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FOR EXPERT REVIEW PANEL USE ONLY
NOT FOR DISTRIBUTION
3
Precision (RSD
r
): 1.5 – 3.0 %
SMPR requirements: 0.1 – 1 mcg/100g ≤ 8 %
˃1.0 mcg/100g ≤ 5 %
All fortified and unfortified SPIFAN matrices were freshly prepared and analyzed in duplicate on six days.
All SPIFAN matrices meet repeatability requirements.
Sample
Replicates
(duplicates on 6 days)
Concentration level
(mcg/100g reconstituted)
RSD
r
SRM 1849
a
12
22.4
1.5
Infant formula powder partially
hydrolyzed milk based
12
4.07
0.5
Infant formula powder partially
hydrolyzed soy based
12
4.43
0.5
Toddler formula powder milk
based
12
10.7
1.9
Infant formula powder milk
based
12
2.90
2.5
Adult nutritional powder low fat
12
31.9
0.7
Child formula powder
12
21.6
1.2
Infant elemental powder
12
10.7
1.9
Infant formula powder FOS/GOS
based
12
1.66
2.6
Infant formula powder soy based 12
5.15
3.0
Infant formula RTF milk based
12
3.86
1.7
Adult nutritional RTF high protein 12
56.8
1.0
Adult nutritional RTF high fat
12
76.2
0.6
Reproducibility (RSD
R
): ---
SMPR requirements: 0.1 – 1 mcg/100g ≤ 16 %
˃1.0 mcg/100g ≤ 12 %
System suitability:
Certified value of NIST 1849a is 1.99 ± 0.13 mg/kg biotin.
.
During each analytical run were injected 7 standards with biotin concentrations ranging from 5 to 100
ng/ml before and after each sample set.
The method demonstrated good polynomial regression (cubic) fit, over a standard range of 5-100 ng/ml
biotin with r
2
greater than 0.999. The calibration error for the lowest 2 levels (near LOQ level) is around
25% and 10% respectively. The calibration error for the rest levels is less than 8%.
Recommendation:
This method is suitable to proceed to First Action Status.
Bio-03 Review Forms