Amino-01 (July 2018)

Single Laboratory Validation Report for Total Amino Acids by UHPLC-UV in Infant Formulas and Adult Nutritionals

From the table above (and Appendix H), >93% of the values are within the requirements and <7% outside. The last column is the average recovery value for each amino acid across all the SLV kit. Those values are between 92.5% and 106.9%. Finally, recoveries for Product 6 (NIST 1849A) were compared with the reference values from the certificate of analysis (CoA). In addition, recoveries were compared to SRM 1869 (CoA in the drafting phase).

Note: Only 7 laboratories were part of the data set for SRM 1849a, where 14 labs participated in SRM 1869. The high value for threonine observed with SRM 1849a was not seen with SRM 1869. This could be attributed to the methods used to evaluate 1849a. Chromatograms Example chromatograms for selected concentrations of the calibration curve and SPIFAN II SLV kit products are presented in Appendix I. Answers to the ERP comments (March 2017) The ERP made several comments and suggestions regarding this method during the mid-year AOAC meeting in March 2017. Answers to those questions are provided in this document and also detailed in Appendix J. Per ERP request, the working group on amino acids reconvened to review the SMPR and submitted a recommendation to the stakeholder panel for modifications. The data presented herein utilize the changes proposed by the working group. The stakeholder panel discuss this during the mid-year meeting in 2018. They requested additional review of the SMPR ranges once again. The WG held three telco’s over May-July. A draft SMPR is scheduled to be reviewed by the stakeholder panel during the 2018 annual meeting. The long discussions on acceptance levels is a testimony to the complexity of each amino acid.

Jaudzems, Guthrie, Lahrichi, and Fuerer – January 2018

page 20/22