AOAC SPIFAN Final Review Forms (March 16, 2016)

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FOR EXPERT REVIEW PANEL USE ONLY
NOT FOR DISTRIBUTION
3
B3 SMPR: 90 – 110%
Validation report from 9/2015: Section 2 Table 4:
SRM 1849a: 99804 ppb niacinamide
CofA: 108 ± 10 mg/kg
4127 ppb nicotinic acid
Precision (RSDr):
B3 SMPR: RSDr: < 5%
Validation report from 9/2015: Section 2 Table 4, for SPIFAN 2 set: 4 of 4 samples met requirement
for RSDr for niacinamide (RSDr: range 1.5 – 2.2%) and nicotinic acid (RSDr: range 0.8 – 1.8%)
individually.
Reproducibility (RSDR):
 System suitability:
System suitability criteria are specified for calibration curve correlation coefficient, the number of
standards which may be excluded from a given analysis, and the residuals observed for the lowest
standards.
Recommendation:
The supplemental comparison data appears to show that methods BVit-01 (MJ) and BVit-02 (AN) produce
values which are in reasonable agreement, with the values from the latter perhaps slightly closer to
fortification levels. However, the lack of spike and recovery data leaves open the question of whether the
method completely recovers niacinamide and nicotinic acid. Without this data the method cannot be
recommended for First Action.
BVit-02 Review Forms