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USP <1116> and Contamination Recovery Rates | IVT

Most of the plate counts should be “zero” The actual numerical plate counts seen are far below the limit of quantification (LOQ) for the plate count method. USP <1116> suggests using “percent contamination recovery rate” as the measure, but other options are available:  The use of quality control (QC) control charts has been suggested for these data The use of most probable number (MPN) analysis has been suggested for analysis of these data-this may be a more appropriate method given the Poisson distribution of the data and its very low numbers.   Limitations...

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