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KMID : 1142220190140020137
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Regulatory Research on Food, Drug & Cosmetic
2019 Volume.14 No. 2 p.137 ~ p.142
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Determination of Phthalate Plasticizer on Hygiene Products using GC-MS
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Han Kyoung-Moon
Cheon Hae-In
Park Sang-Myeong
Kim Gu-Won
Kim Sang-Seop
Shin Ji-Hyun
Lee Rhee-Da
Son Kyung-Hun
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Abstract
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Cleansing & Hygiene products were previously managed as industrial products by the Ministry of Health and Welfare and the Ministry of Trade, Industry and Energy. Currently, it has been managed under the「Cleansing & Hygiene Products Control Act」 to ensure safety and quality since April, 2018. In this study, we improved the test method of phthalate plasticizers (DBP, dibutyl phthalate; BBP, butylbenzyl phthalate; and DEHP, diethylhexyl phthalate) of「Cleansing & Hygiene Products Codex」. This study improved methods such as correcting conditions of columns and analysis. Samples were taken from synthetic resin of disposable swabs and pulverized using freezer mill, followed by n-hexane soxhlet extraction. The GC-MS (Gas chromatography-mass spectrometry) analysis was performed on DB-5MS column. The oven temperature is settled as follows: 110oC ramped to 320oC. The acquisition is performed on full scan (m/z=50-500) and SIM (Selected ion monitoring) mode. Target ions of DBP, BBP, DEHP were 223, 206, 279 m/z and reference ions were (149, 205), (91, 149), (149, 167) m/z on GCMS, respectively. The method was validated by specificity, linearity, accuracy and precision according to ICH(International council for harmonisation of technical requirements for pharmaceuticals for human use) guideline. The LOD (Limit of detection) and LOQ (Limit of quantitation) indicated 0.07~0.30 mg/L and 0.22~0.91 mg/L, approximately, and the linearity showed R2 over 0.99 in the range of 1.0~20.0 mg/L. The intra and inter-day accuracy ranged 83.74~97.51% and precision was 101.65% with the RSD (Relative standard deviation) less than 2.88%. To evaluate the applicability of method, commercial products were monitored. The monitoring results met the「Cleansing & Hygiene Products Codex」, which has an allowance limit of three phthalates less than 0.1%.
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KEYWORD
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hygiene products, phthalate plasticizer, GC-MS
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