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FOR EXPERT REVIEW PANEL USE ONLY

NOT FOR DISTRIBUTION

3

Performance Characteristics

-

Does the method meet the SMPR for the following:

Analytical Range:

Analytical range is: 195-10000 mcg/100 g (complies with SMPR)

LOQ: 195 mcg /100 g

Accuracy/Recovery:

Spike: Recovery on 1 matrix (n=3) . Average recovery 99.5 % for both compounds

Analysis of reference sample (NIST SRM 1849a): 99.1 % recovey (n=4)

Precision (RSD

r

):

< 5 % for all samples except hydrolysed products, which is > 7 % for one day. Not enough data to

know if there is a problem with hydrolysed products.

Reproducibility (RSD

R

):

Not yet performed

System suitability:

Recommendation:

The reviewer recommends the method for First Action consideration after correction of small editorial

issues and clarifying the points discussed above. The possibility of including other B-vitamins should be

evaluated.