Quantitation Limit
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Quantitation Limit

Quantitation Limit
The quantitation limit of an individual analytical procedure is the lowest amount of analyte in a sample which can be quantitatively determined with suitable precision and accuracy. The quantitation limit is a parameter of quantitative assays for low levels of compounds in sample matrices, and is used particularly for the determination of impurities and/or degradation
products.

Source: CPMP/ICH/381/95 - ICH Q2 (R1)

 
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