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 …

Dissolution test as defined by USP is an important determination in assessing the quality of
different pharmaceutical forms. Some years ago, the pooled samples test was introduced …

Dissolution is one of the tests that is required and specified by the United States
Pharmacopeia and National Formulary (USP/NF) to ensure that the drug products meet the …

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 …

In pharmaceutical manufacturing, dissolution test for immediate-release dosage forms is
routinely performed to ensure the drug products conform to the quality standard specified in …

During development of solid dosage products, a pharmaceutical manufacturer is typically
required to propose dissolution acceptance criteria unless the product falls into …

Conclusion Bergum's method is very helpful for constructing acceptance limits and
determining the probability of passing multiple-stage USP tests such as the dissolution test …

To ensure that a drug product will meet standards for identity, strength and stability as
specified in the United States Pharmacopedia and National Formulary (USP/NF), it needs to …

Abstract The US Pharmacopoeia (USP) general monograph provides a standard for
dissolution compliance with the requirements as stated in the individual USP monograph for …

The US Pharmacopeia (USP) general monograph provides a standard for dissolution
compliance with the requirements as stated in the individual USP monograph for a tablet or …