6. AOACSPIFANMethods-2018Awards

140

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Figure 2011.10D. Typical standard chromatogram.

acceptable since repeatability only exceeded the requirement by 1–2%, and all of the products that exceeded the reproducibility requirement except one were near or below the minimum SMPR reproducibility level of 0.3 µg/100 g RTF liquid. Several laboratories provided comments about the method. Some laboratories noted that they did not always know how much vitamin B 12 was in the samples that they were testing, so it was hard to know how much filtrate to load onto the solid-phase extraction cartridge. Some laboratories had safety concerns about working with potassium cyanide, and another laboratory asked for a procedure to check SPE cartridge efficiency and vitamin B 12 recovery. To address these concerns, a safety section and an SPE cartridge qualification procedure were added to the Final Action method.

Conclusions

AOAC Method 2011.10 was collaboratively studied by nine to 11 laboratories from eight different countries with a variety of infant, pediatric, and adult matrixes. Per the AOAC ERP, the method demonstrated acceptable repeatability and reproducibility and met the SPIFAN SMPR for the majority of product matrixes analyzed. Although repeatability and reproducibility for some product matrixes exceeded the requirements in SMPR 2011.005, it was the majority opinion of the ERP that these results were acceptable since repeatability only exceeded the requirement by 1–2%, and all of the products that exceeded the reproducibility requirement except one were near or below the minimum SMPR reproducibility level of 0.3 µg/100 g RTF liquid.

Figure 2011.10E. Typical sample chromatogram.