• Korean Journal of Food Science and Technology
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• v.42 no.4
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• pp.390-397
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• 2010

Residual solvents in foods are defined as organic volatile chemicals used or produced in manufacturing of extracts or additives, or functional foods. The solvents are not completely eliminated by practical manufacturing techniques and they also may become contaminated by solvents from packing, transportation or storage in warehouses. Because residual solvents have no nutritional value but may be hazardous to human health, there is a need to remove them from the final products or reduce their amounts to below acceptable levels. The purpose of this study was to develop and evaluate an analytical method for the screening of residual solvents in health functional foods. Furthermore, the aim of this study was to constitute a reasonable management system based on the current state of the market and case studies of foreign countries. Eleven volatile solvents such as MeOH, EtOH, trichloroethylene and hexane were separated depending on their column properties, temp. and time using Gas Chromatography (GC). After determining the GC conditions, a sample preparation method using HSS (Head Space Sampling) was developed. From the results, a method for analyzing residual solvents in health functional foods was developed considering matrix effect and interference from the sample obtained from the solution of solvents-free health functional foods spiked with 11 standards solutions. Validation test using the developed GC/HSS/MS (Mass Spectrometry) method was followed by tests for precision, accuracy, recovery, linearity and adequate sensitivity. Finally, examination of 104 samples grouped in suits was performed by the developed HSS/GC/MS for screening the solvents. The 11 solvents were isolated from health functional foods based on vapor pressure difference, and followed by separation within 15 minutes in a single run. The limt of detection (LOD), limit of quantification (LOQ), recovery and coefficient of variation (C.V.) of these compounds determined by the HSS/GC/MS were found to be 0.1 pg/mL, 0.1-125 pg/g, 51.0-104.6%, and less than 15%, respectively. Using the developed HSS/GC/MS method, residual solvent from 16 out of 104 health functional products were detected as a EtOH. This method therefore seems t o be a valuable extension ofanalytical method for the identification of residual solvents in health functional food.

• Journal of Food Hygiene and Safety
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• v.32 no.4
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• pp.254-261
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• 2017

Determining the origin of the components in commercially available gelatin, a purified protein derived mostly from pig skin and bovine tissue, is a challenge, leading to concerns on the grounds of religious beliefs and health. Therefore, regular monitoring of labeling compliance by food control authorities is also necessary. In this study, we monitored the origin of gelatin capsules from 181 commercial dietary supplements that were available for purchase on the internet, using species-specific PCR assays. Fifty five products were labeled correctly, declaring that they used bovine-, fish- and plant-derived gelatin, whereas the other 126 capsules were labeled "gelatin" without specifying the origin. Gelatin in these capsules was obtained from cattle (n = 51), pigs (n = 31), or both (n = 44). Therefore, it is important to declare all of the raw materials used to produce gelatin capsules on the labels to best protect consumers' rights, religious beliefs, and health.

• Journal of Food Hygiene and Safety
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• v.25 no.2
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• pp.100-105
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• 2010

This study was conducted to establish a method to analyze azodicarbonamide (ADA) in wheat flour. A new method using high performance liquid chromatography (HPLC) was developed for the determination of ADA in wheat flour. The recovery rate was 91.93~97.54%. The limit of detection for ADA was 0.02 mg/kg and the limit of quantification was 0.05 mg/kg. The monitoring results for ADA contents using the established methods showed that it was detected as the low value of 0.95 mg/kg in one of 51 flour samples (detection rate : 2%), but not detected in 59 bakery samples. The detected ADA level was suitable to its usage standard, compared to the standard (45 mg/kg). Although the detection rate was very low, the established analytical method of ADA will contribute to the management of ADA in processed foods such as wheat flour and bakery.

• Analytical Science and Technology
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• v.21 no.6
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• pp.535-542
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• 2008

A liquid chromatography-electrospray ionization tandem mass spectrometry (LC-ESI/MS/MS) method was developed for the determination and confirmation of clenbuterol in bovine muscle and milk. Clenbuterol and clenbuterol-D9 using as an internal standard in samples were extracted with ethyl acetate after hydrolysis and evaporated to dryness. The extracts were dissolved in 20% methanol and cleaned using HLB solid-phase extraction cartridge. The analytes were detected by LC-ESI/MS/MS on a $C_{18}$ column. Mass spectral acquisition was done in selected reaction monitoring (SRM) in positive ion mode to provide a high degree of sensitivity. Using MS/MS with SRM mode, the transitions (precursor to product) monitored were m/z 277${\rightarrow}$203 for clenbuterol, and m/z 286${\rightarrow}$204 for internal standard. The limits of quantitation (LOQ) and mean recoveries of clenbuterol in bovine muscle were $0.2{\mu}g/kg$ and 84.3~91.1%, respectively. The LOQ and mean recoveries in milk were $0.05{\mu}g/kg$ and 87.7~98.3%, respectively.

• YAKHAK HOEJI
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• v.50 no.3
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• pp.145-153
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• 2006

The adverse events which do not appear in the approval process tend to occur more frequently at the early stage of the use. Therefore new drugs, drugs with different active substances or routes of administration, or drugs with explicitly different efficacy added are particularly chosen for re-examination, and go through a study, which is conducted on 600 to 3,000 subjects over 4 to 6 years. Since the re-examination system was implemented in January 1995, 880 drug products have been designated as the subject of re-examination and among them 194 drugs have been completed their re-examination as of until March 2005. Post Marketing Surveillance to insure drug safety should be correlated with re-examination of new drug, re-evaluation of drug, and adverse event monitoring system. And the first labeling change should reflect all information collected for a defined period of time after the marketing authorization is granted. Furthermore centralized management through spontaneous reporting system of adverse event for whole period of time would be the most desirable type of system.

• Korean Journal of Clinical Pharmacy
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• v.17 no.1
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• pp.46-51
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• 2007

This study was aimed to provide the controlled terminology for adverse drug reactions by selecting an appropriate internationally standardized classifications (WHO-ART or MedDRA). We collected the relevant information on ADR terminology systems including WHO-ART and MedDRA by online searching and visiting pharmaceutical companies and WHO UMC (Uppsala Monitoring Centre, Uppsala, Sweden). For MedDRA, project leader directly communicated with the officer of MSSO (Maintenance and Support Services Organization). Collecting all the pertinent information, two possible terminology classifications or systems (WHO-ART and MedDRA) were compared in the views of acceptability, cost-effectiveness and international feasibility and reviewed by the consultation committee and finally WHO-ART was selected.

• YAKHAK HOEJI
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• v.53 no.3
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• pp.138-144
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• 2009

The purpose was to implement drug utilization review (DUR) for whom were diagnosed with chronic kidney disease (CKD) population using health insurance claim data. This study constructed drug utilization database using Health Insurance Review and Assessment Service (HIRA) database and selected contraindicated drugs with kidney based on previously developed drug utilization guide and reviewing other countries' examples. Main outcome measures were the proportion of prescription for 1 or more drugs of concern. The cohort included 115,948 subjects, who were diagnosed with chronic kidney disease. Inappropriate drugs with CKD patients was some used, and the most commonly prescribed classes were aluminum drugs. However it is difficult to find problems with inappropriate drug because claims data doesn't have laboratory data. Based on the result of retrospective drug utilization review study, more studies should be analysed drug utilization patterns and monitoring system should be developed.

• Mass Spectrometry Letters
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• v.12 no.2
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• pp.31-40
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• 2021

Probable human carcinogenic compounds nitrosamines, have been detected as by-product impurities in sartan pharmaceuticals in recent years which has drawn worries for medication safety. To provide a sensitive and effective method for the quality control of sartan pharmaceuticals, this study established a feasible gas chromatography-tandem mass spectrometry (GC-MS/MS) method for simultaneous determination of 13 nitrosamines. The target analytes were separated on a DB-WAX Ultra Inert column (30 m × 0.25 mm; i.d., 0.25 ㎛) and were then subjected to electron impact ionization in multiple reaction monitoring mode. The established method was validated and further employed to analyze authentic samples. Limits of detection (LODs) and limits of quantification (LOQs) of the 13 nitrosamines were 15-250 ng/g and 50-250 ng/g, respectively, which also exhibited intra-day and inter-day accuracies of 91.4-104.8%, thereby satisfying validation criteria. Five nitrosamines, viz., N-nitrosodiethylamine, N-nitrosodimethylamine, N-nitrosodiphenylamine, N-nitrosomorpholine, and N-nitrosopiperidine were detected at concentrations above their LODs in 68 positive samples out of 594 authentic samples from seven sartans.

• Journal of the Korean Society of Food Science and Nutrition
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• v.38 no.12
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• pp.1779-1784
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• 2009

Establishment of simultaneous analysis method and monitoring for individually analyzing residual eight ergosterol biosynthesis inhibitors, EBI (difenoconazole, diniconazole, fenarimol, fenbuconazole, hexaconazole, myclobutanil, nuarimol and paclobutrazol) pesticides in commercial agricultural products, were conducted. The simultaneous analysis method for the pesticides was established using a GC/MS/MS for EBI pesticides. Residual amount of those pesticides were investigated in 989 commercial agricultural products (fifteen kinds of cereal grains, vegetables, beans, nuts, fruits and mushrooms) from seven metropolitan cities and eight provinces. In EBI pesticides analysis, linearity of GC/MS/MS analysis was 0.9974-0.9992, and that of recoveries were 86-135% with relative standard deviations (RSD) <20%. The limit of quantification (LOQ) of the method ranged from 0.5 to 5.0 mg/kg for eight EBI pesticides. According to the monitoring of the EBI pesticides in commercial agricultural products, difenoconazole, fenarimol, hexaconazole showed various residual levels (total frequency of 8/989 detection, 0.8%). Paclobutrazole showed in excess levels of the MRLs (maximum residue limits) for pesticides in one chard sample by the Korea Food Code. As a result of exposure assessment on the detected 8 individual pesticides, all pesticides (difenoconazole, fenarimol, hexaconazole, paclobutrazole) were evaluated as safe level in comparison to toxicologically acceptable daily intake.

• Korean Journal of Food Science and Technology
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• v.43 no.6
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• pp.675-682
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• 2011

This study was conducted to monitor the concentrations of 24 anti-impotence drugs and their analogues in various foods and dietary supplements, with the aim of ensuring the safety of the foods and supplements. The measurements were done in 226 samples using high performance liquid chromatography/photodiode array detector (HPLC/PDA) and liquid chromatography-electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS). Five male sexual function enhancing products have been detected as follows: acethylvardenafil (21,476 mg/kg; 15 mg/capsule from one sample), sildenafil (52,778 mg/kg, 29 mg/capsule in one sample; 71,535 mg/kg, 48 mg/capsule in one sample), and tadalafil (9,772-55,545 mg/kg, 6-33 mg/capsule in four samples). A sustainable monitoring of anti-impotence drugs and their analogues in various foods and dietary supplement is recommended.