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Cleaning Validation Glossary

Limit of Quantitation

Lowest quantifiable amount

The limit of quantitation (LOQ) or quantitation limit is defined in ICH Q2(R2) Validation of Analytical Procedures as, "The lowest amount of analyte in a sample which can be quantiatively determined with suitable precision and accuracy. The quantitation limit for an anlytical procedure should not be more than the reporting threshold. The quantitation limits is a parameter used for quantitaive assays for low levels of compounds in sample matrices, and particularly is used for the determination of impurites and/or degradation products." For analytical method validation measurements considered quantifiable at this level must be demonstrated with precision, accuracy and linearity under experimental conditions.

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