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Why is the positive product control not 0.5 EU/mL for a 5 to 0.05 EU/mL curve?

April 26, 2017CONTROL curve EU ML positive Product

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Why is the positive product control not 0.5 EU/mL for a 5 to 0.05 EU/mL curve?

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The USP says to select an endotoxin concentration at or near the middle of the endotoxin standard curve. The cartridge is spiked with a predetermined nanogram amount of CSE during the filling operation. The EU/ng value is then determined during release testing using the government Reference Standard Endotoxin (RSE).