ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Excipient

(ICH Q6B) An ingredient added intentionally to the drug substance which should not have pharmacological properties in the quantity used.

Publication Source:

See also: Pharmaceutical Excipients

Excipient

(ICH Q1A (R2)) Anything other than the drug substance in the dosage form.

Publication Source:

Excipient

An inactive ingredient used in the formulation of a drug product.

Publication Source: ISPE Baseline® Guide, Vol. 3: Sterile Product Manufacturing Facilities (Second Edition)

Publication Date: 2011

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