Statistical properties of the USP dissolution test with pooled samples
Related Experiment Video
Updated: Aug 14, 2026

A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients
Published on: August 9, 2022
Carlos D Saccone1, Nora S Meneces, Julio Tessore
1University of the Republic of Uruguay, School of Engineering, Industrial Production Department, Montevideo. csaccone@fing.edu.uy
Abstract:
The Montecarlo simulation method is used to study the statistical properties of the USP pooled dissolution test. In this paper, the statistical behavior of the dissolution test for pooled samples is studied, including: a) the operating characteristic curve showing the probability of passing the test versus the mean amount dissolved, b) the influence of measurement uncertainty on the result of the test, c) an analysis of the dependence of the statistical behavior on the underlying distribution of the individual amounts dissolved, d) a comparison of the statistical behavior of the unit dissolution test versus the pooled dissolution test, e) the average number of stages needed to reach a decision presented as a function of parameters of the lot, f) the relative influence of the three stages of the test on the probability of acceptance.
Related Concept Videos
Drug Dissolution: Requirements and Profile Comparison
In Vitro Drug Dissolution: Compendial Testing Models II
In Vitro Drug Dissolution: Compendial Testing Models I
In Vitro Drug Dissolution: Alternative Methods
Bioequivalence Data: Statistical Interpretation
Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism
Some polymorphic crystals possess lower aqueous solubility than their amorphous counterparts, leading to incomplete absorption. For instance, the oral suspension of Chloramphenicol, which...
