AOAC SPIFAN Nutrients ERP Reviewer Forms 9-20-16

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2
Cons/Weaknesses
• -----
Supporting Data
• General Comment:
- Method Optimization:
Performance Characteristics:
Analytical Range:
LOQ: ---
Accuracy/Recovery:
Precision (RSDr):
SMPR ≤ 7%
Repeatability ranged from 1.1 % to 6.5 %
Reproducibility (RSD R):
SMPR ≤ 11%
Reproducibility ranged from 6.0 % to 9.8 %
(Only one sample, the high fat matrix at 23.4 %)
The HorRat values are all below 1, from 0.17 to 0.78, indicating excellent method
performance
• System suitability:
Recommendation:
The method 2014.02 meets the requirements established, and is fit for purpose for the analysis of vitamin
B12 (cyanocobalamin) in infant formula and adult/pediatric nutritionals.
My recommendation is move this method to Final Action Status.