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Establishing New Acceptance Limits for Dissolution Performance Verification of USPC Apparatus 1 and 2 Using USPC Prednisone Tablets Reference Standard

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An Erratum to this article was published on 01 February 2011

ABSTRACT

Purpose

On 1 March 2010, the US Pharmacopeial Convention released into commerce Lot P1I300 of its Prednisone Tablets Reference Standard for use in periodic performance verification testing (PVT) of dissolution Apparatus 1 and 2. This report presents the collaborative study data, development of the acceptance limits, and results from supporting work for this Lot.

Methods

The collaborative study involved 25 collaborators who provided data for Apparatus 1 and 31 who provided data for Apparatus 2. These limits are for the geometric mean and percent coefficient of variation (%CV) instead of per-individual results as for prior lots. Stability of results and sensitivity to test performance parameters were also studied.

Results

To determine new PVT acceptance limits, the authors calculated geometric mean and variance components as percent coefficient of variation. The move to the geometric mean and %CV criteria brings the acceptance criteria in line with current accepted statistics and provides a more realistic assessment of the system’s performance. Results for Apparatus 1 are stable over time, but for Apparatus 2, the mean decreases over time. Acceptance criteria are adjusted for this trend. Lot P1 demonstrates sensitivity to test performance parameters (vessels and degassing).

Conclusions

Apparatus 1 results are stable over time. Those in Apparatus 2 show a decrease over time in the geometric mean but show no trend in variability. The current tablets are shown to remain sensitive to two operational parameters, degassing and vessel dimensions, not covered by mechanical calibration. The new acceptance limits for Lot P1 are based on geometric mean and %CV for Prednisone Tablets Reference Standard Lot P1I300. The limits better control variability than the prior per-individual-result limits.

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ACKNOWLEDGMENTS

The authors thank Stefan Schuber, PhD, ELS, director, scientific reports at USPC, for editorial assistance.

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Author notes

  1. Gloria G. Huang

    Present address: US Food and Drug Administration, Silver Spring, Maryland, USA

Authors and Affiliations

  1. US Pharmacopeial Convention, Rockville, Maryland, 20852, USA

    Anthony J. DeStefano, Walter W. Hauck, Erika S. Stippler, William E. Brown, Chensheng Li, Barbara J. Jones, Kevin O’Hool, William F. Koch & Roger L. Williams

Authors
  1. Anthony J. DeStefano
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  2. Walter W. Hauck
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  3. Erika S. Stippler
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  4. William E. Brown
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  5. Chensheng Li
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  6. Gloria G. Huang
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  7. Barbara J. Jones
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  8. Kevin O’Hool
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  9. William F. Koch
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  10. Roger L. Williams
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Corresponding author

Correspondence to Anthony J. DeStefano.

Additional information

The opinions expressed here are those of the authors and do not represent the official position of the US Food and Drug Administration or the US government.

An erratum to this article can be found at http://dx.doi.org/10.1007/s11095-011-0373-1

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DeStefano, A.J., Hauck, W.W., Stippler, E.S. et al. Establishing New Acceptance Limits for Dissolution Performance Verification of USPC Apparatus 1 and 2 Using USPC Prednisone Tablets Reference Standard. Pharm Res 28, 505–516 (2011). https://doi.org/10.1007/s11095-010-0295-3

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  • DOI: https://doi.org/10.1007/s11095-010-0295-3

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