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参照《中国药典》1995年版二部“盐酸赖氨酸”项下热原检查剂量 ,确定盐酸赖氨酸注射液的细菌内毒素限值为 6 .0EU .ml- 1 。经干扰试验确证样品的最大无抑制浓度为 5 0 m g.m l- 1 ,对 3批样品的热原检查与细菌内毒素检查对比试验 ,示发现有漏检现象
Reference to the “Chinese Pharmacopoeia” 1995 edition two “lysine hydrochloride” under the pyrogen test dose to determine the lysine hydrochloride injection bacterial endotoxin limit of 6. 0EU .ml-1. Confirmed by the interference test, the maximum non-inhibitory concentration of the sample was 50 m g · ml-1. The pyrogen test and the bacterial endotoxin test of three batches of samples showed that there was a missing test