Clean Analysis Not to Use Harmful Solvent for TLC Identification Test of the Herbal Medicine |
Kim, Ji-Yeon
(National Institute of Food and Drug Safety Evaluation)
Park, Ju-Young (National Institute of Food and Drug Safety Evaluation) Shim, Young-Hoon (National Institute of Food and Drug Safety Evaluation) Cho, Chang-Hee (National Institute of Food and Drug Safety Evaluation) Lee, Jong-Hwa (National Institute of Food and Drug Safety Evaluation) Lee, Dong-Jin (National Institute of Food and Drug Safety Evaluation) Kim, Bo-Joon (National Institute of Food and Drug Safety Evaluation) Kim, Dong-Sup (National Institute of Food and Drug Safety Evaluation) Seong, Rack-Seon (National Institute of Food and Drug Safety Evaluation) Kim, Jong-Hwan (Korea Food and Drug Administration) Lim, Sook (Korea Food and Drug Administration) Shin, Jin-Seon (Korea Food and Drug Administration) Jang, Seung-Yeup (Korea Food and Drug Administration) |
1 | Witschi, C. and Doelker, E. (1997) Residual solvents in pharmaceutical products: acceptable limits, influences on physicochemical properties, analytical methods and documented values. Eur. J. Pharm. Biopharm. 43: 215-242. DOI ScienceOn |
2 | WHO Western Pacific Regional Forum on Harmonization of Herbal Medicines Activity Report (2006). |
3 | WHO Western Pacific Regional Forum on Harmonization of Herbal Medicines Activity Report (2008). |
4 | 대한약전 제9개정 (2007) 식품의약품안전청, 서울. |
5 | 대한약전외한약(생약)규격집 (2007) 식품의약품안전청, 서울 |
6 | 의약품잔류용매기준지침 (2007) 식품의약품안전청, 서울 |
7 | Proceedings of International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Guideline Q3B Impurities in New Drug Products (1997), 스위스. |
8 | David, J. K. and McGovern, T. (2007) Toxicological overview of impurities in pharmaceutical products. Advanced Drug Delivery Reviews 59(1): 38-42. DOI ScienceOn |
9 | Branch, S. K. (2005) Guidelines from the International Conference on Harmonisation (ICH). Journal of Pharmaceutical and Biomedical Analysis 38(5): 798-805. DOI ScienceOn |
10 | WHO Western Pacific Regional Forum on Harmonization of Herbal Medicines Activity Report (2009). |
11 | Heipieper, H. J., Weber, F. J., Sikkema, J. and Keweloh, H. (1994) Mechanism of resistance of whole cells to toxic organic solvents. Trends in Biotechnology 12(10): 409-415. DOI ScienceOn |
12 | Branch, S. K. (2005) Guidelines from the international conference on harmonisation(ICH). Journal of Pharmaceutical and Biomedical Analysis 38(5): 798-805. DOI ScienceOn |
13 | Camarasu, C., Madichie, C. and Williams, R. (2006) Recent progress in the determination of volatile impurities in pharmaceuticals. TrAC, Trends anal. Chem. 25: 768-777. DOI ScienceOn |
14 | Boehlert, J. P. (2000) Regulatory aspects: ICH and pharmacopoeial perspectives. Progress in Pharmaceutical and Biomedical Analysis 4:48-66. |