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AAPS PharmSciTech. 2007 October; 8(4): 11–15.
Published online 2007 October 12. doi:  10.1208/pt0804082
PMCID: PMC2750668

Gauge repeatability and reproducibility for accessing variability during dissolution testing: A technical note

Conclusions

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.

Keywords: Dissolution test, gauge R&R, variability

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Selected References

These references are in PubMed. This may not be the complete list of references from this article.
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