• Korean Journal of Microbiology
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• v.51 no.3
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• pp.199-208
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• 2015

Biologics and medical devices manufactured with bovine-derived raw materials have the risk of viral contamination. Therefore, viral validation study is essential to ensure the safety of the products. Bovine adenovirus type-1 (BAdV-1) is one of the common bovine viral pathogens. For quantitative detection of BAdV-1 during the manufacture of biologics and medical devices, a TaqMan probe real-time PCR method was developed. Specific primers and TaqMan probe for amplifying and detecting BAdV-1 DNA were designed. Specificity, limit of detection (LOD), and robustness of the method was validated according to international guideline on the validation of nucleic acid amplification tests for the pathogen detection. The sensitivity of the assay was found to be $7.44{\times}10^1\;TCID_{50}/ml$. The real-time PCR method was reproducible, very specific to BAdV-1, and robust. Moreover, the method was successfully applied to the validation of Chinese Hamster Ovary (CHO)-K1 cells artificially infected with BAdV-1, a commercial CHO master bank, and bovine type 1 collagen. The overall results indicate that this rapid, specific, sensitive, and robust assay can be reliably used for quantitative detection of BAdV-1 contamination during the manufacture of biologics and medical devices using bovine-derived raw materials.

• The Korean Journal of Pesticide Science
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• v.17 no.3
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• pp.162-167
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• 2013

An analytical method for the simultaneous determination of pencycuron in agricultural products was established by using GC-NPD. The method was validated through the guidelines of linearity, limit of detection (LOD), limit of quantification (LOQ), accuracy and precision. The calibration curve of pencycuron was linear over the concentration range of 0.02-2 mg/kg with correlation coefficient of above 0.9999. The limits of detection and quantification were 0.005 and 0.02 mg/kg. Mean recoveries of pencycuron for each sample were 79.6-107.5% at the level of 0.02 mg/kg and 86.4-112.1% at the level of 0.2 mg/kg and 84.0- 104.9% at the level of 1 mg/kg. Relative standard deviation (RSD) in recoveries were all less than 5%. The intra- and inter-day precision (RSD) were 1.6-3.0% and 5.3-11.5%, respectively. The result of validation indicated that this method was accurate and sensitive assay.

• Journal of the Korean Chemical Society
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• v.60 no.2
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• pp.118-124
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• 2016

Parabens were commonly used for preventing the growth of microorganisms as preservatives in the pharmaceutical, cosmetic and food industry. Also, parabens are known endocrine disruptors because of their estrogenic effects on human. Parabens affect the endocrine system and show adverse effect such as, genital malformations, precocious puberty and testicular cancer in young children, infants and fetuses. In this study, we developed analytical method for four parabens (methyl paraben, ethyl paraben, propyl paraben, butyl paraben) in human breast milk which frequently consumed by newborn baby. The analytes were extracted using liquid-liquid extraction (LLE) after enzyme hydrolysis with protease and lipase, then quantitative analysis was performed by liquid chromatography tandem mass spectrometry (LC-MS/MS). The method validation results were as follows; the linearity of calibration curves were excellent with coefficient of determinations (r²) higher than 0.999, the limit of detections (LODs) were 0.019~0.044 ng/mL, the accuracies were 85.3~105.9% and the precisions were lower than 10%. The average concentration ± standard deviation of parabens in ten human breast milk sample were MP 0.660 ± 0.519 ng/mL, EP 1.631 ± 2.081 ng/mL and PP 0.326 ± 0.320 ng/mL, and BP was not detected.

• Analytical Science and Technology
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• v.27 no.1
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• pp.60-65
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• 2014

The aim of this study was to establish an analytical method for the determination of E,E-farnesol and squalene in makgeolli, which is a traditional type of Korean fermented rice wine. E,E-farnesol and squalene in makgeolli were extracted using stir bar sorptive extraction (SBSE) coupled with gas chromatography-mass spectrometry. SBSE was found to be an effective method for analyzing the E,E-farnesol and squalene levels in makgeolli. The linear dynamic range of the SBSE method for detecting E,E-farnesol and squalene ranged from 0.5 to 200 ng/mL with $R^2=0.9974$ for E,E-farnesol and 100 to 50000 ng/mL with $R^2=0.9982$ for squalene. The limit of detection and the limit of quantification using the SBSE method were 0.1 and 0.5 ng/mL for E,E-farnesol and 15.0 and 40.0 ng/mL for squalene, respectively. The average recoveries obtained were, quantitatively, 101-107% for E,E-farnesol and 98-103% for squalene, respectively, supporting the accuracy of the SBSE-GCMS method.

• Journal of Environmental Health Sciences
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• v.46 no.3
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• pp.324-334
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• 2020

Objectives: This study was conducted to estimate the related health risk by investigating the content of biogenic amines (BAs) in commercial fermented alcoholic beverages. Methods: Ninety-seven samples, including takjus (34), fruit wines (26), distilled liquors (20) and beers (17) were purchased in Gangwon-do (Province) in 2019. The eight BAs (putrescine, cadaverine, spermine, spermidine, tyramine, β-phenylethylamine, histamine, and tryptamine) were analyzed by high performance liquid chromatograph (HPLC) after extraction (0.4 M HClO₄), pigment removal (carbon cartridge) and derivatization (1% dansylchloride). The health risk of exposure to BAs due to ingestion of commercial fermented alcoholic beverages was estimated as the margin of exposure (MOE). Results: Various BAs were detected in takju, fruit wine, distilled liquor and beer. Putrescine (not detected (ND)-12.60 mg/L), cadaverine (ND-5.45 mg/L), tyramine (ND-8.34 mg/L), β-phenylethylamine (ND-13.73 mg/L), histamine (ND-7.96 mg/L), and tryptamine (ND-19.00 mg/L) were found in takju. Putrescine (ND-15.34 mg/L), cadaverine (ND-7.90 mg/L), β-phenylethylamine (ND-3.06 mg/L), histamine (ND-9.68 mg/L), and tryptamine (ND-14.06 mg/L) were identified in fruit wine. Putrescine (less than limit of detection (

• Korean Journal of Environmental Agriculture
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• v.36 no.3
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• pp.211-216
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• 2017

BACKGROUND:This study was conducted to investigate residual organochlorine pesticides (ROCPs) in agricultural soils and crops. Agricultural soil samples and crop samples were collected from 93 cities and counties. METHODS AND RESULTS: Extraction and clean-up for the quantitative analysis of ROCPs were conducted by the modified quick, easy, cheap, effective, rugged, and safe (QuEChERS) method. Recovery and limit of detection (LOD) of ROCPs in agriculturalsoils and crops were 76.5-103.0 and 75.2-93.2%, 0.01-0.08 and $0.10-0.15{\mu}g/kg$, respectively. Detected ROCPs in agricultural soils were ${\alpha}$-endosulfan, ${\beta}$-endosulfan, and endosulfan sulfate, the residue were 2.0-12.0, 1.2-53.1, and $2.2-329.8{\mu}g/kg$, respectively. But these pesticides in all green perilla leaf and green pepper samples were not detected. CONCLUSION: These results showed that ROCPs residues in agricultural soils were not as high as crop safety threatening.

• Korean Journal of Food Science and Technology
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• v.47 no.1
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• pp.1-5
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• 2015

This study aimed to simultaneously determine various carotenoids from different colored paprika using an ultra performance liquid chromatograph (UPLC) equipped with a HSS T3 column. Analysis was performed at 450 nm using gradient conditions with acetonitrile/methanol/methylene chloride (65/25/10) and distilled water. We improved the peak resolution and performed carotenoid analysis within 30 min. We qualitatively analyzed 11 carotenoids (neoxanthin, capsorubin, violaxanthin, capsanthin, zeaxanthin, lutein, ${\alpha}$-cryptoxanthin, ${\beta}$-cryptoxanthin, lycopene, ${\alpha}$-carotene, and ${\beta}$-carotene). For the validation of UPLC methods, we validated the precision and accuracy of capsanthin. Capsanthin showed good linearity ($R^2$=0.9998) in the concentration range of $1-200{\mu}g/mL$ with 2.4 and $7.2{\mu}g/mL$ of limit of detection (LOD) and limit of quantification (LOQ), respectively. The relative standard deviation (RSD) for intra- and inter-day precision was less than 3.83%. Recovery was in the range of 91.86-99.87%. We quantitatively analyzed carotenoid contents from 8 different colored paprika (red, orange, yellow, and green). The most abundant carotenoids were capsanthin in red paprika, and zeaxanthin in orange, yellow, and green paprika.

• Microbiology and Biotechnology Letters
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• v.43 no.3
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• pp.267-274
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• 2015

Biopharmaceuticals and the cell substrates used for their manufacture are currently tested for porcine adventitious viruses due to the widespread use of porcine trypsin in cell culture. Porcine transmissible gastroenteritis virus (PTGV) is one of the major adventitious porcine viruses causing contaminated during the manufacture of biopharmaceuticals. Therefore, rapid and sensitive detection of PTGV is essential in ensuring the safety of biopharmaceuticals. A TaqMan probe real-time RT-PCR method was developed for the quantitative detection of PTGV contamination in cell substrates, raw materials, manufacturing processes, and final products, as well as PTGV clearance validation. Specific primers for the amplification of PTGV RNA were selected, and PTGV RNA was quantified by use of a specific TaqMan probe. Specificity, limit of detection (LOD), and robustness of the method was validated according to international guidelines on the validation of nucleic acid amplification tests. The sensitivity of the assay was calculated to be 1.10 × 10⁰ TCID₅₀/ml. The real-time RT-PCR method was validated to be reproducible, very specific to PTGV, and robust. The established real-time RT-PCR assay was successfully applied to the validation of Chinese Hamster Ovary (CHO)-K1 cells artificially infected with PTGV.

• Analytical Science and Technology
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• v.31 no.4
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• pp.171-178
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• 2018

Recently, for successful lactation, many breastfeeding mothers seek various products, including herbal medicine, dietary supplements, and prescribed medicines, to improve milk production. As demand for galactogogues grows, it is highly possible that pharmaceutical galactogogues may be adulterated with illegal products to maximize their efficacy. For continuous control and supervision of illegal products, we developed and validated a simple and sensitive LC-MS/MS method capable of simultaneously determining five galactogogues. Chromatographic separation was conducted using an Agilent Poroshell $120SB-C_{18}$ column with a mobile phase consisting of 20 mM ammonium formate (pH 5.4) and 100 % acetonitrile. The total run time was 13 min per analyte. The proposed method was performed according to the guidelines of the International Conference of Harmonization and it produced reliable results. This method showed high sensitivity and specificity, with a limit of detection (LOD) and limit of quantitation (LOQ) of 0.01-0.82 ng/mL and 0.02-2.45 ng/mL, respectively, for the solid- and liquid-type samples. Specificity was evaluated by analyzing matrix-blank samples spiked with the target compounds at LOQ levels, which provided a good separation of all peaks without interference. Additionally, the repeatability and intermediate precision were typically <15 %, whereas the recovery was 80-120 % of the values obtained using blank samples. Thus, we concluded that this method could be used for the identification and quantification of galactogogues in food or herbal products.

• Journal of Food Hygiene and Safety
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• v.21 no.2
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• pp.76-81
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• 2006

We optimized conditions of extract solvents and elution solvents for total aflatoxins in foods using HPLC/FLD. The extract solvent was 70% methanol solution including 1% NaCl and the 3 mL of acetonitrile was used as elution solvent using immnuoaffinity column. The detection limits (LOD) was 0.05 ng/g. The recoveries for total aflatoxins ($B_1,\;B_2,\;G_1\;and\;G_2$) studied in foods were cereals ($74.1{\sim}95.5%,\;83.7{\sim}98.8%,\;80.4{\sim}102.4%,\;72.8{\sim}76.5%$), pulses ($85.8{\sim}87.5%,\;83.8{\sim}90.7%,\;92.0{\sim}94.5%,\;60.6{\sim}65.6%$), nuts ($84.6{\sim}97.1%,\;86.0{\sim}94.1%,\;95.5{\sim}111.5%,\;71.0{\sim}89.9%$), processed foods ($81.5{\sim}87.1%,\;82.8{\sim}85.8%,\;85.4{\sim}92.7%,\;68.9{\sim}76.4%$), dried fruits ($83.6{\sim}93.5%,\;78.1{\sim}90.4%,\;93.0{\sim}108.5%,\;64.9{\sim}78.5%$) and other foods ($72.5{\sim}98.3%,\;73.1{\sim}96.4%,\;83.5{\sim}107.2%,\;64.2{\sim}75.8%$), respectively.