MCPD-02 Reviewer Forms (July 19, 2018)

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Reviewer 5

Cons/Weaknesses • The hydrolysis step takes 15-18 hours, which may be an issue for maintaining production schedules. • Requires a separate analysis for the determination of a transformation factor for every matrix.

Supporting Data • General Comment:

- Method Optimization:

• Performance Characteristics:

Analytical Range: Varies between analytes but are sufficient to ensure that all formula samples could be analyzed without dilution.

LOQ: In powdered formula: Bound 2-MCPD- 10 ug/kg, Bound 3-MCPD- 10 ug/kg, Bound Glycidol- 10 ug/kg, 2-MCPD- 5 ug/kg, 3-MCPD- 5 ug/kg In liquid formula: Bound 2-MCPD- 2 ug/kg, Bound 3-MCPD- 2 ug/kg, Bound Glycidol- 2 ug/kg, 2-MCPD- 1 ug/kg, 3-MCPD- 1 ug/kg

Accuracy/Recovery: Spike recoveries averaged 93-107%

Precision (RSD r

): 1.2 – 12%

Reproducibility (RSD R

): Not reported, but likely not more than 2.4 - 24% based on the RSD r .

• System suitability: Recoveries, reproducibilities, inter-day performance, and time of use performance verifications all appear to be determined appropriately and are all within acceptable ranges.

Recommendation: Approve

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