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.

The Real Complexity of Excipient Composition

R. Christian Moreton;David R. Schoneker;Brian Carlin;Phyllis Walsh;Linda A. Herzog;George Collins;Priscilla Zawislak;Joseph Zeleznik

October 2nd 2017

This article seeks to promote dialogue among stakeholders to facilitate consensus regarding requirements for excipients.

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