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Development of Alternative Testing Methods without Hazardous Reagents used in Korean Pharmaceutical Codex  

Kim, Hee-Yun (Hazardous Substances Analysis Division, Seoul Regional Korea Food and Drug Administration)
Kang, Hyun-Kyung (Biologics Research Division, National Institute of Food and Drug Safety Evaluation)
Choi, Seon-Hee (Hazardous Substances Analysis Division, Seoul Regional Korea Food and Drug Administration)
Bang, Su-Jin (Hazardous Substances Analysis Division, Seoul Regional Korea Food and Drug Administration)
Han, Kyung-Jin (Hazardous Substances Analysis Division, Seoul Regional Korea Food and Drug Administration)
Choi, Sung-Hee (Hazardous Substances Analysis Division, Seoul Regional Korea Food and Drug Administration)
Kim, Jin-Hee (Hazardous Substances Analysis Division, Seoul Regional Korea Food and Drug Administration)
Lee, Hwa-Jung (Food Investigation Science Team, National Institute of Food and Drug Safety Evaluation)
Kang, Chan-Soon (Center for Food and Drug Analysis, Busan Regional Korea Food and Drug Administration)
Publication Information
YAKHAK HOEJI / v.54, no.2, 2010 , pp. 142-149 More about this Journal
Abstract
Development of alternative testing methods for the replacement of hazardous reagents with less hazardous ones is strongly enforced because exposure of human and environment to hazardous reagents are restricted and hazardous reagents are gradually prohibited from using in various testing methods. Thus, in this study, we developed 8 monographs from the Korean Pharmaceutical Codex by substituting the use of the hazardous reagents including ICH class 1 such as benzene, chloroform and dioxane to the use of less toxic ones like ICH class 2 or 3 reagents. We also improved their qualification and quantification performance. Among 8 monographs, the 6 newly developed TLC methods for the identification of nifedipine, oxolamine citrate, ketoprofen lysinate, chlorquinaldol, retinol acetate, and riboflavin showed a clear spot of corresponding material without any interference in spite of the replacement with ICH class 2 or 3 reagents. For the quantification of domperidone and trimebutine, HPLC methods were developed for the substitution of UV/VIS spectrometry and titrimetry, respectively. These HPLC methods were validated for the linearity, recovery, reproducibility, and inter-laboratory variations. In conclusion, the newly developed methods could be expected to become valuable tools for revising the Korean Pharmaceutical Codex.
Keywords
Korean pharmaceutical codex; hazardous reagents; alternative testing methos;
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