• 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 Technology
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• v.17 no.2
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• pp.59-66
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• 2013

Purpose: Recently, there is an increase of the number of hospitals using auto dispenser to reduce occupational radiation exposure when drawing up of the $^{18}F-FDG$ dose (5.18 MBq/kg) in a syringe from the dramatic high activity of $^{18}F-FDG$ multidose vial. The aim of this study is to confirm that using auto dispenser actually reduces the radiation exposure for technologists. Also we analyzed the reproducibility of auto dispenser to find optimized dispensing method for the device. Materials and Methods: We conducted three experiments. Comparison of radiation exposure on chest and hands: The chest and hands exposure dose received by technologists during the injection were measured by electronic personal dosimeter (EPD) and ring TLD respectively. Reproducibility of dispensed volume: We draw up the normal saline into 5 and 2 mL syringe using auto dispenser by changing the volume from 1 to 15 mm for 5 times in the same setting of the volume. The weight of 5 normal saline dispensed from the device at same volume was measured using micro balance and calculated standard deviation and coefficient of variation. Reproducibility of dispensed radioactivity: We dispensed 362.6 $MBq{\pm}10%$ of $^{18}F-FDG$ in 5 and 2 mL syringes from the multidose vial of different specific activity. In the same setting of volume, we repeated dispensing for 4 times and compared standard deviation and coefficient of variation of radioactivity between 5 syringes. Results: There was significant difference in the average of chest exposure dose according to the dispensing methods (P<0.05). Also, when dispensing $^{18}F-FDG$ in manual method, exposure dose was 11.5 times higher in right hand and 4.8 times higher in left hand than in auto method. In the result of reproducibility of dispensed volume, standard deviation and coefficient of variation shows decline as the dispensing volume increases. As a result of reproducibility of dispensed radioactivity, standard deviation and coefficient of variation increases as the specific activity increases. Conclusion: We approved that the occupational radiation exposure dose of technologists were reduced when dispensing $^{18}F-FDG$ using auto dose dispenser. Secondly, using small syringes helps to increase reproducibility of auto dose dispense. And also, if you lower the specific activity of $^{18}F-FDG$ in multidose vial below 915-1,020 MBq/mL, you can use auto dispenser more effectively keeping the coefficient of variation lower than 10%.

• KOREAN JOURNAL OF PACKAGING SCIENCE & TECHNOLOGY
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• v.28 no.1
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• pp.31-38
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• 2022

Due to the increasing consumer demands for the safety, shelf life, and quality of food, the application and development of active packaging in the food and packaging industry have been improved. According to the standards and specifications of the Republic of Korea for utensils, containers, and packages, the function of active packaging is to remove or alleviate factors that degrade food quality. Although extensive reviews regarding the development and commercialization of active packaging have been conducted, the legal regulations and safety assessments concerning active packaging have rarely been examined. This review provides information regarding the definition, structure, components, operational mechanisms, and applications for active packaging that actively removes oxygen, moisture, carbon dioxide, and ethylene. Furthermore, the legal regulations and research results related to the development of test methods for safety assessments of active packaging are investigated.

• Journal of Food Hygiene and Safety
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• v.36 no.3
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• pp.228-238
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• 2021

The aim of this research was to develop a rapid and easy multi-residue method for determining dimethipin, omethoate, dimethipin, chlorfenvinphos and azinphos-methyl in agricultural products (hulled rice, potato, soybean, mandarin and green pepper). Samples were prepared using QuEChERS (Quick, Easy, Cheap, Effective, Rugged and Safe) and analyzed using gas chromatography-tandem mass spectrometry (GC-MS/MS). Residual pesticides were extracted with 1% acetic acid in acetonitrile followed by addition of anhydrous magnesium sulfate (MgSO₄) and anhydrous sodium acetate. The extracts were cleaned up using MgSO₄, primary secondary amine (PSA) and octadecyl (C₁₈). The linearity of the calibration curves, which waas excellent by matrix-matched standards, ranged from 0.005 mg/kg to 0.3 mg/kg and yielded the coefficients of determination (R²) ≥ 0.9934 for all analytes. Average recoveries spiked at three levels (0.01, 0.1, 0.5 mg/kg) and were in the range of 74.2-119.3%, while standard deviation values were less than 14.6%, which is below the Codex guideline (CODEX CAC/GL 40).

• Journal of Food Hygiene and Safety
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• v.37 no.3
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• pp.136-142
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• 2022

The research aims to develop a rapid and easy analytical method for methoprene using liquid chromatography-tandem mass spectrometry (LC-MS/MS). A simple, highly sensitive, and specific analytical method for the determination of methoprene in livestock products (beef, pork, chicken, milk, eggs, and fat) was developed. Methoprene was effectively extracted with 1% acetic acid in acetonitrile and acetone (1:1), followed by the addition of anhydrous magnesium sulfate (MgSO₄) and anhydrous sodium acetate. Subsequently, the lipids in the livestock sample were extracted by freezing them at -20℃. The extracts were cleaned using MgSO₄, primary secondary amine (PSA), and octadecyl (C₁₈), which were then centrifuged to separate the supernatant. Nitrogen gas was used to evaporate the supernatant, which was then dissolved in methanol. The matrix-matched calibration curves were constructed using 8 levels (1, 2.5, 5, 10, 25, 50, 100, 150 ng/mL) and the coefficient of determination (R²) was above 0.9964. Average recoveries spiked at three levels (0.01, 0.1, and 0.5 mg/kg), and ranged from 79.5-105.1%, with relative standard deviations (RSDs) smaller than 14.2%, as required by the Codex guideline (CODEX CAC/GL 40). This study could be useful for residue safety management in livestock products.

• Korean Journal of Clinical Pharmacy
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• v.20 no.1
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• pp.66-71
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• 2010

주의력결핍 과잉행동장애는 미국에서 약 200만 명의 어린이에게 나타나는 심각한 만성 신경행동학적 장애이다. 주의력결핍 과잉행동장애 치료의 중심은 약물요법이다. 그러나 현재 환자의 약 30%는 주의력결핍 과잉행동장애를 적응증으로 갖도록 허가된 의약품들을 사용해도 적절한 치료효과를 얻지 못하고 있는 상황이다. Modafinil은 methylphenidate나 amphetamines와 같은 각성제와는 다른 약리학적 기전으로 중추신경계를 항진시킨다. 본 연구는 modafinil의 주의력결핍 과잉행동장애 치료효과에 대한 최신 지견을 얻고자, 1990년부터 2010년 3월까지 MEDLINE에 등재된 논문을 ADHD와 Modafinil이라는 MeSH terms로 검색하여 추출한 자료 중에서 대조군이 사용된 무작위 배정 및 이중맹검 임상연구 사례만을 선별하여 임상적 유용성을 평가하였다. 현재 modafinil은 주의력결핍 과잉행동 장애 치료제로 허가된 의약품은 아니지만 최근 여러 국가에서 시행된 연구들은 modafinil이 안전하고 효과적인 주의력결핍 과잉행동장애 치료제일 수 있다는 결과를 보여주고 있다.

• Journal of Food Hygiene and Safety
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• v.34 no.2
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• pp.124-134
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• 2019

An analytical method was developed for the determination of broflanilide and its metabolites in agricultural products. Sample preparation was conducted using the QuEChERS (Quick, Easy, Cheap, Effective, Rugged and Safe) method and LC-MS/MS (liquid chromatograph-tandem mass spectrometer). The analytes were extracted with acetonitrile and cleaned up using d-SPE (dispersive solid phase extraction) sorbents such as anhydrous magnesium sulfate, primary secondary amine (PSA) and octadecyl ($C_{18}$). The limit of detection (LOD) and quantification (LOQ) were 0.004 and 0.01 mg/kg, respectively. The recovery results for broflanilide, DM-8007 and S(PFP-OH)-8007 ranged between 90.7 to 113.7%, 88.2 to 109.7% and 79.8 to 97.8% at different concentration levels (LOQ, 10LOQ, 50LOQ) with relative standard deviation (RSD) less than 8.8%. The inter-laboratory study recovery results for broflanilide and DM-8007 and S (PFP-OH)-8007 ranged between 86.3 to 109.1%, 87.8 to 109.7% and 78.8 to 102.1%, and RSD values were also below 21%. All values were consistent with the criteria ranges requested in the Codex guidelines (CAC/GL 40-1993, 2003) and the Food and Drug Safety Evaluation guidelines (2016). Therefore, the proposed analytical method was accurate, effective and sensitive for broflanilide determination in agricultural commodities.

• Journal of Food Hygiene and Safety
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• v.34 no.3
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• pp.227-234
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• 2019

An analytical method was developed for the determination of oxytetracycline in agricultural products using the QuEChERS (Quick, Easy, Cheap, Effective, Rugged and Safe) method by liquid chromatography-tandem mass spectrometry (LC-MS/MS). After the samples were extracted with methanol, the extracts were adjusted to pH 4 by formic acid and sodium chloride was added to remove water. Dispersive solid phase extraction (d-SPE) cleanup was carried out using $MgSO_4$ (anhydrous magnesium sulfate), PSA (primary secondary amine), $C_{18}$ (octadecyl) and GCB (graphitized carbon black). The analytes were quantified and confirmed with LC-MS/MS using ESI (electrospray ionization) in positive ion MRM (multiple reaction monitoring) mode. The matrix-matched calibration curves were constructed using six levels ($0.001{\sim}0.25{\mu}g/mL$) and coefficient of determination ($r^2$) was above 0.99. Recovery results at three concentrations (LOQ, $10{\times}LOQ$, and $50{\times}LOQ$, n=5) were from 80.0 to 108.2% with relative standard deviations (RSDs) less than of 11.4%. For inter-laboratory validation, the average recovery was in the range of 83.5~103.2% and the coefficient of variation (CV) was below 14.1%. All results satisfied the criteria ranges requested in the Codex guidelines (CAC/GL 40-1993, 2003) and the Food Safety Evaluation Department guidelines (2016). The proposed analytical method was accurate, effective and sensitive for oxytetracycline determination in agricultural commodities. This study could be useful for safety management of oxytetracycline residues in agricultural products.

• Korean Journal of Psychosomatic Medicine
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• v.26 no.2
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• pp.172-178
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• 2018

Objectives : This study aimed to describe the use of over-the-counter (OTC) drugs and to identify predictors for their use in the elderly living alone. Methods : This is a cross-sectional study that enrolled 1,099 subjects. Data regarding socio-demographic status, medical condition, cognition, mood disorder and use of OTC drugs were collected using self-administered questionnaire and from a specific semi-structured interview by a trained nurse. Data regarding use of OTC drugs were analyzed using descriptive statistics. Logistic regression analysis was applied to examine factors associated with the use of OTC drugs. Results : The use of OTC drugs were reported by 35.4% of the subjects. Analgesics (13.6%) was the most frequent drugs. Depression (OR=1.10, 95% CI=1.10-1.87) and comorbidities measured by cumulative illness rating scale (CIRS) (OR=1.08, 95% CI=1.03-1.12) were significantly associated with the use of OTC drugs in the elderly living alone. Conclusions : Depression and severity of underlying medical conditions could be a predictor of the use of OTC drugs in the elderly living alone. The clinicians should be vigilant regarding the potential use of nonprescription medications in the elderly.

• Analytical Science and Technology
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• v.20 no.2
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• pp.170-175
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• 2007

To determine levels of benzopyrene in olive oils, a selective analytical method of HPLC/FLD has been applied. After removing fat in food samples with hexane, it was extracted in aqueous N,N-DMF solution, cleaned-up on florisil SPE cartridge and analyzed by the instrumental analysis. The mobile phase was a mixture of acetonitrile and water in 8:2 by the isocratic elution and the excitation wavelength of fluorescence detector was 294 nm and emission wavelength of it was 404 nm. The average recovery was about 95 % and the limit of quantitation was $0.9{\mu}g/kg$. The levels of benzopyrene in the selected olive oil samples were ranged from not detected to $1.9{\mu}g/kg$, however, they were under $2.0{\mu}g/kg$, the maximum level of benzopyrene in olive oil which was established in the food code.