The Microbial Assays for Antibiotics Package follows the guidances of the U.S. Pharmacopeia (USP) <81> and Japanese Pharmacopoeia (JP) Chapter 4.02 in separate document types to estimate the potency of cylinder-plate and turbidimetric assays.* It supports you during preparation of the assay by providing customizable documentation options regarding the antibiotic and the inoculum. For instance, information about the incubation, the base and seed layer medium, the equipment, the operator, and the purpose can be recorded. In addition, when performing a cylinder-plate assay as described in the USP <81>, you can apply plate-to-plate variation correction choosing between the correction point method and estimations from the regression line. Next, you can define test systems to prove the validity of your assay. Finally, the results provide you with potency estimations for your test samples including overall test results. Once you have collected data from multiple assay runs, aggregate the independent documents to perform combined potency calculations for each combination group of test samples.
*Set up microbial assays for antibiotics according to regulations by the European Pharmacopoeia with Quantitative response assay documents from the Biological Assay Package.