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Method Validation Report
Version
1
Page
47 of 49
Document Title
Validation Report for the Determination of Thiamin HCl, Riboflavin, Niacin
(Nicotinic Acid and Nicotinamide), Pantothenic acid, Vitamin B6
(Pyridoxine, Pyridoxal and Pyridoxamine) and Biotin in Infant Formula and
Adult Nutritionals by LC-MS/MS
Table 48: Accuracy of Biotin in Partially hydrolyzed protein infant formula powder
Over
Spike
Replicates
Biotin (mcg/100g)
Un-
spiked
Result
Spiked
Result
Resulting
Spiked
Conc
Theoretical
Spiked
Conc (C)
%
Recovery
Acceptable
(A)
(B)
(A+C)
B/(A+C)
Y/N
0%
Replicate 1 21.94
Mean
Replicate 2 22.72
22.51
Replicate 3 22.86
50%
Replicate 1
35.87
33.82
11.32
106.07
Y
Replicate 2
35.07
33.82
11.32
103.69
Y
Replicate 3
35.78
33.82
11.32
105.79
Y
100%
Replicate 1
47.37
45.14
22.63
104.96
Y
Replicate 2
46.98
45.14
22.63
104.08
Y
Replicate 3
47.43
45.14
22.63
105.08
Y
Acceptance Criteria: All individual recovery results should be within 90 % to 110 %.
IV. CONCLUSION
The results documented in this report confirmed that the acceptance criteria outlined in
SMPR were met.
BVIT-01 (SLV)
FOR ERP/WORKING GROUP USE ONLY
DO NOT DISTRIBUTE
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