quantitation limit
- Guideline or reference source
- ICHQ2 Validation of analytical procedures
- Definition
- 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.
- Broader Term
- validation parameters
- Related Term
- accuracy
- analytical procedure
- detection limit
- linearity
- precision
- range
- robustness
- specificity
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