Validation of dissolution testing: evaluation of vibration levels of dissolution apparatuses

N. Kaniwa, N. Katori, N. Aoyagi, S. Kojima, N. Ishigame, Y. Seta, T. Shinba, K. Fujiwara, T. Nakai, Y. Oda

Research output: Contribution to journalArticlepeer-review

Abstract

The collaborative study participated by seven laboratories was carried out to develop a dissolution standard for evaluating vibration levels of dissolution apparatuses using enteric-coated granules of cefalexin (EG). Dissolution apparatuses could be divided into two groups according to their vibration levels and the dissolution test results of EG by the rotating basket method at 50 rpm. The critical value of acceleration was about 0.05 m/s2. The upper limit of normal dissolution rates of EG was calculated from the results of the rotating basket method at 50 rpm obtained from low vibration apparatuses. All high vibration apparatuses used in this study were distinguished by the limit from low vibration apparatuses, although most of them were not distinguished by current USP calibrators. These results suggest that EG would be useful as a calibrator for detection of apparatuses on high vibration levels.

Original languageEnglish
Pages (from-to)189-191
Number of pages3
JournalKokuritsu Iyakuhin Shokuhin Eisei Kenkyūjo hōkoku = Bulletin of National Institute of Health Sciences
Issue number116
Publication statusPublished - 1998

All Science Journal Classification (ASJC) codes

  • Medicine(all)

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