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Variability of USP Lot P Prednisone Reference Standard Tablets
- Article from:
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Pharmaceutical Technology
- Article date:
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June 1, 2008
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Copyright informationCopyright Advanstar Communications, Inc. Jun 2008. Provided by ProQuest LLC. (Hide copyright information)
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Acceptance criteria for prednisone tablets have been criticized for several years as being too wide, based specifically on the USP Prednisone Reference Standard Tablets. In response, USP has conducted research on the performance of its Prednisone RS Tablets and dissolution procedure. The authors demonstrate that anecdotal reports of prednisone tablet variability are inaccurate.
The United States Pharmacopeial Convention provides reference standard tablets for use in performance verification testing of dissolution Apparatus 1 and 2 (1-3). The performance verification test (PVT) is specified in United States Pharmacopeia (USP) General Chapter Dissolution (711) (4) with specific elements ...