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3
LOQ:
•
The SMPR LoQ (0.1 mcg/100g reconstituted) is achieved at the lowest standard curve concentration
using the typical sample weight specified in the method for this concentration of analyte.
Accuracy/Recovery:
SMPR:
0.1
– 1 mcg/100g reconstituted: 80 - 120%
> 1 mcg/100g reconstituted: 90 – 110%
•
Spike and recovery: Four placebo samples (Child Formula, Infant Elemental, Adult RTF High Fat, IF Milk
RTF) were spiked at +50% and +150% of typical target, 3 days in duplicate, with recveries meeting the
SMPR requirements ranging from 95.2% – 100%. One fortified sample (Adult RTF High Protein) was
spiked similarly and showed recovery of 96.7% - 104%, also meeting the SMPR requirement. (Table 3)
•
SRM 1849a: the sample was analyzed on 6 different days; the results (range 196.5 – 200.0 mcg/100g as
is) were all well within the Certified Mass Fraction range (199 ± 13 mcg/100g as is). (Table 2)
Precision (RSD
r
):
SMPR:
0.2
– 1 mcg/100g reconstituted: ≤ 8%
> 1 mcg/100g reconstituted: ≤ 6%
Reproducibility (RSD
R
):
SMPR:
0.1
– 1 mcg/100g reconstituted: ≤ 16%
> 1 mcg/100g reconstituted: ≤ 12%
RSD
IR
was characterized by duplicate analysis of the 12 fortified SPIFAN samples across 6 days (2
analysts, 2 instruments). All values were below 3.2%. Although they were not calculated
individually, none of the within day precision values appeared to be greater than this value. The
method could likely meet the SMPR requirements if extended to MLT. (Table 4)
•
System suitability:
-
Not stated.
Recommendation:
Add system suitability and calculations. Although the entire SPIFAN set was not spiked, acceptable for
First Action status.
Bio-02 Review Forms