AOAC SPIFAN Review Team Meeting Book-July 22, 2015

B-VIT-01 FOR ERP/WORKING GROUP USE ONLY DO NOT DISTRIBUTE

Simultaneous Determination of Thiamine HCl, Riboflavin, Niacin (Nicotinic Acid and Nicotinamide), Pantothenic acid, Vitamin B6 (Pyridoxine, Pyridoxal and Pyridoxamine) and Biotin in Infant Formula and Adult Nutritionals

CONFIDENTIAL METHOD FOR ERP ASSESSMENT ONLY

98%) (C8D3H9N2O2.2HCl) Isotope Biotin (chemical purity 97%) (6,6-D2, 98%) (C10D2H14N2O3S) Thiamine Hydrochloride (Vitamin B1 ) (C12H17ClN4OS-HCl) Riboflavin (Vitamin B2) (C17H2ON4O6) Calcium pantothenate (C18H32CaN2O10) Pyridoxine hydrochloride (C8H11NO3. HCl) Pyridoxal hydrochloride (C8H9NO3.HCl) Pyridoxamine dihidrochloride (C8H12N2O2. 2HCl) Biotin (C10H16N2O3S) Deionized water (DI) Resistivity ≥ 18.2 M  75 mM Formic acid-20% MeOH mixture solution Nicotinamide (C6H6N2O), USP Nicotinic acid (C6H5NO2) Thiamine Cl (Vitamin B1) stock internal standard solution Riboflavin (Vitamin B2) stock internal standard solution Nicotinamide stock internal standard solution Nicotinic acid stock internal standard solution Pantothenic acid stock internal standard 1 N HCl 50 mM HCl 1 % Formic acid

contamination

16

97%

N/A

CIL

Until exhausted or evidence of contamination See remark below See remark below See remark below See remark below See remark below See remark below as per COA

Room temp away from

light and moisture

17

99.8%

N/A

USP

2-8  C

18

100 %

N/A

USP

2-8  C

19

99.9%

N/A

USP

2-8  C

20

99.8%

N/A

USP

2-8  C

21

99%

N/A

USP

2-8  C

22

99.5%

N/A

USP

2-8  C

23

N/A

Sigma- Aldrich Sigma- Aldrich

-20 to-30  C

≥ 99 %

24

N/A

as per COA

-20 to-30  C

≥ 98 %

25

99.3%

N/A

USP

See remark below

2-8  C

26

Fresh

27

1

1 year

Room temperature Room temperature Room temperature Room temperature

28

2

1 year

29

3

1 year

30

4

1 year

31

20 mcg/ml

5

Until exhausted or evidence of contamination Until exhausted or evidence of contamination Until exhausted or evidence of contamination Until exhausted or evidence of contamination Until exhausted or

2-8  C

32

20 mcg/ml

6

2-8  C

33

270 mcg/ml

7

2-8  C

34

25 mcg/ml

8

2-8  C

35

30 mcg/ml

9

2-8  C

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