This article reviews sources of excipient variability, including raw materials and processing, both of which may vary from supplier to supplier and from plant to plant for a single manufacturer.

Understanding Concomitant Components in Pharmaceutical Excipients

Jennifer Putnam;Katherine L. Ullman;Priscilla Zawislak;David Schoneker;George Collins;Douglas G. Muse;Brian Carlin;Joseph Zeleznik;R. Christian Moreton

February 3rd 2021

Viewpoint: Continued dialogue among pharma stakeholders is needed to achieve consensus regarding excipient composition.

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