The USP performance verification test, part II: Collaborative study of USP's Lot P prednisone tablets

Pharmaceutical Research

Volumn 25, Issue 5, 2008, Pages 1110-1115

  Glasgow, Maria ^a   Dressman, Shawn ^a   Brown, William ^a   Foster, Thomas ^b   Schuber, Stefan ^a   Manning, Ronald G ^c   Wahab, Samir Z ^a   Williams, Roger L ^a   Hauck, Walter W ^a  

^a UNITED STATES PHARMACOPEIA   (United States)

^b UNIVERSITY OF KENTUCKY MEDICAL CENTER   (United States)

^c U S DEPARTMENT OF HEALTH AND HUMAN SERVICES   (United States)

Author keywords

Acceptance limits; Disintegration; Dissolution; Performance Verification Test; United States Pharmacopeia

Indexed keywords

PREDNISONE;

APPARATUS; ARTICLE; DRUG FORMULARY; DRUG SOLUBILITY; LABORATORY; METHODOLOGY; PRIORITY JOURNAL; STANDARD; TABLET; UNITED STATES;

ALGORITHMS; CHEMISTRY, PHARMACEUTICAL; PHARMACOPOEIAS AS TOPIC; PREDNISONE; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; SPECTROPHOTOMETRY, ULTRAVIOLET; TABLETS; UNITED STATES;

EID: 40949111218     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-007-9482-2     Document Type: Article

References (9)

1. G. Deng, A. J. Ashley, W. E. Brown, et al. The USP performance verification test, part I: USP Lot P Prednisone Tablets-quality attributes and experimental variables contributing to dissolution variance. DOI 10.1007/s11095-007-9498-7 (2008)
2. USP, USP 30-NF 25, Dissolution <711>, Apparatus Suitability Test, US Pharmacopeial Convention, Inc., Rockville, MD, 2006, p. 282.
3. ISO, Guide 43-1. Proficiency Testing by Interlaboratory Comparisons-Development and Operation of Proficiency Testing Schemes, 2nd ed., ISO, Geneva, Switzerland, 1997.
4. USP, USP 30-NF 25, Validation of Compendial Procedures <1225>. US Pharmacopeial Convention, Inc., Rockville, MD, 2006, pp. 680-683.
5. ICH, Q2 (R1) Validation of Analytical Procedures: Text and Methodology. www.ich.org/LOB/media/MEDIA417.pdf. Accessed June 28, 2007.
6. R. A. Johnson and D. W. Wichem, Applied Multivariate Statistical Analysis, fifth edition, Upper Saddle River, NJ: Prentice Hall, 2002.
7. W. W. Hauck, V. P. Shah, S. W. Shaw, and C. T. Ueda Reliability and reproducibility of vertical diffusion cells for determining release rates from semisolid dosage forms. Pharm. Res. 24:2018-2024 (2007).
8. ISO. Guide 5725. Accuracy (Trueness and Precision) of Measurement Methods and Results-Part 6: Use in Practice of Accuracy Values, ISO, Geneva, Switzerland, 1994.
9. W.W. Hauck, R.G. Manning, T.L. Cecil, W. Brown, and R.L. Williams. Proposed changed to acceptance criteria for dissolution performance verification testing. Pharm. Forum. 33:574-579 (2007).