Definitions


16. analyte A specific chemical entity being quantified or otherwise determined, which can be an intact drug, biomolecule or its derivative, metabolite and/or degradation product in a biological matrix.


17. analyte fortification Addition of the compound of interest to the biological matrix for preparation of calibration standard or quality control samples (QCs). A common informal term is ‘spiking’.


18. analytical procedure The sequence of steps necessary to perform a complete analysis described in adequate detail to permit the procedure to be reliably and reproducibly performed by someone knowledgeable in the field. Also see ‘Method’.


19. analytical range The range of concentration, or other similar measurement of abundance, of analyte in a given matrix over which the method is applicable without modification.


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