510 / 620
Table 3
Product
SPIFAN Code Analyte
Nr. replicates (n)
Conc. Level
(mcg/100g)
RSDr
RSD iR
Conc. Level
(mcg/100g)
RSDr
RSD iR
Child Formula Powder Lot#00847RF00 Thiamine
12
< LOQ
X
≤ Z % ≤ W %
(duplicate on
ND
Analyte 1: Thiamine
20-2000
5
10
each 6 days)
< LOQ
Analyte 2: Riboflavin
30-4000
5
10
ND
Analyte 3: Niacin
200-10000
5
10
< LOQ
Analyte 4: Pantothenic acid 50-2300
5
15
ND
Analyte 5: B6 (as Pyridoxine) Oct-00
5
10
ND
Analyte 6: Biotin
0.1-1
8
16
ND
Analyte 1
ND
Analyte 2
ND
Analyte 3
< LOQ
Analyte 4
< LOQ
Analyte 5
Global Mean % #DIV/0! #DIV/0!
Analyte 6: Biotin
> 1
6
12
Child Formula Powder Lot#00847RF00 Riboflavin
12
97.49
1.1
8.2
Analyte 1
(duplicate on
96.04
Analyte 2
each 6 days)
94.82
4.0
Analyte 3
89.66
Analyte 4
104.57
3.9
Analyte 5
98.94
Analyte 6
102.57
2.0
Analyte 1
99.77
Analyte 2
105.79
2.5
Analyte 3
109.53
Analyte 4
114.97
2.0
Analyte 5
118.31
Analyte 6
Global Mean % 2.6
8.2
Child Formula Powder Lot#00847RF00 Niacin
12
-Nicotinic acid (duplicate on
ND
each 6 days)
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
Global Mean % #DIV/0! #DIV/0!
Child Formula Powder Lot#00847RF00 -Nicotinamide
12
ND
(duplicate on
ND
each 6 days)
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
Global Mean % #DIV/0! #DIV/0!
Child Formula Powder Lot#00847RF00 Pantothenic acid
12
44.78
2.6
3.8
(duplicate on
46.49
each 6 days)
47.94
1.1
47.23
51.84
3.3
49.51
48.30
1.5
49.33
49.10
4.5
46.07
47.65
1.0
48.32
Global Mean % 2.3
3.8
Child Formula Powder Lot#00847RF00 Vitamin B6
-Pyridoxine
12
ND
(duplicate on
ND
each 6 days)
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
Global Mean % #DIV/0! #DIV/0!
Child Formula Powder Lot#00847RF00 -Pyridoxal
12
5.57
3.5
4.2
(duplicate on
5.85
each 6 days)
6.19
1.8
6.03
6.02
1.6
5.88
5.70
2.7
5.48
5.62
2.4
5.81
5.38
2.7
5.59
Global Mean % 2.5
4.2
Child Formula Powder Lot#00847RF00 -Pyridoxamine
12
1.64
7.9
6.0
(duplicate on
1.47
each 6 days)
1.77
2.1
1.83
1.78
5.2
1.66
1.81
7.9
1.62
1.79
5.3
1.66
1.70
1.4
1.74
Global Mean % 5.0
6.0
Child Formula Powder Lot#00847RF00 Biotin
12
ND
(duplicate on
ND
each 6 days)
ND
ND
ND
ND
ND
ND
Precision - repeatability.
REQUIREMENTS SMPR
SPIFAN ERP Checklist v1.0
BVit-01 - MEF FORM
FOR ERP USE ONLY
DO NOT DISTRIBUTE