caa a22 4500 445312793 CHVBK 20180317142636.0 cr unu---uuuuu 170323e20110301xx s 000 0 eng 10.1007/s11095-010-0295-3 doi (NATIONALLICENCE)springer-10.1007/s11095-010-0295-3 Establishing New Acceptance Limits for Dissolution Performance Verification of USPC Apparatus 1 and 2 Using USPC Prednisone Tablets Reference Standard [Elektronische Daten] [Anthony DeStefano, Walter Hauck, Erika Stippler, William Brown, Chensheng Li, Gloria Huang, Barbara Jones, Kevin O'Hool, William Koch, Roger Williams] 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. Springer Science+Business Media, LLC, 2010 dissolution nationallicence performance verification nationallicence prednisone reference standard tablets nationallicence DeStefano Anthony US Pharmacopeial Convention, 20852, Rockville, Maryland, USA aut Hauck Walter US Pharmacopeial Convention, 20852, Rockville, Maryland, USA aut Stippler Erika US Pharmacopeial Convention, 20852, Rockville, Maryland, USA aut Brown William US Pharmacopeial Convention, 20852, Rockville, Maryland, USA aut Li Chensheng US Pharmacopeial Convention, 20852, Rockville, Maryland, USA aut Huang Gloria US Food and Drug Administration, Silver Spring, Maryland, USA aut Jones Barbara US Pharmacopeial Convention, 20852, Rockville, Maryland, USA aut O'Hool Kevin US Pharmacopeial Convention, 20852, Rockville, Maryland, USA aut Koch William US Pharmacopeial Convention, 20852, Rockville, Maryland, USA aut Williams Roger US Pharmacopeial Convention, 20852, Rockville, Maryland, USA aut Pharmaceutical Research Springer US; http://www.springer-ny.com 28/3(2011-03-01), 505-516 0724-8741 28:3<505 2011 28 11095 https://doi.org/10.1007/s11095-010-0295-3 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s11095-010-0295-3 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- DeStefano Anthony US Pharmacopeial Convention, 20852, Rockville, Maryland, USA aut NATIONALLICENCE 700 1- Hauck Walter US Pharmacopeial Convention, 20852, Rockville, Maryland, USA aut NATIONALLICENCE 700 1- Stippler Erika US Pharmacopeial Convention, 20852, Rockville, Maryland, USA aut NATIONALLICENCE 700 1- Brown William US Pharmacopeial Convention, 20852, Rockville, Maryland, USA aut NATIONALLICENCE 700 1- Li Chensheng US Pharmacopeial Convention, 20852, Rockville, Maryland, USA aut NATIONALLICENCE 700 1- Huang Gloria US Food and Drug Administration, Silver Spring, Maryland, USA aut NATIONALLICENCE 700 1- Jones Barbara US Pharmacopeial Convention, 20852, Rockville, Maryland, USA aut NATIONALLICENCE 700 1- O'Hool Kevin US Pharmacopeial Convention, 20852, Rockville, Maryland, USA aut NATIONALLICENCE 700 1- Koch William US Pharmacopeial Convention, 20852, Rockville, Maryland, USA aut NATIONALLICENCE 700 1- Williams Roger US Pharmacopeial Convention, 20852, Rockville, Maryland, USA aut NATIONALLICENCE 773 0- Pharmaceutical Research Springer US; http://www.springer-ny.com 28/3(2011-03-01), 505-516 0724-8741 28:3<505 2011 28 11095 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer