Dissolution Testing and Metrological Measurement of Quality for Solid Oral Dosage Forms - Pharmaceutical Technology

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Dissolution Testing and Metrological Measurement of Quality for Solid Oral Dosage Forms
USP applies metrological principles to the dissolution procedure alone and in collaborative studies to understand and minimize potential sources of variability.

Pharmaceutical Technology

16. USP, "The USP Performance Test: Mechanical Calibration vs. a Periodic Performance Verification Test with Reference Standard Tablets (Calibrators)" [and links therein]. Web page, 2006, accessed at http://www.usp.org/USPNF/notices/calibratorsPublicStatement.html on Mar. 26 2007.

17. 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).

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

19. M.R. Liddell et al., "Evaluation of Glass Dissolution Vessel Dimensions and Irregularities," Dissolution Technol. 14 (1) 28–33 (2007).

20. ISO, Guide 43: Proficiency Testing by Interlaboratory Comparisons. Parts 1–2. 2nd ed. (Geneva, Switzerland, ISO, 1997).

21. FDA, "Mechanical Qualification of Dissolution Apparatus 1 and 2" (2006) accessed at http:// http://www.fda.gov/cder/Offices/OTR/dissolution.pdf on Mar. 27 2007.

22. ASTM Committee E55 on Pharmaceutical Application of Process Analytical Technology and Subcommittee E55.03 on General Pharmaceutical Standards, Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus, (Work Item Number WK9936) (ASTM, West Conshohocken, PA, 2006).


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