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FOR EXPERT REVIEW PANEL USE ONLY

NOT FOR DISTRIBUTION

3

LOQ:

stated as 2 mg/100 g but how this number was calculated is not clear. SPMR sets LOQ at 0.4

mg/100g so the specifications are not met

Accuracy/Recovery:

Accuracy is validated by analyzing SRM 1849a. All recoveries for this sample met SMPR

Precision (RSD

r

):

Repeatability for all amino acids except for Tyrosine (2.6 % >2.0% requirement) met SMPR.

Tryptophan repeatability is not listed

Reproducibility (RSD

R

):

Reproducibility listed meets specifications for most amino acids though

how reproducibility was calculated is not clear since all data seem to belong to a single laboratory.

System suitability:

not stated

Recommendation:

The method uses common methodology that should be well suited for analysis of total amino acids but

more data are needed to fully evaluate the method against SMPR. It is recommended that all SPIFAN

matrices were analyzed using this method. In addition the following questions need to be addressed:

-

Describe clearly the validation study and the results

-

Clarify the information on analytical range and LOQ

-

Provide information on back-calculated errors for standards

-

Add information on check samples and check standards to system suitability section

- Increase the number of calibrators to 6 for all amino acids

- It is not necessary to include all chromatograms and full data reports for each sample and standard.

Several representative chromatograms and summary of the results would be sufficient

Decision on recommending this method as AOAC First Action is better made after data for more SPIFAN

matrices are collected.

Amino-03 Review Forms