LCGC-11-01-2020 | LCGC North America

Validation of Stability-Indicating HPLC Methods for Pharmaceuticals: Overview, Methodologies, and Case Studies

November 01, 2020

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This installment is the third in a series of three articles on stability testing of small-molecule pharmaceuticals. This article provides a comprehensive and updated overview of the validation of stability-indicating methods for drug substances and drug products, and addresses regulatory requirements, validation parameters, methodologies, acceptance criteria, trends, and software tools. Examples of generic protocols, reporting templates, and data summaries are included as supplemental reference resources.