ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Excipients

(USP) Components of a finished medicinal drug product other than the active pharmaceutical ingredient (API). They are included in the formulation to facilitate manufacture, enhance stability, control release of API from the product, assist in product identification, or enhance other product characteristics.

Publication Source: ISPE Baseline® Guide, Vol. 7: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)

Publication Date: 2010

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