15 research outputs found
The impact of chemical composition on the antioxidant, antifungal and antibacterial activity of commercial Macedonian cold-pressed oils
The chemical composition and quality of four commercial cold-pressed oils (poppy seed oil, almond oil, walnut oil and wheat germ oil) from Macedonia were examined in this
work. Regarding the fatty acid composition, the highest level of oleic acid was determined in almond oil (67.57Β±0.02%) and wheat germ oil (38.14Β±0.04%), whereas the poppy seed oil and walnut oil were the richest sources of linoleic acid with abundance of 72.28Β±0.06% and
60.73Β±0.01% respectively. The significant quantity of Ξ±-linoleic acid (ALA) was detected
only in walnut oil (11.74Β±0.01%). The highest level of Ξ±-tocopherol (23.77Β±0.01 mg/100 g of
oil) was quantified in almond oil while Ξ³-tocopherol was the most abundant in walnut and
wheat germ oils.
The results from antioxidant assays showed that Vitamin-E-active compounds were
the most important minor compounds responsible for antioxidant activity against DPPH
radical, whereas total phenolic compounds were the most active against ABTS radical.
Phytosterols, as minor compounds present in the oils, did not contribute significantly to the
total antioxidant potential of the oils but, their levels in particular oils, together with fatty
acids, can be useful and reliable markers for the purity of the oils and determination of the
composition of blends.
Regarding antimicrobial activity, the cold-pressed poppy seed oil had antibacterial
activity against Listeria monocytogenes whereas, significant antifungal activity against
Candida albicans indicated almond, walnut and poppy seed oils
Comparison of the impact of two versions of reagent and ancillary sets on the [18F]FDG radiochemical yield
Aim: The purpose of this study is to compare the impact of the optimised versus standard version of the reagent
set and ancillary kit on the [18F]FDG radiochemical yield.
Materials and Methods: [18F]Fradioisotope is produced in a cyclotron (GE PETtrace 16.5 MeV) by irradiating
enriched 18O water with protons.
[
18F]FDG radiosynthesis (a nucleophilic 18F-fluorination followed by base-catalyzed hydrolysis) is conducted
using an automated synthesizer IBA Synthera V2 module and a single-use disposable system β Integrated Fluid
Processor (IFP) as well as reagents and ancillary set. There are two commercially available versions of these sets.
In the new version of the reagents set, the molar ratio acetonitrile-water in the cryptand solution is 4:1 instead of
1:1. As the separation cartridge in the new version of the ancillary kit is used QMA Carbonate Plus Light, instead
of QMA Plus Light. A modification is also made in the purification cartridges, Oasis HLB in place of the C18
cartridge.
In this study, 100 [18F]FDG batches in total are analyzed. 50 batches were synthesized using the standard version
of the reagent and ancillary kits, while the other 50 batches were with the optimised version.
The mean radiochemical yield (RCY), decay-corrected, and relevant standard deviation (SD) are calculated for
both types of analyzed batches.
Results: [18F]FDG batches produced using the optimised version of reagents and ancillary kit has higher RCY
(65.01% Β± 4.52%) compared to the batches produced using the standard version (57.83% Β± 3.61%).
Conclusion: This study confirms that the optimisation of the reagent and ancillary sets contributes to a higher
radiochemical yield of the produced [
18F]FDG
Design of feasibility study for the establishment of production of zirconium-89 radioisotope and implementation of 89Zr-radiopharmaceuticals in clinical practice in the Republic of North Macedonia
The radiopharmaceuticals based on zirconium-89 (89Zr) radiometal, in the last decade, have increased application in both preclinical and clinical studies. The most frequently used 89Zr-radiopharmaceutical is 89Zr-trastuzumab used in the management of patients with breast cancer. Breast cancer is the most common cancer among women in North Macedonia and the most common cause of death from malignant neoplasms in this population, therefore the introduction of new nuclear medicine procedures in these patients might improve the management of this disease. However, the introduction of radioisotope and radiopharmaceutical production requires significant investments, both manpower and financial.
In order to assess the feasibility of establishing the production of zirconium-89 radioisotope and 89Zr-radiopharmaceuticals at the University Institute of Positron Emission Tomography (UI PET), a feasibility study is designed.
The purpose of this work is to present the design conceptualization of a feasibility study for the establishment of production of zirconium-89 radioisotope and implementation of 89Zr-radiopharmaceuticals in clinical practice in the Republic of North Macedonia and to present the initial results from the first phases of the study. This feasibility study is designed to include preliminary analysis, market research, technical feasibility analysis, economic analysis, review and analysis of all data and feasibility conclusion.
The evaluation of the data from the analyses conducted in all study phases is needed to identify the favourable and unfavourable factors and circumstances in order to make a final assessment of the feasibility of establishing the zirconium-89 radioisotope and 89Zr-radiopharmaceuticals production and implementation of 89Zr-trastuzumab use in nuclear medicine practice.
Keywords: feasibility study, zirconium-89 radioisotope, 89Zr-radiopharmaceuticals, production, 89Zr-trastuzuma
Aseptic process validation of [18F]Sodium Fluoride radiopharmaceutical in-house production
Sodium fluoride ([18F]NaF) is a PET radiopharmaceutical for vizualization of the skeletal system and microcalcification. In the originally designed in-house method, [18F]NaF is recovered in aqueous solution after cyclotron irradiation, sterilized by passage through a 0.22 ΞΌm sterile filter and dispensed under aseptic conditions. To ensure the microbiological safety of drugs produced under aseptic conditions, validation of aseptic procedures is always recommended. This is essential for radiopharmaceuticals because most of them are released for administration before any sterility test can be completed due to their radioactive nature.
This study reports the validation of the aseptic process applied to the internal production of [18F]NaF carried out in two phases: testing the number of viable microorganisms in radiopharmaceutical product prior to sterilization and process simulation studies (media fill tests). We found that all samples were sterile and the endotoxin concentration was well below the maximum acceptable level reported in the Ph Eur. monograph on [18F]NaF. The results confirmed that the entire production process of [18F]NaF can be carried out under strictly aseptic conditions following the validated procedures preserving the sterility of the final product
Production of [11C] Choline in The University Institute for PET β new perspective in diagnostics of prostate malignancy in R. of Macedonia
[11C] Choline injection is radiopharmaceutical for oncological PET imaging of tumors which overexpress choline kinase. The most important clinical application of this PET radiopharmaceutical is in prostate cancer that can be visualized precisely, having differentiated localization located in comparison with benign tissue. The uptake of specific radiopharmaceutical remains constant thereafter, allowing better visualization of
this kind of tumor. [11C]Choline PET/CT could represent an important imaging modality also in the detection of distant relapses in prostate cancer patients with biochemical recurrence
Optimization of production of [11C]CH3I with Methylator II for synthesis and development of [11C]radiopharmaceuticals
Aim: University Institute of Positron Emission Tomography Skopje is equipped with the Methylator II (Comecer Spa. Former Veenstra In- struments BV.), a module designed for the production of high spe- cific activity MethylIodide ([11C]CH3I) and/or Methyl Triflate ([11C]CH3OSO2CF3) and CarbonSynthon I (Comecer Spa.) for produc- tion of simple 11C radiopharmaceuticals. The synthesis process starts with the production of [11C]CO2 in the cyclotron (GE PETtrace 16.5MeV) via the 14N(p,Ξ±)11C nuclear reaction. The produced [11C]CO2 is delivered into the Methylator, where it first was trapped and sub- sequently reduced to [11C]CH4 and converted thereafter into [11C]CH3I and/or [11C]CH3OSO2CF3. The trapped [11C]CO2 in the Methanizer was reduced into a [11C]CH4 with hydrogen on a nickel catalyst (Shinwasorb) at a rather moderate temperature 350 0C. The next step was the purification of the [11C]CH4 over a Carboxen 1000 column, with the knowledge that the H2 will flow about 7 times fas- ter than [11C]CH4 through carbon packing causing the separation of H2 and CH4. This is one of the most important steps in the produc- tion process which affects directly the equilibrium reaction which forms the [11C]CH3I and HI, which is formed in the iodine oven by the reaction of H2 and I2 as well
Methods: Optimization experiments where performed maximizing the yield of [11C]CH3I. By changing the time for switching the valve V04 (see diagram) the effectiveness of the purification was influ- enced. In βActiveβ state the formed [11C]CH4 and excess of H2 was di- rected toward waste, but in βInactiveβ state in direction of the Iodine Oven. If the time was too short the reduced [11C]CH4 would not be separated thorougly enough from the H2, but when the time was too long the produced [11C]CH4 would be lost into waste. The first syntheses were performed with V04 active for 25 sec upon release of the [11C]CH4, after which it was deactivated. Different timings for switching the valve were tested and the different yields were obtained.
Results Our result presented in the Table showed that yield of [11C] CH3I and [11C] Choline is purification time depended. By increasing the time of purification (from 20 to 37 seconds) obtained trapped [11C] CO2, is more than four time higher and harvested [11C] CH3I as well. After 37 seconds we obtained 41% of [11C] CH3I that is directly reflected to the yield of [11C] Choline (34.6), fitting with our protocol for synthesis of [11C] Choline.
Conclusion: The module and software give us a big opportunity and flexibility for testing and optimization of the production achieving a better yield, and also the development of new 11C radiopharmaceuticals
ΠΠΊΠΎΠ½ΠΎΠΌΡΠΊΠΎ Π²Π»ΠΈΡΠ°Π½ΠΈΠ΅ Π½Π° ΡΠ°ΡΠΌΠ°ΠΊΠΎΠ³Π΅Π½Π΅ΡΡΠΊΠΈΡΠ΅ ΡΠ΅ΡΡΠΈΡΠ°ΡΠ° Π²ΡΠ· ΡΠ°ΡΠΌΠ°ΠΊΠΎΡΠ΅ΡΠ°ΠΏΠΈΡΠΊΠΈΠΎΡ ΠΏΡΠΈΡΡΠ°ΠΏ
Π‘ΠΎΠ³Π»Π°ΡΠ½ΠΎ ICH Topic E15, ΡΠ°ΡΠΌΠ°ΠΊΠΎΠ³Π΅Π½ΠΎΠΌΠΈΠΊΠ°ΡΠ° (Π°Π½Π³. pharmacogenomics - PGx) ΡΠ΅ Π΄Π΅ΡΠΈΠ½ΠΈΡΠ° ΠΊΠ°ΠΊΠΎ ΡΡΡΠ΄ΠΈΡΠ° Π½Π° Π²Π°ΡΠΈΡΠ°ΡΠΈΠΈ Π½Π° ΠΊΠ°ΡΠ°ΠΊΡΠ΅ΡΠΈΡΡΠΈΠΊΠΈΡΠ΅ Π½Π° ΠΠΠ ΠΈ Π ΠΠ ΡΡΠΎ ΡΠ΅ ΠΏΠΎΠ²ΡΠ·Π°Π½ΠΈ ΡΠΎ ΠΎΠ΄Π³ΠΎΠ²ΠΎΡΠΎΡ Π½Π° Π»Π΅ΠΊΠΎΡ, Π° ΡΠ°ΡΠΌΠ°ΠΊΠΎΠ³Π΅Π½Π΅ΡΠΈΠΊΠ°ΡΠ° (pharmacogenetics β PGt) ΠΏΡΠ΅ΡΡΡΠ°Π²ΡΠ²Π° ΠΏΠΎΠ΄Π³ΡΡΠΏΠ° Π½Π° ΡΠ°ΡΠΌΠ°ΠΊΠΎΠ³Π΅Π½ΠΎΠΌΠΈΠΊΠ°ΡΠ° ΠΈ ΡΠ΅ Π΄Π΅ΡΠΈΠ½ΠΈΡΠ° ΠΊΠ°ΠΊΠΎ ΡΡΡΠ΄ΠΈΡΠ° Π½Π° Π²Π°ΡΠΈΡΠ°ΡΠΈΠΈ Π²ΠΎ ΠΠΠ ΡΠ΅ΠΊΠ²Π΅Π½ΡΠ°ΡΠ° ΠΏΠΎΠ²ΡΠ·Π°Π½ΠΈ ΡΠΎ ΠΎΠ΄Π³ΠΎΠ²ΠΎΡΠΎΡ Π½Π° Π»Π΅ΠΊΠΎΡ. ΠΠ²Π°ΡΠ° ΡΠ΅ΡΠΌΠΈΠ½ΠΈ, ΡΠ°ΡΠΌΠ°ΠΊΠΎΠ³Π΅Π½Π΅ΡΠΈΠΊΠ° ΠΈ ΡΠ°ΡΠΌΠ°ΠΊΠΎΠ³Π΅Π½ΠΎΠΌΠΈΠΊΠ°, ΡΠ΅ΡΡΠΎ ΡΠ΅ ΠΊΠΎΡΠΈΡΡΠ°Ρ Π½Π°ΠΈΠ·ΠΌΠ΅Π½ΠΈΡΠ½ΠΎ.ΠΡΠ°ΡΠ΅Π½ΠΊΠ°ΡΠ° PGx ΡΠ΅ΡΡΠΎΠΏΠ°ΡΠΈ ΡΠ΅ ΠΊΠΎΡΠΈΡΡΠΈ ΠΎΠ΄Π½Π΅ΡΡΠ²Π°ΡΡΠΈ ΡΠ΅ ΠΈ Π½Π° ΡΠ°ΡΠΌΠ°ΠΊΠΎΠ³Π΅Π½Π΅ΡΠΈΠΊΠ°ΡΠ° ΠΈ Π½Π° ΡΠ°ΡΠΌΠ°ΠΊΠΎΠ³Π΅Π½ΠΎΠΌΠΈΠΊΠ°ΡΠ°.
Π¦Π΅Π»ΡΠ° Π½Π° ΡΠ°ΡΠΌΠ°ΠΊΠΎΠ³Π΅Π½ΠΎΠΌΡΠΊΠΎΡΠΎ ΠΈΡΡΡΠ°ΠΆΡΠ²Π°ΡΠ΅ Π΅ Π΄Π° ΡΠ΅ ΠΈΠ΄Π΅Π½ΡΠΈΡΠΈΠΊΡΠ²Π°Π°Ρ ΡΠΎΠ±ΡΡΠ½ΠΈΡΠ΅ Π³Π΅Π½Π΅ΡΡΠΊΠΈ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»ΠΈ Π½Π° ΠΎΠ΄Π³ΠΎΠ²ΠΎΡΠΎΡ Π½Π° Π»Π΅ΠΊΠΎΡ ΡΡΠΎ ΠΌΠΎΠΆΠ΅ Π΄Π° Π±ΠΈΠ΄Π΅ ΠΈΡΠΊΠΎΡΠΈΡΡΠ΅Π½ΠΎ Π²ΠΎ ΠΊΠ»ΠΈΠ½ΠΈΡΠΊΠ°ΡΠ° ΠΏΡΠ°ΠΊΡΠ° Π·Π° Π΄Π° ΡΠ΅ ΠΈΠ΄Π΅Π½ΡΠΈΡΠΈΠΊΡΠ²Π°Π°Ρ ΠΏΠ°ΡΠΈΠ΅Π½ΡΠΈΡΠ΅ ΡΠΎ ΡΠΈΠ·ΠΈΠΊ ΠΎΠ΄ ΠΏΠΎΡΠ°Π²Π° Π½Π° Π½Π΅ΡΠ°ΠΊΠ°Π½ΠΈ ΡΠ΅Π°ΠΊΡΠΈΠΈ Π½Π° Π»Π΅ΠΊΠΎΠ²ΠΈ, ΠΎΠ½ΠΈΠ΅ ΠΊΠΎΠΈ Π½Π΅ ΠΌΠΎΠΆΠ°Ρ Π΄Π° ΠΈΠΌΠ°Π°Ρ ΠΊΠΎΡΠΈΡΡ ΠΎΠ΄ Π»Π΅ΠΊΠΎΠ²ΠΈΡΠ΅ ΠΈ ΠΎΠ½ΠΈΠ΅ ΠΊΠΎΠΈΡΡΠΎ ΠΈΠΌΠ°Π°Ρ ΠΏΠΎΡΡΠ΅Π±Π° ΠΎΠ΄ Π°Π»ΡΠ΅ΡΠ½Π°ΡΠΈΠ²Π½Π° ΡΠ°ΡΠΌΠ°ΠΊΠΎΡΠ΅ΡΠ°ΠΏΠΈΡΠ°. ΠΡΠ°ΡΠ½Π°ΡΠ° ΡΠ΅Π» Π΅ Π΄Π° ΡΠ΅ ΠΏΡΠΈΠ»Π°Π³ΠΎΠ΄Π°Ρ Π»Π΅ΠΊΠΎΠ²ΠΈΡΠ΅ Π½Π° ΠΏΠΎΠ΅Π΄ΠΈΠ½ΡΠΈ ΠΈΠ»ΠΈ Π³ΡΡΠΏΠΈ ΠΏΠ°ΡΠΈΠ΅Π½ΡΠΈ ΠΊΠΎΠΈ ΡΠ΅ ΠΈΠ·Π²Π»Π΅ΡΠ°Ρ ΠΌΠ°ΠΊΡΠΈΠΌΡΠΌ ΠΏΠΎΠ»Π·Π° ΠΎΠ΄ Π»Π΅ΠΊΠΎΡ ΠΈ ΡΠ΅ ΠΈΠΌΠ°Π°Ρ Π½Π°ΠΌΠ°Π»Π΅Π½ ΡΠΈΠ·ΠΈΠΊ ΠΎΠ΄ ΡΠΎΠΊΡΠΈΡΠ½ΠΎΡΡ Π½Π° Π»Π΅ΠΊΠΎΠ²ΠΈΡΠ΅, ΡΠΎ ΡΡΠΎ ΡΠ΅ ΡΠ΅ ΠΌΠ°ΠΊΡΠΈΠΌΠΈΠ·ΠΈΡΠ° ΠΎΠ΄Π½ΠΎΡΠΎΡ Π½Π° ΠΊΠΎΡΠΈΡΡ-ΡΠΈΠ·ΠΈΠΊ ΠΎΠ΄ Π»Π΅ΠΊΠΎΠ²ΠΈΡΠ΅. ΠΠ²ΠΎΡ ΠΊΠΎΠ½ΡΠ΅ΠΏΡ Π΅Π²ΠΎΠ»ΡΠΈΡΠ°Π» Π²ΠΎ ΠΈΠ½Π΄ΠΈΠ²ΠΈΠ΄ΡΠ°Π»ΠΈΠ·ΠΈΡΠ°Π½Π° ΠΌΠ΅Π΄ΠΈΡΠΈΠ½Π° (ΠΏΠ΅ΡΡΠΎΠ½Π°Π»ΠΈΠ·ΠΈΡΠ°Π½Π° ΠΌΠ΅Π΄ΠΈΡΠΈΠ½Π°), Π½ΠΎΠ²Π° ΠΌΠ΅Π΄ΠΈΡΠΈΠ½ΡΠΊΠ° ΠΏΡΠ°ΠΊΡΠΈΠΊΠ° ΡΡΠΎ Π³ΠΎ ΠΊΠΎΡΠΈΡΡΠΈ Π³Π΅Π½Π΅ΡΡΠΊΠΈΠΎΡ ΠΏΡΠΎΡΠΈΠ» Π½Π° ΠΏΠΎΠ΅Π΄ΠΈΠ½Π΅ΡΠΎΡ (ΠΈΠ»ΠΈ Π΄ΡΡΠ³ΠΈ Π½Π΅Π³Π΅Π½Π΅ΡΡΠΊΠΈ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»ΠΈ) Π·Π° Π½Π°ΡΠΎΡΡΠ²Π°ΡΠ΅ Π½Π° ΠΎΠ΄Π»ΡΠΊΠΈΡΠ΅ Π΄ΠΎΠ½Π΅ΡΠ΅Π½ΠΈ Π²ΠΎ Π²ΡΡΠΊΠ° ΡΠΎ ΠΏΡΠ΅Π²Π΅Π½ΡΠΈΡΠ°ΡΠ°, Π΄ΠΈΡΠ°Π³Π½ΠΎΡΡΠΈΠΊΠ°ΡΠ° ΠΈ Π»Π΅ΠΊΡΠ²Π°ΡΠ΅ΡΠΎ Π½Π° Π±ΠΎΠ»Π΅ΡΡΠ°. ΠΠΎΡΡΠΎΡΠ°Ρ ΠΌΠ½ΠΎΠ³Ρ ΡΡΡΠ΄ΠΈΠΈ Π·Π° Π³Π΅Π½Π΅ΡΡΠΊΠΈ ΡΠ°ΠΊΡΠΎΡΠΈ ΠΊΠΎΠΈ Π³ΠΎ ΠΎΠ΄ΡΠ΅Π΄ΡΠ²Π°Π°Ρ ΠΎΠ΄Π³ΠΎΠ²ΠΎΡΠΎΡ Π½Π° Π»Π΅ΠΊΠΎΡ, Π½ΠΎ ΠΏΠΎΠ²Π΅ΡΠ΅ΡΠΎ ΠΈΠ»ΠΈ ΠΈΠΌΠ°Π°Ρ Π΄Π°Π΄Π΅Π½ΠΎ Π½Π΅Π³Π°ΡΠΈΠ²Π½ΠΈ ΡΠ΅Π·ΡΠ»ΡΠ°ΡΠΈ ΠΈΠ»ΠΈ ΠΏΠΎΠ·ΠΈΡΠΈΠ²Π½ΠΈ ΡΠ΅Π·ΡΠ»ΡΠ°ΡΠΈ ΠΊΠΎΠΈ Π½Π΅ ΠΌΠΎΠΆΠ΅ Π΄Π° ΡΠ΅ ΠΏΠΎΠ²ΡΠΎΡΠ°Ρ Π²ΠΎ Π½Π°ΡΠ΅Π΄Π½ΠΈΡΠ΅ ΡΡΡΠ΄ΠΈΠΈ. ΠΠ΅ΡΡΡΠΎΠ°, ΠΏΠΎΡΡΠΎΡΠ°Ρ Π½Π΅ΠΊΠΎΠ»ΠΊΡ Π²Π°ΠΆΠ½ΠΈ Π½Π°ΠΎΠ΄ΠΈ Π½Π° Π³Π΅Π½Π΅ΡΡΠΊΠΈΡΠ΅ ΡΠ°ΠΊΡΠΎΡΠΈ Π²ΠΎ ΡΠ°Π·Π»ΠΈΡΠ½ΠΈ ΠΊΠ»ΠΈΠ½ΠΈΡΠΊΠΈ ΠΎΠ±Π»Π°ΡΡΠΈ, ΠΊΠΎΠΈΡΡΠΎ Π³ΠΎ ΠΈΠΌΠ°Π°Ρ ΠΏΠΎΠ΄ΠΎΠ±ΡΠ΅Π½ΠΎ Π·Π½Π°Π΅ΡΠ΅ΡΠΎ Π·Π° ΠΌΠ΅Ρ
Π°Π½ΠΈΠ·ΠΌΠΈΡΠ΅ Π½Π° Π΄Π΅ΡΡΡΠ²ΠΎ Π½Π° Π»Π΅ΠΊΠΎΠ²ΠΈΡΠ΅, Π²ΠΊΠ»ΡΡΠΈΡΠ΅Π»Π½ΠΎ ΠΈ ΡΠΎΠΊΡΠΈΡΠ½ΠΎΡΡΠ°, Π·Π° ΠΊΠΎΡΠ° ΡΠ΅ ΠΏΡΠ΅ΠΏΠΎΡΠ°ΡΡΠ²Π° ΡΠ΅ΡΡΠΈΡΠ°ΡΠ΅ ΠΏΡΠ΅Π΄ Π΄Π° ΡΠ΅ ΠΎΡΠΏΠΎΡΠ½Π΅ ΡΠΎ Π»Π΅ΠΊΡΠ²Π°ΡΠ΅Ρ
Quality control of PET radiopharmaceuticals, with reference to its specifics vs quality control of conventional pharmaceuticals
Radiopharmaceutical preparations or radiopharmaceuticals are medicinal products which, when ready for use, contain one or more radionuclides (radioactive isotopes) included for a medicinal purpose. As well as pharmaceuticals, they undergo strict quality control (QC) tests and procedures before release for use in patients. PET radiopharmaceuticals are usually formulated as sterile, apyrogenic injections, so they have to fulfill requirements for quality, efficacy and safety of conventional parenteral preparations. The specifics of QC of the radiopharmaceuticals arise from the very nature and the short half-life of the radioisotopes. The presence of radioisotope require introducing tests for radionuclidic and radiochemical identity and purity which are unique for radiopharmaceuticals. The presence of undesirable, extraneous radionuclides increases the undue radiation dose to the patient and may also degrade the scintigraphic images. Radionuclidic purity (RNP) is defined as the fraction of the total radioactivity in the form of the desired radionuclide present in a radiopharmaceutical, usually expressed as a percentage. RNP is determined by measuring the half-lives and emitted gamma radiation (gamma spectroscopy method). Radiochemical purity (RCP) is the fraction of the total radioactivity in the desired chemical form in the radiopharmaceutical. For most radiopharmaceuticals, radiochemical purity above 95 % is desirable, since the impurities will almost certainly have a different biodistribution which can distort the image and interfere with the interpretation of the scan. Determination of the radiochemical purity can be carried out by a variety of chromatographic methods like TLC, HPLC. Unlike conventional pharmaceuticals, radiopharmaceuticals cannot be manufactured, then tested and left in quarantine until the results of all tests are available, as most (if not all) of the radioactivity will decay to a level when this radiopharmaceutical will become useless. The radiopharmaceuticals have to be manufactured, tested for quality and then administered to the patient within a short period of time. Since the execution of some of the tests takes more time, it is not mandatory these tests to be completed before release for use. These tests are strictly defined in the individual pharmacopeia monographs. In addition, due to the presence of source of radiation, all aspects of radiation protection should be retained while doing the tests for quality control of radiopharmaceuticals. Key words: radiopharmaceuticals, QC control, radioisotope, radionuclide impurity, radiochemical impurity, radiation protection
ΠΠΈΠ·Π°ΡΠ½ Π½Π° ΡΡΡΠ΄ΠΈΡΠ° Π½Π° ΡΡΠ°Π±ΠΈΠ»Π½ΠΎΡΡ Π½Π° ΡΠ°Π΄ΠΈΠΎΡΠ°ΡΠΌΠ°ΡΠ΅Π²ΡΡΠΊΠΈ ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΈ
Π‘ΡΠ°Π±ΠΈΠ»Π½ΠΎΡΡΠ° Π½Π° Π»Π΅ΠΊ Π΅ Π΄Π΅ΡΠΈΠ½ΠΈΡΠ°Π½Π° ΠΊΠ°ΠΊΠΎ ΡΠΏΠΎΡΠΎΠ±Π½ΠΎΡΡ Π½Π° Π»Π΅ΠΊΠΎΡ Π΄Π° ΠΎΡΡΠ°Π½Π΅ Π²ΠΎ ΠΊΡΠΈΡΠ΅ΡΠΈΡΠΌΠΈΡΠ΅ Π½Π° ΠΏΡΠΈΡΠ°ΡΠ»ΠΈΠ²ΠΎΡΡ Π·Π° ΠΈΠ΄Π΅Π½ΡΠΈΡΠΈΠΊΠ°ΡΠΈΡΠ°, ΡΠΈΡΡΠΎΡΠ°, ΠΊΠ²Π°Π»ΠΈΡΠ΅Ρ Π΄Π΅ΡΠΈΠ½ΠΈΡΠ°Π½ΠΈ Π²ΠΎ ΡΠΏΠ΅ΡΠΈΡΠΈΠΊΠ°ΡΠΈΡΠ° Π²ΠΎ Π΄Π΅ΡΠΈΠ½ΠΈΡΠ°Π½ Π²ΡΠ΅ΠΌΠ΅Π½ΡΠΊΠΈ ΠΏΠ΅ΡΠΈΠΎΠ΄.
ΠΠ°ΡΡΠΈΡΠΎΠΊΠΎ ΠΏΡΠΈΡΠ°ΡΠ΅Π½ΠΈ Π²ΠΎΠ΄ΠΈΡΠΈ Π·Π° ΡΡΠ°Π±ΠΈΠ»Π½ΠΎΡΡ ΡΠ΅ Π²ΠΎΠ΄ΠΈΡΠΈΡΠ΅ ΠΈΠ·Π΄Π°Π΄Π΅Π½ΠΈ ΠΎΠ΄ ΠΠ½ΡΠ΅ΡΠ½Π°ΡΠΈΠΎΠ½Π°Π»Π½Π°ΡΠ° ΠΊΠΎΠ½ΡΠ΅ΡΠ΅Π½ΡΠΈΡΠ° Π·Π° Ρ
Π°ΡΠΌΠΎΠ½ΠΈΠ·Π°ΡΠΈΡΠ° (ICH) ΠΊΠΎΠΈ Ρe ΠΎΠ΄Π½Π΅ΡΡΠ²Π°Π°Ρ Π½Π° Π΄ΠΈΠ·Π°ΡΠ½ΠΈΡΠ°ΡΠ΅ Π½Π° ΡΡΡΠ΄ΠΈΠΈ Π½Π° ΡΡΠ°Π±ΠΈΠ»Π½ΠΎΡΡ Π½Π° Π½ΠΎΠ²ΠΈ Π»Π΅ΠΊΠΎΠ²ΠΈΡΠΈ ΡΡΠΏΡΡΠ°Π½ΡΠΈ ΠΈ ΡΠ°ΡΠΌΠ°ΡΠ΅Π²ΡΡΠΊΠΈ ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΈ ΠΈ Π½Π°ΡΠΈΠ½ΠΎΡ Π½Π° Π΅Π²Π°Π»ΡΠ°ΡΠΈΡΠ° Π½Π° ΠΏΠΎΠ΄Π°ΡΠΎΡΠΈΡΠ΅ Π΄ΠΎΠ±ΠΈΠ΅Π½ΠΈ ΠΎΠ΄ ΡΡΡΠ΄ΠΈΠΈΡΠ΅ Π½Π° ΡΡΠ°Π±ΠΈΠ»Π½ΠΎΡΡ.
ΠΠ° Π΄ΠΈΠ·Π°ΡΠ½ΠΈΡΠ°ΡΠ΅ Π½Π° ΡΡΡΠ΄ΠΈΡΠ° Π½Π° ΡΡΠ°Π±ΠΈΠ»Π½ΠΎΡΡ Π·Π° ΡΠ°Π΄ΠΈΠΎΡΠ°ΡΠΌΠ°ΡΠ΅Π²ΡΡΠΊΠΈ ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΈ (Π Π€Π) ΠΎΠ²ΠΈΠ΅ Π²ΠΎΠ΄ΠΈΡΠΈ Π½Π΅ ΠΌΠΎΠΆΠ°Ρ Π΄Π° Π±ΠΈΠ΄Π°Ρ ΡΠ»Π΅Π΄Π΅Π½ΠΈ Π²ΠΎ ΡΠ΅Π»ΠΎΡΡ, Π±ΠΈΠ΄Π΅ΡΡΠΈ ΠΈΠΌΠ° ΠΎΠ΄ΡΠ΅Π΄Π΅Π½ΠΈ ΠΎΠ³ΡΠ°Π½ΠΈΡΡΠ²Π°ΡΠ°. Π€ΡΠ΅ΠΊΠ²Π΅Π½ΡΠΈΡΠ°ΡΠ° Π½Π° ΡΠ΅ΡΡΠΈΡΠ°ΡΠ΅ Π·Π° Π²ΡΠ΅ΠΌΠ΅ Π½Π° ΠΈΠ·Π²Π΅Π΄ΡΠ²Π°ΡΠ΅ Π½Π° ΡΡΡΠ΄ΠΈΡΠ° Π½Π° ΡΡΠ°Π±ΠΈΠ»Π½ΠΎΡΡ Π½Π΅ ΠΌΠΎΠΆΠ΅ Π΄Π° Π±ΠΈΠ΄Π΅ ΠΏΡΠΈΠΌΠ΅Π½Π΅ΡΠ° ΠΊΠ°Ρ Π Π€Π ΠΏΠΎΡΠ°Π΄ΠΈ ΠΊΡΠ°ΡΠΊΠΈΠΎΡ ΡΠΎΠΊ Π½Π° ΡΠΏΠΎΡΡΠ΅Π±Π°, ΠΎΠ΄Π½ΠΎΡΠ½ΠΎ ΠΊΡΠ°ΡΠΊΠΈΠΎΡ ΠΏΠΎΠ»ΡΠΆΠΈΠ²ΠΎΡ Π½Π° ΡΠ°Π΄ΠΈΠΎΠΈΠ·ΠΎΡΠΎΠΏΠΎΡ.
Π¦Π΅Π»ΡΠ° Π½Π° ΠΈΠ·Π²Π΅Π΄ΡΠ²Π°ΡΠ΅ΡΠΎ Π½Π° ΡΡΡΠ΄ΠΈΠΈΡΠ΅ Π½Π° ΡΡΠ°Π±ΠΈΠ»Π½ΠΎΡΡ Π΅:
* Π΄Π° ΡΠ΅ ΠΎΠ±Π΅Π·Π±Π΅Π΄Π°Ρ ΠΏΠΎΠ΄Π°ΡΠΎΡΠΈ Π·Π° ΡΡΠ°Π±ΠΈΠ»Π½ΠΎΡΡ Π½Π° ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΡ (Π±Π°Π·ΠΈΡΠ°Π½ΠΎ Π½Π° Π½Π°ΡΠΌΠ°Π»ΠΊΡ ΡΡΠΈ ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΡΡΠ²Π΅Π½ΠΈ ΡΠ΅ΡΠΈΠΈ) Π²ΡΠ· ΠΎΡΠ½ΠΎΠ²Π° Π½Π° ΡΠ΅Π·ΡΠ»ΡΠ°ΡΠΈΡΠ΅ ΠΎΠ΄ ΡΠΈΠ·ΠΈΡΠΊΠΈΡΠ΅, Ρ
Π΅ΠΌΠΈΡΠΊΠΈΡΠ΅, Π±ΠΈΠΎΠ»ΠΎΡΠΊΠΈΡΠ΅ ΠΈ ΠΌΠΈΠΊΡΠΎΠ±ΠΈΠΎΠ»ΠΎΡΠΊΠΈΡΠ΅ ΡΠ΅ΡΡΠΎΠ²ΠΈ;
* Π΄Π° ΡΠ΅ Π΄Π΅ΡΠΈΠ½ΠΈΡΠ° ΡΠΎΠΊ Π½Π° ΡΠΏΠΎΡΡΠ΅Π±Π° ΠΈ Π½Π°ΡΠΈΠ½ Π½Π° ΡΡΠ²Π°ΡΠ΅ ΡΡΠΎ ΡΠ΅ ΠΌΠΎΠΆΠ΅ Π΄Π° ΡΠ΅ ΠΏΡΠΈΠΌΠ΅Π½Π°Ρ Π½Π° ΡΠΈΡΠ΅ Π½Π°ΡΠ΅Π΄Π½ΠΈ ΡΠ΅ΡΠΈΠΈ ΠΏΡΠΎΠΈΠ·Π²Π΅Π΄Π΅Π½ΠΈ ΠΈ ΠΏΠ°ΠΊΡΠ²Π°Π½ΠΈ ΠΏΠΎΠ΄ ΠΈΡΡΠΈΡΠ΅ ΡΡΠ»ΠΎΠ²ΠΈ
Determination of quality and antioxidant activity of traditional homemade fruit vinegars produced with double spontaneous fermentation
The quality and antioxidant potential of six traditional homemade vinegars produced using traditional methods was object of this study. The physicochemical characterization of vinegars produced from apple (Malus domestica), raspberry (Rubus idaeus), blueberry (Vaccinium myrtillus), blackberry (Rubus fruticosus), rose hip (Rosa canina) and persimmon (Diospyros kaki), was performed by measuring the ethanol content, total acidity, pH and dry matter in different vinegar production steps throughout a double spontaneous fermentation process, i.e., without any addition of yeasts or acetic acid bacteria. Π spontaneous fermentation of fruits for vinegar production encompasses initially an alcoholic fermentation for 24 days, where fructose, glucose and sucrose, as most abundant sugars, are broken down into carbon dioxide (CO2) and ethanol as main metabolic compounds, as well as other metabolic byβproducts and volatile comβ pounds in trace amounts. The highest total phenolic compounds were measured by vinegar produced from rose hip (20.2 mg of gallic acid/mL) while the lowest concentration was determined for apple vinegar (0.29 mg of gallic acid/mL). The results from total phenolic comβ pounds were in strong correlation with the antioxidant capacity. In this way, the use of traditional processes for the production of fruit vinegars proved to be very promising in terms of producing differentiated vinegars and, concomitantly, reaching high levels of healthβpromoting antioxidant capacities