Регуляторные исследования и экспертиза лекарственных средств (Feb 2018)

Assessing the impact of the automation on the variability of the «Dissolution» test results as exemplified by «Betahistine hydrochloride tablets 16 mg»

  • G. F. Vasilenko,
  • N. S. Dubovik,
  • I. E. Shohin,
  • G. N. Gildeeva,
  • G. V. Ramenskaya,
  • L. A. Pavlova

Journal volume & issue
Vol. 0, no. 3
pp. 53 – 57

Abstract

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The article analyses the results of dissolution testing of Betahistine hydrochloride 16 mg tablets using both manual and automatic sampling. The analysis showed that the data obtained with manual sampling are statistically identical to those obtained with automatic sampling in terms of average values and variance (with significance level α = 0,05), which confirms that the automation of the dissolution test does not affect the variability of test results.

Keywords