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Silliker

Chem, Res. Center Crete, IL – Report of A Validation of LC-MS/MS Method for Folate Analysis

31

Table 22: 5-formyl-THF analysis in BCR 485 (dried vegetable powder) over a period of about 3

months

5-CHO-THF

Results

09/11/12

09/14/12

09/18/12

10/19/12

10/26/12

11/02/12

mcg/g

Mean

0.063

0.070

0.073

0.065

0.059

0.071

%RSD

10.6%

51.1%

12.1%

2.9%

18.7%

12.2%

N =

3

3

3

3

3

3

5-CHO-THF

Results

11/07/12

11/13/12

12/27/12

Grand

Grand SD

mcg/g

Mean

0.075

0.052

0.054

0.063

0.010

%RSD

5.2%

13.0%

3.2%

15.6%

N =

3

3

6

25

25

There is no value provided for 5-formyl-THF for this sample by BCR

Total folate as folic acid results obtained for the BCR 485 (dried vegetable powder) by the method

over a period of about 3 months are presented in Table 29. The results obtained were quite

consistent over period of analysis. Values obtained for total folate as folic acid was about 96% of

the lowest range specified for this reference material. Interday as well as intraday precision of the

method over a period of about 3 months was found to be satisfactory.

Table 23: Total folate as folic analysis in BCR 485 (dried vegetable powder) over a period of

about 3 months

Vitamers sum as Folic

09/11/12 09/14/12 09/18/12 09/21/12 10/10/12 10/12/12 10/19/12

mcg/g

Mean

2.312

2.465

2.208

2.494

3.018

3.333

2.931

%RSD

3.5%

2.3%

1.0%

3.5%

2.2%

8.0%

1.9%

N =

3

3

3

3

3

3

3

Vitamers sum as Folic

10/26/12 11/02/12 11/07/12 11/13/12 12/27/12 Grand

Grand

SD

mcg/g

Mean

2.922

3.195

2.654

2.422

2.716

2.710

0.339

%RSD

0.1%

2.3%

2.4%

0.6%

3.0%

12.5%

N =

3

2

3

3

6

38

38

Certified Total Folate

Value*

3.15 + 0.28

*BCR Certified Total Folate value as folic acid obtained by microbiological assay (L. rhamnosus)

Method Accuracy Evaluation Repeated:

The method accuracy was repeated again recently (API 5500 from ABSciex). The results are presented

in the following Table. The results of this investigation again help in establishing the accuracy of the

method.

2011.06 (Fol-22) w/SLV

FOR ERP USE ONLY

DO NOT DISTRIBUTE