Statistical properties of the dissolution test of USP

Abstract

The Monte Carlo simulation method is used to study statistical properties of the USP dissolution test. Some interesting aspects of immediate release dissolution are presented, including: a. A unified operating curve that allows estimation of the probability of acceptance (Pa) of a lot as a function of its statistical parameters. b. Verification that the statistical behavior is only slightly affected by the underlying distribution of the individual amounts dissolved. c. The average number of samples required to reach a decision is presented as a function of parameters of the lot. d. The relative influence of the three stages of the test in the probability of acceptance.