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ERP Comments and Author Replies:

6.

A satisfactory recovery or the method performance at the LOQ level (0.2 mg/100g) need to be established.

LOQ calculated from S/N at 10% of WS1 standard

7.

The specificity of the carnitine analysis by the method may be further established by use of a confirmation transition in the analyzed matrices.

Added, but no

criterion set.

8

SRM 1849a carnitine value is based on the free carnitine analysis and may not establish accuracy of the total carnitine analysis by the method.

Actually it’s hard to say

whether it’s free or total: Certificate preparation paragraph is called “Total choline, Free Carnitine”, but NIST used MW digestion and averaged in with manufacturer

(Abbott uses total) and other collaborators (?)

1.

The authors need to provide data of the method performance (accuracy and inter-day precision) on analysis of the SPIFAN samples.

Done.

2.

The authors may explain discrepancy in the results between their method and the results generated using the AOAC 2012.17 method for “Adult Low Fat” sample.

Well below QL

3.

How this method will be applied to the Adult shake/adult nutritional samples so that the method precision is within the SMPR requirements. The current data

indicate a high % RSD for free carnitine in this matrix of the Abbott products.

Below QL

4.

Data for spike recovery at different concentration of the analytical range may be generated using SMPR matrices to make sure the method performs with in the

SMPR requirements in this respect.

Agreed -done

5.

Recovery of carnitine from Acetyl carnitine by the method may be evaluated to establish a satisfactory analysis of the method of the bound carnitine.

Agreed - done

Carn-05 MEF Form

FOR ERP USE ONLY

DO NOT DISTRIBUTE