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영어

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.