Inside USP: Metrology and USP Dissolution - Pharmaceutical Technology

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Inside USP: Metrology and USP Dissolution
The United States Pharmacopeia emphasizes mechanical calibration and a performance test to esnure integrity of the dissolution procedure.

Pharmaceutical Technology
Volume 3, Issue 32

8. P. Nithyanandan et al., "Evaluation of the Sensitivity of USP Prednisone Tablets to Dissolved Gas in the Dissolution Medium Using USP Apparatus 2," Dissolution Technol. 13 (3), 15–18 (2006).

9. J. Eaton et al., "Perturbation Study of Dissolution Apparatus Variables—A Design of Experiment Approach," Dissolution Technol. 14 (1), 20–26 (2007).

10. M.R. Liddell et al., "Evaluation of Glass Dissolution Vessel Dimensions and Irregularities," Dissolution Technol. 14 (2),
28–33 (2007).

11. W.W. Hauck et al., "Proposed Change to Acceptance Criteria for Dissolution Performance Verification Testing," Pharm. Forum 33 (3), 574–579 (2007). Reprinted in: Dissolution Technol. 14 (3), 8–12 (2007).

12. W.W. Hauck et al., "Reliability and Reproducibility of Vertical Diffusion Cells for Determining Release Rates from Semisolid Dosage Forms," Pharm. Res. 24 (11), 2018–2024 (2007).

13. M. Liddell et al., "Dissolution Testing Variability: Effect of Using Vessels from Different Commercial Sources," Am. Pharm. Rev. 10 (6), 122–128 (2007).

14. R.G. Manning et al., "Dissolution Testing and Metrological Measurement of Quality for Solid Oral Dosage Forms," Pharm. Technol. 31 (5), 68–74 (2007).

15. G. Deng et al., "Frequency-domain Vibration Measurement and Analysis in Dissolution Testing," poster presented at the 2007 Annual AAPSMeeting (San Diego, CA).

16. International Bureau of Weights and Measures et al., International Vocabulary of Basic and General Terms in Metrology, Second Ed., ISO (Geneva, Switzerland, 1993), p. 47.

17. 21 USC 501(b). Federal Food, Drug, and Cosmetic Act.

18. ISO, Standard 5725 Accuracy (Trueness and Precision) of Measurement Methods and Results, Parts 1–6, ISO (Geneva, Switzerland, 1994).

19. FDA, "ORA Laboratory Procedure. Assuring the Quality of Test Results. ORA-Lab.5.9," 2007, available at http://www.fda. gov/ora/science_ref/lm/vol2/secion/5_09.pdf, accessed Jan. 29, 2008.

20. P. Nithyanandan et al., "Dissolution Variability: Comparison of Commercial Dosage Forms with US Pharmacopeia Lot P Prednisone Reference Standard Tablets," AAPS PharmSciTech., in press (2008).

21. Z. Gao et al., "Gauge Repeatability and Reproducibility for Accessing Variability during Dissolution Testing: A Technical Note," AAPS PharmSciTech. 8 (4), Art. 82 (2007).


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