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Particle Size Limits to Pass the Acceptance Value (AV)-Based USP Content Uniformity Test for Tablets.

Authors
  • Lou, Hao1
  • Hageman, Michael J2
  • 1 Department of Pharmaceutical Chemistry, University of Kansas, Lawrence, KS 66047, USA; Biopharmaceutical Innovation and Optimization Center, University of Kansas, Lawrence, KS 66047, USA.
  • 2 Department of Pharmaceutical Chemistry, University of Kansas, Lawrence, KS 66047, USA; Biopharmaceutical Innovation and Optimization Center, University of Kansas, Lawrence, KS 66047, USA. Electronic address: [email protected]
Type
Published Article
Journal
Journal of Pharmaceutical Sciences
Publisher
Elsevier
Publication Date
Oct 01, 2021
Volume
110
Issue
10
Pages
3527–3534
Identifiers
DOI: 10.1016/j.xphs.2021.07.005
PMID: 34302841
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

The papers published by Yalkowsky et al. and Rohrs et al. offer a method to correlate the probability of passing USP content uniformity (CU) test with maximum allowed particle size and distribution. Their work also provides a guidance for setting the particle size specification especially for a low dose drug. However, their methods are developed based on the previous USP CU test and the up-to-date version of USP/NF (e.g., USP42/NF37) has adopted a new Acceptance Value (AV)-based CU criterion. In this study, using the same assumptions and conditions that are utilized in their papers, we develop a new method to calculate the upper limit of particle size that ensures the pass of the AV-based CU test at a given probability (e.g., 0.99). It turns out that, compared to the previous CU test (e.g., the CU test in USP28/NF23), to pass the AV-based CU test, similar but slightly smaller particle size is needed. Published by Elsevier Inc.

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