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自 198 0年美国药典创建细菌内毒素检查法(BET)以来 ,各国药典为确保在BET试验时的准确有效 ,都规定了严谨的试验方法学、标准物质 (细菌内毒素 )同一性以及在使用新批号的鲎试剂之前或当对试验结果有影响的试验条件变化时必须对鲎试剂标示灵敏度进行复核等。在美国 ,2 0 0 1年
Since the establishment of the bacterial endotoxin test (BET) by the United States Pharmacopeia in 198 0, pharmacopoeia states that rigorous test methodology, reference material (bacterial endotoxin) identity, and the use of The new lot number of reagent before or when the test results affect the impact of changes in the test conditions must be marked 鲎 reagent sensitivity review. In the United States, 2001