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Single Laboratory Validation Report for Total Amino Acids by UHPLC-UV in Infant Formulas and Adult Nutritionals
Jaudzems, Lahrichi, and Fuerer
–
January 2017
page 15/20
Tyr
Val
From the correlation coefficient R
2
of the regression lines (> 0.99), the standard deviation of
the residuals, and the graphs of the residuals, we conclude that the calibration curves are
linear between
(0.25 and 10) pmol/μL for Cys2 and (
0.25 and 50) pmol/µL for all other amino
acids.
4.3
Limit of quantification
The scope of this method implies working at effective concentrations higher than the LoQ
stipulated in the SMPR. Therefore, the LoQ for the different amino acids were set to the
lowest point of their linearity ranges (see point
4.2 above). This is equivalent to 0.25 pmol per
injection (1 µL) for all amino acids studied.
Using an average molecular weight of 110 g/mol and a sample mass of 200 mg
(reconstituted powder),
0.25 pmol/μL (derivatized sample) corresponds to 2.5 mg/100 g in
the reconstituted sample according to the following three equations:
Equation 1: concentration of analyte in the hydrolysate (4 and 10 are the dilutions occurring
during the neutralization and derivatization steps, respectively).
Equation 2: amount of analyte in the sample
Equation 3: amount of analyte in 100 g of reconstituted powder
AMINO-01 (FEBRUARY 2017)
SLV REPORT
FOR ERP USE ONLY
DO NOT DISTRIBUTE