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KMID : 1142220120070010039
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Regulatory Research on Food, Drug & Cosmetic
2012 Volume.7 No. 1 p.39 ~ p.46
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Establishment of Endotoxin Limits of Pharmaceuticals
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Baek Wan-Sook
Chun In-Koo
Lee Min-Hwa
Kim In-Kyu
Lee So-Young
Kim Eun-Joung
Jeong Hyun-Ju
Kang Min-Ji
Lee Dug-Hyung
Yoon Sung-Aea
Ra Jun-Sik
Yoo Dong-Kyun
Lee Eun-Hee
Kang Chan-Sun
Kim Kil-Soo
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Abstract
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The aim of this study is to establish the limit of endotoxin on the pharmaceuticals. 16 items listed in the Korean Pharmacopoeia Codex were selected as sample and the endotoxin limit was calculated according to Decision of Limit for Bacterial Endotoxins, General Information of Korean Pharmacopoeia. And the contents of endotoxin in the samples were assayed according to Bacterial Endotoxin Test, the General Test, process and apparatus of Korean Pharmacopoeia and the experimental values were compared with calculated limits of endotoxin of the samples, and then final endotoxin limits of the samples were prepared.
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KEYWORD
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Endotoxin Limits, Pharmaceuticals, Korean Pharmacopoeia, Korean Pharmaceutical Codex
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