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In this study, the gauge R&R method was used to analyze sources of variability for the paddle apparatus (USP apparatus 2). An initial evaluation of gauge R&R dissolution testing results using the amount dissolved at 30 minutes for a 10-mg prednisone tablet showed no instrument or operator contributions to variability but did highlight some vessel differences within an instrument. Based on this finding, a new mechanical calibration step was developed to improve the performance of the measurement system.
Gauge R&R analysis is useful for determining the sources of variability in a measurement system. In addition, the extensive characterization and variability knowledge obtained during gauge R&R testing of a product can be used to develop the mean and SD information necessary to set up an internal standard for dissolution testing.