RDC_166_2017_Anvisa-Ingles

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RDC 166/2017 – AnvisaII – from the residual standard deviation of the regression line;III – from the estimated noise resulting from the analysis of a proper number of blanksamples.Formula 3. Limit of quantification calculation.LQ = 10.σICWhere: IC is the calibration curve inclination, σ is the standard deviation and may beobtained in 3 ways:I – from the standard deviation of the intercept with Y-axis of at least 3 calibration curvesconstructed containing analyte concentration near the assumed limit of detection;II – from the residual standard deviation of the regression line;III – from the estimated noise resulting from the analysis of a proper number of blanksamples.ANNEX IIITable 1. Conditions for method robustness evaluationStability of analytical solutionsSample PreparationSpectrophotometryLiquid ChromatographyExtraction timeFilter compatibilityVariation of solution pHDifferent solvent batches or manufacturersVariation of mobile phase pHVariation of mobile phase compositionDifferent column batches or manufacturersTemperaturePágina 20 de 21This text does not replace the one(s) published in the Official Gazette Brazil. Translation for consultation. Translation not sworn.
RDC 166/2017 – AnvisaMobile phase flowGas ChromatographyOther analytical techniquesDifferent column batches or manufacturersTemperatureInert gas velocityVariations to be tested shall be assessedcritically, and their results shall be providedPágina 21 de 21This text does not replace the one(s) published in the Official Gazette Brazil. Translation for consultation. Translation not sworn.
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RDC_166_2017_Anvisa-Ingles

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