436 / 670
Limit of Quantitation (LOQ)
The Limit of Quantitation for the analysis was determined through back calculation of the
lowest calibration standards of 10 ng/mL through the default weights and dilution factors.
A concentration of 0.05 mg/100g for carnitine and choline in both analyses can be
achieved. The LOQ required by the SMPR for total choline is 2.0 mJ J DQG
mg/100g for carnitine. The free and total analyses were both tested at these levels in the
elemental infant formula placebo to verify the method can quantitate at these levels with
precision and accuracy (Tables 10 and 11).
Table 10. LOQ Free Analysis
Choline
Day/
Fortification
Innate Marginal Recovery
MEAN
SD
RSD
r
Replicate (mg/100g)
(mg/100g)
(%)
(%)
(%)
(%)
1/1
1.5
0.118
89.9
93.9
5.7
6.1
1/2
1.5
0.118
97.9
2/1
1.5
0.118
94.8
92.8
2.9
3.1
2/2
1.5
0.118
90.7
3/1
1.5
0.118
100.0
100.2
0.2
0.2
3/2
1.5
0.118
100.3
MEAN
95.6
Overall RSD
r
3.9
Carnitine
Day/
Fortification
Innate Marginal Recovery
MEAN
SD
RSD
r
Replicate (mg/100g)
(mg/100g)
(%)
(%)
(%)
(%)
1/1
0.16
<LOQ
102.0
101.6
0.6
0.6
1/2
0.16
<LOQ
101.2
2/1
0.16
<LOQ
95.7
101.1
7.6
7.5
2/2
0.16
<LOQ
106.4
3/1
0.16
<LOQ
102.9
104.8
2.7
2.6
3/2
0.16
<LOQ
106.7
MEAN
102.5
Overall RSD
r
4.6
Chol-08/Carn-07 (February 2016)
FOR ERP USE ONLY
DO NOT DISTRIBUTE