The manufacturing process includes the addition of buffers and detergents which contribute a further source of variability.This means that the enzyme activity cannot be determined exactly for each lot of lysate manufactured. The extract is relatively crude mixture and is not a single purified enzyme. It is a complex mixture of enzymes and co-factors. The LAL reagent (lysate of the horseshoe crab Limulus polyphemus) is of biological origin.The LAL reagent is a contributor to assay variation for the following reasons: These include the LAL reagent, endotoxin control standard, standard curves, and dilution error. LAL Test VariabilityÄifferent aspects of the LAL test can cause variability. 2 This paper examines some of the reasons for LAL test variation, focusing on photometric methods (chromogenic and turbidimetric), and considers how variation can be assessed through good laboratory quality control. 1 This variation derives from 3 principle sources: reagents, product, and method. Here the LAL assay has a relatively high level of variability even for a biological assay. With any biological tests, measurements are susceptible to variations in analytical conditions. The Limulus amebocyte lysate (LAL) assay is the compendial test for the examination of bacterial endotoxin in pharmaceutical products (as described in USP chapter ), in-process material, and pharmaceutical grade water.
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