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Systematic error associated with apparatus 2 of the USP dissolution test III: limitations of calibrators and the USP suitability test.

作者信息

Cox D C, Furman W B, Thornton L K, Moore T W, Jefferson E H

出版信息

J Pharm Sci. 1983 Aug;72(8):910-3. doi: 10.1002/jps.2600720817.

DOI:10.1002/jps.2600720817
PMID:6620145
Abstract

The calibrator tablets now used in the USP suitability test do not reveal common sources of systematic error associated with Apparatus 2. When the apparatus was operated under conditions near or beyond USP tolerances, changes in the results of the USP calibrators were slight, whereas those of several samples of commercial prednisone tablets were significant. Thus, the USP calibrators and requirements do not guarantee suitability of the equipment for general dissolution testing of drug products.

摘要

相似文献

1
Systematic error associated with apparatus 2 of the USP dissolution test III: limitations of calibrators and the USP suitability test.
J Pharm Sci. 1983 Aug;72(8):910-3. doi: 10.1002/jps.2600720817.
2
Typical variability in drug dissolution testing: study with USP and FDA calibrator tablets and a marketed drug (glibenclamide) product.药物溶出度测试中的典型变异性：使用美国药典（USP）和美国食品药品监督管理局（FDA）校准片以及一种市售药物（格列本脲）产品的研究
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Systematic error associated with apparatus 2 of the USP dissolution test I: Effects of physical alignment of the dissolution apparatus.与美国药典溶出度试验装置2相关的系统误差I：溶出度试验装置物理对齐的影响。
J Pharm Sci. 1982 Apr;71(4):451-2. doi: 10.1002/jps.2600710419.
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Systematic error associated with apparatus 2 of the USP dissolution test IV: effect of air dissolved in the dissolution medium.
J Pharm Sci. 1983 Sep;72(9):1061-4. doi: 10.1002/jps.2600720923.
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Systematic error associated with apparatus 2 of the USP dissolution test II: Effects of deviations in vessel curvature from that of a sphere.与美国药典溶出度试验II装置2相关的系统误差：溶出杯曲率与球体曲率偏差的影响。
J Pharm Sci. 1982 Apr;71(4):395-9. doi: 10.1002/jps.2600710405.
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Collaborative study of the USP dissolution test for prednisone tablets with Apparatus 2.泼尼松片采用装置2的美国药典溶出度试验的协作研究。
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The USP Performance Verification Test, Part I: USP Lot P Prednisone Tablets: quality attributes and experimental variables contributing to dissolution variance.美国药典性能验证测试，第一部分：美国药典批次P泼尼松片：影响溶出度差异的质量属性和实验变量
Pharm Res. 2008 May;25(5):1100-9. doi: 10.1007/s11095-007-9498-7. Epub 2008 Jan 3.
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Hydrodynamic investigation of USP dissolution test apparatus II.美国药典溶出度试验装置II的流体动力学研究。
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Dissolution of prednisone tablets in the presence of an arch-shaped fiber optic probe in a USP dissolution testing apparatus 2.在 USP 溶解试验仪 2 中，使用弓状光纤探头使泼尼松片剂溶解。
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The USP Performance Verification Test, Part II: collaborative study of USP's Lot P Prednisone Tablets.美国药典性能验证测试，第二部分：美国药典P批次泼尼松片的协作研究
Pharm Res. 2008 May;25(5):1110-5. doi: 10.1007/s11095-007-9482-2. Epub 2008 Jan 3.

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