Abstract
Introduction The dissolution test as defined in the United States Pharmacopoeia (1) is used in judging the quality of pharmaceutical products. Dissolution testing is a method for evaluating physiological availability that depends upon having the drug in a dissolved state. The USP Dissolution testing involves three stages and the acceptance criteria are defined for each stage as a function of a quantity Q,a percentage of the label value that is established for each drug product in its monograph. Acceptance criteria are shown in Table 1. These acceptance criteria are complex and the behavior of the test for samples of varying quality levels is not easily predictable from the knowledge of its drug properties. Pharmaceutical manufacturers are interested in many of the statistical properties of the dissolution test. The following aspects of immediate release dissolution were studied:
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