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KMID : 1142220150100010011
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Regulatory Research on Food, Drug & Cosmetic
2015 Volume.10 No. 1 p.11 ~ p.37
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Establishment for Pesticides Analytical Method in Korea Quasi-Drug Codex
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Kim Sang-Seop
Lee Han-Na
Kim Jin-Ho
Ahn Jae-Hyung
Choi Yong-Kyu
Kim Hyun-Ju
Lee Jung-Pyo
Kim Dal-Hwan
Hyen Seong-Ye
Park Chang-Won
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Abstract
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As insect vector-born diseases caused by mosquitoes etc. occur all year around due to global warming and environmental changes, the use of pesticides to prevent infection is also on the dramatic rise. In this regards, safety and efficacy are considered the most important figures of pesticides. Most of the pesticide testing methods for the safety and quality control of pesticides listed in「Korean Quasi-drug Codex, KQC」are difficult to be used with state-of-the-art analysis equipments. Therefore, it is necessary to develop standardized testing methods which are not only adequate for domestic circumstances, but also comply with international standards to ensure efficient review and promote exports and expedited commercialization of pesticides. The purpose of this study is to improve testing (assay) methods for materials contained in pesticides listed in KQC. CIPAC international test methods and domestically authorized methods were compared and reviewed for 10 items including bioallethrin. Starting materials were validated based on ‘Validation Guidelines on Testing Methods of Medicines’ to establish appropriate testing methods. As a result of validation, system conformance (peak area relative standard deviation 2.0% or lower), specificity (no peak overlap), linearity (R2 value of 0.999 or more), accuracy (recovery 80~110%), precision (relative standard deviation 1.0% or lower) turned out to be all conformed to validation standards. We expect this study will contribute to enhanced safety and global competitiveness of pesticides and promote comsumer trusts by securing supply of pesticides of assured quality.
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KEYWORD
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Quasi-drug, 10 Pesticides, Assay
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FullTexts / Linksout information
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Listed journal information
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