Systematic Error Associated with Apparatus 2 of the USP Dissolution Test V: Interaction of Two Tableted Prednisone Formulations with Glass and Plastic Vessels
作者： Don C. Coxx , William B. Furman
关键词: Dosage form 、 Solubility 、 Dissolution 、 Systematic error 、 Materials science 、 Mineralogy 、 Dissolution testing 、 Reference values 、 Chromatography 、 Pharmaceutical Science
摘要: Recently marketed glass vessels that are uniform and pass USP specifications were compared with plastic also specifications. Two lots of prednisone tablets, Tablet 1 2, tested in both types vessels. gave higher results (+12.7% label claim) at 50 rpm but equivalent either vessel 75 rpm. 2 (+22% The type used to obtain dissolution for tablets should be specified.
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sci-hub.se 参考文章(8)
Don C. Cox, William B. Furman, Collaborative study of the USP dissolution test for prednisone tablets with Apparatus 2. Journal of Pharmaceutical Sciences. ,vol. 73, pp. 670- 676 ,(1984) , 10.1002/JPS.2600730520
Don C. Cox, William B. Furman, Larry K. Thornton, Terry W. Moore, Everett H. Jefferson, Systematic Error Associated with Apparatus 2 of the USP Dissolution Test III: Limitations of Calibrators and the USP Suitability Test Journal of Pharmaceutical Sciences. ,vol. 72, pp. 910- 913 ,(1983) , 10.1002/JPS.2600720817
ROBERT A. HATCHER, THE UNITED STATES PHARMACOPEIA. Journal of the American Medical Association. ,vol. L, pp. 30- 34 ,(1908) , 10.1001/JAMA.1908.25310270030002F
Don C. Cox, Clyde E. Wells, William B. Furman, Thomas S. Savage, Alfred C. King, Systematic Error Associated with Apparatus 2 of the USP Dissolution Test II: Effects of Deviations in Vessel Curvature from That of a Sphere Journal of Pharmaceutical Sciences. ,vol. 71, pp. 395- 399 ,(1982) , 10.1002/JPS.2600710405
Don C. Cox, William B. Furman, Donald P. Page, Systematic Error Associated with Apparatus 2 of the USP Dissolution Test IV: Effect of Air Dissolved in the Dissolution Medium Journal of Pharmaceutical Sciences. ,vol. 72, pp. 1061- 1064 ,(1983) , 10.1002/JPS.2600720923
Don C. Cox, William B. Furman, Systematic error associated with apparatus 2 of the USP dissolution test I: Effects of physical alignment of the dissolution apparatus. Journal of Pharmaceutical Sciences. ,vol. 71, pp. 451- 452 ,(1982) , 10.1002/JPS.2600710419
Ashok C. Shah, Craig B. Peot, John F. Ochs, Design and Evaluation of a Rotating Filter—Stationary Basket In Vitro Dissolution Test Apparatus I: Fixed Fluid Volume System Journal of Pharmaceutical Sciences. ,vol. 62, pp. 671- 677 ,(1973) , 10.1002/JPS.2600620430
Albert Serino, Centering tool for dissolution vessels. Journal of Pharmaceutical Sciences. ,vol. 71, pp. 725- 725 ,(1982) , 10.1002/JPS.2600710635