" /> Pharmaceutical Excipient - CISMeF





Preferred Label : Pharmaceutical Excipient;

NCIt synonyms : Drug Excipient; Excipient;

NCIt related terms : Inert Ingredient; Inactive Ingredient;

NCIt definition : Any intentionally added component of a finished pharmaceutical product other than the claimed therapeutic or diagnostic ingredient(s). The excipients are added to facilitate administration or manufacture, improve product delivery, promote the consistent release and bioavailability of the drug, enhance stability, assist in product identification, or enhance other product characteristics. Pharmaceutical excipients do not affect therapeutic effects of the preparation or suitable tests or assays. The term does not apply to macromolecular compounds like albumin, or compounds like amino acids and sugars that are used in biological products, nor does it apply to process or product-related impurities (e.g. degradation products, residual solvents), or extraneous contaminants.;

Alternative definition : PQCMC: An ingredient that is added for a purpose other than the intended pharmacological action.; CDISC: Any component of a study product other than an active ingredient. (After FDA 21 CFR 210.3(b)(8));

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04/05/2025


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