IiCalculation

Calculate the endotoxin concentration of each replicate of solution A using the standard curve generated by the series of positive controls, solution C.

The test is not valid unless the following 3 requirements are met:

(a) the result obtained with solution D (negative control) does not exceed the limit of the blank value required in the description of the lysate employed,

(b) the results obtained with the series of positive controls, solution C, comply with the requirements for validation defined under 3. Preparatory testing, (i) Assurance of criteria for the standard curve,

(c) the endotoxin recovery, calculated from the endotoxin concentration found in solution B after subtracting the endotoxin concentration found in solution A, is within the range of 50-200 per cent.

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