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고시의약품 시험에 사용되는 유해시약 대체 시험법 개발
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  • 고시의약품 시험에 사용되는 유해시약 대체 시험법 개발
  • Development of Alternative Testing Methods without Hazardous Reagents used in Korean Pharmaceutical Codex
저자명
김희연,강현경,최선희,방수진,한경진,최승희,김진희,이화정,강찬순,Kim. Hee-Yun,Kang. Hyun-Kyung,Choi. Seon-Hee,Bang. Su-Jin,Han. Kyung-Jin,Choi. Sung-Hee,Kim.
간행물명
약학회지
권/호정보
2010년|54권 2호|pp.142-149 (8 pages)
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대한약학회
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정기간행물|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

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.