• The Journal of the Korea Contents Association
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• v.9 no.11
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• pp.240-246
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• 2009

Quality control test in this field of study were carried out in 3 categories, radionuclidic purity, chemical purity and radiochemical purity. Also, indication efficiency was tested every 3 hours changed after binding the radiopharmaceutical to see how long the medicine is available for usage after indicating. The result showed that currently used radiopharmaceutical have good radionuclidic purity and chemical purity. However, radiochemical purity indication showed small differences depending on indication method and indication period. Radiopharmaceutical are indicated by treatment providers, so they need to pay more attention to the indication process and quality control to provide more efficient treatment.

• The Korean Journal of Nuclear Medicine
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• v.30 no.3
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• pp.351-360
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• 1996

Chitosan is a polysaccharide of natural orgin obtained by full or partial deacetylation of chitin, a very abudant natural polymer, which has the properties of biocompatibilities, bioaffinities, and biodegradabilities. The free amino group of chitosan should be participated in forming chelate with holmium (${\beta}$-emitter). $^{166}Ho(NO_3)_3\;5H_2O$ of high radionuclidic purity of upto 99.9% was made by neutron irradiation of naturally occuring $^{166}Ho(NO_3)_3\;5H_2O$, and then reacted with the prepared chitosan solution. The effect of pH, reaction time, the concentration and viscosity of chitosan and the amount of $^{166}Ho$ on forming $^{166}Ho$-chitosan complex ($^{166}Ho$-CHICO) were investigated. $^{166}Ho$-chitosan macroaggregate($^{166}Ho$-CHIMA) was made from $^{166}Ho$-CHICO. Their physical properties such as radionuclidic purity, particle size distribution, stability in vitro and vivo were examined. Their high in vitro and vivo stability makes them attractive agents for internal radiotherapy by local administeration.

• Journal of Radiopharmaceuticals and Molecular Probes
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• v.5 no.1
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• pp.48-53
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• 2019

A bone metastasis is an important factor for prognosis and treatment of breast or prostate cancer patients. [$^{18}F$]Sodium fluoride ([$^{18}F$]NaF) is a PET radiopharmaceutical that can detect bone metastasis. Conventional [$^{18}F$]NaF production process included radioactive metal impurities because the product was prepared by adding saline after beam irradiation to $[^{18}O]H_2O$. In this study, we apply the method of removing radionuclidic impurities. To meet the criteria prescribed by GMP in quality control, we designed the custom-made [$^{18}F$]NaF automatic module. The mean radiochemical yield was $82.1{\pm}4.4%$ (n = 32) productions for 3 years) and the total preparation time was 4 min. The final produced [$^{18}F$]NaF solution meets the USP criteria for quality control. Thus, this fully automated system is validated for clinical use.

• Korean Journal of Clinical Laboratory Science
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• v.53 no.1
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• pp.1-10
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• 2021

Radiopharmaceuticals are drugs that contain radioisotopes and are used in the diagnosis, treatment, or investigation of diseases. Radiopharmaceuticals must be manufactured in compliance with good manufacturing practice regulations and subjected to quality control before they are administered to patients to ensure the safety of the drug. Radiopharmaceuticals for administration to humans need to be sterile and pyrogen-free. Hence, sterility tests and membrane filter integrity tests are carried out to confirm the asepticity of the finished drug product, and a bacterial endotoxin test conducted to assess contamination, if any, by pyrogens. The physical appearance and the absence of foreign insoluble substances should be confirmed by a visual inspection. The chemical purity, residual solvents, and pH should be evaluated because residual by-products and impurities in the finished product can be harmful to patients. The half-life, radiochemical purity, radionuclidic purity, and strength need to be assessed by analyzing the radiation emitted from radiopharmaceuticals to verify that the radioisotope contents are properly labeled on pharmaceuticals. Radiopharmaceuticals always carry the risk of radiation exposure. Therefore, the time taken for quality control tests should be minimized and care should be taken to prevent radiation exposure during handling. This review discusses the quality control procedures and acceptance criteria for a diagnostic radiopharmaceutical.

• The Korean Journal of Nuclear Medicine
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• v.28 no.2
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• pp.227-233
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• 1994

Irradiation of 20mg of natural $Dy(NO_3)_3$ in a neutron flux of $2{\times}10^{13}n/cm^2$ sec for 4 hours gave 5.76 Ci of $^{165}Dy$(specific activity, 610mCi/mg Dy) with high radionuclidic purity (>99.9 %). $^{165}Dy-MA$ was prepared in a quantitative yield by reacting the aqueous solution of $^{165}Dy(NO_3)_3$ with sodium borohydride solution in 0.2N NaOH. Coulter particle analyzer exhibited mean particle size of $2.6{\mu}m$ (range $1{\sim}6{\mu}m$), Even though the $^{165}Dy-MA$ suspension in saline was stored at $37^{\circ}C$ for 24 hours or autoclaved at $121^{\circ}C$ for 30minutes, there was no significant change in particle size and leakage problem indicating the prepared $^{165}Dy-MA$ is sufficiently stable. In-vivo retention studies were carried out by administering $^{165}Dy-MA$ into the knee joint space of normal rabbits. Gamma camera analysis showed high retention in joint space of normal rabbits. Gamma camera analysis showed high retention in joint space even at 24 hours after administration (> 99.9%). The ease with which the $^{165}Dy-MA$ can be made in the narrow size range and their high invitro and vivo stability make them attractive agents for radiation synovectomy.