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Limit of Detection (LOD) and Limit of Quantitation (LOQ)

The LOD was estimated as 3× the signal-to-noise ratio (S/N) and the LOQ as 10× the S/N. The

system baseline noise for the LOD and LOQ was determined by measuring peak-to-peak noise

between 6.5 and 7.0 min over five injections of a prepared sample. The estimated LOD and LOQ

for Chloride were 0.001 and 0.0034 mg/L respectively.

Summary

The accuracy data for Chloride met the criteria specified in the SMPR for some samples. The

%reproducibility RSD mentioned in SMPR is >4%. For some SPIFAN kit products, %

reproducibility RSD for Chloride is found to be <4% (in 4-6% range). The limit of quantitation

was estimated to be 0.003 mg/L. The limit of detection was estimated to be 0.001 mg/L.

Acceptable linearity was demonstrated over a range of 50 to 1000 mg/L.

This method is found to be suitable for the analysis of Chloride in infant formula and adult

nutritional formulas.

Chlor-03 SLV

FOR ERP USE ONLY

DO NOT DISTRIBUTE