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A substance used (as in detecting or measuring a component, in preparing a product, or in developing photographs) because of its chemical or biological activity.
Publication Source: ISPE Good Practice Guide: Quality Laboratory Facilities
Publication Date: 2012
(ICH Q3A (R2)) A substance other than a starting material, intermediate, or solvent that is used in the manufacture of a new drug substance.
(ICH Q6A) A substance, other than a starting material or solvent, which is used in the manufacture of a new drug substance.
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