π½ΡΡ
ΡΡΠ°Π½Π΄Π°ΡΡΠ½ΡΡ
ΠΎΠ±ΡΠ°Π·ΡΠΎΠ² Π΄Π»Ρ ΠΎΠΏΡΠ΅Π΄Π΅Π»Π΅Π½ΠΈΡ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Π΅ΠΉ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° ΡΠ°Π΄ΠΈΠΎΡΠ°ΡΠΌΠ°ΡΠ΅Π²ΡΠΈΡΠ΅ΡΠΊΠΈΡ
Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½Π½ΡΡ
ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ² Π² ΡΠ°ΠΌΠΊΠ°Ρ
Π³Π°ΡΠΌΠΎΠ½ΠΈΠ·Π°ΡΠΈΠΈ ΠΎΡΠ΅ΡΠ΅ΡΡΠ²Π΅Π½Π½ΠΎΠΉ ΡΠ°ΡΠΌΠ°ΠΊΠΎΠΏΠ΅ΠΈ Ρ Π€Π°ΡΠΌΠ°ΠΊΠΎΠΏΠ΅Π΅ΠΉ ΠΠ²ΡΠ°Π·ΠΈΠΉΡΠΊΠΎΠ³ΠΎ ΡΠΊΠΎΠ½ΠΎΠΌΠΈΡΠ΅ΡΠΊΠΎΠ³ΠΎ ΡΠΎΡΠ·Π° ΠΈ ΠΠ²ΡΠΎΠΏΠ΅ΠΉΡΠΊΠΎΠΉ ΡΠ°ΡΠΌΠ°ΠΊΠΎΠΏΠ΅Π΅ΠΉ
ΠΠΏΡΡ ΠΏΡΠΎΠ²Π΅Π΄Π΅Π½ΠΈΡ Π²Π°Π»ΠΈΠ΄Π°ΡΠΈΠΈ ΠΌΠ΅ΡΠΎΠ΄ΠΈΠΊ ΠΎΠΏΡΠ΅Π΄Π΅Π»Π΅Π½ΠΈΡ ΡΠ°Π΄ΠΈΠΎΡ ΠΈΠΌΠΈΡΠ΅ΡΠΊΠΈΡ ΠΏΡΠΈΠΌΠ΅ΡΠ΅ΠΉ Π² ΡΠ°Π΄ΠΈΠΎΡΠ°ΡΠΌΠ°ΡΠ΅Π²ΡΠΈΡΠ΅ΡΠΊΠΈΡ Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½Π½ΡΡ ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠ°Ρ
Most important quality attributes of any radiopharmaceutical (RPh) are its radiochemical purity (RCP) or content of radiochemical impurities (RCIs) that have to comply with respective norms and limits. However, at present, there is no unified approach to validation of analytical methods in the context of highly radioactive samples.The aim of the study was to develop an approach to validation of methods for determination of RCI content in RPhs.Materials and methods: the authors determined the content of RCIs in a radiopharmaceutical formulation containing a complex of technetium-99m and methylenediphosphonic acid by the radiometric method after isolation of impurities from the main compound by thin-layer chromatography using silica gel and methyl ethyl ketone (for sodium pertechnetate determination) and silica gel and 13.6% sodium acetate solution (for determination of hydrolysed reduced technetium-99m). The radioactivity was registered by a chromatogram scanner with a detector of gamma-rays with energies from 0.05 to 1.5 MeV.Results: the paper analyses existing official approaches to validation of analytical procedures and compares them with the results of experimental studies described in available publications. It assesses the validation parameters for compliance with the acceptance criteria set forth in the current regulations and substantiates selectivity of chromatographic determination of impurities under the selected test conditions. Coefficients of variation for repeatability, reproducibility, and accuracy did not exceed 4.5, 2.8, and 8.9%, respectively, given the relative error of not more than 10.5%. The study demonstrated signal linearity for the 10-fold dilution of the standardised sodium pertechnetate solution, it also demonstrated correspondence between the applied and detected radioactivity when performing the test in the impurity content range of 0.5β5%. The validation procedure was associated with significant radiation burden for the personnel of the quality control laboratory.Conclusions: the authors suggested a methodological approach to validation of methods for determination of RCI content in technetium-99m-based RPhs. This approach may be used in the development of a guideline on validation of analytical methods for RCP/RCI determination in RPhs, or for introduction of relevant sections into existing documents.ΠΠ°ΠΆΠ½Π΅ΠΉΡΠΈΠΌΠΈ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»ΡΠΌΠΈ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° Π»ΡΠ±ΠΎΠ³ΠΎ ΡΠ°Π΄ΠΈΠΎΡΠ°ΡΠΌΠ°ΡΠ΅Π²ΡΠΈΡΠ΅ΡΠΊΠΎΠ³ΠΎ Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½Π½ΠΎΠ³ΠΎ ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠ° (Π Π€ΠΠ) ΡΠ²Π»ΡΡΡΡΡ Π΅Π³ΠΎ ΡΠ°Π΄ΠΈΠΎΡ
ΠΈΠΌΠΈΡΠ΅ΡΠΊΠ°Ρ ΡΠΈΡΡΠΎΡΠ° (Π Π₯Π§) ΠΈΠ»ΠΈ ΡΠΎΠ΄Π΅ΡΠΆΠ°Π½ΠΈΠ΅ ΡΠ°Π΄ΠΈΠΎΡ
ΠΈΠΌΠΈΡΠ΅ΡΠΊΠΈΡ
ΠΏΡΠΈΠΌΠ΅ΡΠ΅ΠΉ (Π Π₯Π), Π·Π½Π°ΡΠ΅Π½ΠΈΡ ΠΊΠΎΡΠΎΡΡΡ
Π½ΠΎΡΠΌΠΈΡΠΎΠ²Π°Π½Ρ. ΠΠ΄Π½Π°ΠΊΠΎ Π² Π½Π°ΡΡΠΎΡΡΠ΅Π΅ Π²ΡΠ΅ΠΌΡ Π½Π΅ ΡΡΡΠ΅ΡΡΠ²ΡΠ΅Ρ Π΅Π΄ΠΈΠ½ΠΎΠ³ΠΎ ΠΏΠΎΠ΄Ρ
ΠΎΠ΄Π° ΠΊ Π²Π°Π»ΠΈΠ΄Π°ΡΠΈΠΈ Π°Π½Π°Π»ΠΈΡΠΈΡΠ΅ΡΠΊΠΈΡ
ΠΌΠ΅ΡΠΎΠ΄ΠΈΠΊ Π² ΡΡΠ»ΠΎΠ²ΠΈΡΡ
ΡΠ°Π±ΠΎΡΡ Ρ Π²ΡΡΠΎΠΊΠΎΡΠ°Π΄ΠΈΠΎΠ°ΠΊΡΠΈΠ²Π½ΡΠΌΠΈ ΠΎΠ±ΡΠ°Π·ΡΠ°ΠΌΠΈ.Π¦Π΅Π»Ρ ΡΠ°Π±ΠΎΡΡ: ΡΠΎΡΠΌΠΈΡΠΎΠ²Π°Π½ΠΈΠ΅ ΠΏΠΎΠ΄Ρ
ΠΎΠ΄Π° ΠΊ Π²Π°Π»ΠΈΠ΄Π°ΡΠΈΠΈ ΠΌΠ΅ΡΠΎΠ΄ΠΈΠΊΠΈ ΠΎΠΏΡΠ΅Π΄Π΅Π»Π΅Π½ΠΈΡ ΡΠΎΠ΄Π΅ΡΠΆΠ°Π½ΠΈΡ Π Π₯Π Π² Π Π€ΠΠ.ΠΠ°ΡΠ΅ΡΠΈΠ°Π»Ρ ΠΈ ΠΌΠ΅ΡΠΎΠ΄Ρ: ΠΊΠΎΠ»ΠΈΡΠ΅ΡΡΠ²Π΅Π½Π½ΠΎΠ΅ ΠΎΠΏΡΠ΅Π΄Π΅Π»Π΅Π½ΠΈΠ΅ Π Π₯Π Π² ΡΠ°Π΄ΠΈΠΎΡΠ°ΡΠΌΠ°ΡΠ΅Π²ΡΠΈΡΠ΅ΡΠΊΠΎΠΉ ΠΊΠΎΠΌΠΏΠΎΠ·ΠΈΡΠΈΠΈ, ΡΠΎΠ΄Π΅ΡΠΆΠ°ΡΠ΅ΠΉ ΠΊΠΎΠΌΠΏΠ»Π΅ΠΊΡ ΡΠ΅Ρ
Π½Π΅ΡΠΈΡ-99ΠΌ Ρ ΠΌΠ΅ΡΠΈΠ»Π΅Π½Π΄ΠΈΡΠΎΡΡΠΎΠ½ΠΎΠ²ΠΎΠΉ ΠΊΠΈΡΠ»ΠΎΡΠΎΠΉ, ΠΏΡΠΎΠ²ΠΎΠ΄ΠΈΠ»ΠΈ ΡΠ°Π΄ΠΈΠΎΠΌΠ΅ΡΡΠΈΡΠ΅ΡΠΊΠΈΠΌ ΠΌΠ΅ΡΠΎΠ΄ΠΎΠΌ ΠΏΠΎΡΠ»Π΅ ΡΠ°Π·Π΄Π΅Π»Π΅Π½ΠΈΡ ΠΏΡΠΈΠΌΠ΅ΡΠ΅ΠΉ ΠΈ ΠΎΡΠ½ΠΎΠ²Π½ΠΎΠ³ΠΎ ΡΠΎΠ΅Π΄ΠΈΠ½Π΅Π½ΠΈΡ Ρ ΠΏΠΎΠΌΠΎΡΡΡ ΡΠΎΠ½ΠΊΠΎΡΠ»ΠΎΠΉΠ½ΠΎΠΉ Ρ
ΡΠΎΠΌΠ°ΡΠΎΠ³ΡΠ°ΡΠΈΠΈ Π² ΡΠΈΡΡΠ΅ΠΌΠ΅ ΡΠΈΠ»ΠΈΠΊΠ°Π³Π΅Π»ΡβΠΌΠ΅ΡΠΈΠ»ΡΡΠΈΠ»ΠΊΠ΅ΡΠΎΠ½ Π΄Π»Ρ ΠΎΠΏΡΠ΅Π΄Π΅Π»Π΅Π½ΠΈΡ Π½Π°ΡΡΠΈΡ ΠΏΠ΅ΡΡΠ΅Ρ
Π½Π΅ΡΠ°ΡΠ° ΠΈ Π² ΡΠΈΡΡΠ΅ΠΌΠ΅ ΡΠΈΠ»ΠΈΠΊΠ°Π³Π΅Π»Ρ β 13,6% ΡΠ°ΡΡΠ²ΠΎΡ Π½Π°ΡΡΠΈΡ Π°ΡΠ΅ΡΠ°ΡΠ° Π΄Π»Ρ ΠΎΠΏΡΠ΅Π΄Π΅Π»Π΅Π½ΠΈΡ Π³ΠΈΠ΄ΡΠΎΠ»ΠΈΠ·ΠΎΠ²Π°Π½Π½ΠΎΠ³ΠΎ Π²ΠΎΡΡΡΠ°Π½ΠΎΠ²Π»Π΅Π½Π½ΠΎΠ³ΠΎ ΡΠ΅Ρ
Π½Π΅ΡΠΈΡ-99ΠΌ. Π Π΅Π³ΠΈΡΡΡΠ°ΡΠΈΡ ΡΠ°Π΄ΠΈΠΎΠ°ΠΊΡΠΈΠ²Π½ΠΎΡΡΠΈ ΠΏΡΠΎΠ²ΠΎΠ΄ΠΈΠ»Π°ΡΡ Ρ ΠΏΠΎΠΌΠΎΡΡΡ Ρ
ΡΠΎΠΌΠ°ΡΠΎΠ³ΡΠ°ΠΌΠΌ-ΡΠΊΠ°Π½Π΅ΡΠ° Ρ Π΄Π΅ΡΠ΅ΠΊΡΠΎΡΠΎΠΌ, ΡΠ΅Π³ΠΈΡΡΡΠΈΡΡΡΡΠΈΠΌ Π³Π°ΠΌΠΌΠ°-ΠΊΠ²Π°Π½ΡΡ Ρ ΡΠ½Π΅ΡΠ³ΠΈΠ΅ΠΉ ΠΎΡ 0,05 Π΄ΠΎ 1,5 ΠΡΠ.Π Π΅Π·ΡΠ»ΡΡΠ°ΡΡ: ΡΠ°ΡΡΠΌΠΎΡΡΠ΅Π½Ρ ΠΈ ΠΏΡΠΎΠ°Π½Π°Π»ΠΈΠ·ΠΈΡΠΎΠ²Π°Π½Ρ ΡΡΡΠ΅ΡΡΠ²ΡΡΡΠΈΠ΅ Π½ΠΎΡΠΌΠ°ΡΠΈΠ²Π½ΡΠ΅ ΠΏΠΎΠ΄Ρ
ΠΎΠ΄Ρ ΠΊ Π²Π°Π»ΠΈΠ΄Π°ΡΠΈΠΈ Π°Π½Π°Π»ΠΈΡΠΈΡΠ΅ΡΠΊΠΈΡ
ΠΌΠ΅ΡΠΎΠ΄ΠΈΠΊ Π² ΡΡΠ°Π²Π½Π΅Π½ΠΈΠΈ Ρ ΡΠ΅Π·ΡΠ»ΡΡΠ°ΡΠ°ΠΌΠΈ ΠΎΠΏΠΈΡΠ°Π½Π½ΡΡ
Π² Π»ΠΈΡΠ΅ΡΠ°ΡΡΡΠ΅ ΡΠΊΡΠΏΠ΅ΡΠΈΠΌΠ΅Π½ΡΠ°Π»ΡΠ½ΡΡ
ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΠΉ, ΠΏΡΠΎΠ²Π΅Π΄Π΅Π½Π° ΠΎΡΠ΅Π½ΠΊΠ° Π²Π°Π»ΠΈΠ΄Π°ΡΠΈΠΎΠ½Π½ΡΡ
ΠΏΠ°ΡΠ°ΠΌΠ΅ΡΡΠΎΠ² Π½Π° ΡΠΎΠΎΡΠ²Π΅ΡΡΡΠ²ΠΈΠ΅ ΠΊΡΠΈΡΠ΅ΡΠΈΡΠΌ ΠΏΡΠΈΠ΅ΠΌΠ»Π΅ΠΌΠΎΡΡΠΈ, ΠΏΡΠ΅Π΄ΡΡΠ²Π»ΡΠ΅ΠΌΡΠΌ Π΄Π΅ΠΉΡΡΠ²ΡΡΡΠΈΠΌΠΈ Π½ΠΎΡΠΌΠ°ΡΠΈΠ²Π½ΡΠΌΠΈ Π΄ΠΎΠΊΡΠΌΠ΅Π½ΡΠ°ΠΌΠΈ. ΠΠΎΠΊΠ°Π·Π°Π½Π° ΡΠ΅Π»Π΅ΠΊΡΠΈΠ²Π½ΠΎΡΡΡ Ρ
ΡΠΎΠΌΠ°ΡΠΎΠ³ΡΠ°ΡΠΈΡΠ΅ΡΠΊΠΎΠ³ΠΎ ΠΎΠΏΡΠ΅Π΄Π΅Π»Π΅Π½ΠΈΡ ΠΏΡΠΈΠΌΠ΅ΡΠ΅ΠΉ Π² Π²ΡΠ±ΡΠ°Π½Π½ΡΡ
ΡΡΠ»ΠΎΠ²ΠΈΡΡ
Π°Π½Π°Π»ΠΈΠ·Π°. ΠΠΎΡΡΡΠΈΡΠΈΠ΅Π½ΡΡ Π²Π°ΡΠΈΠ°ΡΠΈΠΈ ΠΏΡΠΈ Π²ΡΠΏΠΎΠ»Π½Π΅Π½ΠΈΠΈ ΡΠ΅ΡΡΠΎΠ² Β«ΠΠΎΠ²ΡΠΎΡΡΠ΅ΠΌΠΎΡΡΡ, Π²ΠΎΡΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΠΈΠΌΠΎΡΡΡ ΠΈ ΠΏΡΠ°Π²ΠΈΠ»ΡΠ½ΠΎΡΡΡΒ» Π½Π΅ ΠΏΡΠ΅Π²ΡΡΠ°Π»ΠΈ 4,5; 2,8 ΠΈ 8,9% ΡΠΎΠΎΡΠ²Π΅ΡΡΡΠ²Π΅Π½Π½ΠΎ ΠΏΡΠΈ ΠΎΡΠ½ΠΎΡΠΈΡΠ΅Π»ΡΠ½ΠΎΠΉ ΠΏΠΎΠ³ΡΠ΅ΡΠ½ΠΎΡΡΠΈ Π½Π΅ Π±ΠΎΠ»Π΅Π΅ 10,5%. ΠΡΠΎΠ΄Π΅ΠΌΠΎΠ½ΡΡΡΠΈΡΠΎΠ²Π°Π½Π° Π»ΠΈΠ½Π΅ΠΉΠ½ΠΎΡΡΡ ΡΠΈΠ³Π½Π°Π»Π° ΠΏΡΠΈ ΡΠ°Π·Π²Π΅Π΄Π΅Π½ΠΈΠΈ Π² 10 ΡΠ°Π· ΠΌΠΎΠ΄Π΅Π»ΡΠ½ΠΎΠ³ΠΎ ΡΠ°ΡΡΠ²ΠΎΡΠ° Π½Π°ΡΡΠΈΡ ΠΏΠ΅ΡΡΠ΅Ρ
Π½Π΅ΡΠ°ΡΠ°, Π΄ΠΎΠΊΠ°Π·Π°Π½ΠΎ ΡΠΎΠΎΡΠ²Π΅ΡΡΡΠ²ΠΈΠ΅ Π½Π°Π½Π΅ΡΠ΅Π½Π½ΠΎΠΉ ΠΈ Π΄Π΅ΡΠ΅ΠΊΡΠΈΡΡΠ΅ΠΌΠΎΠΉ ΡΠ°Π΄ΠΈΠΎΠ°ΠΊΡΠΈΠ²Π½ΠΎΡΡΠΈ ΠΏΡΠΈ Π°Π½Π°Π»ΠΈΠ·Π΅ Π² Π΄ΠΈΠ°ΠΏΠ°Π·ΠΎΠ½Π΅ ΡΠΎΠ΄Π΅ΡΠΆΠ°Π½ΠΈΡ ΠΏΡΠΈΠΌΠ΅ΡΠ΅ΠΉ 0,5β5%. ΠΠΎΠΊΠ°Π·Π°Π½ΠΎ, ΡΡΠΎ Π²ΡΠΏΠΎΠ»Π½Π΅Π½ΠΈΠ΅ ΠΏΡΠΎΡΠ΅Π΄ΡΡΡ Π²Π°Π»ΠΈΠ΄Π°ΡΠΈΠΈ ΡΠ²ΡΠ·Π°Π½ΠΎ ΡΠΎ Π·Π½Π°ΡΠΈΡΠ΅Π»ΡΠ½ΡΠΌΠΈ ΡΠ°Π΄ΠΈΠ°ΡΠΈΠΎΠ½Π½ΡΠΌΠΈ Π½Π°Π³ΡΡΠ·ΠΊΠ°ΠΌΠΈ Π½Π° ΠΏΠ΅ΡΡΠΎΠ½Π°Π» Π»Π°Π±ΠΎΡΠ°ΡΠΎΡΠΈΠΈ ΠΊΠΎΠ½ΡΡΠΎΠ»Ρ ΠΊΠ°ΡΠ΅ΡΡΠ²Π°.ΠΡΠ²ΠΎΠ΄Ρ: ΠΏΡΠ΅Π΄Π»ΠΎΠΆΠ΅Π½ ΠΌΠ΅ΡΠΎΠ΄ΠΎΠ»ΠΎΠ³ΠΈΡΠ΅ΡΠΊΠΈΠΉ ΠΏΠΎΠ΄Ρ
ΠΎΠ΄ ΠΊ Π²Π°Π»ΠΈΠ΄Π°ΡΠΈΠΈ ΠΌΠ΅ΡΠΎΠ΄ΠΈΠΊ ΠΎΠΏΡΠ΅Π΄Π΅Π»Π΅Π½ΠΈΡ ΡΠΎΠ΄Π΅ΡΠΆΠ°Π½ΠΈΡ Π Π₯Π Π² Π Π€ΠΠ Π½Π° ΠΎΡΠ½ΠΎΠ²Π΅ ΡΠ΅Ρ
Π½Π΅ΡΠΈΡ-99ΠΌ, ΠΊΠΎΡΠΎΡΡΠΉ Π² Π΄Π°Π»ΡΠ½Π΅ΠΉΡΠ΅ΠΌ ΠΌΠΎΠΆΠ΅Ρ Π±ΡΡΡ ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π½ ΠΏΡΠΈ ΡΠ°Π·ΡΠ°Π±ΠΎΡΠΊΠ΅ ΠΎΡΠ΄Π΅Π»ΡΠ½ΠΎΠ³ΠΎ Π΄ΠΎΠΊΡΠΌΠ΅Π½ΡΠ° ΠΏΠΎ Π²Π°Π»ΠΈΠ΄Π°ΡΠΈΠΈ Π°Π½Π°Π»ΠΈΡΠΈΡΠ΅ΡΠΊΠΈΡ
ΠΌΠ΅ΡΠΎΠ΄ΠΈΠΊ ΠΎΠΏΡΠ΅Π΄Π΅Π»Π΅Π½ΠΈΡ Π Π₯Π§ ΠΈΠ»ΠΈ Π Π₯Π Π΄Π»Ρ Π Π€ΠΠ ΠΈΠ»ΠΈ Π²Π½Π΅ΡΠ΅Π½ΠΈΡ ΡΠΎΠΎΡΠ²Π΅ΡΡΡΠ²ΡΡΡΠΈΡ
ΡΠ°Π·Π΄Π΅Π»ΠΎΠ² Π² Π΄Π΅ΠΉΡΡΠ²ΡΡΡΠΈΠ΅ Π΄ΠΎΠΊΡΠΌΠ΅Π½ΡΡ
QUALITY CONTROL OF RADIOPHARMACEUTICALS IN MEDICAL INSTITUTIONS
One of the major nuclear medicine agent is radiopharmaceutical (RPh) which is a composition comprising a radioactive isotope in certain chemical form. Quality control, namely the determination of radiochemical purity of radiopharmaceuticals produced in a medical institution, prior to administration to the patient is mandatory in all developed countries of the world since the mid-1980s. In our country, virtually the same procedure has been mandatory since the beginning of 2016, along with other measures, the implementation of which should guarantee the high quality and safety of nuclear medicine procedures according to the Order of the Ministry of Health of the Russian Federation from 27.04.2015 N 211n Β«On approval of the radiopharmaceutical preparation directly in medical institutionsΒ», which came into force from January 01, 2016. This article presents the main approaches to the implementation of quality control (determination of radiochemical purity) of radiopharmaceuticals manufactured directly in the medical institutions
Results from ikaite investigations in the Kara Sea
The authigenic carbonate mineral ikaite is specific of low-temperature high latitude environments. The depletion of ikaite carbon in 13C isotopes in most cases implies a causal relation of ikaite generation with methane geochemistry. In this paper we present new data on ikaite minerals in Holocene sediments sampled along the Yenisei channel at the southern (74Β°N) and northern (77Β°N) ends. Stable carbon isotopes of the ikaite crystals were studied in conjunction with the hydrochemistry and isotope geochemistry of the sediments. Pore water and natural gas samples were separated from sediments to describe the methane carbon isotope distribution pattern throughout two sedimentary sequences embedding the ikaite crystals of different isotope composition (-24 per mil and -42 per mil). The biogenic nature of the methane is indicated by 51 C values being as low as -104.4 per mil. In the case of the moderately depleted sample (-24 per mil) from the southern location the small-scale ikaite formation fits best into the concept of a 'closedΒ» sediment system, with a limited diagenetic carbon dioxide source being present. In the second case, formation of highly abundant and isotopically depleted ikaite crystals (-42 per mil) were caused by upwards flux of biogenic methane from below. Contribution of two main carbon sources to the ikaite crystals was estimated by using a isotope-mass balance equation. Organic-derived CO2 constitutes the principal source in both samples, amounting to 50 % of the total carbon of the strongly depleted ikaite crystals (-42 per mil) sampled at the northern end and 83 % for the moderately (-24 per mil) depleted crystals from the southern end. Methane-derived CO2 comes to 42 % for the isotopically light ikaite crystals and to 9% for the isotopically heavy crystals. The importance of sediment lithology and diffusive transport for ikaite formation is emphazied
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