Microsoft Word - Candidates for 2018 ERP of the Year

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BPA-04 Revision Summary

We appreciate the thoughtful comments made by the ERP. Please see below for our responses to the comments and the summary of the changes in the revised report (highlighted in yellow).

Safety about ammonium fluoride

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We have added “In particular, prepare mobile phase A (1 mM ammonium fluoride in UPW) in a fume hood with appropriate personal protective equipment. Do not mix mobile phase A with an acidic solution. Flush the LC system with a 50:50 (v/v) water-acetonitrile mixture after using mobile phase A.” in the Safety section.

• LOQ calculation in matrices (as a minimum, in coffee matrix)

We have included the LOQ calculation by LOQ = blank mean + 10 standard deviations using the result obtained by 10 analysis of blank coffee drink samples. The LOQ was calculated to be 0.245 µg/L, which met the LOQ requirement of ≤ 0.5 µg/L in the SMPR.

Blank concentration

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We have addressed the reagent blank concentration in the System Suitability/Analytical Quality Control section. For the determination of the LOQ, the mean blank coffee drink concentration is provided in Table 5. It was < 10% of the estimated LOQ.

• Chromatograms for blanks, particularly coffee

The chromatograms for all ten matrices evaluated in this study, together with the corresponding LOQ level spikes, are shown in Appendix II.

Quality control standard preps

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The preparation of the quality control sample is described in step 2 of the Sample Preparation procedure.

Correction on typo re: balance

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The balance accuracy typo has been corrected.

Significant figures on sample amount

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The significant figures of sample amount have been corrected to reflect the pipet precision.

03/12/2018