The Product Quality Research Institute elemental impurity interlaboratory study: Results and implications for industry

The Product Quality Research Institute elemental impurity interlaboratory study: Results and implications for industry

Introduction: Pharmaceutical laboratories experienced a paradigm shift in drug product elemental impurity (EI) expectations in International Council on Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline Q3D and United States Pharmacopeia (USP) General Chapters...

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Bibliographic Details
Main Authors: James M. Harrington, Donna S. Seibert, Glenn Williams, Thanh Nguyen, Denise McClenathan, Stephen W. Erickson
Format: Article
Language:English
Published: Elsevier 2025-06-01
Series:Journal of Trace Elements and Minerals
Subjects:
Elemental impurities
Method development
Interlaboratory study
USP 232/233
ICH Q3D
Online Access:http://www.sciencedirect.com/science/article/pii/S2773050625000187
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