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Method Validation Report

Version

1

Page

44 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 45: Accuracy of Pyridoxine in Partially hydrolyzed protein infant formula powder

Over

Spike

Replicates

Pyridoxine (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 1 345.64

Mean

Replicate 2 374.40

363.20

Replicate 3 369.56

50%

Replicate 1

528.44

547.17

183.97

96.58

Y

Replicate 2

531.42

547.17

183.97

97.12

Y

Replicate 3

527.68

547.17

183.97

96.44

Y

100%

Replicate 1

741.57

731.15

367.94

101.43

Y

Replicate 2

699.42

731.15

367.94

95.66

Y

Replicate 3

714.15

731.15

367.94

97.68

Y

Acceptance Criteria: All individual recovery results should be within 90 % to 110 %.

BVIT-01 (SLV)

FOR ERP/WORKING GROUP USE ONLY

DO NOT DISTRIBUTE

Page 57