The random vibration effects on dissolution testing with USP apparatus 2
โ Scribed by Zongming Gao; Terry W. Moore; Lucinda F. Buhse; William H. Doub
- Publisher
- John Wiley and Sons
- Year
- 2009
- Tongue
- English
- Weight
- 317 KB
- Volume
- 98
- Category
- Article
- ISSN
- 0022-3549
No coin nor oath required. For personal study only.
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Environmental vibration induced by laboratory equipment, building construction, or even by the analysts themselves is one of the more complicated factors affecting dissolution testing. It is difficult to control and/or calibrate by mechanical means or performance-based methods. In this study, dissol
In this study, gauge repeatability and reproducibility (gauge R&R) was used to analyze variability for USP apparatus 2 dissolution measurement systems. Experiments were designed to assess the variability due to apparatus, operator, and sample tablet. Since dissolution testing is a destructive test,
The authors thank Robert E. Graham for providing the degradation products and commercial samples. Laura M. Tuck lor her analytical work on the enema, and Stephen M. Walters for a constructive editorial review.