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For dissolution strategy validation applications, precision is calculated about two degrees, repeatability and intermediate precision. Repeatability refers to the application of your course of action inside of 1 laboratory about a short timeframe by just one analyst employing one instrument. Repeatability is determined by replicate measurements of
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Protein solutions or proteins in blood and blood fractions could bind endotoxin and render it unavailable for detection within the LAL test. Alternatively, some proteases degrade the proteins of the enzyme cascade while some (eg, trypsin) activate it.FDA has identified which the revealed USP and AAMI documents describing approaches and calculation