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

研究成果: Contribution to journalArticle査読

抄録

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.

本文言語英語
ページ(範囲)189-191
ページ数3
ジャーナルKokuritsu Iyakuhin Shokuhin Eisei Kenkyūjo hōkoku = Bulletin of National Institute of Health Sciences
116
出版ステータス出版済み - 1998

All Science Journal Classification (ASJC) codes

  • 医学(全般)

フィンガープリント

「Validation of dissolution testing: evaluation of vibration levels of dissolution apparatuses」の研究トピックを掘り下げます。これらがまとまってユニークなフィンガープリントを構成します。

引用スタイル