• 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.

• Analytical Science and Technology
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• v.35 no.3
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• pp.93-115
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• 2022

Potential impurities in pharmaceuticals could be produced during manufacture, distribution, and storage and affect quality and safety of pharmaceuticals. In particular, highly reactive impurities could result in carcinogenic (mutagenic) effects on human body. International Conference on Harmonisation (ICH) has provided M7(R1) guideline for "Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk" and recommended an adoption of this guideline to the authorities. ICH M7(R1) guideline provides classification, accepted intakes, and controls of potential impurities in pharmaceuticals. However, since appropriate and unified analytical methods for impurities in pharmaceuticals have not been provided in this guideline, most potential impurities in pharmaceuticals are still difficult to manage and supervise by pharmaceutical companies and regulatory authorities, respectively. In this review, we briefly described definition of unintended mutagenic impurities, basic information in ICH M7(R1) guideline, and analytical methods to determine potential impurities. This review would be helpful to manage and supervise potential impurities in pharmaceuticals by pharmaceutical companies and regulatory authorities.

• Journal of Food Hygiene and Safety
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• v.36 no.1
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• pp.34-41
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• 2021

The purpose of this research is to improve analysis methods of determining the contents of fatty acids in infant formulas and follow-up formulas. A gas chromatography (GC) method was performed on a GC system coupled to flame ionization detector, with a fused silica capillary column (SP2560, 100 m×0.25 mm, 0.20 ㎛). The method was validated using standard reference material (SRM, NIST 1849a). Performance parameters for method validation such as specificity, linearity, limits of detection (LOD) and quantification (LOQ), accuracy and precision were examined. The linearity of standard solution with correlation coefficient was higher than 0.999 in the range of 0.1-5 mg/mL. The LOD and LOQ were 0.01-0.06 mg/mL and 0.03-0.2 mg/mL, respectively. The recovery using standard reference material was confirmed and the precision was found to be between 0.8% and 2.9% relative standard deviation (RSD). Optimized methods were applied in sample analysis to verify the reliability. All the tested products had acceptable contents of fatty acids compared with component specification for nutrition labeling. The result of this research will provide efficient experimental information and strengthen the management of nutrients in infant formula and follow-up formula.

• Proceedings of the Korea Information Processing Society Conference
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• 2010.11a
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• pp.161-164
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• 2010

식품의약품안전청은 산발적으로 흩어져 있던 임상시험 관련 정보를 통합하여 서비스하기 위한 방안으로 임상시험정보방을 개설하게 되었다. 임상시험승인현황 등 원시자료는 종이형태로 생산, 관리된다. 이를 통계자료로 활용하기 위해서 식품의약품안전청의 관련 시스템인 KiFDA 시스템에 입력을 하게 된다. 이 시스템에 입력된 데이터는 실시간으로 임상시험관련 웹서비스 시스템에 구축된다. 이때에 실시간 통계정보의 정확성이 무엇보다 중요하다. KiFDA 시스템의 데이터베이스의 실시기관명과 임상시험계획승인제도(IND) 승인리스트 원본의 실시기관명이 틀린 것도 있었다. 이는 동일한 실시기관도 화면에서는 서로 다른 실시기관으로 보일 수 있다는 것을 의미한다. 결국 통계자료가 부정확하게 표출되는 데는 이런 원인들이 있었던 것이다. 본 논문에서는 기존의 문제점을 개선하기위해 임상시험정보방의 효율적인 통계모델링을 설계하여 물리적 데이터베이스를 구축하였다.

• The Journal of the Korea Contents Association
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• v.11 no.6
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• pp.33-41
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• 2011

RFID technology is already used in the various application fields such as identification card, traffic card and etc. Many RFID application systems using UHF have been developed in the field of asset management, logistics and security. Because a human being can make mistakes, we need the system that can efficiently manage the special assets such as small arms, jewelry and medicine and can monitor them in real time. In this paper, we proposed a special assets management system to keep assets in safe custody, to monitor their safety status in real time and to manage distribution channels and history of those assets. The developed system is called Smart Cabinet because it has cabinet's form. Smart Cabinet integrates such technologies as RFID, smart card, fingerprint recognition, several sensors and LCD display in order to provide the functions for special asset management. Those functions include condition monitoring of assets, traceability management, distribution channels and security logs, which are to interact with a management server. The article demonstrated the potentiality of RFID by presenting special asset management solutions dedicated to guns and medicine management, and also showed the effectiveness and possibility of those solutions.

• Journal of Food Hygiene and Safety
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• v.34 no.1
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• pp.22-29
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• 2019

Validamycin A is an aminoglycoside fungicide produced by Streptomyces hygroscopicus that inhibits trehalase. The purpose of this study was to develop a method for detecting validamycin A in agricultural samples to establish MRL values for use in Korea. The validamycin A residues in samples were extracted using methanol/water (50/50, v/v) and purified with a hydrophilic-lipophilic balance (HLB) cartridges. The analyte was quantified and confirmed by liquid chromatograph-tandem mass spectrometer (LC-MS/MS) in positive ion mode using multiple reaction monitoring (MRM). Matrix-matched calibration curves were linear over the calibration ranges (0.005~0.5 ng) into a blank extract with $R^2$ > 0.99. The limits of detection and quantification were 0.005 and 0.01 mg/kg, respectively. For validation validamycin A, recovery studies were carried out three different concentration levels (LOQ, $LOQ{\times}10$, $LOQ{\times}50$, n = 5) with five replicates at each level. The average recovery range was from 72.5~118.3%, with relative standard deviation (RSD) less than 10.3%. All values were consistent with the criteria ranges requested in the Codex guidelines (CAC/GL 40-1993, 2003) and the NIFDS (National Institute of Food and Drug Safety) guideline (2016). Therefore, the proposed analytical method is accurate, effective and sensitive for validamycin A determination in agricultural commodities.

• Journal of Food Hygiene and Safety
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• v.39 no.2
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• pp.72-82
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• 2024

This study aimed to develop a scientifically and systematically standardized xylooligosaccharide analytical method that can be applied to products with various formulations. The analysis method was conducted using HPLC with Cadenza C₁₈ column, involving pre-column derivatization with 1-phenyl-3-methyl-5-pyrazoline (PMP) and UV detection at 254 nm. The xylooligosaccharide content was analyzed by converting xylooligosaccharide into xylose through acid hydrolysis. The pre-treated methods were compared and evaluated by varying sonication time, acid hydrolysis time, and concentration. Optimal equipment conditions were achieved with a mobile phase consisting of 20 mM potassium phosphate buffer (pH 6)-acetonitrile (78:22, v/v) through isocratic elution at a flow rate of 0.5 mL/min (254 nm). Furthermore, we validated the advanced standardized analysis method to support the suitability of the proposed analytical procedure such as specificity, linearity, detection limits (LOD), quantitative limits (LOQ), accuracy, and precision. The standardized analysis method is now in use for monitoring relevant health-functional food products available in the market. Our results have demonstrated that the standardized analysis method is expected to enhance the reliability of quality control for healthy functional foods containing xylooligosaccharide.

• 건강소식
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• v.34 no.11
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• pp.18-23
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• 2010

잘 쓰면 약이고 못 쓰면 독이 된다는 '약'에 대한 금언처럼 필요할 때만 적정 용량을 최적의 시간에 복용해야 하는데 실상은 그렇지 못하다. 수요가 고급을 창출한다는 경제 원리에 따라 의약품이 20~30년 전에 비해 값싸게 공급되다보니 의약분업 시행에도 불구하고 불필요한 약을 먹게 되는 경우가 많다. 약의 폐해와 안전하고 비용 대비 효율이 높은 약물 복용법에 대해 알아본다.

• Proceedings of the SAREK Conference
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• 2009.06a
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• pp.520-526
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• 2009

This study proposed the optimum design values for the biological clean room system observing the regulations of Hazard Analysis Critical Control Point (HACCP). Even though the standard for industrial clean room system has been well established, the basis for biological food clean room system is the first stage. In order to prevent the contaminations in advance for food storages, processes, and distributions, the criterion of Hazard Analysis Critical Control Point is positively required. This study also suggested the possible ways of how to avoid the hazardous contaminations.

• Air Cleaning Technology
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• v.23 no.3
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• pp.1-9
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• 2010

This study proposed the optimum design values for the biological clean room system observing the regulations of Hazard Analysis Critical Control Point (HACCP). Even though the standard for industrial clean room system has been well established, the basis for biological food clean room system is the first stage. In order to prevent the contaminations in advance for food storages, processes, and distributions, the criterion of Hazard Analysis Critical Control Point is positively required. This study also suggested the possible ways of how to avoid the hazardous contaminations.