RDC_166_2017_Anvisa-Ingles

RDC 166/2017 – Anvisa
(1) If reproducibility was carried out, intermediate precision does not need to be carried out.
(2) In the identification test, combining one or more analytical procedures may be needed to reach the required level
of discrimination.
(3) It may be required in some cases.
ANNEX II
(Republicado no DOU nº 156, de 15 de agosto de 2017)
Formula 1. Accuracy calculation.
Experimental mean concentration
Recovery = x 100
Theoretical concentration
Or
CA (added sample) – CA (sample)
Recovery = x 100
CTA
Where: CA is the experimental concentration of analyte and CTA is the theoretical
concentration of analyte added.
Formula 2. Limit of detection calculation.
LD= 3.3.σ
IC
Where: IC is the calibration curve inclination, σ is the standard deviation and may be
obtained in 3 ways:
I – from the standard deviation of the intercept with Y-axis of at least 3 calibration curves
constructed containing analyte concentration near the assumed limit of detection;
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This text does not replace the one(s) published in the Official Gazette Brazil. Translation for consultation. Translation not sworn.