Assay for content

Assays for content of constituents of known therapeutic activity where these are not yet known with certainty, assays of marker substances must be used. All of these methods must be fully validated, using standard and accepted protocols for analytical method validation. 

Assay for content. The following characteristics are recommended for LC assay validation accuracy, precision, specificity, linearity, and range. The quantitation limit (QL) is assessed for analytes having responses near the QL. Specificity is evaluated as discussed for ID tests. 

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