Calculating the Probability of Passing the USP Dissolution Test
By Prasanth Sambaraju
Published in: Pharmaceutical On-Line
Published on: January 9, 2023
One of the reported methods to estimate the probability of passing the USP dissolution test uses Mathematica software for calculation. The goal of this article is to calculate the probability of passing the USP dissolution test from that method using Microsoft Excel.
Dissolution testing is performed to provide in vitro drug release information and to accurately predict the in vivo drug release. Dissolution tests are performed at different stages of the drug manufacturing process to ensure that the drug product meets the standards as specified in the United States Pharmacopoeia (USP). USP provides requirements for sampling, testing, and acceptance criteria for tests like content uniformity and dissolution.1,2 A manufacturing process is said to be in regulatory compliance only if it meets the acceptance criteria for all the tests specified in USP. To ensure there is a high probability of passing these tests, sponsors establish in-house specification limits to ensure there is a high probability of meeting these acceptance criteria. Different methods are reported in the literature to calculate the probability of passing the dissolution test.
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