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));