Sources of variation during collaborative evaluation of in vitro dissolution tests for two solid preparations

Author:

Cartwright A C1

Affiliation:

1. British Pharmacopoeia Commission Laboratory, Government Buildings Block 2, Honeypot Lane, Stanmore, Middlesex

Abstract

Abstract Collaborative in vitro dissolution tests on a sample of commercial tolbutamide tablets and a sample of oxytetracycline capsules were carried out in eight laboratories. The two preparations tested showed differences between the products in release characteristics, particularly in the disintegration phase. This may have caused the difference in the pattern of variance in the two trials. In the case of tolbutamide tablets the value of the repeatability standard deviation was small, and therefore the major contribution to the variance was in the difference between laboratories. With oxytetracycline capsules the major contribution to the variance lies in the random errors common to all laboratories (i.e. the within-laboratory variance). One major source of inter-laboratory variance was identified as the level of vibration at the side of the dissolution flask. Another source of variation was found to be due to using a stated extinction coefficient instead of comparing the absorbances of the samples to those of a solution of a reference substance.

Publisher

Oxford University Press (OUP)

Subject

Pharmaceutical Science,Pharmacology

Reference10 articles.

Cited by 2 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

1. Factors That Influence Dissolution Testing;Drugs and the Pharmaceutical Sciences;1991-09-25

2. A collaborative in vitro dissolution study using the flow-through method;International Journal of Pharmaceutics;1987-07

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