AOAC SPIFAN Final Review Forms (March 16, 2016)

FOR EXPERT REVIEW PANEL USE ONLY

NOT FOR DISTRIBUTION

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Performance Characteristics:

Analytical Range:

Requirement for analytical range (0.50 – 300 µg/100 g) not met;

reported ranges

were 0.31 – 140 µg/100 g for folic acid, 1.6 – 140 µg/100 g for 5-MTHF

LOD:

Requirement for LOD (≤0.10 µg/100 g) not met

; reported values were 0.14 µg/100 g for folic

acid, 0.75 µg/100 g for 5-MTHF

LOQ: reported values were 0.31 µg/100 g for folic acid, 1.6 µg/100 g for 5-MTHF. This meets the

requirement in the SMPR for folic acid of ≤0.50 µg/100 g. There is no stated requirement for 5-

MTHF.

Accuracy/Recovery:

Requirement for recovery (90 – 110 %) for folic acid not met;

values reported

were 85 % for folic acid, 95 % for 5-MTHF

Precision (RSD

Requirement for repeatability precision (≤11 % or ≤7 %) not met;

repeatability

information is reported at 8 %, but unclear at what level and for what samples.

Reproducibility (RSD

): within lab reported as 6 %, which is within the limits in the SMPR.

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System suitability: not described

Recommendation: I do not recommend this method be moved forward to first action.

Fol-20 Review Forms